The FDA approved a blood test to help detect colorectal cancer. Called Shield (Guardant Health), the test can be used for initial screening of adults ages 45 and older at average risk of the disease. It is the first approved blood test for the condition. The agency’s thumbs-up means that the test meets performance measures that insurers, including Medicare, require for coverage. In a study conducted at more than 200 clinical sites in 37 states, Shield demonstrated 83% sensitivity for the detection of colorectal cancer, with 90% specificity for advanced neoplasia ( N Engl J Med 2024;390:973–83 ). The hope is that this straightforward test will increase the rate of colorectal cancer screening in the United States, which hovers around 59%. In a study of more than 100,000 people, researchers found that those with less healthy lifestyles were more likely to reduce their risk of colorectal cancer with regular aspirin use than those with healthier behaviors ( JAMA Oncol 2024 Aug 1 [Epub ahead of print] ). Regular aspirin use was defined as two or more 325 mg tablets a week or a daily 81 mg dose; less healthy lifestyles were characterized by higher body mass index, smoking, greater alcohol consumption, less physical activity, and poorer diet. Those with the unhealthiest lifestyles had a 3.4% chance of developing colorectal cancer if they didn’t take aspirin regularly, whereas those who did had a 2.1% chance of developing the disease. In contrast, people with the healthiest lifestyles had a 1.5% chance of developing colorectal cancer if they took aspirin regularly and a 1.6% chance if they didn’t. This result suggests that physicians can pursue a nuanced approach when prescribing aspirin for disease prevention. The FDA approved Janssen’s daratumumab and hyaluronidase-fhij (Darzalex Faspro) in combination with bortezomib, lenalidomide, and dexamethasone, for patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplantation. Efficacy was evaluated in the PERSEUS trial, in which 709 patients ages 70 and younger were assigned to receive all of the drugs or just bortezomib, lenalidomide, and dexamethasone. Treatment with daratumumab/hyaluronidase and the other agents yielded a 60% decrease in the risk of disease progression or death, as well as an improvement in progression-free survival (PFS), compared to the control arm.   The FDA expanded the indication for dostarlimab (Jemperli; GSK) with carboplatin and paclitaxel, followed by single-agent dostarlimab, to treat adults with primary advanced or recurrent endometrial cancer. This treatment regimen for the drug, which binds to PD1 to block interactions with PD-L1 and PD-L2, was OK’d in July 2023 to treat primary advanced or recurrent endometrial cancer that is mismatch repairdeficient or microsatellite instability-high. The new approval was based on results of the phase III RUBY study, which found statistically significant improvements in PFS and overall survival (OS) in the cohort that received dostarlimab compared with the group that received placebo with carboplatin and paclitaxel followed by placebo. Incyte discontinued development of five oncology drugs —two oral PD-L1 inhibitors, a LAG-3 mAb, a TIM-3 mAb, and a LAG-3xPD1 bispecific antibody—to “focus on innovative high-impact clinical programs.” However, during an earnings call with investors, executives also announced positive topline results from two phase III clinical trials evaluating retifanlimab (Zynyz). In squamous cell anal carcinoma, the humanized mAb targeting PD1 met its primary endpoint of PFS; in non–small cell lung cancer, the drug met its primary endpoint of OS. Full results will be shared later this year.

