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The FDA approved tafasitamab (Monjuvi; Incyte) for patients with relapsed or refractory follicular lymphoma in combination with the immunomodulatory imide drug lenalidomide and the anti-CD20 mAb rituximab. Tafasitamab, a CD-19 targeting mAb, was approved for large B-cell lymphoma in July 2020. The decision to approve the drug for follicular lymphoma was based on results from the phase III inMIND study, in which patients received lenalidomide and rituximab and were randomly assigned to receive either tafasitamab or a placebo. Median PFS was 22.4 months in the tafasitamab group and 13.9 months in the placebo group.

Maryland–based biotech NextCure acquired the rights to the CDH6-targeting antibody–drug conjugate (ADC) SIM0505 from Chinese company Simcere Zaiming for up to $745 million in combined upfront and milestone payments. SIM0505 contains a topoisomerase 1 inhibitor payload and is in a phase I dose escalation trial in China. Simcere Zaiming will retain the rights to develop and market the candidate within China.

German biotechnology company BioNTech will buy CureVac , which specializes in mRNA-based therapeutics, in a deal valued at approximately $1.25 billion. With the deal, BioNTech aims to strengthen its research, development, manufacturing, and commercialization of investigational mRNA-based cancer immunotherapy, but it did not disclose which of CureVac’s candidates will help achieve this goal. The agreement marks the latest chapter in BioNTech’s recent dealmaking in oncology: The company struck an $11 billion deal last week with Bristol Myers Squibb to collaborate on the BNT327, BioNTech’s PD-L1xVEGF-A bispecific antibody for multiple tumor types (Cancer Discov 2025 June 2 [Epub]).

The FDA approved mitomycin (Zusduri; Urogen Pharma) formulated as an intravesical solution––administered directly into the bladder through a catheter––for patients with non–muscle invasive bladder cancer (NMIBC). In the single-arm ENVISION trial, 240 patients with low-grade NMIBC that recurred after surgery received the solution once a week for 6 consecutive weeks. A complete response, defined as no detectable disease in the bladder, was reached at 3 months by 78% of the participants, and 79% of patients who mounted any response maintained it for at least 12 months.

The FDA approved taletrectinib (Ibtrozi, Nuvation Bio) , a tyrosine kinase inhibitor (TKI), for patients with locally advanced or metastatic ROS1 -positive non–small cell lung cancer (NSCLC). The decision was based on the single-arm TRUST-I and TRUST-II trials, which enrolled 169 and 101 patients, respectively. For patients who had never been treated with a ROS1 TKI, the objective response rate (ORR) was 90% in TRUST-I and 72% in TRUST-II, with 72% and 63%, respectively, of those who responded having a duration of response (DOR) of 12 months or longer. For patients who had previously received a ROS1 TKI, the ORR was 52% in TRUST-I and 62% in TRUST-II, with 74% and 83%, respectively, of those who responded having a DOR of 6 months or longer.

During a Senate Appropriations Committee budget hearing yesterday, NIH director Jay Bhattacharya, MD, was criticized by senators from both parties over the agency’s termination of research grants and the Trump administration’s proposed cuts to its budget. Senator Susan Collins (R-Maine) noted that the proposed fiscal year 2026 budget, which would slash NIH funding to $18 billion a year––just 60% of current levels––would “delay or stop effective treatments and cures” and would risk allowing China to advance in front of the United States in biomedical research. Should the budget pass, the NCI will see its yearly funding drop from $7.2 billion a year to $4.5 billion annually, a nearly 38% decrease.

Although there are only 3,000 cases of appendiceal adenocarcinoma (AA) diagnosed in the United States each year, the rare cancer is far more common in those born in the 1970s and 1980s compared with those born in the decades prior, when controlling for age. According to research published today in the Annals of Internal Medicine (Ann Intern Med 10 June 2025 [Epub ahead of print]), AA incidence more than tripled among those born in the United States during 1976–1984, and quadrupled in those born during 1981–1989, compared with those born during 1941–1949. The onset of other gastrointestinal cancers, such as gastric and colorectal, are also increasing in those below 50 years old, suggesting that there may be a common cause.

