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Noted This Week - 2013 Archive
Archive of cancer-related news briefs, by week, for 2013
December 19, 2013
- The mortality rates for all cancers combined decreased by 1.8% per year among men and by 1.4% per year among women from 2001 to 2010, according to the Annual Report to the Nation on the Status of Cancer. Relatively sizeable drops in lung, colorectal, breast, and prostate cancer mortality accounted for two thirds of the overall reduction. Researchers from the National Cancer Institute, the American Cancer Society, the Centers for Disease Control and Prevention, and the North American Association of Central Cancer Registries coauthored the report.
- The U.S. Food and Drug Administration and the European Medicines Agency announced that they will share information on inspections of bioequivalence studies submitted in support of generic drug approvals. This collaborative effort provides a mechanism to conduct joint facility inspections for generic drug applications submitted to both agencies.
- Onconova Therapeutics of Newtown, PA, announced the discontinuation of its phase III ONTRAC study of intravenous rigosertib plus gemcitabine in first-line metastatic pancreatic cancer after a planned interim analysis determined that the combination was unlikely to demonstrate a statistically significant improvement in overall survival compared with gemcitabine alone.
- The success rate for competing research project grant (RPG) applications submitted to the NIH fell from 17.6% in fiscal year (FY) 2012 to 16.8% in FY2013, blogged Sally Rockey, PhD, the deputy director for Extramural Research at NIH. In FY2013, NIH received 49,581 RPG applications, of which 8,310 were awarded, compared with 51,313 applications and 9,032 in FY2012.
- The International Agency for Research on Cancer also released its latest data on cancer incidence, mortality, and prevalence worldwide. According to the agency's GLOBOCAN 2012, an estimated 14.1 million new cancer cases and 8.2 million cancer-related deaths occurred in 2012, compared with 12.7 million and 7.6 million, respectively, in 2008. It also estimates that the number of new cancer cases will rise to 19.3 million by 2025, with more than half occurring in less-developed countries.
Earlier This Year:
Noted This Week Archive
- In a phase II trial of Prophage Series G-200, a heat shock protein–based therapeutic vaccine made with individual patients' tumors, more than 90% of 41 patients with high-grade recurrent glioblastoma multiforme (GBM) were alive 6 months after surgery and 30% were alive at 12 months. The expected median overall survival for patients with recurrent GBM is 3 to 9 months, but patients in the trial had a median overall survival of 11 months.
- Despite disappointing results in trials of bevacizumab (Avastin;Genentech) and another angiogenesis inhibitor, ramucirumab, presented December 11 to 14 at the 2013 San Antonio Breast Cancer Symposium in Texas, "I still think there potentially is a role for antiangiogenesis, were we to find a predictive biomarker," said John R. Mackey, MD, a professor of oncology at the University of Alberta in Edmonton, Canada. Mackey presented results of a trial of ramucirumab, which did not significantly prolong progression-free survival in a phase III trial of women with inoperable recurrent or metastatic HER2-negative breast cancer.
December 12, 2013
- Chimeric antigen receptor T-cell therapy showed positive results in trials among 59 leukemia patients who had exhausted conventional treatment options, researchers from the University of Pennsylvania in Philadelphia and the Children's Hospital of Philadelphia reported at the American Society of Hematology annual meeting in New Orleans, LA. Among the results, two of the first three chronic lymphocytic leukemia patients in the study remain in remission after 3 years, with stable persistence of their reengineered cells. Additionally, an 89% complete response rate was demonstrated among adult and pediatric patients with acute lymphoblastic leukemia.
- A study of 3,864 postmenopausal women at increased risk for developing breast cancer showed that those given anastrozole (Arimidex; AstraZeneca) were 53% less likely to have developed breast cancer compared with those assigned to a placebo, after a median follow-up of 5 years. Women who took the aromatase inhibitor reported very few side effects in study results presented at the San Antonio Breast Cancer Symposium (SABCS) in San Antonio, TX, and published in The Lancet.
- Up to 18% of the lung cancers detected by low-dose computed tomography may not have progressed enough to become life-threatening if left undetected, according to an analysis of National Lung Cancer Screening Trial data published in JAMA Internal Medicine.
- In a phase II trial among 120 postmenopausal women with HR-positive, HER2-negative metastatic breast cancer, adding the BCR/ABL and Src family tyrosine kinase inhibitor dasatinib (Sprycel; Bristol-Myers Squibb) to standard therapy with letrozole increased median progression-free survival from 9.9 months to 20.1 months. The findings were reported at SABCS.
- The Novartis investigational compound LBH589 (panobinostat) in combination with bortezomib and dexamethasone met the primary endpoint of significantly extending progression-free survival in patients with relapsed multiple myeloma when compared with bortezomib plus dexamethasone alone in a phase III trial. Full results from the trial with the pan-deacetylase inhibitor will be presented at an upcoming medical congress, the company said.
- In female patients with type 2 diabetes, use of insulin sensitizers was associated with a 21% decreased cancer risk compared to use of insulin secretagogues, in a retrospective analysis of 25,613 diabetes patients published in Diabetes, Obesity and Metabolism.
December 5, 2013
- Juno Therapeutics, which will develop cancer immunotherapies based on T-cell reprogramming, was jointly launched by the Fred Hutchinson Cancer Research Center, Memorial Sloan-Kettering Cancer Center, and Seattle Children's Research Institute. Based in Seattle, WA, the startup initially raised $120 million for work to develop therapies based on chimeric antigen receptor and T-cell receptor technologies.
- Celgene of Summit, NJ, and OncoMed Pharmaceuticals of Redwood City, CA, will partner to develop and commercialize up to six of OncoMed's anti-cancer stem cell products. OncoMed will receive $$77.25 million up front, with potential payments totaling up to several billion dollars if various milestones are achieved. OncoMed's leading product candidate demcizumab (OMP-21M18), a monoclonal antibody that inhibits Delta-Like Ligand 4 in the Notch signaling pathway, is in three phase Ib clinical trials.
- The top 12 pharmaceutical companies have launched 105 products since 2010, with a projected value of $770 billion, according to a report from Deloitte and Thomson Reuters. This year the average cost of bringing drugs to market climbed to $1.3 billion, the report estimates.
- The European Medicines Agency's Committee for Medicinal Products for Human Use is recommending a two-dose schedule for giving GlaxoSmithKline's Cervarix human papillomavirus vaccine to 9-to-14-year-old girls. This schedule potentially could be easier to deliver than the standard three-dose schedule, expanding the population that could benefit from protection against cervical cancer.
- Cancer Research UK warned that proposed changes to European Union legislation on patient data protection could make it illegal to carry out certain clinical studies such as the UK Collaborative Trial of Ovarian Cancer Screening.
- A study of 75,000 Korean adolescents found that those using e-cigarettes were more likely to be trying to quit smoking, but were less likely to have done so, and were smoking more. "We are witnessing the beginning of a new phase of the nicotine epidemic and a new route to nicotine addiction for kids," said Stanton Glantz, PhD, professor of medicine at the University of California in San Francisco and senior author on a paper published in the Journal of Adolescent Health.
November 27, 2013
- India's Drug Controller General gave regulatory approval for a biosimilar of Genentech's Herceptin (trastuzumab) developed by Mylan of Pittsburgh, PA, and Biocon of Bangalore, India.
- The U.S. Food and Drug Administration (FDA) approved Nexavar (sorafenib; Bayer HealthCare Pharmaceuticals and Onyx Pharmaceuticals) for treatment of patients with metastatic differentiated thyroid cancer. Approval was based on a clinical study of 417 patients, in which those who received Nexavar showed a 41% increase in median progression-free survival compared with those given placebo. The drug, which inhibits the VEGF receptor and several other targets, was approved for advanced renal cancer in 2005 and for unresectable liver cancer in 2007.
- Additionally, the FDA granted regular approval for Xalkori (crizotinib; Pfizer) for treating patients with ALK-positive metastatic non–small cell lung cancer detected by an FDA-approved test. The ALK inhibitor had received accelerated approval in 2011.
- The Chinese Academy of Sciences' Shanghai Institute of Materia Medica and Crown Bioscience of Santa Clara, CA, agreed to build a mouse clinical trial center in Taicang, Jiangsu province, People's Republic of China. The center initially will focus on gathering and building the world's largest collection of patient-derived xenograft models, which will include liver, lung, gastric, and colorectal cancer models.
- The FDA granted its first marketing authorization for clinical use of a next-generation genomic sequencer. FDA head Margaret Hamburg, MD, and NIH director Francis Collins, MD, PhD, described the decision in a New England Journal of Medicine commentary
- The agency also warned 23andMe of Mountain View, CA, that its consumer-direct DNA kit is a medical device and needs clearance for marketing, especially for applications such as detecting BRCA mutations that might play a role in treatment decisions.
- Clovis Oncology of Boulder, CO, acquired Ethical Oncology Science of Milan, Italy, for its lucitanib, an oral inhibitor for FGF receptors 1 and 2 and VEGF receptors 1, 2, and 3. The purchase price is $200 million upfront plus other potential payments depending on achieving certain milestones. Clovis will partner with Servier of Suresnes, France, for global development of lucitanib.
- If graphic warning labels similar to Canada's were required on cigarette packs in the United States and led to similar drops in smoking rates, the number of U.S. smokers would drop by up to 8.6 million, according to findings published in Tobacco Control.
November 21, 2013
- Updated interim data from a phase Ib clinical trial showed that a cohort of 135 patients with advanced melanoma treated with Merck's MK-3475 investigational PD-1 inhibitor demonstrated an estimated overall survival rate of 81% after 1 year across all doses. The objective response rate across all doses, given as monotherapy, was 41% using RECIST criteria. The company plans to launch combination trials in melanoma and other cancers in the next few months.
- The European Commission approved Roche's Kadcyla antibody–drug conjugate for the treatment of adults with inoperable HER2-positive, locally advanced or metastatic breast cancer who have previously received Herceptin (trastuzumab; Genentech) and a taxane.
- Sanofi discontinued clinical development of its investigational JAK2 inhibitor fedratinib after recent reports of cases consistent with Wernicke's encephalopathy in clinical-trial participants with myeloproliferative neoplasms.
- Next year, the world market for prescription drugs will hit the $1 trillion mark, according to a report from the IMS Institute for Health Informatics in Parsippany, NJ. China will represent 34% of the growth in global medicine spending over the next 5 years, the IMS Institute predicts.
- U.S. children ages 9 to 18 who survived leukemia for 5 years or longer showed a 9% decrease in arterial health after chemotherapy compared with healthy siblings, according to research presented at the American Heart Association's Scientific Sessions 2013 in Dallas, TX, on November 17.
- According to an analysis from the American Cancer Society, Africa may become "the future epicenter of the tobacco epidemic." The report warns that if current trends continue, the number of adults in Africa who smoke could increase to 573 million by 2100, from 77 million today. The report's authors suggest that if countries put appropriate tobacco polices in place, they could avoid 139 million premature deaths by that date.
- Stellenbosch University in Stellenbosch, South Africa, has established the African Cancer Institute, which will conduct cancer research and work to improve cancer prevention, diagnosis, and management in Africa. The new institute signed a memorandum of collaboration with The University of Texas MD Anderson Cancer Center in Houston.
November 14, 2013
- In a phase III trial of people with previously untreated chronic lymphocytic leukemia (CLL), treatment with Roche's Gazyva (obinutuzumab) combined with chlorambucil significantly boosted progression-free survival compared with Rituxan (rituximab; Roche) plus chlorambucil, achieving a median of 26.7 months compared with 15.2 months respectively. Earlier this month, the U.S. Food and Drug Administration approved Gazyva for such CLL patients. Full study results will be presented next month at the annual meeting of the American Society of Hematology.
- The American Society of Clinical Oncology formally began development of its CancerLinQ system, which will offer a series of successively more powerful quality improvement tools for physicians, with the first components becoming available by early 2015. Future enhancements will include the ability to analyze many thousands of cancer patient outcomes to create a continuous cycle of learning, the society said.
- The Institute of Cancer Research in London, UK, launched a greatly expanded version of its CanSAR drug development platform, said to be the world's biggest disease database of its kind. Made freely available to researchers around the world, CanSAR 2.0 holds more than 8 million experimentally derived measurements, nearly 1 million biologically active chemical compounds, and data from more than 1,000 cancer cell lines.
- Dana-Farber Cancer Institute, Brigham and Women's Hospital, and Boston Children's Hospital, all in Boston, MA, and the Broad Institute of MIT and Harvard in Cambridge, MA, launched the Joint Center for Cancer Precision Medicine. One of the center's key programs will obtain and characterize patient biopsies during treatment. Researchers will work with leaders of the Profile cancer genetics research project, which now sequences the DNA in 305 cancer-related genes of consenting patients at the three hospitals.
- In a phase III trial of 280 women with operable HER2-positive invasive breast cancer who were given trastuzumab (Herceptin; Genentech) plus anthracycline and taxane chemotherapy, the rates of pathologic complete response and cardiac complications were similar, regardless of whether the drugs were given sequentially or concurrently. The trial was reported in Lancet Oncology.
- The European Commission approved Bristol-Myers Squibb's Yervoy (ipilimumab) for first-line treatment of adult patients with advanced melanoma. The drug initially was approved in Europe in 2011 for patients with previously treated disease.
November 7, 2013
- In a phase III trial among more than 14,000 females ages 16 to 26, Merck's V503 investigational human papillomavirus (HPV) vaccine prevented approximately 97% of cervical, vaginal, and vulvar precancers caused by HPV types 31, 33, 45, 52, and 58, and generated immune responses to HPV types 6, 11, 16, and 18 that were noninferior to those generated by the company's Gardasil vaccine. The company plans to submit a Biologics License Application for V503 to the U.S. Food and Drug Administration (FDA) this year.
- The FDA approved obinutuzumab (Gazyva; Genentech) for use with chlorambucil to treat patients with previously untreated chronic lymphocytic leukemia. The drug is the first with a Breakthrough Therapy designation to receive the agency's approval.
- Additionally, the FDA asked Ariad Pharmaceuticals of Cambridge, MA, to suspend sales and marketing of its leukemia drug Iclusig (ponatinib) because of the risk of life-threatening blood clots and severe narrowing of blood vessels.
- ImmunoGen of Waltham, MA, stopped a phase II trial in small cell lung cancer of its antibody–drug conjugate IMGN901 in combination with etoposide and carboplatin compared to treatment with etoposide and carboplatin alone. The move followed an independent data-monitoring committee's finding that the addition of IMGN901 was not likely to demonstrate a significant improvement in progression-free survival. The committee also noted an imbalance in the rate of infection and infection-related deaths between the trial arms.