The European Commission approved CStone Pharmaceuticals’ sugemalimab (Cejemly), combined with chemotherapy, as an initial treatment for patients with squamous or non-squamous metastatic non–small cell lung cancer (NSCLC) with no sensitizing EGFR mutations or ALK , ROS1 , or RET aberrations. The decision was based on results of the phase III GEMSTONE-302 trial, which demonstrated that the anti–PD-L1 mAb sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival compared with placebo and chemotherapy. The FDA released final guidance on the use of “real-world” data and electronic health records. The publication is intended to provide drug sponsors and others with “considerations when proposing to use electronic health records or medical claims data in clinical studies to support a regulatory decision for effectiveness or safety.” The guidance is available at https://www.fda.gov/media/152503/download . In May, the FDA issued a final rule for regulating laboratory-developed tests (LDT; see Cancer Discov 2024 Jun 25 [Epub] ). But now, as part of its funding recommendations for fiscal year 2025, the U.S. House Appropriations Committee “directs the FDA to suspend its efforts to implement the rule and continue working with Congress to modernize the regulatory approach to LDTs.” Lawmakers believe that the proposed regulatory framework “is a significant shift in the way LDTs are regulated and changed expectations for patients, doctors, and laboratories … at the risk of greatly altering the laboratory testing infrastructure and reducing patient access to information that informs their healthcare decision making.” As for its funding recommendation, the Appropriations Committee called for an allocation of $3.5 billion for the FDA , which would be added to $3.25 billion in user fees. The full House must approve the legislation and work with the U.S. Senate to determine the final appropriation. To read the legislation, see https://docs.house.gov/meetings/AP/AP00/20240710/117503/HMKP-118-AP00-20240710-SD004.pdf . The FDA authorized the marketing of several e-cigarette products. Following what it called “an extensive scientific review,” the agency gave an OK to R.J. Reynolds Vapor Company to market the Vuse Alto Power Unit and six Vuse Alto tobacco-flavored pods, which are sealed, prefilled, and nonrefillable. The decision does not mean that the tobacco products are safe or that they have been approved by the FDA. Aveo Oncology announced that the TiNivo-2 phase III clinical trial did not meet its primary endpoint of improved PFS . The trial assessed a combination of the VEGF receptor tyrosine kinase inhibitor tivozanib (Fotivda) and the PD-1 inhibitor nivolumab (Opdivo; Bristol Myers Squibb) in patients with advanced metastatic renal cell carcinoma (RCC) whose disease progressed following prior immune checkpoint inhibitor (ICI) therapy. However, using tivozanib alone yielded a clinically meaningful improvement in PFS when used as a second-line treatment after combination ICI therapy. This is the second such trial to suggest that there is no clinical benefit for patients with RCC to receive immunotherapy after disease progression with previous checkpoint inhibitors. Endpoints News reported that Caribou Biosciences will end its CAR-NK research and lay off 21 employees, about 12% of its staff. The company will instead direct its efforts toward its allogeneic chimeric antigen receptor (CAR) T-cell therapy. Trials of Caribou’s allogeneic CARs are underway in B-cell lymphoma, multiple myeloma, and acute myeloid leukemia. Endpoints also reported that Genentech will end a collaboration and licensing deal with Relay Therapeutics related to the development of the oral SHP2 inhibitor migoprotafib (GDC-1971/RLY-1971). Genentech said the decision was not based on any new safety concerns. The drug had been tested as a monotherapy and is under study in combination with other drugs. The companies had been hopeful that migoprotafib could be combined with Genentech’s investigational KRAS G12C inhibitor, divarasib, to treat a variety of solid tumors. The Biden Cancer Moonshot program hosted the White House Africa Cancer Forum, which brought together 10 African countries to discuss their cancer care priorities. As part of the event, numerous public, organizational, and industry initiatives totaling more than $100 million were announced that will expand access to cancer prevention, detection, and treatment across Africa, as well as drive innovation. A full list of ventures can be found at https://www.whitehouse.gov/ostp/news-updates/ . Also related to Africa: The University of Texas MD Anderson Cancer Center in Houston will expand its efforts to enhance cancer prevention, treatment, research, and education efforts in Zambia. MD Anderson began collaborating with the country’s Cancer Diseases Hospital in Lusaka in 2013, focusing mainly on radiation oncology. Under the new agreement, MD Anderson will work directly with the Zambian Ministry of Health to address cervical and breast cancer care—namely, expanding cervical cancer screening and treatment of pre-invasive disease and training for Zambian radiologists in breast cancer imaging and diagnosis.