In a letter addressed to NIH director Jay Bhattacharya, MD, dubbed the Bethesda Declaration , NIH staff members criticized many of the agency’s actions under the Trump administration. Representing all 27 NIH institutes and centers, the 336 signatories––most of whom remained anonymous, and many of whom were affected by recent layoffs––objected to the politicization of research and interruptions to global research collaborations wrought by the NIH, as well as the reduction in indirect costs for research and the layoffs of essential NIH staff. Fifty-five of the signatories are from the NCI. Over 5,000 others in the scientific community have signed the declaration thus far, including 22 Nobel laureates.

Arvinas submitted a new drug application (NDA) to the FDA for vepdegestrant ––its ER-targeting proteolysis targeting chimera (PROTAC) drug––for patients with ER-positive, HER2-negative, ESR1 -mutated advanced or metastatic breast cancer previously treated with endocrine-based therapy. The move comes on the heels of the phase III VERITAC-2 study, the results of which were presented last week at the American Society of Clinical Oncology (ASCO) Annual Meeting 2025. In the trial, 270 patients received either vepdegestrant or the selective ER degrader fulvestrant: median progression-free survival was 5 months in the vepdegestrant arm and 2.1 months in the fulvestrant arm (Cancer Discov 2025 June 1).

In patients with metastatic melanoma, a set of mitochondrial DNA alleles known as the MT haplogroup-T is associated with a far lower likelihood of response to immune checkpoint inhibitors (ICI) compared with those lacking the haplogroup. The findings, published today in Nature Medicine , were derived from 1,225 patients treated with the CTLA-4 inhibitor ipilimumab (Yervoy; Bristol Myers Squibb) and/or the PD-1 targeting nivolumab (Opdivo; Bristol Myers Squibb) in the phase III CheckMate 067 study. Those with the haplogroup were less likely to respond to both single agents and their combination; for nivolumab alone, the haplotype conferred a 3.46-times lower likelihood of response.

According to a newly published article, immune cells with a loss of the Y chromosome (LOY) are less equipped to attack cancer cells than their Y chromosome-containing counterparts (Nature 2025 Jun 4 [Epub ahead of print]). The absence of the Y chromosome in a subset of white blood cells known as peripheral blood mononuclear cells has been known to accompany higher cancer mortality, but the mechanism behind this observation hadn’t been clear. The researchers found that LOY in CD4+ and CD8+ T cells led to immunosuppression; furthermore, LOY in malignant epithelial cells strongly predicted LOY in nearby benign cells, suggesting that LOY can somehow be induced across neighboring cells.

The FDA today approved Bayer’s darolutamide (Nubeqa) for metastatic castration-sensitive prostate cancer (mCSPC) with or without chemotherapy. The decision was based on the results of the phase III ARANOTE trial, in which researchers randomly assigned 669 patients in a 2:1 fashion to receive the androgen receptor inhibitor plus androgen deprivation therapy or a placebo plus androgen deprivation therapy. Darolutamide reduced the risk of disease progression or death by 46% compared with the placebo. Separately, during the 2025 American Society of Clinical Oncology’s Annual Meeting, held May 30–June 3, researchers reported better health-related quality-of-life among patients who received darolutamide in the ARANOTE trial.

Bristol Myers Squibb (BMS) announced today that it will pay BioNTech as much as $11 billion to jointly develop BNT327, a PD-1/VEGF-A bispecific antibody, to treat multiple tumor types; the agent is currently in trials assessing its effectiveness as a first-line treatment for small cell and non–small cell lung cancers, with a trial to start in triple-negative breast cancer later this year. Under the terms of the deal, BMS will pay BioNTech $1.5 billion upfront and $2 billion in non-contingent anniversary payments through 2028 and up to $7.6 billion for meeting certain milestones. Last month, Pfizer announced it will pay as much as $6 billion to develop 3SBio’s PD-1/VEGF bispecific antibody SSGJ-707 (Cancer Discov 2025 May 30).

An EGFR– IL13Rα2 dual-targeted chimeric antigen receptor (CAR) T-cell therapy successfully reduced tumor size in patients with glioblastoma (GBM) in a phase I trial assessing intracerebroventricular delivery of the CAR in patients with EGFR-amplified disease following recurrence. Tumors shrank in eight of the 13 patients (62%) who had measurable disease at the time of the CAR T cell infusion, with one partial response; one patient has ongoing stable disease lasting more than 16 months. The median progression-free survival was 1.9 months, and the median overall survival had not been reached after a median follow-up time of 8.1 months. The findings were presented at the 2025 American Society of Clinical Oncology Annual Meeting, held May 30–June 3 in Chicago, IL, and simultaneously published ( Nat Med 2025 Jun 1 ).