- The Huntsman Cancer Institute (HCI) at the University of Utah in Salt Lake City will expand its research facilities with a 220,000-square-foot addition. The new space is projected to cost $100 million and will support research in leukemia, sarcoma, brain cancer, and other cancers. Programming and design for the six-floor expansion is under way and construction is slated to begin in 2014. Funding is coming from HCI founder Jon Huntsman, the Church of Jesus Christ of Latter-day Saints, and other donors.
- In an updated estimate, the NIH said it funded 640 fewer grants in fiscal year 2013 than had been planned before federal sequestration limits came into effect.
- The Cancer Prevention and Research Institute of Texas (CPRIT) is moving ahead with new grants, after state leaders lifted a moratorium. CPRIT had awarded $836 million between 2009 and the start of the moratorium in December 2012. The chair of the Institute's scientific review council will be Richard Kolodner, PhD, of the Ludwig Institute for Cancer Research's branch at the University of California, San Diego.
- U.S. life scientists across academia, industry, and government earn an average of nearly $96,000 per year in total compensation, including base salary, bonuses, and other income, compared with a European average of $66,700, according to an annual salary survey by The Scientist. For those working in oncology, the average annual U.S. compensation was about $91,000 in academia and $137,000 in industry.
October 31, 2013
- Bristol-Myers Squibb's nivolumab achieved a 2-year survival rate of 24% among 129 heavily pretreated patients with non–small cell lung cancer, in updated results from a phase I trial presented at the 15th World Conference on Lung Cancer in Sydney, Australia, on October 29. The PD-1 immune checkpoint inhibitor is also being studied as a monotherapy and in combination with other therapies in more than 24 trials in gastric cancer, hematologic cancer, hepatocellular carcinoma, melanoma, pancreatic cancer, renal cell carcinoma, small cell lung cancer, and triple-negative breast cancer.
- The Carlos Slim Foundation of Mexico City, Mexico, has contributed $74 million to the second phase of a genomics research partnership with the Broad Institute of Harvard and MIT in Cambridge, MA. The partnership will support discovery programs focusing on cancer and other health problems that are particularly relevant to Mexico and Latin America. Broad Institute scientists will collaborate with researchers at the National Institute of Genomic Medicine of Mexico and other Mexican research institutions.
- Medivation of San Francisco, CA, and Astellas Pharma of Tokyo, Japan, announced that the phase III PREVAIL trial of Xtandi (enzalutamide) met its primary endpoints of overall and progression-free survival in chemotherapy-naïve patients with advanced prostate cancer, and the study will be stopped early. Xtandi provided a 30% reduction in risk of death compared with placebo, the companies said. The drug was approved by the U.S. Food and Drug Administration in 2012 for the treatment of patients with metastatic castration-resistant prostate cancer who had previously received docetaxel.
- The University of Texas MD Anderson Cancer Center and IBM are collaborating on an Oncology Expert Advisor powered by IBM's Watson "cognitive computing" Big Data system. First applied to leukemia, the Expert Advisor is designed to provide personalized, evidence-based treatment and management options for patients, and to automatically match patients to appropriate clinical trials.
- Myriad Genetics of Salt Lake City, UT, filed a lawsuit against Quest Diagnostics of Madison, NJ, alleging infringement of Myriad's patents covering BRCA1 and BRCA2 gene testing, in US District Court for the District of Utah. Earlier this month, Quest introduced the BRCAvantage test and asked the US District Court for the California Northern District for a determination that offering genetic testing for BRCA1 and BRCA2 mutations wouldn't infringe on Myriad patents.
- Five years after completion, 29% of large clinical trials remain unpublished<, according to a study published in BMJ, which looked at trials with at least 500 participants that were prospectively registered with ClinicalTrials.gov and completed prior to 2009. Non-publication was seen among 32% of trials that received industry funding and 18% of those that did not. "A substantial number of study participants were exposed to the risks of trial participation without the societal benefits that accompany the dissemination of trial results," the authors commented.
October 24, 2013
- The 16-day U.S. federal shutdown "had a major impact on our business of supporting extramural research," wrote Sally Rockey, PhD, NIH deputy director for extramural research, in her blog. Over 200 review meetings were canceled and more than 11,000 applications were affected by these cancellations, she added. NIH released updated guidance on how it will resume full extramural activities.
- The National Cancer Institute (NCI) released a checklist of 30 criteria for evaluating molecular tests that will guide decisions made during NCI-supported clinical cancer trials. The checklist was published in Nature, with an accompanying commentary in BMC Medicine.
- TetraLogic of Malvern, PA, filed for a $103.5 million initial public offering. The biotech is focused on developing second mitochondrial activator of caspases (SMAC) mimetics. Its lead candidate, birinapant, is in phase I and II trials that have enrolled over 275 patients with various solid-tumor and hematological cancers.
- Fifteen charities and advocacy groups joined to form the Metastatic Breast Cancer Alliance, intended to advance education and research on the disease. Celgene, Genentech, and Pfizer will help to sponsor the effort.
- The World Health Organization's International Agency for Research on Cancer (IARC) officially classified outdoor air pollution as a group 1 carcinogen, after an expert group concluded that there is sufficient evidence that exposure to such pollution causes lung cancer. The most recent data suggest that in 2010, 223,000 lung cancer deaths worldwide resulted from air pollution, the IARC noted.
- Recommendations for boosting patient accrual for cancer clinical trials, based on a 2010 NCI–American Society of Clinical Oncology symposium, were published in the Journal of Oncology Practice.
- Immunotherapies such as PD-1 checkpoint blockade inhibitors will "completely dominate the field of metastatic melanoma treatment," predicted Alexander Eggermont, MD, PhD, director general of the Cancer Institute Gustave Roussy in Villejuif-Paris, France. "We will see clinical cures for 50% of patients with metastatic melanoma in the next 5 to 10 years," he suggested at the International Conference on Molecular Targets and Cancer Therapeutics. Held in Boston, MA, October 19 through 23, the conference was sponsored by the American Association for Cancer Research, NCI, and the European Organisation for Research and Treatment of Cancer.
October 17, 2013
- With the shutdown of the US federal government ended after 16 days, agencies are struggling to resume business as normal. The National Cancer Institute (NCI) furloughed about 80% of its staff, postponed site visits to evaluate cancer centers and large programs, and held off on many meetings to review grants, noted NCI director Harold Varmus, MD, in a letter to the research community on October 11. "Avoiding a major crisis in grant-making and program development this year may be possible only if all members of the NCI communities are willing to help alleviate the consequences of the shutdown," he added.
- Roche plans to invest about $880 million to expand its manufacturing facilities for biologic products. The company, which says it is the world's largest supplier of such products, has 39 investigational biologic medicines in its pipeline.
- Quest Diagnostics of Madison, NJ, introduced the BRCAvantage test, which helps to assess the risk of inherited breast and ovarian cancers. The company, which claims to be the world's leading provider of diagnostic information services, also asked the US District Court for the California Northern District for a determination that offering genetic testing for BRCA1 and BRCA2 won't infringe on patents held by Myriad Genetics of Salt Lake City, UT. A similar case was filed by Counsyl of South San Francisco, CA, in September.
- Hundreds of researchers from almost 50 countries have joined in the OncoArray Consortium, which aims to identify the genetic basis of breast, colorectal, lung, ovarian, and prostate cancer. The project will use a custom array developed by Illumina of San Diego, CA, that incorporates about 530,000 markers to perform genotyping on more than 425,000 patient samples.
- Gilead Sciences of Foster City, CA, stopped its phase III trial of idelalisib in 220 previously treated chronic lymphocytic leukemia patients after an interim analysis showed statistically significant efficacy in progression-free survival for patients receiving idelalisib plus rituximab (Rituxan; Genentech and Biogen Idec) compared with those receiving rituximab alone. Idelalisib is an investigational oral inhibitor of PI3Kδ. Data from the study will be presented at a future scientific conference.
- AstraZeneca took another step to strengthen its portfolio of cancer drugs, as its MedImmune biologics research and development arm acquired Spirogen of London, UK. MedImmune will pay $200 million up front plus up to $240 million based on development milestones for Spirogen, which focuses on antibody–drug conjugate technology.
October 10, 2013
- Memorial Sloan-Kettering Cancer Center, The Rockefeller University, and Weill Cornell Medical College of New York, NY, formed the Tri-Institutional Therapeutics Discovery Institute. The independent organization, designed to expedite early-stage drug discovery and develop innovative therapies for patients, was founded with $20 million in private funding and has partnered with Takeda Pharmaceutical.
- Like other federal agencies, the U.S. Food and Drug Administration (FDA) has suspended most operations during the ongoing government shutdown. However, the FDA is continuing its reviews of drugs and devices whose "user fees" were paid by manufacturers before October 1, with the exception of biosimilars.
- Karyopharm Therapeutics of Natick, MA, filed for a proposed initial public offering of stock to raise up to $80 million. The company's selective inhibitors of nuclear export target the nuclear export protein XPO1, said to mediate the export of most tumor suppressor proteins. Karyopharm's lead drug candidate, selinexor (KPT-330), is being studied in multiple phase I clinical trials in patients with heavily pretreated relapsed and/or refractory hematological and solid tumor malignancies.
- The VEGFR-2 antagonist ramucirumab (Eli Lilly) improved survival in patients with advanced gastric or gastroesophageal junction adenocarcinoma progressing after first-line chemotherapy, in a phase III clinical trial reported in The Lancet. Among 355 patients in 29 countries studied in the REGARD trial, median overall survival was 5.2 months for those in the ramucirumab group and 3.8 months for those in the placebo group. An earlier analysis of trial results was presented in January at the American Society of Clinical Oncology 2013 Gastrointestinal Cancers Symposium in San Francisco, CA.
- "As America keeps hitting the brakes on scientific research, we are, in effect, accelerating the damage done to our continued leadership in global bioscience, in health outcomes, and in the economic power that we have always derived from basic research," Stefano Bertuzzi, PhD, executive director of the American Society for Cell Biology, told reporters at a Washington, DC, press conference. "Americans will pay dearly for these slowdowns, sequestrations, and shutdowns in finding cures and on maintaining economic competitiveness."
October 3, 2013
- Merck is cutting about one fifth of its global workforce, a new round of about 8,500 layoffs in addition toan earlier reduction of about 7,500 employees. The company said the move would help it pursue its highest-potential growth opportunities, such as anti–PD-1 cancer immunotherapies. Merck also announced that it is creating a new organization to deliver its MK-3475 anti–PD-1 drug to patients around the world.
- In a phase III trial of 602 women with advanced HER2-positive breast cancer whose cancer recurred or progressed despite previous treatments, those given Genentech's Kadcyla (T-DM1, ado-trastuzumab emtansine) achieved median progression-free survival (PFS) of 6.2 months, compared with PFS of 3.3 months for those who received their physician's choice of treatment. Patients given Kadcyla also experienced fewer serious adverse side effects than those in the control group. The study was reported at the European Cancer Congress (ECC) 2013, held in Amsterdam, the Netherlands, from September 27 through October 1.
- Among 53 patients with non–small cell lung cancer (NSCLC) who received Roche's anti–PD-L1 drug MPDL3280A, 26% of smokers responded, compared with only 10% of never-smokers, according to preliminary results from a phase I clinical trial presented at the ECC.
- The NIH is seeking public comments on its draft Genomic Data Sharing Policy, which promotes the sharing, for research purposes, of large-scale human and nonhuman genomic data generated from NIH-supported research.
- Following the shutdown of the U.S. federal government, most activities of the NIH, the Food and Drug Administration (FDA), and other biomedical funding and regulatory agencies have been suspended.
- The FDA granted accelerated approval to Genentech's Perjeta (pertuzumab) for neoadjuvant treatment of early-stage breast cancer, the first drug to receive such approval. "We are seeing a significant shift in the treatment paradigm for early-stage breast cancer," said Richard Pazdur, MD, director of the agency's Office of Oncology Drug Products.
- Counsyl of South San Francisco, CA, has asked the California Northern District Court for a determination that offering genetic testing for BRCA1 and BRCA2 won't infringe on patent claims held by Myriad Genetics of Salt Lake City, UT.
- Infinity Pharmaceuticals of Cambridge, MA, disclosed that in a phase II study of 226 patients with NSCLC who had a history of smoking, its retaspimycin hydrochloride, a heat shock protein 90 inhibitor, did not meet the study endpoints for overall survival. The company will not initiate any new trials of the drug.
- During the next 50 years, the dominant contributions to the global cancer burden will be from India, China, and Nigeria, predicted the State of Oncology 2013 report, presented at the ECC.
September 26, 2013
- Roche's Kadcyla (ado-trastuzumab emtansine, formerly known as T-DM1) received positive regulatory decisions in the European Union and Japan. The EU's Committee for Medicinal Products for Human Use recommended approval of the antibody–drug conjugate for treatment of adults with HER2+, inoperable, locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination. The Japanese Ministry of Health, Labor, and Welfare approved Kadcyla for treatment of inoperable or recurrent HER2+ breast cancer.
- The National Cancer Institute (NCI) gave The University of Texas MD Anderson Cancer Center in Houston a $48.6 million, 5-year support grant. During the 5 years between renewals of its grant, MD Anderson said, it published more than 12,000 papers and remained the top external recipient of NCI funding, with more than 220 grants in effect totaling $120 million annually.
- Merck Serono will launch a new phase III trial for the MUC1 antigen-specific cancer immunotherapy tecemotide (formerly known as Stimuvax and developed by Oncothyreon) for patients with inoperable, locally advanced non–small cell lung cancer. A previous phase III trial did not improve overall survival (OS) in that population, but a subgroup of patients who received tecemotide after concurrent chemotherapy and radiation achieved a median OS of 30.8 months versus 20.6 months in patients treated with placebo.
- Bind Therapeutics of Cambridge, MA, whose lead cancer nanotherapeutic is in phase II clinical trials, and Biocept Laboratories of San Diego, CA, which provides circulating tumor cell–based diagnostics, filed for initial public offerings—joining this year's unusually large crop of biotechnology firms taking that step.
- A large retrospective study of the NCI's Surveillance, Epidemiology, and End Results database showed that married patients were 17% less likely to have metastatic disease when first diagnosed with cancer than patients who were not married. In addition, married patients with nonmetastatic disease were 53% more likely to receive therapy indicated for their disease than unmarried patients, according to a paper in the Journal of Clinical Oncology.