When combined with pembrolizumab (Keytruda; Merck), eftilagimod alpha had a clinically meaningful objective response rate of 35.5% as an initial therapy for patients with PD-L1–negative head and neck squamous cell carcinoma. That compares favorably to an earlier trial in which just 5.4% of such patients responded to anti–PD-L1 monotherapy. The disease control rate among the 31 patients in the trial was 58.1%, with 10% experiencing a complete response. Eftilagimod alpha is a soluble LAG-3 protein and MHC class II agonist that activates antigen-presenting cells, leading to the activation and proliferation of CD8 + T cells. The results were presented at the July session of the ESMO Virtual Plenary, which is available for on-demand viewing at https://oncologypro.esmo.org/meeting-resources/esmo-virtual-plenary-resources . The FDA issued a revised draft guidance for industry on addressing misinformation about medical devices and prescription drugs (see https://www.fda.gov/media/179827/download ), which replaces a similar draft guidance issued in June 2014. According to its introduction, the guidance “sets out an enforcement policy for certain kinds of internet-based communications that firms might choose to use to address internet-based misinformation about or related to the firm’s approved/cleared medical product when that misinformation is created or disseminated by an independent third party.” The document provides “illustrative examples … to help support firms” that want to correct false, inaccurate, or misleading statements. The FDA will accept comments on the draft guidance, which can be submitted at https://www.regulations.gov , until September 9. Researchers reported that in a phase III 502-patient trial, those with recurrent cervical cancer who received tisotumab vedotin (Tivdak; Pfizer/Genmab) lived longer than those who received chemotherapy ( N Engl J Med 2024;391:44–55 ). Patients were randomly assigned to receive either the Tissue Factor–targeting antibody–drug conjugate or the investigator’s choice of chemotherapy—topotecan, vinorelbine, gemcitabine, irinotecan, or pemetrexed. The median overall survival in the tisotumab vedotin group was 11.5 months compared with 9.5 months in the chemotherapy group; the median progression-free survival was 4.2 months and 2.9 months, respectively. Nearly all patients in both groups experienced adverse events, with grade 3 or greater adverse events occurring in 52% and 62.3%, respectively. The supply of cisplatin now exceeds demand, bringing an end to a national shortage that has plagued cancer treatment providers since it was declared by the FDA on February 10, 2023. To that end, the agency worked closely with five cancer drug manufacturers to increase manufacturing capacity; helped a sixth company that had stopped producing an approved product to reenter the market; and temporarily exercised discretion in not enforcing importation requirements to meet patient needs while ensuring that manufacturing sites were thoroughly evaluated to protect the health and safety of patients in the United States. Seven manufacturers are now producing the drug for the U.S. market. Radionetics Oncology announced the formation of a strategic partnership with Eli Lilly to advance Radionetics’ novel small molecule G protein coupled receptor–targeted radiopharmaceuticals to treat a range of malignancies, including breast and lung cancers. Under the terms of the deal, Radionetics will receive an initial payment of $140 million, and Lilly obtains the exclusive right to acquire Radionetics for $1 billion. Amgen discontinued the development of AMG 794, an investigational bispecific T-cell engager that was being studied in a phase I trial as a treatment for various solid tumors, such as non–small cell lung cancer and epithelial ovarian cancer. The drug was designed to target the tight junction protein CLDN-6, which is involved in cell signaling and highly expressed in cancerous cells but not healthy ones. The company shared the decision in an update on www.clinicaltrials.gov but did not explain the reasoning behind it.   Shorla Oncology announced that the FDA approved a ready-to-dilute formulation of thiotepa (Tepylute) to treat breast and ovarian cancers. The new injectable version of the drug is easier to prepare than the current powder formulation, resulting in more accurate dosing and “just-in-time preparation,” the company says. Shorla currently sells two products—a generic form of nelarabine, a nucleoside metabolic inhibitor, to treat T-cell acute lymphoblastic leukemia (ALL) and T-cell lymphoblastic lymphoma; and, with Eversana, the oral methotrexate solution Jylamvo to treat ALL, cutaneous T-cell lymphoma, and other conditions.