According to the international phase III NIVOPOSTOP trial, Bristol Myers Squibb’s PD-1 inhibitor nivolumab (Opdivo) added to adjuvant chemoradiotherapy can cut the risk of disease recurrence in patients with locally advanced head and neck squamous cell carcinoma (HNSCC). Researchers enrolled 666 patients in the trial, all of whom received standard-of-care (SOC) chemoradiotherapy, with half prescribed nivolumab as well. After 3 years, 63.1% of the patients who received nivolumab had no signs of recurrence compared with 52.5% of patients who received only chemoradiotherapy. The data were reported at the 2025 American Society of Clinical Oncology Annual Meeting, taking place from May 30–June 3 in Chicago, IL.

A 14-gene molecular assay can help identify patients with lung cancer who could benefit from chemotherapy after surgery, according to results of a study presented at the 2025 American Society of Clinical Oncology Annual Meeting in Chicago, IL. Researchers enrolled 421 patients with stage IA–IIA non-squamous non–small cell lung cancer who had their tumors surgically removed, tested using the RiskReveal assay (Razor Therapeutics), and then classified as low, intermediate, or high risk. Patients at intermediate and high risk of recurrence received adjuvant chemotherapy (87) or underwent observation (107). Those who received adjuvant chemotherapy had a 78% lower risk of cancer recurrence than those in the observation group; further, 96% of patients who received chemotherapy did not have a cancer recurrence, compared with 79% in the observation group.

A BRAF and EGFR inhibitor duo prolongs life in some patients with BRAF V600E -mutant metastatic colorectal cancer, according to results from the phase III BREAKWATER study presented at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. A total of 236 patients received encorafenib (Braftovi; Array Biopharma/Pfizer) and cetuximab (Erbitux; Eli Lilly)––the BRAF and EGFR inhibitors, respectively––with mFOLFOX6 chemotherapy, 158 received encorafenib/cetuximab alone, and 243 received the chemotherapy regimen with or without the angiogenesis inhibitor bevacizumab—the current standard of care. Overall survival was 30.3 months with encorafenib/cetuximab plus mFOLFOX6 arm, 19.5 months in the encorafenib/cetuximab arm, and 15.1 months in the control arm. The FDA has already granted accelerated approval to the encorafenib/cetuximab/mFOLFOX6 regimen for first-line treatment of the disease.

Merck and Daiichi Sankyo pulled their accelerated approval application for patritumab deruxtecan (HER3-DXd), an antibody–drug conjugate (ADC) that targets HER3, under study against certain lung cancers. According to an announcement released today by the partners, the decision was based on results from the phase III HERTHENA-Lung02 trial, in which the ADC failed to improve overall survival in patients with advanced or metastatic EGFR -mutated non–small cell lung cancer. The companies also noted that discussions with the FDA also played a role in the decision but did not share details on the content of these discussions.

Inavolisib (Itovebi; Genentech) boosted survival in patients with HR-positive, HER2-negative advanced breast cancer and extended the time they could wait before starting chemotherapy. In the phase III INAVO120 trial, median overall survival was 34 months for the 161 patients who received inavolisib, a PI3K inhibitor, with the CDK4/6 inhibitor palbociclib (Ibrance; Pfizer) and the estrogen blocker fulvestrant, compared with 27 months for those who received a placebo instead of inavolisib. The median time until patients needed to start chemotherapy was 35.6 months in the inavolisib group compared with 12.6 months in the placebo group. The results were presented during a press conference in advance of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, where they will be presented more formally.

Treatment with lurbinectedin (Zepzelca; Jazz Pharmaceuticals) and atezolizumab (Tecentriq; Genentech) improved overall survival (OS) in patients with extensive-stage small cell lung cancer (ES-SCLC) in the phase III IMforte trial. Median OS among the 242 patients with ES-SCLC who received the alkylating agent lurbinectedin, which damages cancer cell’s DNA, and the anti–PD-L1 mAb, respectively,  was 13.2 months, compared with 10.6 months in the 241 patients who received atezolizumab alone. Progression-free survival in the two groups was 5.4 months and 2.1 months, respectively. The results were presented during a press conference in advance of the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, where they will be presented more formally.