- The UK National Institute for Health and Care Excellence recommended Genomic Health's Oncotype DX genetic breast cancer test for aid in chemotherapy treatment decisions for patients with early-stage, HR+ invasive breast cancer.
- Nike cofounder Phil Knight pledged to give Oregon Health and Science University (OHSU) a $500 million award for cancer research, but with an important footnote: For the award to be delivered, OHSU must raise an equivalent sum within 2 years.
September 19, 2013
- More than 240 representatives from organizations that promote funding for medical research met with more than 200 US House and Senate officials on September 18. The "Hill Day" event was a continuation of the Rally for Medical Research initiative, which drew more than 10,000 people to Washington, DC, in April 2013 to encourage sustained investment in the NIH.
- The number of US cancer survivors rose to 13.7 million as of January 2012, noted the Cancer Progress Report 2013, released on September 17 by the American Association for Cancer Research (AACR). Continued progress "will only be possible if we make funding for cancer research and biomedical science a national priority," emphasized Charles Sawyers, MD, AACR president and chair of the human oncology and pathogenesis program at Memorial Sloan-Kettering Cancer Center in New York, NY.
- Bristol-Myers Squibb announced that in a phase III trial of patients with previously treated castration-resistant prostate cancer, those given Yervoy (ipilimumab) did not demonstrate statistically significant improvement in overall survival compared to those who received a placebo. Another phase III trial of Yervoy is continuing that examines the CTLA-4 inhibitor's effect on overall survival in patients with less-advanced castration-resistant prostate cancer who have received no prior cytotoxic treatment.
- In a phase III trial of 1,314 patients with stage II melanoma, vaccination with GM2-KLH-QS21, which stimulates the production of antibodies to the GM2 ganglioside, did not improve relapse-free survival, reported a paper in the Journal of Clinical Oncology.
- Agenus, of Lexington, MA, said that an updated analysis from a phase II trial of 46 patients with newly diagnosed glioblastoma multiforme showed that those treated with its Prophage Series G-100 (HSPPC-96) autologous vaccine in combination with the current standard of care (radiation and temozolomide) achieved median progression-free survival of 17.8 months, compared to 6.9 months for patients treated only with the standard of care.
- An analysis of data from 88,902 participants in the Nurses' Health Study and the Health Professionals Follow-up Study showed that 40% of all colorectal cancers might be prevented by regular colonoscopy screening, according to a paper in the New England Journal of Medicine.
- The number of employees at U.S. biotechnology firms increased 13% from 2011 to 2012, but the average number of employees per firm dedicated to research and development remained flat at 92, according to an annual briefing from the consulting firm BDO USA in Chicago, IL.
September 12, 2013
- The U.S. Food and Drug Administration (FDA) approved Celgene's Abraxane (paclitaxel protein-bound particles for injectable suspension) to treat patients with metastatic pancreatic cancer, in combination with Eli Lilly's gemcitabine. A phase III clinical trial with 861 participants reported in January showed that those treated with Abraxane plus gemcitabine lived, on average, 1.8 months longer than those given gemcitabine alone.
- Weill Cornell Medical College in New York, NY, received a $100 million gift from longtime benefactors Joan and Sanford I. Weill and the Weill Family Foundation. The award will be split between two new centers, one of them specializing in personalized medicine for cancer.
- GlaxoSmithKline announced that a phase III trial of the MAGE-A3 cancer immunotherapeutic in patients with advanced melanoma whose tumors expressed MAGE-A3 failed to show significantly extended disease-free survival compared with placebo. The trial will continue, assessing a subset of MAGE-A3––positive patients, with results expected in 2015.
- An analysis published in Cancer supports greater use of annual mammography in women ages 40 to 49, as recommended by the American Cancer Society and the American Congress of Obstetricians and Gynecologists. The study of 7,301 patients found that 71% of confirmed breast cancer deaths occurred in the 20% of participants who did not receive regular mammograms. Additionally, 50% of deaths occurred in women under age 50.
- Bayer HealthCare, of Whippany, NJ, and the Broad Institute of Harvard and MIT, of Cambridge, MA, will collaborate in a 5-year project to discover and develop therapeutic agents that target cancer genome alterations.
- Otsuka Pharmaceutical of Tokyo, Japan, will acquire Astex Pharmaceuticals of Dublin, CA, for about $886 million. Astex's DNA hypomethylating agent Dacogen (decitabine; licensed to Eisai) is FDA-approved for treating myelodysplastic syndromes. The company's SGI-110 hypomethylating agent is being evaluated in multiple clinical studies for various hematological and solid tumor oncology indications, and its AT13387 HSP90 inhibitor is in trials for prostate and lung cancers.
- Myriad Genetics of Salt Lake City, UT, introduced a multigene diagnostic test that analyzes 25 genes associated with breast, colorectal, ovarian, endometrial, pancreatic, prostate, and gastric cancers, and melanoma. The company plans to present clinical validity data for its myRisk Hereditary Cancer test at the Collaborative Group of the Americas on Inherited Colorectal Cancer annual meeting in October and the San Antonio Breast Cancer Symposium in December.
- Oncolytics Biotech of Calgary, Alberta, Canada, reported positive final tumor-response data for a phase II single-arm trial of its Reolysin viral cancer treatment for squamous cell carcinoma of the lung, with 23 of 25 evaluable patients showing tumor shrinkage.
- About 40% of women scheduled to undergo mammography have never discussed their personal breast cancer risk with their doctors, according to a survey of 9,873 New York women presented at the 2013 Breast Cancer Symposium in San Francisco, CA, on September 7. "We were shocked," said lead author Jonathan Herman, MD, of Hofstra North Shore-LIJ School of Medicine in New Hyde Park, NY. "This has to change. Let's move beyond the pink ribbons and go to your physician's office and ask about your breast cancer risk."
September 5, 2013
- Bristol-Myers Squibb's brivanib, a dual inhibitor of vascular endothelial growth factor and fibroblast growth factor receptors, did not significantly boost overall survival (OS) in two phase III trials for patients with advanced hepatocellular carcinoma, the results of which were published in the Journal of Clinical Oncology. In the BRISK-PS study with 395 patients who progressed on or after sorafenib (Nexavar; Onyx Pharmaceuticals and Bayer Healthcare) or were intolerant to sorafenib, median OS survival was 9.4 months for treatment with brivanib and 8.2 months for placebo. In the BRISK-FL study with 1,150 patients given first-line therapy, median OS was 9.9 months for those treated with sorafenib and 9.5 months for those treated with brivanib.
- With every daily drink of alcohol a girl or woman consumes before her first full-term pregnancy, she increases her lifetime risk of breast cancer by 13%, according to a study published in the Journal of the National Cancer Institute. The analysis is based on a review of the health histories of 91,005 mothers enrolled in the Nurses' Health Study II from 1989 to 2009.
- The European Commission approved Bayer Healthcare's Stivarga (regorafenib) for adults with metastatic colorectal cancer who have previously been treated with, or are not considered candidates for, other therapies. The FDA approved the drug for patients with the disease in September 2012.
- The European Medicines Agency's Committee for Medicinal Products for Human Use recommended marketing authorization for the BRAF inhibitor Tafinlar (dabrafenib; GlaxoSmithKline) for treatment of adult patients with advanced melanoma expressing a BRAF V600 gene mutation. The drug was approved for such patients by the U.S. Food and Drug Administration (FDA) in May 2013.
- While legal battles continue over intellectual property rights concerning analyses of the BRCA1 and BRCA2 genes for predicting the risk of cancers, GeneDx of Gaithersburg, MD, launched a suite of genetic tests for inherited cancer, among them a 26-gene panel for breast and ovarian cancers that includes BRCA1 and BRCA2. In July, Myriad Genetics of Salt Lake City, UT, sued Ambry Genetics of Aliso Viejo, CA, and Gene by Gene of Houston, TX, alleging infringement of patents covering methods related to analyzing the two genes.
- Federal budget constraints have made 2013 the "darkest ever" year for the NIH, director Francis Collins, MD, PhD, told the New York Times. Cutbacks mandated by the federal budget sequestration process, Collins remarked, have added to the difficulties raised when Congress handles appropriations via annual continuing resolutions. "Continuing resolutions discourage you from trying something new and bold," he said. "You're supposed to tread water. And science is very badly served by that tread-water message."
August 29, 2013
- In a trial of 1,110 patients with clear-cell metastatic renal-cell carcinoma, Votrient (pazopanib; GlaxoSmithKline) and Sutent (sunitinib; Pfizer) demonstrated comparable efficacy, but safety and quality-of-life profiles favored Votrient, according to a study in the New England Journal of Medicine.
- Amgen announced plans to buy Onyx Pharmaceuticals of South San Francisco, CA, for $10.4 billion. Onyx's Kyprolis (carfilzomib) is approved by the U.S. Food and Drug Administration for treating multiple myeloma. The company's other assets include partnerships with Bayer HealthCare Pharmaceuticals on Nexavar (sorafenib), approved for treating liver cancer and kidney cancer, and Stivarga (regorafenib), approved for treating colorectal cancer and gastrointestinal stromal tumors.
- MedImmune, AstraZeneca's biologics research and development arm, will acquire Amplimmune of Gaithersburg, MD, for $225 million plus up to $275 million based on development milestones. Amplimmune's drug candidates include two programmed cell death 1 inhibitors: AMP-224 is in phase 1b trials in lymphoma and ovarian cancer, and AMP-514 is in late-stage preclinical development.
- The X Prize Foundation cancelled its Genomics X Prize competition, explaining that genomic sequencing technologies have advanced so quickly that the prize no longer offered a suitable goal. Announced in 2006, the competition offered a $10 million reward for accurately and rapidly sequencing 100 whole human genomes at a cost of $10,000 or less per genome. The project created cell lines from more than 100 centenarians, whose genomes will be sequenced and put into an open data forum, said X Prize Foundation Chair Peter Diamandis, MD.
- Similar numbers of men and women are diagnosed with melanoma each year in the UK, but men are 70% more likely to die of the disease, according to Cancer Research UK.
- In the United States, African-American women are significantly less likely to initiate HPV vaccination compared with white women, according to a study in the Journal of Adolescent Health. This difference "cannot simply be explained by differential access to health care," commented the researchers, who called for work to identify ways to increase vaccination rates in this population.
August 22, 2013
- On the basis of significant evidence that links indoor tanning to increased risk of developing skin cancer, Illinois passed a law prohibiting indoor tanning by people under age 18. Tanning salons that violate the law, which goes into effect on January 1, can be fined $250. Five other states have similar laws on the books: California, Nevada, Oregon, Texas, and Vermont.
- In a tactical move, Roche has decided to relinquish patent rights to its breast cancer drug Herceptin (trastuzumab) in India, opening the market to generic versions. The move, which follows months of debate about the cost of Herceptin, precludes the Indian government from issuing a compulsory license to another manufacturer. Herceptin currently faces no competition in India.
- The U.S. Food and Drug Administration (FDA) granted orphan drug designation to ADXS-HPV for the treatment of human papilloma virus–associated anal cancer. The immunotherapeutic, under development by Advaxis (Princeton, NJ), is currently being evaluated in a phase I/II study. Orphan drug designation entitles the drug's sponsor to protocol assistance from the FDA, federal grants, tax credits, and seven years of marketing exclusivity independent of other intellectual property, if the drug is approved.
- Epizyme announced that the FDA also granted orphan drug designation to its EPZ-5676, a small-molecule inhibitor of the DOT1L histone methyltransferase, for the treatment of acute leukemias in which MLL is rearranged due to a chromosomal translocation (MLL-r). The Cambridge, MA, company has partnered with Abbott Laboratories to develop a companion diagnostic to identify patients with MLL-r, which affects fewer than 5,000 people a year in the United States.
- Scientists at The Institute of Cancer Research in London, UK, reported finding four new genetic variants linked to the development of multiple myeloma, including one that influences aging. That genetic marker is linked to TERC, which regulates the length of telomere "caps" on the ends of DNA. Normally, these caps erode over time, causing tissues to age, but some cancer cells seem to ignore the aging trigger and keep dividing.
- Wisconsin Senator Tammy Baldwin announced that she will file a bill in September to help young investigators trying to build careers in scientific and medical research amid reduced federal funding and sequestration. The proposed Next Generation Research Act will promote policies and awards to support young scientists, improve mentoring of new researchers by established ones, and expand workforce diversity efforts. It would also direct the National Academy of Sciences to study barriers to entry into biomedical research.
- More than 20% of 690 women who used a web-based risk-assessment tool to calculate their chances of developing breast cancer over the next 5 years didn't believe the assessment, according to a study from the University of Michigan Comprehensive Cancer Center. Although the tool included questions about age and ethnicity, as well as personal and family history of breast cancer, the most common reason the women said they didn't believe the result was that their family history should have made them either more or less likely to develop the disease. "If people don't believe their risk numbers, it doesn't allow them to make informed medical decisions," says senior study author Angela Fagerlin, PhD.
August 15, 2013
- Vical of San Diego, CA, announced that its Allovectin (velimogene aliplasmid) immunotherapy failed to meet efficacy endpoints in a phase III trial for patients with metastatic melanoma. The company will shut down Allovectin development and its other work on potential cancer treatments.
- The U.S. Food and Drug Administration granted orphan drug designation status to the E7777 investigational compound (denileukin diftitox; Eisai) for cutaneous T-cell lymphoma.
- Three companies announced a joint initiative to deliver a personalized medicine service for physicians treating cancer—GenoSpace of Cambridge, MA; PathGroup of Brentwood, TN; and the Thomson Reuters IP & Science business in Philadelphia, PA.
- The median cost to bring a drug to market was $350 million for companies that launched one drug in the past decade, but rose to $5.5 billion per drug for companies that brought more than eight drugs to market in that time, according to an analysis in Forbes.
- In a phase III study, patients with stage IV metastatic squamous cell lung cancer lived significantly longer when given necitumumab (IMC-11F8; Lilly) in combination with gemcitabine and cisplatin as a first-line treatment, compared to chemotherapy alone, Lilly announced. It did not release specific data from the trial for necitumumab, a fully human monoclonal antibody designed to block the ligand-binding site of the human epidermal growth factor receptor. If approved, the drug "could be the first biologic therapy indicated to treat patients with squamous lung cancer," noted Richard Gaynor, MD, vice president for product development and medical affairs at Lilly Oncology.
- Bind Therapeutics and Acceleron Pharma, both of Cambridge, MA, joined the ranks of biotechnology firms developing cancer treatments that have filed for an initial public offering of stock this summer.