Thanks to a green light from the FDA, adagrasib (Krazati) became the first KRAS G12C inhibitor approved for colorectal cancer. Specifically, the Bristol Myers Squibb/Mirati Therapeutics drug plus the EGFR inhibitor cetuximab (Erbitux; Lilly) may be used to treat adults with KRAS G12C -mutated locally advanced or metastatic colorectal cancer who have tried fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy. The decision was based on data from KRYSTAL-1, a multicenter, single-arm expansion cohort trial. Among 94 patients, the overall response rate (ORR) was 34%, and all responses were partial responses. The median duration of response (DOR) was 5.8 months, but 31% of responding patients had a DOR of at least 6 months. Some of the most common adverse reactions were rash, nausea, diarrhea, vomiting, and fatigue. Researchers reported the discovery of the bridge recombinase mechanism, a tool that can recombine and rearrange DNA in a programmable way ( Nature 2024;630:984–93 ). “The bridge RNA system is a fundamentally new mechanism for biological programming,” said Patrick Hsu, PhD, senior author of the study. “Bridge recombination can universally modify genetic material through sequence-specific insertion, excision, inversion, and more, enabling a word processor for the living genome beyond CRISPR.” The system stems from insertion sequence 110 elements, a transposable element, or “jumping gene” that can move within or between microbial genomes. Although the discovery could have implications for cancer, it has been used only in bacteria. The FDA has issued a draft guidance aimed at increasing diversity in clinical trials. The document describes the format and content of Diversity Action Plans, the situations in which a plan is required, and the timing and process for submitting a plan to the FDA. It also pushes study researchers and sponsors “to consider many dimensions of clinical trial diversity, even those that extend beyond age, ethnicity, sex, and race, to enroll populations that represent the patients who will be treated if the product is approved”—for example, pregnant or lactating women. This draft guidance replaces one issued on April 14, 2022; comments on the new document may be submitted until September 26 at https://www.regulations.gov . Genmab announced that the FDA granted accelerated approval to epcoritamab (Epkinly) to treat patients with relapsed or refractory (r/r) follicular lymphomas (FL) who have tried at least two systemic therapies. The approval was based on the phase I/II EPCORE NHL-1 clinical trial, which involved 127 adults with r/r disease who had already received a median of three therapies. The ORR was 82%, with a complete response rate of 60%; 67% of patients achieved minimal residual disease negativity ( Lancet Haematol 2024 Jun 15 [Epub ahead of print] ). After a median of 14.8 months, more than half of the patients continued to respond to epcoritamab, and the median DOR was not reached. Epcoritamab is an off-the-shelf bispecific CD20-directed CD3 T-cell engager. Daiichi Sankyo announced that development of patritumab deruxtecan has hit a snag. Although the FDA did not raise any concerns about the safety or effectiveness of the first-in-class HER3-directed antibody–drug conjugate, the agency raised concerns related to the inspection of a third-party manufacturing facility and opted not to approve it. The drug is under development with Merck for the treatment of adults with locally advanced or metastatic EGFR-mutated NSCLC who have already received at least two systemic therapies. The companies pledged to work with the FDA and the third-party manufacturer to address the agency’s feedback and bring the drug to patients as quickly as possible. Merck KGaA announced the discontinuation of its phase III Trilynx study , which was evaluating xevinapant plus chemoradiotherapy in patients with inoperable locally advanced squamous cell carcinoma of the head and neck. The decision follows a preplanned interim analysis performed by the study’s Independent Data Monitoring Committee, which found that the trial would be unlikely to prolong event-free survival. The company also decided to stop its phase III X-Ray Vision trial, which was comparing xevinapant plus radiotherapy with placebo plus radiotherapy in patients with locally advanced head and neck cancer who had surgery to remove tumors. Xevinapant, formerly Debio 1143, is an oral small molecule inhibitor of apoptosis protein. AstraZeneca announced that the ADJUVANT BR.31 phase III trial of durvalumab (Imfinzi) did not significantly improve disease-free survival compared with placebo in patients with stage IB-IIIA non-small cell lung cancer (NSCLC) who had surgery and whose tumors expressed PD-L1 on at least 25% of tumor cells. The PD1 inhibitor is standard-of-care treatment for patients with inoperable stage III NSCLC whose disease has not progressed after receiving chemoradiotherapy. Studies of durvalumab as a monotherapy and in combinations for use in other situations involving NSCLC continue. However, durvalumab plus chemotherapy did demonstrate significant improvement in event-free survival and overall survival compared with neoadjuvant chemotherapy in muscle-invasive bladder cancer , AstraZeneca reported. Patients in the experimental arm received durvalumab and neoadjuvant chemotherapy prior to surgery followed by adjuvant durvalumab. Data from the NIAGARA phase III trial will be presented at an upcoming medical conference.

Patients with pancreatic cancer who receive chemotherapy before and after surgery live longer than would be expected from surgery and adjuvant chemotherapy, the current regimen for the 15% to 20% of patients with operable disease, researchers reported ( JAMA Oncol 2024 Jun 20 [Epub ahead of print] ). In a phase II, single-arm trial, 46 patients began treatment with modified FOLFIRINOX; their 12-month progression-free survival (PFS) rate was 67%, and their median PFS and overall survival (OS) were 16.6 months and 37.2 months, respectively. For the 37 patients who received chemotherapy and surgery, the median OS was 46.2 months, and for the 19 patients who finished all chemotherapy before and after surgery, the median OS was not reached. The FDA OK’d blinatumomab (Blincyto; Amgen) for patients who are at least 1 month old with CD19-positive Philadelphia chromosome–negative B-cell precursor acute lymphoblastic leukemia (ALL) in the consolidation phase of multiphase chemotherapy. Efficacy was evaluated in two trials: Study E1910 and Study 20120215. In the former, 224 patients received either a consolidation regimen comprised of multiple blinatumomab monotherapy cycles plus multiple cycles of intensive chemotherapy or intensive chemotherapy alone. The 3-year OS rates were 84.8% and 69%, respectively. In Study 20120215, 111 children and young adults with the disease received either blinatumomab or a combination of intensive chemotherapies. The 5-year OS was 78.4% and 41.4%, respectively; the 5-year relapse-free survival was 61.1% and 27.6% respectively. The FDA approved pembrolizumab (Keytruda; Merck) for yet another indication: When given with a regimen of carboplatin and paclitaxel, it may be used to treat primary advanced or recurrent endometrial carcinoma. The PD-1 inhibitor was evaluated in the KEYNOTE-868/NRG-GY018 trial, in which patients were assigned to one of two cohorts based on mismatch repair status—222 patients enrolled in the mismatch repair deficient (dMMR) group and 558 in the mismatch repair proficient (pMMR) group. Patients in each group received either the pembrolizumab regimen or a placebo with paclitaxel and carboplatin. All the patients who received pembrolizumab had a longer PFS than the patients who received the placebo. In the dMMR cohort, the median PFS was not reached at 6.5 months; in the pMMR group, the median PFS was 11.1 months and 8.5 months, respectively. The drug is approved for dozens of indications in about 20 cancer types. The American Society of Radiation Oncology (ASTRO) published an updated clinical guideline for using radiation therapy to treat patients with oropharyngeal squamous cell carcinoma (OPSCC) caused by the human papillomavirus (HPV) ( Pract Radiat Oncol 2024 Jun 18 [Epub ahead of print] ). The new recommendations address using radiation therapy as a “standalone curative treatment or in combination with surgery and/or chemotherapy,” and they cover treatment planning and response assessment. According to the organization, HPV-positive OPSCC is the “most common type of HPV-associated cancer in men, second only to cervical cancer in women,” and more than 70% of newly diagnosed oropharyngeal cancer are HPV related. In addition, ASTRO announced that Vivek Kavadi, MD, MBA, will become its CEO , effective November 1. He will replace Laura Thevenot, who has served as ASTRO’s CEO for 22 years. Currently, Kavadi is chief radiation oncology officer for The US Oncology Network.