- The Indian market for drugs treating breast cancer, lung cancer, colorectal cancer, prostate cancer, and non-Hodgkin lymphoma will grow by 6.5% annually to $239 million in 2018, from $153.3 million in 2011, predicts Research and Markets of Dublin, Ireland. This relatively slow growth will largely reflect the country's tightening price control regulations, the market research firm commented.
August 8, 2013
- The NIH reached an agreement with the family of Henrietta Lacks for controlled access by biomedical researchers to whole-genome data on HeLa cells originally created from Lacks's tumor. In one part of the agreement, NIH-funded researchers who generate full genome sequence data from HeLa cells will be expected to deposit their data into a single database for sharing. Separately, a haplotype-resolved genome and epigenome analysis of the CCL-2 strain of HeLa cells published in Nature identified an insertion of the human papilloma virus near the MYC oncogene that may help to explain the aggressiveness of Lacks's cancer, researchers said.
- Novartis announced that a global phase III clinical trial demonstrated that Afinitor (everolimus) did not increase overall survival compared with placebo in patients with locally advanced or metastatic hepatocellular carcinoma after progression on or intolerance to Nexavar (sorafenib; Bayer and Onyx Pharmaceuticals). Results of phase III trials of Afinitor for treating gastrointestinal and lung neuroendocrine tumors, HER2-positive breast cancer, lymphoma, and tuberous sclerosis complex are expected in 2014 and 2015.
- India's Intellectual Property Appellate Board rejected one patent for GlaxoSmithKline's breast cancer drug Tykerb (lapatinib) but upheld another patent for the drug, preserving its patent protection in the country until 2019.
- The American Society for Clinical Oncology launched a survey that asks its members to assess the impact on physicians and patients of federal budget cuts to cancer research.
- A study of 3,837 men with diabetes ages 67 and older who took the diabetes drug metformin after being diagnosed with prostate cancer showed that metformin lowered the risk of prostate cancer death, according to an article published in the Journal of Clinical Oncology.
- A study of 1,763 postmenopausal women found that those currently taking calcium-channel blockers who have used the drugs for 10 years or longer had more than twice the risk of both invasive ductal and lobular breast cancers compared with those who had never used such drugs, reported an article in JAMA Internal Medicine. The drugs combat high blood pressure.
- Ambry Genetics of Aliso Viejo, CA, filed an antitrust counterclaim against Myriad Genetics of Salt Lake City, UT, in response to the patent infringement lawsuit Myriad and other plaintiffs filed against Ambry in July in the United States District Court for the District of Utah. The suits concern patents for analysis of BRCA1 and BRCA2 genes for assessing cancer risk. In June, the U.S. Supreme Court ruled against Myriad's patent claims on the isolated BRCA1 and BRCA2 genes but did not address the company's related claims.
- Draft guidelines from the UK National Institute for Health and Care Excellence (NICE) do not recommend pertuzumab (Perjeta; Roche) as a treatment for recurring or metastatic HER2-positive breast cancer. "The main clinical trial did not reflect current medical practice in the UK, and despite the research data suggesting the treatment could help delay the growth and spread of the disease, the evidence was not robust enough to confirm for how long pertuzumab may actually extend people's lives," explained NICE chief executive Sir Andrew Dillon.
August 1, 2013
- A National Cancer Institute working group recommended steps against cancer overdiagnosis and overtreatment, including changes to terminology, in a viewpoint article published in JAMA. Among the group's suggestions, the term "cancer" should be reserved "for describing lesions with a reasonable likelihood of lethal progression if left unchanged."
- The European Federation of Pharmaceutical Industries and Associations and the Pharmaceutical Research and Manufacturers of America jointly endorsed a statement of principles for sharing clinical trial data. "Under the new commitments, biopharmaceutical companies will dramatically increase the amount of information available to researchers, patients, and members of the public," the associations declared.
- Survival rates for patients with HIV-associated lymphoma have not improved in the United States since the adoption of antiretroviral therapies in the mid-1990s, reported a study in the Journal of the National Cancer Institute. Lymphoma is the most frequent cancer-related cause of death among people with HIV.
- An interim analysis of the CLL11 phase III clinical trial showed that obinutuzumab (GA101; Genentech) plus chlorambucil offered significant improvement in progression-free survival over rituximab (Rituxan; Genentech/Biogen Idec) plus chlorambucil for people with previously untreated chronic lymphocytic leukemia. Genentech said that final data from the study of obinutuzumab, the first glycoengineered type II anti-CD20 drug, will be submitted for presentation at the American Society of Hematology annual meeting in December.
- The U.S. Preventive Services Task Force issued a draft recommendation to screen people who are at high risk for lung cancer with annual low-dose computed tomography scans. The recommendation covers people who are 55 to 80 years old, have smoked an average of one pack of cigarettes daily for 30 years or more, and are either current smokers or have quit in the past 15 years.
- Foundation Medicine of Cambridge, MA, which offers genomic tests for cancer patients and drug companies, filed for an initial public offering that would raise about $86 million.
July 25, 2013
- The U.S. Food and Drug Administration (FDA) halted a phase III trial evaluating the immunomodulatory drug lenalidomide (Revlimid) as an initial therapy for chronic lymphocytic leukemia (CLL) in patients age 65 and older. Based on preliminary survival data submitted to the FDA by the drug's manufacturer, Celgene (Summit, NJ), trial participants who took lenalidomide had a 92% increased risk for death compared with those who took the chemotherapy drug chlorambucil (Leukeran; GlaxoSmithKline). The agency still considers lenalidomide a safe and effective treatment for certain patients with multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma.
- Madison, NJ-based Quest Diagnostics completed the sale of its rights to royalties from the commercialization of ibrutinib to Royalty Pharma (New York, NY) for $485 million. Under development by Pharmacyclics and Johnson & Johnson (through its Janssen Biotech subsidiary), the Bruton's tyrosine kinase inhibitor ibrutinib is a potential therapy for patients with CLL, small lymphocytic lymphoma, and mantle cell lymphoma. Quest gained the rights to ibrutinib royalties in 2011 when it purchased Celera, a developer of molecular diagnostic products.
- Cancer Research UK also announced that it has hired the software development firm Guerilla Tea to create a mobile phone game that will help pinpoint genetic causes of cancer. While playing GeneGame, the general public can aid in analyzing massive amounts of genetic data, speeding identification of drivers of disease. The game is scheduled for release later this year.
- Published in JAMA, an analysis of survival rates among women diagnosed with breast cancer between 1991 and 2005 shows that the survival gap between blacks and whites persists. Using data from the U.S. Surveillance, Epidemiology, and End Results database, the study compared 7,375 black women ages 65 and older with three sets of 7,375 white control patients. One set matched on demographics; another matched on demographics plus disease presentation; and a third matched on demographics, disease presentation, and treatment. The absolute difference in 5-year survival for black women was lower in every group (12.9%, 4.4%, and 3.6% respectively). The researchers suggest that patients' condition at diagnosis, not subsequent treatment, largely accounts for the differences.
- Oncology drug developer Spectrum Pharmaceuticals (Henderson, NV) acquired Talon Pharmaceuticals, a biopharmaceutical company based in South San Francisco, CA, for $11.3 million plus $195 million in future payments based on achieving certain milestones. Spectrum will gain worldwide rights to Marqibo (vincristine sulfate), which is approved for the treatment of adults with Philadelphia chromosome-negative acute lymphoblastic leukemia and under study for other indications, and an experimental menadione topical lotion for the treatment and prevention of skin rashes caused by EGFR inhibitors.
- According to a report from Cancer Research UK, the 10-year survival rate for patients in the UK with malignant melanoma has reached 80% in men and 90% in women. Forty years ago, just 38% of men and 58% of women lived 10 years or longer.
July 18, 2013
- The University of Kentucky Markey Cancer Center in Lexington was designated a National Cancer Institute (NCI) cancer center, the first in the state and the 68th in the country.
- NCI researchers have carried out a comprehensive analysis of coding variants in the NCI-60 panel of cell lines identified by whole exome sequencing. The result is the world's largest data set of cancer-related genetic variations, "containing 6 billion data points that connect drugs with genomic variants for the whole human genome across cell lines from nine tissues of origin, including breast, ovary, prostate, colon, lung, kidney, brain, blood, and skin," said co-corresponding author Yves Pommier, MD, PhD. Details of the analysis were published in Cancer Research, and the data set is available in CellMiner and the Ingenuity Systems Knowledge Base.
- The risk of infertility is almost 50% higher among women who survived childhood cancer than women who haven't had cancer, but almost two thirds of those who tried to get pregnant for at least a year eventually conceived, according to an article in Lancet Oncology.
- In a study of more than 10,000 men with nonmetastatic prostate cancer reported in JAMA, use of androgen deprivation therapy was associated with more than twice the risk of acute kidney injury.
- Cancer Research UK began a 9-year, $21 million study called TRACERx (TRAcking Non-small Cell Lung Cancer Evolution Through Therapy) that will recruit 850 lung cancer patients. Researchers will take biopsies from multiple parts of patients' tumors before and after surgery, and subsequently if the disease recurs, as well as examine circulating DNA in patients' blood.
- "The roughly 2000 sequencing instruments in labs and hospitals around the world can collectively sequence 15 quadrillion nucleotides per year, which equals about 15 petabytes of compressed genetic data," notes a commentary in IEEE Spectrum. "To put this into perspective, if you were to write this data onto standard DVDs, the resulting stack would be more than 2 miles tall.… Clearly, we're dealing with a data deluge in genomics. This data is vital for the advancement of biology and medicine, but storing, analyzing, and sharing such vast quantities is an immense challenge."
July 11, 2013
- Myriad Genetics of Salt Lake City, UT, and other patent holders filed suit against Ambry Genetics of Aliso Viejo, CA, in U.S. District Court for the District of Utah, alleging infringement of claims covering cDNA and methods of use related to the BRCA1 and BRCA2 genes. Ambry announced that it would add BRCA1 and BRCA2 testing to some of its molecular diagnostic products following the U.S. Supreme Court ruling in June that struck down Myriad's claims related to isolated DNA.
- A meta-analysis of 17 cohort studies of almost 313,000 people in nine European countries found that prolonged exposure to particulate air pollution significantly boosts the risk of lung cancer even when levels of particulate are below European Union standards, according to a study in The Lancet Oncology.
- The UK National Institute for Health and Care Excellence (NICE) again recommended against treating women who have advanced HER2-negative, HR-positive breast cancer with everolimus (Afinitor; Novartis) plus exemestane (Aromasin; Pfizer), on the basis of cost-effectiveness. "We are disappointed that the evidence for everolimus isn't stronger, especially as we acknowledge that the drug could represent a new way of treating HER2-negative, HR-positive advanced breast cancer by restoring a tumor's sensitivity to hormone therapy," said Sir Andrew Dillon, NICE chief executive.
- People with Alzheimer's disease may have lower risk of cancer, and vice versa, the largest study to date on the topic reported in Neurology. The risk of cancer dropped by half for people with Alzheimer's disease, and the risk of that disease was reduced by 35% for people with cancer. The study followed 204,468 people age 60 and older for 6 years in Italy.
- The U.S. Food and Drug Administration (FDA) granted Genentech's obinutuzumab (GA101) priority review for treating patients with previously untreated chronic lymphocytic leukemia. In a phase III trial, obinutuzumab demonstrated an 86% reduction in the risk of disease progression or death when combined with chlorambucil compared with chlorambucil alone, the company said. The drug, described as the first glycoengineered type 2 anti-CD20 monoclonal antibody in development for B-cell malignancies, received a Breakthrough Therapy designation from the FDA in May.
- Immunocore of Oxford, UK, will partner with GlaxoSmithKline to develop immunotherapies that link T-cell receptors with anti-CD3 antibody fragments to target difficult-to-treat cancers or viral infections. The deal could exceed $500 million. Immunocore reached another development agreement in June with Genentech, with milestone payments potentially exceeding $300 million for each target program. Immunocore's IMCgp100 is in phase I/II clinical trials for the treatment of melanoma.
July 3, 2013
- Melanoma recurs in 6.8% of patients 10 or more years after initial treatment, although these patients tend to live longer after their cancer returns than patients whose disease recurs in the first 3 years, reported a study in the Journal of the American College of Surgeons. White male teens and young adults are 55% more likely to die of melanoma than their female counterparts, according to a separate study published in JAMA Dermatology.
- Celgene of Summit, NJ, and MorphoSys of Planegg, Germany, will partner to develop the MOR202 monoclonal antibody, which targets CD38 to treat patients with multiple myeloma and certain leukemias. Celgene is paying $92 million upfront and investing $60 million in shares of MorphoSys, in a deal that potentially could reach a total of $818 million if all milestones are met. MOR202 is being evaluated in a phase I/IIa trial in patients with relapsed or refractory myeloma.
- Onyx Pharmaceuticals of South San Francisco, CA, turned down an unsolicited $10 billion buyout proposal from Amgen but said it will talk with other potential acquirers. The company makes Kyprolis (carfilzomib), approved by the U.S. Food and Drug Administration (FDA) for multiple myeloma; Nexavar (sorafenib), approved for liver and kidney cancer; and Stivarga (regorafenib), approved for colon cancer, in partnership with Bayer.
- A phase II clinical trial comparing the phosphatidylserine-targeting antibody bavituximab plus carboplatin and paclitaxel versus carboplatin and paclitaxel alone in patients with advanced non-small cell lung cancer (NSCLC) did not show sufficient difference in survival between the two arms of the trial to continue pursuing the combination. Bavituximab developer Peregrine Pharmaceuticals of Tustin, CA, will go ahead with a phase III trial evaluating the drug plus docetaxel versus docetaxel alone in approximately 600 patients with metastatic, non-squamous NSCLC who have progressed after standard front-line therapy.
- Tobacco control measures established in 41 countries between 2007 and 2010 will prevent about 7.4 million premature deaths by 2050, reported a study published in the Bulletin of the World Health Organization.
- Last year's Creating Hope Act, which provides a transferable FDA priority review voucher to companies who develop drugs for rare pediatric diseases, "has the potential for real impact, particularly in smaller markets like pediatric cancer, where special incentives can make all the difference," noted Margaret Hamburg, MD, FDA commissioner, in a speech at the Alexandria Summit on Oncology in New York, NY, on June 27. "We already have several requests in the pipeline for these vouchers, including one for a pediatric cancer indication."