The FDA granted accelerated approved to repotrectinib (Augtyro; Bristol Myers Squibb) for some patients ages 12 and older with solid tumors harboring an NTRK gene fusion; specifically, the drug is indicated for these patients if they have locally advanced or metastatic disease—or if surgery is likely to cause severe morbidity—and if their disease has progressed despite treatment or has no other satisfactory therapy. Efficacy was assessed in the TRIDENT-1 study, which included 88 patients, 48 of whom had already been treated with a TRK tyrosine kinase inhibitor (TKI). The overall response rate (ORR) in the TKI-naive group was 58% compared with 50% in the group that had already received a TKI. The duration of response was not estimable and 9.9 months, respectively. During the June session of the ESMO Virtual Plenary (available at www.esmo.org), researchers announced that IBI363 (Innovent Biologics) showed effectiveness in a clinical trial in non–small cell lung cancer (NSCLC). Among 70 patients with wild-type NSCLC who received a dose of at least 0.3 mg/kg, the ORR was 18.2% and the disease control rate (DCR) was 69.7%. In the 37 patients with squamous cell carcinoma, 13 had a partial response (PR); the ORR was 35.1% and the DCR was 75.5% after a median follow-up of about 5.6 months. And in nine patients who received IBI1363 at a dose of 3 mg/kg, all six patients with squamous NSCLC and one patient with adeno NSCLC experienced a PR; the ORR was 100% and 33.3%, respectively. The DCR for these seven patients was 100%. Results of trials testing the first-in-class PD-1/IL2 α-bias bispecific antibody fusion protein in other solid tumors, including melanoma and colorectal cancers—initially presented at the American Society of Clinical Oncology 2024 Annual Meeting in early June—also demonstrated improved survival. Roche announced that the European Commission approved alectinib (Alcensa) for some adults with ALK-positive NSCLC with a high risk of recurrence. The decision was based on the phase III ALINA study, in which patients whose tumors had been surgically removed and who received the ALK inhibitor experienced a 76% drop in the risk of disease recurrence or death compared with those who received platinum-based chemotherapy ( N Engl J Med 2024;390:1265–76 ). An exploratory analysis also showed improvement in disease-free survival in patients with central nervous system metastases. The U.S. Department of Justice and the FDA have created a federal, multi-agency task force to combat the illegal distribution and sale of electronic cigarettes (e-cigarettes) and vaping products. Other law enforcement partners will join the effort—including the Bureau of Alcohol, Tobacco, Firearms, and Explosives; the U.S. Marshals Service; the U.S. Postal Inspection Service; and the Federal Trade Commission—to investigate and prosecute offenders of various statutes. Violations may result in felony convictions and fines, as well as the seizure of unauthorized products. “Manufacturers, distributors, and retailers market a wide range of products that appeal directly to school-age users, such as candy and fruit flavors, some of which come in devices designed to be easily concealed,” according to the FDA. Nicotine can be particularly harmful to adolescents and young adults because it can interfere with brain development.  Johnson & Johnson agreed to pay $700 million in response to allegations that it misled consumers about the safety of its talcum-based powder products. If judicial approval is granted, the company will also permanently halt the manufacture, marketing, and sale of all products that contain talc; the products were pulled from North American shelves in 2020. The payments will go to 42 states and Washington D.C. More than 50,000 lawsuits alleging that the products caused cancer, mostly filed by women diagnosed with ovarian cancer, remain pending.