June 27, 2013
- Worldwide sales of oncology drugs will climb from $68.0 billion in 2012 to $114.4 billion in 2018, when they will make up 12.2% of the total drug market, predicts a report from market intelligence firm Evaluate, of London, UK. The report also suggests that Roche will continue to be the largest provider of oncology drugs, with $30.3 billion in sales in 2018, and that its angiogenesis inhibitor Avastin (bevacizumab) will become the top-selling oncology drug, with sales of $7.7 billion that year.
- Regular aspirin use is associated with a lower risk of BRAF-wild-type colorectal cancer but not with risk of BRAF-mutated cancer, according to a study published in the Journal of the American Medical Association.
- The Translational Genomics Research Institute and Ventana Medical Systems, both in Phoenix, AZ, will partner to discover and develop diagnostic markers for cancer, with their first joint project focused on pancreatic cancer.
- Naked mole-rat fibroblasts secrete extremely high-molecular-mass hyaluronan (HA) that may play a role in the animals' high resistance to cancer, according to a report in Nature. If the high-molecular-mass HA is removed from naked mole-rat cells, the cells readily form tumors in mice, the researchers found.
- "Pay for delay" arrangements, in which the maker of a branded drug pays another firm to delay introduction of a generic version of the drug, came under fire in both the United States and the European Union for their potential anti-competitive effects. On June 17, the U.S. Supreme Court ruled that the Federal Trade Commission and other parties could bring lawsuits against companies making such arrangements. On June 19, the European Commission announced plans to fine Lundbeck, of Copenhagen, Denmark, and several makers of generic drugs for deals involving a Lundbeck drug.
- African American men diagnosed with very-low-risk prostate cancer are much more likely than white men to have unrecognized aggressive disease, according to a study of 1,801 men reported in the Journal of Clinical Oncology. Active surveillance of such cancers in African American men may not represent the best disease management, the researchers suggested.
- The U.S. Food and Drug Administration (FDA) put a partial hold on a clinical trial treating patients with relapsed or refractory acute myeloid leukemia or high-risk myelodysplastic syndrome with a combination of tosedostat (Cell Therapeutics) and 5-azacitidine or cytarabine, after one patient died of myocarditis. New patients cannot be entered in any ongoing protocol for tosedostat, an aminopeptidase inhibitor, until FDA review is completed.
June 20, 2013
- The U.S. Supreme Court ruled that isolated genes are natural products and thus cannot be patented. The ruling struck down patents for the BRCA1 and BRCA2 genes held by Myriad Genetics of Salt Lake City, UT, and several diagnostic companies quickly announced plans to incorporate analysis of those genes into tests for risk of inherited breast and ovarian cancers. The court emphasized that the decision "does not involve method claims, patents on new applications of knowledge about the BRCA1 and BRCA2 genes, or the patentability of DNA in which the order of the naturally occurring nucleotides has been altered."
- A phase III trial evaluating Amgen's trebananib plus paclitaxel versus placebo plus paclitaxel in recurrent ovarian cancer met its primary endpoint of progression-free survival (PFS). Median PFS was 7.2 months in the trebananib arm versus 5.4 months in the control arm. Overall survival data are expected in 2014.
- Johnson & Johnson announced plans to acquire Aragon Pharmaceuticals of San Diego, CA, for an up-front cash payment of $650 million, plus contingent payments of up to $350 million. Aragon's second-generation androgen receptor signaling inhibitor ARN-509 is in phase II clinical development for treating castration-resistant prostate cancer.
- Since the National Cancer Institute launched its Operational Efficiency Working Group in 2008, median time to clinical trial activation decreased from 541 to 442 days for phase I and II trials, and from 727 to 395 days for phase III trials, according to a study in the Journal of the National Cancer Institute.
- Onconova Therapeutics of Newtown, PA, plans to raise up to $75 million in an initial public offering. The company's most advanced product is rigosertib, which inhibits both the PI3K and the PLK pathways. The drug is in phase III clinical trials for higher-risk myelodysplastic syndromes (MDS) and metastatic pancreatic cancer, in two phase II trials for transfusion-dependent lower-risk MDS, and a phase II trial for head and neck cancers.
- The U.S. Food and Drug Administration approved the use of Xgeva (denosumab; Amgen) to treat adults and some adolescents with giant cell tumor of the bone, a rare and usually noncancerous tumor. A monoclonal antibody that binds to RANKL (a protein essential for maintenance of healthy bone), Xgeva was approved in 2010 to prevent fractures when cancer has spread to the bones.
June 13, 2013
- The U.S. Food and Drug Administration (FDA) will not approve Aveo Pharmaceuticals' tivozanib (Tivopath) for the treatment of renal cell carcinoma (RCC) and recommended that the Cambridge, MA, company conduct an additional clinical study in RCC patients. Last month, in a 13–1 vote, an FDA advisory committee recommended against approving the drug because it did not extend overall survival. Although the company will halt development of tivozanib for RCC, it still plans to test the drug as a treatment for breast and colorectal cancers.
- Dozens of organizations have agreed to join an effort to create a nonprofit global alliance to develop technology platforms and practice standards to facilitate the sharing of genomic and clinical data while maintaining patient privacy—including the NIH, the UK's Wellcome Trust, China's BGI-Shenzhen, and Genome Canada. An organizing committee released a white paper that outlines the core principles, goals, and challenges for the alliance, which was conceived at a meeting of genomic medicine organizations in January.
- Siddhartha Mukherjee, MD, author of The Emperor of All Maladies: A Biography of Cancer, and documentary filmmaker Ken Burns will collaborate on a three-part, six-hour film inspired by the Pulitzer Prize–winning book. Educational materials, public screenings, and conferences will be produced in conjunction with the documentary. Sponsored in part by Stand Up To Cancer, the American Association for Cancer Research, and the American Cancer Society, the film will air on PBS in the spring of 2015.
- The state of Connecticut approved $1.54 billion over 10 years to fund the Institute for Systems Genomics (ISG), an interdisciplinary, virtual center that will bring together faculty members from the University of Connecticut (UCONN) and researchers at the Jackson Laboratory for Genomic Medicine, which is being built at the UCONN Health Center in Farmington. Created in December 2012, the ISG will engage investigators from all nine of the university's schools in genomics and personalized medicine research.
- Agios Pharmaceuticals of Cambridge, MA, plans to raise $86 million through an initial public offering. The company's two most-developed drugs, AG-120 and AG-221, target mutant IDH1 and IDH2, which initiate and drive cancer growth by blocking differentiation.
- Survival rates have increased significantly among patients who received blood stem cell transplants from both related and unrelated donors, according to a study published in the Journal of Clinical Oncology that analyzed outcomes over 12 years for more than 38,000 patients with life-threatening blood cancers and other diseases. Among patients with acute myeloid leukemia who received a transplant from a related donor, 100-day survival rates increased from 85% to 94%; rates for unrelated transplants increased from 63% to 86%. One-year survival also increased for patients receiving a transplant from an unrelated donor—from 48% to 63%. Similar improvements were also noted in patients with acute lymphoblastic leukemia and myelodysplastic syndrome.
June 3–6, 2013
- Pointing to successful prevention and treatment programs for HIV/AIDS, tuberculosis, and malaria that have been developed in poor countries, Paul Farmer, MD, PhD, chair of the Department of Global Health and Social Medicine at Harvard Medical School in Boston, MA, challenged the medical community to find ways to do the same for cancer. Based on his experiences in Africa and elsewhere, he suggested that expert cancer consultations could be done via the Internet, medications could be supplied by various organizations, and local health care providers could be trained. "If it can be done in Rwanda, it can be done in other places," he said. Farmer spoke at the opening session of the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in Chicago, IL, on June 1.
- Long-term follow-up of an expanded phase I study of the PD-1 inhibitor nivolumab (Bristol-Myers Squibb) in patients with stage IV melanoma showed that 31% of patients experienced tumor shrinkage of at least 30%, in results reported at the ASCO annual meeting. Median overall survival was 17 months across all doses.
- Sanofi terminated internal development for iniparib after unfavorable results in a phase III trial for squamous NSCLC and in a phase II study for platinum-resistant ovarian cancer. Iniparib was designed to inhibit PARP1 but had been shown not to do so at pharmacologic concentrations.
- Among other results reported at the ASCO annual meeting, a phase III clinical trial in 940 women with advanced ovarian cancer found that treatment with the oral multikinase inhibitor pazopanib (Votrient; GlaxoSmithKline) following initial successful chemotherapy extended disease-free survival by an average of 5.6 months compared to placebo.
- The U.S. Food and Drug Administration approved two GlaxoSmithKline drugs, dabrafenib (Tafinlar) and trametinib (Mekinist), for patients with metastatic or unresectable melanoma. Dabrafenib, a BRAF inhibitor, was approved to treat patients with melanoma whose tumors harbor the BRAF V600E gene mutation. Trametinib, a MEK inhibitor, was approved to treat patients whose tumors harbor the BRAF V600E or V600K gene mutations. Both were approved with the THxID BRAF test (made by bioMérieux of Grenoble, France), which will help determine if tumors have the V600E or V600K mutation.
- When used in the frontline setting, the angiogenesis inhibitor bevacizumab (Avastin) failed to increase overall survival for patients newly diagnosed with glioblastoma, according to Mark Gilbert, MD, professor of neuro-oncology at The University of Texas MD Anderson Cancer Center in Houston, who presented the findings during the ASCO annual meeting plenary session. Although the drug did prolong progression-free survival by 3.4 months compared with placebo in the trial, which included 637 patients, that increase was not statistically significant. However, despite the findings, neuro-oncologist Howard Fine, MD, from New York University Medical Center in New York City, said, "I feel very strongly that bevacizumab represents the single most important therapeutic agent in glioblastoma since temozolomide," and that future trials should address how best to use it in patients.
- Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, received the ASCO Public Service Award at the organization's annual meeting. In accepting the award, Pazdur said, "Every day, I walk into my office with a smile on my face knowing that all voices have been heard, that our decisions are based on the best available scientific information, and our actions—free of both financial and academic conflicts of interest—are based on the underlying principles of ensuring safe and effective cancer medications for Americans."
- Among 78 patients with ALK+ metastatic non–small cell lung cancer (NSCLC) who took 750 mg of Novartis's ALK1 inhibitor LDK378 daily, the overall response rate was 60%, according to results of a phase I trial presented at the ASCO annual meeting. Two phase II trials are recruiting for testing LDK378 in this population, and phase III trials are being planned. In March, the U.S. Food and Drug Administration gave a Breakthrough Therapy designation to LDK378, and Novartis plans to apply for marketing approval for the drug in early 2014.
- In another PD-1 inhibitor trial reported at the ASCO annual meeting, 38% of patients with advanced metastatic melanoma treated with Merck's lambrolizumab (MK3475) responded to treatment. Results of the study, the first clinical trial for lambrolizumab, were also published in the New England Journal of Medicine.
- Sanofi terminated internal development for iniparib after unfavorable results in a phase III trial for squamous NSCLC and in a phase II study for platinum-resistant ovarian cancer. Iniparib was designed to inhibit PARP1 but had been shown not to do so at pharmacologic concentrations.
- Fibrous dysplasia has been found in a Neandertal rib more than 120,000 years old, reports a paper in PLOS One. "Evidence for cancer is extremely rare in the human fossil record," noted senior author David Frayer, PhD, of the University of Kansas in Lawrence. "This case shows that Neandertals, living in an unpolluted environment, were susceptible to the same kind of cancer as living humans."
May 30, 2013
- An analysis of 2,506 African American and 21,454 white men diagnosed with early prostate cancer showed that average time from diagnosis to initiation of treatment was seven days longer overall for African American patients than for white patients, according to a study in Cancer. Compared to white patients, African American patients also are less likely to undergo prostate screening, more likely to be diagnosed with advanced cancer, and less likely to receive aggressive treatment, noted senior author Ronald Chen, MD, MPH, of the University of North Carolina at Chapel Hill.
- Citigroup predicted that within 10 years, global sales of cancer immunotherapy drugs could grow to $35 billion yearly, making them the top-selling drugs ever.
- "We are going to have to change the way drugs are developed," remarked Janet Woodcock, MD, head of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research, in a speech to the Personalized Medicine Coalition in Washington, DC, reported by MedPage Today. "Ever-smaller subsets of patients are being identified, and we're really going to have to put our heads together and figure out how do you study these small subsets of diseases."
- Two thirds of patients who have been diagnosed with leukemia, melanoma, or non–small cell lung cancer report at least one type of nonadherent behavior, such as not taking their medication as directed, according to survey results presented by Kantar Health of New York, NY, at the International Society for Pharmacoeconomics and Outcomes Research Annual Meeting in New Orleans, LA.
- Giving pediatric patients with acute myeloid leukemia a liposomal formulation of anthracycline-based chemotherapy at a more-intense-than-standard dose during initial treatment may produce high survival rates without any added cardiotoxicity, according to a study published in Blood.
- Mayo Clinic of Rochester, MN, and Cancer Genetics of Rutherford, NJ, launched OncoSpire Genomics, a joint venture aiming to develop and commercialize cancer diagnostic tests that use next-generation sequencing. The venture's initial focus will be on hematological and urogenital cancers.
May 23, 2013
- The U.S. Food and Drug Administration (FDA) approved Xofigo (radium Ra 223 dichloride; Bayer) to treat men with metastatic castration-resistant prostate cancer that has spread to bones but not to other organs. "Xofigo binds with minerals in the bone to deliver radiation directly to bone tumors, limiting the damage to the surrounding normal tissues," noted Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA's Center for Drug Evaluation and Research.
- Novartis said that its everolimus (Afinitor) mTOR inhibitor significantly extended disease-free survival in women with HER2-positive advanced breast cancer who had had prior therapy. The phase III BOLERO-3 clinical trial compared treatment with everolimus plus trastuzumab and vinorelbine (Herceptin; Genentech) versus treatment with placebo plus trastuzumab and vinorelbine. The company will release results for the trial at the American Society for Clinical Oncology 2013 Annual Meeting in Chicago, IL, on June 2.
- Pfizer discontinued a phase III study of its antibody-drug conjugate inotuzumab ozogamicin in patients with relapsed or refractory CD22-positive aggressive non-Hodgkin lymphoma who were not candidates for intensive high-dose chemotherapy. An interim analysis concluded that treatment with inotuzumab ozogamicin plus rituximab (Rituxan; Genentech) did not improve overall survival compared to treatment with either bendamustine plus rituximab or gemcitabine plus rituximab. A phase III trial in adult acute lymphoblastic leukemia will continue for inotuzumab ozogamicin, which targets CD22.
- The global market for in vitro cancer diagnostic testing reached $4.8 billion in 2012 and will grow at 9% annually for the next few years, predicted a report from Kalorama Information of Rockville, MD.
- Oncolytics Biotech of Calgary, Alberta, Canada, said that in a phase II clinical trial of patients with metastatic melanoma treated with intravenous administration of its Reolysin oncolytic virus combined with carboplatin and paclitaxel, a preliminary analysis showed that 3 of 14 patients exhibited partial response and an additional 7 patients had stable disease. The company said that the preliminary results were very encouraging and support continued clinical studies.
- Philanthropist Hansjörg Wyss of Wilson, WY, doubled his support for the Wyss Institute for Biologically Inspired Engineering at Harvard University in Cambridge, MA, with a second $125 million gift. The 4-year-old Wyss Institute aims to solve complex challenges in healthcare and the environment via multidisciplinary research.
- In another major donation, philanthropist Lyda Hill of Dallas, TX, pledged $50 million to the Moon Shots program at The University of Texas MD Anderson Cancer Center in Houston, TX. The gift is the largest single private philanthropic contribution to date for the Moon Shots initiative, which is expected to cost $3 billion in its first decade.
- The UK National Institute for Health and Care Excellence (NICE) has advised the country's National Health Service against 2 uses of bevacizumab (Avastin; Genentech/Roche) for treatment of advanced ovarian cancer, saying that such uses would not be cost-effective. In May, NICE gave guidance against the use of bevacizumab with carboplatin and gemcitabine to treat the first recurrence of such cancer that returns 6 months or more after initial treatment with platinum-based chemotherapy. In December, NICE recommended against using bevacizumab in combination with paclitaxel and carboplatin as a first treatment for advanced ovarian cancer.
May 16, 2013
- The U.S. Food and Drug Administration (FDA) approved erlotinib (Tarceva; Astellas Pharma) for first-line treatment of metastatic non-small cell lung cancer in patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations. The indication was approved along with an EGFR-mutation companion diagnostic test from Roche Molecular Diagnostics.
- In a deal negotiated with the Global Alliance for Vaccines and Immunization, Merck and GlaxoSmithKline lowered pricing on their human papillomavirus vaccines to below $5 in the world's poorest countries. The cuts potentially could help to protect millions of girls from developing cervical cancer.
- As Takeda Pharmaceuticals of Tokyo reorganizes its research and development efforts, oncology research by its Millennium Pharmaceuticals subsidiary will be merged into Takeda's global research organization. President and chief executive officer Deborah Dunsire, MD, is leaving the Cambridge, MA-based company, acquired by Takeda in 2008.
- The National Cancer Institute has requested feedback from the research community about areas where state-of-the-art technology is insufficient for clinical care or for exploring biological or epidemiological facets of cancer.
- The University of Nebraska Medical Center and the Nebraska Medical Center broke ground for the Fred & Pamela Buffett Cancer Center in Omaha. The $323 million project will include the Suzanne and Walter Scott Cancer Research Center, a 252,000-square-foot research tower designed to hold 98 labs. The Nebraska legislature has pledged $50 million to support the research tower, which like the rest of the Cancer Center is scheduled for completion in 2016.
- In a phase II randomized trial among 130 postmenopausal women with advanced ER-positive breast cancer, treatment combining the aromatase inhibitor exemestane and the histone deacetylase inhibitor entinostat (Syndax Pharmaceuticals) extended progression-free survival (PFS) and overall survival over treatment with exemestane and a placebo. Protein lysine hyperacetylation in the entinostat-treated biomarker subset was associated with prolonged PFS, according to an article published in the Journal of Clinical Oncology.
- Eli Lilly announced that a phase III study failed to show a statistically significant increase in disease-free survival among patients with diffuse large B-cell lymphoma who were at high risk of relapse following rituximab-based chemotherapy and were treated with enzastaurin rather than placebo. The company has stopped development of enzastaurin, which is designed to inhibit the PKC-β and AKT pathways.
May 9, 2013
- The National Cancer Institute's (NCI) final fiscal year 2013 budget will be about $4.78 billion, a reduction of 5.8% from fiscal year 2012. Given NCI's fixed costs and a decision not to reduce salaries for NIH trainees, "other components of the budget must absorb the entire reduction, lowering their allocations by an average of over 7%," wrote NCI director Harold Varmus, MD, in a message sent to grantees on May 7. "We have had to make appreciable reductions in ongoing (non-competing) grants (about 6%), centers and other research programs (6.5%), and research and development contracts (8.5%). Similar or even larger reductions were applied to the discretionary parts of other budgets, such as research management and support and the intramural program. . . . We can now expect to fund slightly more than 1,000 new and competing grants—less, but only a bit fewer, than the nearly 1,100 funded in each of the past couple of years."
- The CD38 monoclonal antibody daratumumab (Janssen Research & Development) was given FDA "Breakthrough Therapy" designation for treatment of patients with advanced multiple myeloma who have received at least three prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent. The designation is intended to expedite the development and review time for promising new medicines.
- Minimal dose computed tomography offers much greater sensitivity in detecting new or recurrent lung cancer, with an equivalent amount of radiation, compared to conventional chest X-rays, according to a study of 271 patients presented by University of Toronto researchers at the American Association for Thoracic Surgery annual meeting in Minneapolis, MN.
- The U.S. Food and Drug Administration's (FDA) Oncologic Drug Advisory Committee recommended against approval of the investigational VEGF inhibitor tivozanib (Aveo and Astellas Pharma) for treatment of advanced renal cell carcinoma. Among their reasons, panelists emphasized that in a phase III trial comparing tivozanib to sorafenib, patients who started out on tivozanib showed slightly lower overall survival.
- The American Urological Association (AUA) updated its clinical guidelines for early detection of prostate cancer, bringing the guidelines closer to those of the American Cancer Society and the U.S. Preventive Services Task Force. The AUA guidelines now recommend against routine screening for men aged 40 to 54 at average risk of the disease or for men over 70. They also suggest that men aged 55 to 69 discuss screening with their doctors, and that those who proceed with screening have it done on a biennial schedule.
- The incidence of testicular cancer continues to climb among U.S. males, according to a study presented at the annual meeting of the AUA in San Diego, CA. Growth was highest among Hispanic men, for whom incidence climbed at an annual rate of 5.6% between 2002 and 2009, when it reached 6.3 in 100,000. Overall, nearly 8,000 new cases of the disease, the most common cancer for U.S. men between the ages of 15 and 34, are expected to be diagnosed this year.
- Intas Pharmaceuticals of Ahmedabad, India, launched a biosimilar version of rituximab (Rituxan; Biogen IDEC and Genentech) for treating non-Hodgkin lymphoma in that country.
May 2, 2013
- Adding genomics-based testing to standard diagnostic workups for endometrial cancer could change the recommended course of treatment for some women with the disease, according to a study of 373 women by The Cancer Genome Atlas (TCGA) project reported in Nature.
- In other TCGA work, published in the New England Journal of Medicine, researchers predicted that they have found nearly all the major mutations that occur in patients with acute myeloid leukemia.
- The U.S. Food and Drug Administration designated Merck's lambrolizumab (MK-3475) as a "Breakthrough Therapy" for the treatment of patients with advanced melanoma. The designation is intended to expedite the development and review of the antibody therapy, which targets the programmed death-1 inhibitory receptor expressed on activated lymphocytes.
- Girls receiving 2 doses of human papillomavirus (HPV) vaccines had immune responses to HPV-16 and HPV-18 infection that were noninferior to responses for young women who received 3 doses, according to a study in the Journal of the American Medical Association.
- The cost of treatments for chronic myeloid leukemia (CML) in the United States has reached unsustainably high levels and may result in patients being undertreated or untreated, declared a Blood article supported by more than 100 CML experts.
- The American Cancer Society Cancer Action Network predicted that the president's proposal to raise the federal cigarette tax by 94 cents would save the country more than $63 billion in long-term health-care expenses, including $821 million over 10 years from fewer smoking-related lung cancer cases.
- The General Court of the European Union issued an interim ruling that the European Medicines Agency should suspend its release of detailed patient-level data from clinical trials submitted for drug approvals.
- Among a cohort of more than 600,000 Norwegian men and women, female smokers showed a 19% increased risk of developing colon cancer compared with never-smokers, while male smokers had an 8%% increased risk of the disease compared with never-smokers, reported a study in Cancer Epidemiology, Biomarkers & Prevention.
April 25, 2013
- A history of non-melanoma skin cancer was significantly associated with a 15% higher risk of other primary cancers in men and a 26% higher risk of other primary cancers in women, according to a prospective study of 46,237 white men and 107,339 white women in PLOS Medicine.
- The breast cancer gene patents held by Myriad Genetics of Salt Lake City, UT, were debated before both the U.S. Supreme Court and the Australian Full Federal Court.
- Dartmouth-Hitchcock Medical Center in Lebanon, NH, will break ground this spring on a $116.5 million translational medical research building, focusing on cancer and other diseases.
- The Patient-Centered Outcomes Research Institute, an independent non-profit organization authorized by Congress in 2010, announced plans to spend up to $68 million to support development of a "National Patient-Centered Clinical Research Network," offering improved ability to conduct comparative clinical effectiveness research.
- The U.S. Supreme Court upheld the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the federal government authority to regulate tobacco.
- Epizyme of Cambridge, MA, which is developing small molecule histone methyltransferase inhibitors for cancer treatment, aims to raise up to $69 million in an initial public offering. The company is conducting a phase I trial of one inhibitor for mixed-lineage rearranged leukemia, and expects to begin a phase I/II trial of a second inhibitor for a genetically defined subtype of non-Hodgkin lymphoma by July.
- The average age for a scientist at BGI of Shenzhen, China, is 23, reported Nature Biotechnology's Bioentrepreneur Trade Secrets blog. "There is no existing talent; they all have to be trained," said Wang Jun, PhD, executive director of BGI, the world's largest genomics organization. "And the best way to train them is to recruit them from the top universities and to throw them into real projects."
- "In today's increasingly outcomes-focused, evidence-driven health care systems, biotech companies cannot afford to pursue an R&D strategy that only focuses on whether or not their drug works," said Glen Giovannetti, Global Life Sciences Leader at Ernst & Young in Boston, MA. "They need to also understand whether it will be valued and reimbursed by payers."
April 18, 2013
- In the proposed fiscal year 2014 U.S. presidential budget, the National Institutes of Health would receive $31.3 billion, compared to $28.4 billion in the current fiscal year following cuts imposed by the sequestration legislation. The National Cancer Institute would get $5.1 billion, compared to $4.8 billion this fiscal year.
- Beijing's Cancer Prevention and Control Research Office reportedly found that cancer has replaced cardiovascular disease as the leading cause of death in the city and predicted that annual cancer mortality in China will climb from about 2.5 million to 3 million deaths by 2020.
- Thermo Fisher Scientific of Waltham, MA, agreed to buy Life Technologies of Carlsbad, CA, for about $13.6 billion plus the assumption of about $2.2 billion in debt. Life Technologies supplies next-generation sequencing platforms (including Ion Torrent sequencers) and molecular diagnostic systems among its thousands of lab products and services.
- The Academy for Medical Development and Collaboration (AMDeC) has shut down operations. Based in New York, NY, the organization was formed 15 years ago to foster collaboration among medical research organizations in the metropolitan area. The consortium's accomplishments ranged from the New York Cancer Project, which studied more than 18,000 ethnically diverse New York City residents to understand factors in developing cancer, to the Facilities Instrumentation Resources Services & Technologies registry, designed to leverage core research facilities as a "virtual laboratory" for its members.
- The Delaware Cancer Consortium, the state's cancer control program, achieved a 41% reduction in colorectal mortality rates for African Americans, reports a study in the Journal of Clinical Oncology.
- Partly in a response to the spread of smoke-free environments, "the tobacco industry ramped up marketing expenditures on smokeless tobacco products nearly 120% between 2005 and 2008," according to the American Cancer Society (ACS) "Cancer Prevention & Early Detection Facts & Figures (CPED) 2013 report". The ACS estimates that this year about 174,100 cancer deaths in the United States will be caused by tobacco use.
- This year's $500,000 Albany Medical Center Prize in Medicine and Biomedical Research went to 3 cancer researchers: Nowell, MD, of the University of Pennsylvania; Janet Rowley, MD, of the University of Chicago; and Brian Druker, MD, of Oregon Health & Science University. Five Albany Prize recipients have subsequently won a Nobel Prize.
- Founded in 2009 to merge 2 startup diagnostic companies and apply circulating tumor cell technology to cancer treatment, On-Q-ity of Waltham, MA, has closed shop. "Crashing two Fords together doesn't make a Porsche," backer Bruce Booth, PhD, of Atlas Ventures, wrote in a Forbes commentary. "Trying to merge 2 really interesting diagnostic technologies embedded in 2 struggling, cash-burning businesses into one company and have it smoothly integrate was a very bad assumption."
April 4–11, 2013
- Hoping to reverse the downward trend of NIH funding, the Rally for Medical Research in Washington, DC, drew thousands of scientists and patient advocates, most of them joining the April 8th event from the American Association for Cancer Research (AACR) Annual Meeting 2013 across the street. "We're living in a time of huge medical need and enormous scientific opportunity, but we're cutting back," Marc Tessier-Lavigne, PhD, president of Rockefeller University, told the crowd. Pointing out that NIH spending comes to about $100 per person in the United States annually, compared with yearly health costs totaling around $8,000, Tessier-Lavigne described diminished research budgets as a form of Catch-22. "Funding medical research is a no-brainer," added Chris Van Hollen, a member of the U.S. House of Representatives from Maryland. "We need to invest in our future."
- With its budget dropping about 5% this year, the National Cancer Institute (NCI) is seeking to maintain grant funding to the extent that is possible and otherwise "trimming everything we can trim," NCI director Harold Varmus, MD, told attendees at the AACR annual meeting, held April 6–10. "NCI still has a budget of $4.8 billion, and a lot can be done with that."
- In founding Stand Up To Cancer 5 years ago, "We wanted to break down some of the walls and some of the unhealthy competition in cancer research," remarked journalist and TV talk show host Katie Couric, who received the 2013 AACR Award for Distinguished Public Service at the conference. "Our scientists have learned that to collaborate and to share everything from clinical trial findings to tissue samples to their experiences and frustrations has had a profound impact on the way they're conducting their research."
- Stand Up To Cancer and the St. Baldrick's Foundation of Monrovia, CA, announced a new pediatric cancer Dream Team, with a $14.5-million grant focusing on difficult childhood cancers. The 4-year effort will be co-led by John Maris, MD, of the Children's Hospital of Philadelphia in Philadelphia, PA, and Crystal Mackall, MD, of the Pediatric Oncology Branch of the National Cancer Institute.