This week: Tidbits from the American Association for Cancer Research (AACR) Annual Meeting, held April 5–10, in San Diego, CA, and other news. Soon, there may be a new standard of care for patients with previously treated KRAS G12C -mutated colorectal cancer , researchers announced at the AACR meeting. The phase I/II KRYSTAL-1 trial, which was concurrently published, tested the KRAS G12C inhibitor adagrasib (Krazati; Mirati) plus the EGFR inhibitor cetuximab (Erbitux) in 94 patients with metastatic disease. The objective response rate was 34%, and the disease control rate was 85.1%, with responses lasting a median of 5.8 months ( Cancer Discov 2024 Apr 8 [Epub] ). The median progression-free survival (PFS) was 6.9 months, and the median overall survival (OS) was 15.9 months. The study did not test the combination against adagrasib alone, but the researchers said that the drug duo compared favorably with historical data. At the AACR meeting, researchers reported that an investigational exosome-based liquid biopsy detected 97% of stage 1 and 2 pancreatic cancers, when treatment is more likely to be successful, if used in conjunction with CA19-9 biomarker testing, which is unreliable at detecting early-stage disease on its own. The team identified eight microRNAs found only in exosomes shed from pancreatic cancers and combined them with five cell-free DNA markers to develop a signature associated with the disease. After training the signature on 252 patients from Japan with or without the disease, it was validated in 732 patients from South Korea, China, and the United States with or without pancreatic cancer and demonstrated that at least 88% of cases could be detected; when used with CA19-9 biomarker testing, the liquid biopsy detected 97% of pancreatic cancers in the U.S. cohort.   AstraZeneca’s AZD1390, an ATM inhibitor, proved efficacious with manageable side effects when combined with standard intensity-modulated radiation therapy to treat patients with either recurrent or newly diagnosed glioblastoma, according to data reported at the AACR meeting. Of the 115 patients in the phase I trial, researchers reported that 15.7% experienced a grade 3 or 4 adverse event, and 4.3% discontinued taking the drug, which was designed to cross the blood–brain barrier. An initial look at data from patients with recurrent disease found a median OS of 12.7 months, whereas median OS for patients receiving standard care typically ranges from 6 months to 12 months.  In the phase III, 610-patient COMPASSION-15 trial, Akeso Biopharma’s cadonilimab improved survival in patients with untreated metastatic gastric or gastroesophageal cancer , including those with PD-L1–low tumors. A bispecific antibody that targets both PD-1 and CTLA4, cadonilimab plus chemotherapy led to a median PFS of 7 months and a median OS of 15 months, compared with 5.3 months and 10.8 months for placebo plus chemotherapy. Notably, researchers at the AACR meeting said that those with low PD-L1 expression had a PFS of 6.9 months and an OS of 14.8 months compared with 4.6 months and 11.1 months, respectively. The study was conducted only in China, so the results could be different in other countries. Also at the AACR meeting, Patricia LoRusso, DO, began her 1-year term as president of the organization. The physician-researcher, who hails from Yale University School of Medicine in New Haven, CT, succeeds Philip Greenberg, MD. Reminding meeting attendees that funding for fiscal year (FY) 2024 dropped by $378 million for the NIH and by $96 million for the NCI, LoRusso stressed that everyone needs to press Congress for more significant appropriations in the years to come. “We need NIH and NCI funding for education—not only educating the scientists, not only educating the workforce, but also educating the patients and the advocates. Because [by] working together, hopefully, we will be able to advocate, so that we can restore the funding that we’ve lost and … gain additional funding. More importantly, we can educate on the importance of what we do, the importance of recruitment to clinical research, the importance of team science, and the importance of working together as a community.” Those sentiments were echoed by Liz Jaffee, MD, deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins in Baltimore, MD, who chairs the President’s Cancer Panel. During a session on the Cancer Moonshot program, she said that “we believe that we need a concerted and collaborative push, and we need both the public and private sectors to participate and collaborate. We’re not going to be able to do this alone. The government cannot do this alone, academia cannot do this alone, industry cannot do this alone. We all need to do this together.” In other news: GLP-1 receptor agonists do not seem to increase the risk of thyroid cancer ( BMJ  2024;385:e078225 ). After multiple reports that these diabetes/weight-loss drugs, such as semaglutide (Ozempic; Novo Nordisk) were linked with the malignancy, researchers turned to national cancer registries in Denmark, Norway, and Sweden. They compared patients who received GLP1 agents to those who followed a treatment regimen with DPP4 inhibitors. After a median follow up of 3.9 years in the GLP-1 group and 5.4 years in the DPP4 group, the incidence rate of thyroid cancers were 1.33 events per 10,000 patient years and 1.46 events per 10,000 patient years, respectively.