- If the U.S. Food and Drug Administration (FDA) uses its Accelerated Approval process correctly, "there will be drugs that have to come off the market," commented Richard Pazdur, MD, director of the agency's Office of Oncology Drug Products, during a session about regulatory affairs at the AACR annual meeting. "If we're demonstrating the right degree of flexibility, there will be successes and there will be failures."
- While the FDA has not been given authority to take drug pricing into account when weighing drug approvals, "we're trying to be ethically pure in not considering cost, but we're being socially blind in not doing so," commented Mikkael Sekeres, MD, MS, of the Cleveland Clinic in Cleveland, OH, chair of the FDA Oncologic Drug Advisory Committee, in the same session.
- BIND Biosciences of Cambridge, MA, changed its name to BIND Therapeutics and signed a collaboration agreement with Pfizer under which the company could receive up-front and development milestone payments totaling approximately $50 million, plus about $160 million in regulatory and sales milestone payments, for each drug commercialized.
- Asked at the AACR meeting why his company is so interested in the chimeric antigen receptor T cell therapies it is developing in its partnership with the University of Pennsylvania, William Sellers, vice president and global head of oncology at Novartis Institutes for BioMedical Research in Cambridge, MA, had a quick answer. "It was very simple," Sellers said. "It had the potential to cure cancer. This is pretty rare."
- As the era of personalized medicine begins, a huge spectrum of potential treatments, ranging from FDA-approved drugs to drugs in clinical trials to investigational agents in pre-clinical studies, raises the question "What is 'clinically available' for cancer patients today?" said Charles Perou, PhD, of the University of North Carolina at Chapel Hill, at the meeting. "Each institution has a different place to draw that line. We need medical societies to help us make the decision."
- In a decision closely followed by drug manufacturers around the world, the Indian Supreme Court allowed makers of generic drugs to keep copying Novartis's Gleevec (imatinib mesylate), known as Glivic outside the United States. The ruling heightened major concerns among pharmaceutical and biotech firms about their intellectual property rights in India and other developing countries. Analysts noted that most people in India cannot afford even the generic price of $170 per month for the drug, given an average annual per capita income estimated at below $200.
- The American Society of Clinical Oncology (ASCO) demonstrated a prototype of CancerLinQ, a major initiative to offer a "learning health system" that boosts cancer care and research. The prototype includes de-identified data from 100,000 U.S. patients with breast cancer. "Only the 3% of patients who participate in clinical trials are able to contribute to advances in treatment," commented Sandra Swain, MD, president of ASCO. "CancerLinQ will transform cancer care by unlocking that wealth of information and enabling every patient to be a cancer knowledge donor."
- Clavis Pharma of Oslo, Norway, disclosed that the phase III CLAVELA study among patients with relapsed or refractory acute myeloid leukemia showed no significant difference in overall survival between those treated with the company's drug, elacytarabine (CP-4055), as opposed to the investigator's choice of treatment. Clavis suspended all development work on elacytarabine, which combines the chemotherapy agent cytarabine with a fatty acid.
- In a randomized study of 231 patients with chemotherapy-induced peripheral neuropathy, use of the antidepressant drug duloxetine for 5 weeks led to a greater reduction in pain compared with placebo, according to a study published in JAMA. About 20% to 40% of patients with cancer who receive neurotoxic chemotherapy develop painful chemotherapy-induced peripheral neuropathy, which can persist from months to years beyond treatment, the researchers noted.
March 28, 2013
- The UK National Health Service (NHS) has launched its first multi-gene test for cancer patients using next-generation sequencing technology. Researchers at the University of Oxford and Oxford University Hospitals NHS Trust said that the 46-gene test "heralds the arrival of genomic medicine, with whole genome sequencing of patients just around the corner."
- Incidence of anal carcinoma increased dramatically in U.S. men and women after 1997, according to an analysis of Surveillance, Epidemiology, and End Results data reported in the Journal of Clinical Oncology.
- After scientists at the European Molecular Biology Laboratory in Heidelberg published genome sequencing data on a HeLa cell line in an early online article in G3: Genes, Genomes, Genetics, some data were pulled from public view when privacy concerns were raised and descendants of Henrietta Lacks said they had not been consulted. "We are actively working to arrive at a solution where the final published manuscript and associated data address the concerns raised while maintaining the standards of the Genetic Society of America journals and our data policy," said Brenda Andrews, PhD, editor-in-chief of the journal.
- Incidence of anal carcinoma increased dramatically in U.S. men and women after 1997, according to an analysis of Surveillance, Epidemiology, and End Results data reported in the Journal of Clinical Oncology.
- Cerulean Pharma of Cambridge, MA, said that in a randomized phase IIb study among 157 patients with advanced non-small cell lung cancer, its CRLX101 nanopharmaceutical did not meet the primary efficacy endpoint of overall survival. A dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1α, CRLX101 is designed to release its camptothecin payload over an extended period of time. The agent is being studied in 4 other ongoing clinical trials.
- The total number of U.S. cancer survivors is expected to rise from approximately 13.7 million in 2012 to 18 million by 2022, reports the American Association for Cancer Research's Second Annual Report on Cancer Survivorship, published in Cancer Epidemiology, Biomarkers & Prevention.
- Stanford University of Medicine and Lucile Packard Children's Hospital in Palo Alto, CA, received a $6.9 million NIH grant to study post-transplant lymphoproliferative disorder, a malignancy of the white blood cells that strikes children who have received solid organ transplants.
- Of the 13 anticancer drugs the U.S. Food and Drug Administration approved in 2012, "only one may extend life by more than a median of six months," noted Ezekiel Emanuel, MD, and 21 coauthors in a commentary in the New York Times. "All cost more than $5,900 per month of treatment."
March 21, 2013
- AstraZeneca will cut 1,600 research jobs and consolidate most of its drug development work at centers in Cambridge, UK; Gaithersburg, MD; and Mölndal, Sweden. The company will invest around $500 million in a new research facility in Cambridge and shift its global headquarters there as well.
- "The FDA has yet to receive an application for a biosimilar or interchangeable product, but we know there is much industry interest in them," FDA Director Margaret Hamburg, MD, told the Massachusetts Biotechnology Council on March 15 in Boston. "As of yesterday, FDA's drugs center had received 51 requests for meetings on 12 different biological products, it had held 38 initial meetings with potential sponsors, and had received 15 Investigational New Drug applications for biosimilar development programs."
- The U.S. Food and Drug Administration (FDA) is evaluating unpublished reports that suggest an increased risk of pancreatitis and pancreatic duct metaplasia in patients with type 2 diabetes treated with incretin mimetic drugs.
- Novartis's LDK378 ALK inhibitor has received Breakthrough Therapy designation from the FDA for treatment of patients with ALK+ metastatic non–small cell lung cancer whose disease progressed during treatment with crizotinib (Xalkori; Pfizer) or who could not tolerate crizotinib.
- Initial results of the Zometa European Study showed no difference in the incidence of bone metastasis in high-risk metastatic prostate cancer patients who were treated with zoledronic acid (Zometa; Novartis) versus those in a control arm, according to results presented at the European Association of Urology Congress in Milan, Italy, on March 19.
- Amgen said that in a phase III trial for more than 400 patients with advanced melanoma, talimogene laherparepvec treatment showed a statistically significant improvement in the primary endpoint of durable response rate compared with subcutaneous granulocyte-macrophage colony-stimulating factor. Talimogene laherparepvec is an oncolytic immunotherapy designed to cause local lytic destruction of tumors and to stimulate a systemic antitumor immune response. Durable response rate was defined as the rate of complete or partial response lasting continuously for at least 6 months.
- The MEK-1/2 inhibitor selumetinib (AZD6244; AstraZeneca) failed to meet planned endpoints in a phase II trial for women with recurrent or persistent endometrial cancer, researchers reported at the Society of Gynecologic Oncology annual meeting in Los Angeles, CA, on March 10.
- Chronic fatigue is at least 3 times more prevalent among adult survivors of acute lymphoblastic leukemia and lymphoma experienced during childhood or adolescence than in the general adult population, according to an article in the Journal of Adolescent and Young Adult Oncology.
- Almost half of U.S. parents say they won't have their teenage daughters vaccinated against the human papilloma virus (HPV), according to a report in Pediatrics. The percentage of parents opposing the vaccine climbed from 40% in 2008 to 44% in 2010. "HPV causes essentially 100% of cervical cancer, and 50% of all Americans get infected at least once with HPV," noted senior author Robert Jacobson, MD.
March 14, 2013
- Aeterna Zentaris of Quebec City, Canada, will discontinue an ongoing phase III study comparing its perifosine to placebo when combined with bortezomib (Velcade; Millennium Pharmaceuticals) and dexamethasone in patients with relapsed or relapsed/refractory multiple myeloma. An interim analysis suggested little likelihood that significant improvement would be reached in the primary endpoint of progression-free survival for treatment with perifosine, which inhibits AKT and RAF/MEK/ERK signaling.
- Vaccine developer Biovest International of Tampa, FL, has entered its second bankruptcy. During its reorganization process, Biovest plans to continue seeking approvals in the European Union and Canada for its BiovaxID personalized vaccine for treatment of follicular non-Hodgkin's lymphoma.
- Around the world, nearly 28,000 principal investigators ran clinical studies in 2012, with 61% of them based in North America, down from 84% in 1996, said an analysis from the Tufts Center for the Study of Drug Development in Boston.
- The Rally for Medical Research, which aims to raise awareness about the need for increased investment in the National Institutes of Health, expects to draw more than 8,000 supporters in Washington, DC, on April 8.
- Women are 30% less likely to die of ovarian cancer within 5 years if they receive guideline-recommended treatment, but 63% of them don't get that care, reported a study of 13,321 patients presented at the Society of Gynecologic Oncology Annual Meeting on Women's Cancer in Los Angeles on March 11. Each year more than 15,000 women die of ovarian cancer in the United States, where it is the fifth leading cause of cancer-related mortality among women.
- Median time to publication among 1,336 clinical trials published in 2009 was 21 months, according to a study in JAMA Internal Medicine. Time to publication was slightly longer for trials funded by industry (24 months) than for trials funded by government and non-profit organizations (20 months).
March 7, 2013
- As the U.S. federal budget sequester funding cuts kick in, the National Cancer Institute (NCI) and the other National Institutes of Health will decrease spending by about 5% for the fiscal year that started October 1. NCI has not disclosed details on how these funds will be adjusted. "Almost every segment will have to take some reduction," director Harold Varmus, MD, told the NCI scientific advisory board on March 4. "We don't want the most vulnerable part of the budget–grants–to absorb the whole burden." The sequester will intensify the limitations of budgets that have been steadily dropping in real dollars, and Varmus acknowledged that downsizing spending further by trimming the amounts of individual grants is becoming increasingly difficult. "I know this is a problem," he said. "The cost per postdoc in a lab is going up steadily. We can't reduce the size of grants forever."
- Sponsored by Cancer Research UK and the Citizen Science Alliance, a "GameJam" event brought together scientists with technology gurus to design a mobile game to accelerate cures for cancer. The London workshop aimed to identify engaging and scientifically meaningful ways for the public to help analyze gene data. This effort is the second game collaboration by the 2 organizations; the first game, Cell Slider, launched in October 2012, analyzes archived cancer tissue samples.
- A study by the National Foundation for American Policy revealed that among a group of 1,500 researchers at 7 leading U.S. comprehensive cancer centers, 42% are immigrants, with 56 countries represented. Among these foreign-born scientists, 21% came from China, 10% from India, 7% from Germany, 7% from Canada, and 6% from the UK.
- In 2012, use and costs for cancer medications increased by 3.4% and 22.3%, respectively, in the United States, reported Express Scripts of St. Louis, MO, a company that manages more than a billion prescriptions each year.
- Among 1,139 women newly diagnosed with breast cancer, 23% described symptoms of posttraumatic stress disorder, according to results from a study reported in the Journal of the National Cancer Institute.
- An Indian patent appeal board turned down an appeal from Bayer Healthcare to reject a compulsory license allowing sales of a generic version of Nexavar (sorafenib), used to treat liver and kidney cancer.
February 28, 2013
- The U.S. Food and Drug Administration (FDA) approved the multikinase inhibitor Stivarga (regorafinib; Bayer HealthCare Pharmaceuticals) to treat patients with advanced gastrointestinal stromal tumors (GIST) whose tumors cannot be removed surgically and who no longer respond to other drugs. In a clinical study of 199 patients with GIST that progressed after treatment with imatinib (Gleevec; Novartis) or sunitinib (Sutent; Pfizer), tumor progression was delayed by an average of 3.9 months longer in those who took Stivarga as opposed to a placebo. Stivarga was approved for the treatment of colorectal cancer in September 2012.
- The National Cancer Institute announced that its Provocative Questions program is accepting applications for funding again this year. The initiative supports research on 24 questions related to cancer risk prevention, development, detection, diagnosis, and treatment that have been notoriously difficult to answer, under-studied, or brought about by new discoveries. For a list of questions, many of which are new or have been rewritten, and application deadlines, visit http://provocativequestions.nci.nih.gov/?cid=WTq_cgov.
- Abbott Laboratories is working with Johnson & Johnson to create a genetic diagnostic test to help identify which patients with chronic lymphocytic leukemia are most likely to benefit from the promising investigational drug ibrutinib. Johnson & Johnson and Pharmacyclics, Inc., are developing the drug, which recently received the new "breakthrough therapy" designation from the FDA. This designation is awarded to experimental drugs with the potential to offer substantial improvements over existing medicines in an effort to get them to patients faster.
- A phase III trial conducted by Germany's Merck KGaA of its experimental drug cilengitide showed that, when combined with the standard chemotherapy temozolomide and radiotherapy, the drug did not significantly increase survival in patients newly diagnosed with glioblastoma and methylated MGMT gene promoter status. A phase II study of the drug will continue in patients whose tumors have an unmethylated MGMT gene promoter status.
- The head of the Broad Institute in Cambridge, MA, a leader in the human genome project and an advisor to President Obama, Eric Lander, PhD, has filed an amicus brief with the U.S. Supreme Court, offering his personal views on legal challenges to Myriad Genetics' patents on the BRCA1 and BRCA2 genes. Although the brief notes that it is "in support or neither party," it argues that Myriad's patents "create an insurmountable barrier to scientific innovation." The Supreme Court is expected to hear the case in April.
- The family of Francis Crick, who discovered the structure of DNA with James Watson, has put a letter he wrote to his son about the discovery in 1953 and his Nobel Prize medal, along with other heirlooms, up for auction. Experts estimate that the medal is worth $500,000 and that the letter will fetch between $1 million and $2 million. A portion of the proceeds will benefit the Salk Institute and the Francis Crick Institute, scheduled to open in London, England, in 2015.
February 21, 2013
- The U.K. National Institute for Health and Clinical Excellence issued a draft recommendation for the use of the Oncotype DX assay in guiding chemotherapy decisions for people with estrogen receptor–positive, HER2-negative, and lymph node–negative early breast cancer. The recommendation followed a revised pricing agreement with the test provider, Genomic Health of Redwood City, CA.
- Abbott Laboratories spinoff AbbVie of North Chicago, IL, suspended phase II trials of its experimental BCL-2 inhibitor ABT-199 leukemia drug following 2 patient deaths.
- Peregrine Pharmaceuticals of Tustin, CA, announced that in a phase III clinical trial in patients with previously untreated advanced pancreatic cancer, treatment with bavituximab in combination with gemcitabine led to a median overall survival of 5.6 months, barely above survival for 5.2 months with gemcitabine alone. Bavituximab, a first-in-class phosphatidylserine-targeting monoclonal antibody, is being tested in 7 clinical trials, the company said.
- The market for breast cancer therapies in Brazil, Russia, India, and China will climb from $1.7 billion in 2012 to $2.5 billion in 2017, predicts Decision Resources of Burlington, MA. During that period, the use of targeted therapies in those countries is expected to rise from $615 million to $1.16 billion.
- Relative survival rates for patients with advanced renal cell carcinoma (RCC) have not improved in the era of targeted agents, according to data presented by Binay Shah, MD, of Saint Joseph Regional Medical Center in Lewiston, Idaho, at the American Society for Clinical Oncology (ASCO) Genitourinary Cancers Symposium in Orlando, FL. One-year relative survival rates from 2001 to 2004 and from 2006 to 2009 were 27.0% and 27.1%, respectively.
- Final results from a phase III trial comparing 2 drug treatments for use in patients with advanced RCC showed no meaningful statistical difference in overall survival between treatments with the VEGF inhibitor tivozanib (AVEO Oncology and Astellas Pharma) or with sorafenib (Nexavar; Bayer Healthcare and Onyx Pharmaceuticals), as presented at the ASCO Genitourinary Cancers Symposium. Previously reported results from the TIVO-1 (TIvozanib Versus sOrafenib in 1st line advanced RCC) trial had shown that tivozanib provided a statistically significant improvement in progression-free survival, the primary endpoint of the study, when it was compared with sorafenib.
- Each year in the United States, alcohol is responsible for about 20,000 cancer deaths, accounting for about 3.5% of all cancer mortality, according to an article in the American Journal of Public Health. Average consumption of 1.5 drinks per day or less accounted for 30% of all alcohol-attributable cancer deaths, said researchers at Boston University School of Medicine and School of Public Health.
February 14, 2013
- Janssen Research & Development of Raritan, NJ, and Pharmacyclics of Sunnyvale, CA, announced that the U.S. Food and Drug Administration (FDA) gave "Breakthrough Therapy" designations to their oral agent ibrutinib as a monotherapy for 2 B-cell malignancies: relapsed or refractory mantle cell lymphoma and Waldenstrom macroglobulinemia. Ibrutinib, designed to target Bruton tyrosine kinase, is the first oncology drug to receive a Breakthrough Therapy designation, given on the basis of at least one clinically significant endpoint such as substantial treatment effects in early clinical development.
- The National Cancer Institute released draft guidelines aimed to improve practices in the creation and analysis of tests used for genomic-based classification of patients in clinical trials.
- Geographic site, demographic factors, adherence to initial therapy, and infection recurrence may be as important as the choice of antibiotic regimen in eradicating Helicobacter pylori, according to a study in 7 Latin American communities published in the Journal of the American Medical Association. The bacterium infects more than half of the world's adults, and chronic infection is the dominant risk factor for gastric cancer.
- The Breast Cancer and the Environment: Priority and Prevention report published what was said to be the largest survey to date of peer-reviewed science on breast cancer and the environment. Compiled by the congressionally mandated Interagency Breast Cancer and Environmental Research Coordinating Committee, the report calls for a national breast cancer prevention strategy to prioritize and increase investments in breast cancer prevention.
- From 1989 to 2008, California's tobacco control program cost $2.4 billion but reduced health care costs by $134 billion, said researchers at the University of California, San Francisco, in PloS One.
- The FDA approved Pomalyst (pomalidomide; Celgene) to treat patients with relapsed or refractory multiple myeloma who have received at least 2 prior therapies, including lenalidomide and bortezomib. "Pomalyst is the third drug in a class of immunomodulatory agents that includes lenalidomide and thalidomide and is the second drug approved in the past year to treat multiple myeloma," notes Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in FDA's Center for Drug Evaluation and Research.
February 7, 2013
- Genentech of South San Francisco, CA, announced that its obinutuzumab (GA101) demonstrated an improvement in progression-free survival among people with previously untreated chronic lymphocytic leukemia in a phase III trial's first stage. The study compared the efficacy and safety of this investigational drug in combination with chlorambucil chemotherapy with the efficacy and safety of chlorambucil alone. Obinutuzumab is the first glycol-engineered, type 2 anti-CD20 monoclonal antibody in development for B-cell malignancies, according to the company.
- Celsion of Lawrenceville, NJ, said that its ThermoDox heat-activated formulation of liposomal doxorubicin combined with radiofrequency ablation did not meet the primary endpoint of progression-free survival in a phase III study among 701 patients with hepatocellular carcinoma.
- About 60% of respondents in a survey of 4,341 people in 6 countries revealed their belief that pharmaceutical companies are more interested in treating cancer than curing it. These responses were part of the Patient Access to Cancer Care Excellence (PACE) survey of cancer knowledge and attitudes, sponsored by Lilly.
- In the United States, cancer mortality rates for men are dropping faster among African Americans than among whites, according to an American Cancer Society (ACS) report published in CA: A Cancer Journal for Clinicians. However, racial disparities have widened for colorectal cancer and female breast cancer, and 5-year relative survival rates are lower for African Americans than whites for most cancers at each stage of diagnosis. "These disparities largely reflect unequal access to health care and other socioeconomic factors," says Otis W. Brawley, MD, ACS chief medical officer.
- "Personalized medicine is the dream of every oncologist and the legitimate expectation of every cancer patient," says Martine Piccart, MD, PhD, president of the European Society of Medical Oncology. "But there is clearly a long way to go towards achieving this goal. We need to collaborate very intensively with partners in and outside of Europe and make sure we don't sit back in the myth that personalized cancer medicine is already here."
January 31, 2013
- Following a state audit, the Cancer Prevention and Research Institute of Texas in Austin is pulling the plug on the Statewide Clinical Trials Network of Texas, which is closing down the clinical trials it was launching with partners across the state.
- The U.S. Food and Drug Administration (FDA) approved the use of Gleevec (imatinib; Novartis) in combination with chemotherapy to treat children newly diagnosed with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukemia. The tyrosine kinase inhibitor was approved in 2011 to treat children newly diagnosed with Ph+ chronic myeloid leukemia.
- The time required for regulatory approval for starting clinical research varied widely across geographic regions in the Adjuvant Lapatinib and/or Trastuzumab Treatment Optimization (ALTTO) international phase III study, according to an analysis in The Oncologist. The median time to regulatory approval was 236 days in South America, 62 days in the Asia-Pacific, 52 days in Europe, and 26 days in North America, the study reported.
- The FDA also gave a thumbs-up to Avastin (bevacizumab; Genentech) plus an irinotecan- or oxaliplatin-containing chemotherapy for second-line treatment of patients with metastatic colorectal cancer who had been initially treated with Avastin along with a different irinotecan- or oxaliplatin-containing chemotherapy.
- Stemline Therapeutics of New York, NY, which develops therapeutics that target cancer stem cells and tumor bulk, raised about $38 million in the first U.S. biotech initial public offering of 2013.
- In the United Kingdom, boys born in 2015 will have almost triple the risk of being diagnosed with prostate cancer later in life as that of boys born in 1990, primarily due to increased use of prostate-specific antigen testing, predicts Cancer Research UK.
January 17, 2013
- U.S. cancer death rates dropped from their peak of 215.1 per 100,000 people in 1991 to 173.1 per 100,000 in 2009, with mortality rates continuing to fall for lung, colorectal, breast, and prostate cancer, according to the American Cancer Society's annual Cancer Statistics report. While incidence rates are declining for most cancers, they are increasing among both men and women for melanoma of the skin and cancers of the liver, thyroid, and pancreas, the report says.
- Daiichi Sankyo of Tokyo, Japan, and ArQule of Woburn, MA, announced that in a phase II trial in patients with refractory or relapsed colorectal cancer, the MET inhibitor tivantinib (ARQ 197) used in combination with irinotecan and cetuximab did not meet the trial endpoints of progression-free survival and objective response rate.
- Ezatiostat HCL (Telintra), a drug manufactured by Telik of Palo Alto, CA, has been granted orphan drug designation by the FDA for treatment of myelodysplastic syndrome. The drug inhibits the enzyme glutathione S-transferase P1-1, leading to activation of Jun kinase, a key regulator of cellular growth and differentiation of blood precursor cells, according to the company.
- Smartphone applications designed to evaluate photographs of skin lesions for the likelihood of cancer often return inaccurate results, according to a study published in JAMA Dermatology
- Morphotek of Exton, PA, said that in a phase III study, the combination of farletuzumab with carboplatin and a taxane did not meet the primary endpoint of progression-free survival in patients with platinum-sensitive epithelial ovarian cancer experiencing their first relapse. Farletuzumab is a monoclonal antibody that binds to folate receptor-α, a folate-binding protein expressed on ovarian and other epithelial cancer cells.
- The U.S. Food and Drug Administration (FDA) will give priority review to afatinib for treatment of locally advanced or metastatic non–small cell lung cancer (NSCLC) with an epidermal growth factor receptor mutation detected by an FDA-approved test. Under development by Boehringer Ingelheim Pharmaceuticals of Ridgefield, CT, afatinib is an ErbB family inhibitor in phase III clinical trials for advanced NSCLC, head and neck cancers, and breast cancers.
- Worldwide revenues for small-molecule cancer drugs reached $21.7 billion in 2011 and will rise to $32.7 billion in 2016, estimated Visiongain of London in a market research report. Separately, the global market for breast imaging technologies will climb to about $5 billion by 2017, estimated the research firm MarketsandMarkets of Dallas, TX.
January 10, 2013
- Overall U.S. cancer death rates dropped by 1.8% per year for men, 1.4% for women, and 1.8% for children from 2000 to 2009, according to the 2013 Annual Report to the Nation on the Status of Cancer. Overall cancer incidence rates declined by 0.6% per year for men, remained stable for women, and increased by 0.6% per year for children during that period. Additionally, the study revealed increased incidence rates for certain cancers related to human papillomavirus (HPV) and called for increased efforts to boost HPV vaccination coverage.
- Created to facilitate multi-institutional cancer research, the Statewide Clinical Trials Network of Texas has signed agreements with 20 research institutions and community-based oncology groups.
- President Obama signed the Recalcitrant Cancer Research Act into law. Originally known as the Pancreatic Cancer Research and Education Act, the bill mandates that the National Cancer Institute evaluate its efforts in pancreatic cancer, lung cancer, and other recalcitrant cancers, and focus on ways to improve outcomes.
- BIND Biosciences of Cambridge, MA, agreed with Amgen of Chesterbrook, PA, to collaborate on a kinase inhibitor nanomedicine for treatment of a range of solid tumors. The nanomedicine will be the first application of BIND's tissue-targeting delivery technology to molecularly targeted drugs.
- Patients with non–small cell lung cancer who took beta blockers while receiving radiotherapy survived longer, reported a study in Annals of Oncology. Researchers found that 155 patients who were on beta blockers for conditions such as high blood pressure and heart disease lived an average of 23.7 months compared with an average of 18.6 months for 567 patients who were not on beta blockers.
- Sanofi in Malvern, PA, has stopped work on the vascular disrupting agent ombrabulin, on which it partnered with Ajinomoto of Tokyo, Japan. A phase III clinical trial of the drug in sarcoma failed to show sufficient clinical benefit to support marketing approval submissions, and a phase II study in ovarian cancer was shut down after an interim analysis, Sanofi said.
- Funding levels for the NIH and other U.S. federal agencies remain unclear as last-minute legislation pushed off the date of automatic "sequestration" budget cuts to March 1. The agencies are now operating under a continuing budget resolution that expires at the end of March.
- For patients with a life expectancy of less than 10 years, the harms of breast and colorectal cancer screening are likely to outweigh the benefits, according to a study analyzing 5 breast and 4 colorectal cancer screening trials that was published in BMJ.
January 3, 2013
- In 2012, the U.S. Food and Drug Administration (FDA) approved 13 drugs that target cancer.
- After years of financial difficulties, the Nevada Cancer Institute in Las Vegas will close on January 31.
- Formerly known as the Pancreatic Cancer Research and Education Act, the Recalcitrant Cancer Research Act passed Congress as part of the National Defense Authorization Act that is awaiting President Obama's signature. The bill mandates that the National Cancer Institute evaluate its efforts in pancreatic cancer, lung cancer, and other recalcitrant cancers, and focus on ways to improve outcomes.
- Rates of preventive cancer screenings in the United States showed some dips from 1999 to 2010, with substantial differences between rates for white-collar and blue-collar workers, according to a study led by University of Miami researchers with results published in Frontiers in Cancer Epidemiology and Prevention.
- BGI-Shenzhen of Senzhen, China, announced its approval from the Committee on Foreign Investment in the United States (CFIUS) to acquire DNA sequencing firm Complete Genomics of Mountain View, CA. CFIUS is an interagency group led by the U.S. Treasury Department that reviews investments in U.S. companies from a national-security perspective.
- The FDA has given Aeterna Zentaris of Quebec City, Quebec, Canada, a special protocol assessment (SPA) for an open-label, randomized phase III trial of about 500 women that will compare the doxorubicin peptide conjugate AEZS-108 with doxorubicin as second-line therapy for locally advanced, recurrent, or metastatic endometrial cancer. The grant of the SPA indicates that the trial design, endpoints, and planned analyses are suitable for a regulatory submission. AEZS-108 is in phase II trials in prostate, breast, and bladder cancer, the company said.