Atezolizumab

SAN DIEGO, Oct. 14, 2026 /PRNewswire/ -- Equity Insider News Commentary - Global spending on cancer medicines reached $252 billion in 2024 and is forecast to exceed $400 billion by 2028, according to the IQVIA Institute, with the United States accounting for roughly 46% of the total. The pace of new treatments has picked up with it: about 150 new active substances entered the U.S. oncology market between 2015 and 2024, and launch activity in 2020 to 2024 ran nearly 40% ahead of the prior five years. Active Companies from around the markets with current developments this week include: Oncolytics Biotech, Inc. (NASDAQ: ONCY), Revolution Medicines, Inc. (NASDAQ: RVMD), Eli Lilly and Company (NYSE: LLY), Genmab A/S (NASDAQ: GMAB), Exelixis, Inc. (NASDAQ: EXEL). The past several weeks have shown how quickly that pipeline is turning into new standards of care. On August 26, the U.S. Food and Drug Administration approved the first broad RAS-targeted medicine for metastatic pancreatic cancer, one of the hardest-to-treat solid tumors. In the first two weeks of October, regulators approved a new first-line use for a blood cancer therapy, a first-line maintenance treatment for HER2-positive metastatic breast cancer and a checkpoint inhibitor combination for stage III mismatch repair-deficient colon cancer, while two large Phase 3 trials in lymphoma and multiple myeloma reported positive topline results. Gastrointestinal cancers are drawing a growing share of that attention. RAS mutations drive many pancreatic and colorectal tumors, and for years they were considered nearly impossible to drug. Colorectal cancer adds a second challenge: most metastatic cases are microsatellite stable, a form that has generally responded poorly to the checkpoint inhibitors that transformed treatment in other cancers. Companies are attacking the problem from several directions, with targeted RAS inhibitors, new drug combinations and therapies designed to make tumors more visible to the immune system. Investors will get a fresh look at much of this work soon. The European Society for Medical Oncology holds its 2026 Congress in Madrid from October 23 to 27, one of the largest annual meetings for new cancer data, and two of the companies below have pointed to colorectal cancer updates before year-end. Oncolytics Biotech, Inc. (NASDAQ: ONCY) Oncolytics is developing pelareorep, an intravenously delivered immunotherapy designed to turn immunologically "cold" tumors "hot," and colorectal cancer is now at the center of its clinical plans. On September 28 the company reported accelerating enrollment in REO 033, a randomized study in second-line RAS-mutant, microsatellite-stable metastatic colorectal cancer that compares pelareorep plus FOLFIRI and bevacizumab with FOLFIRI and bevacizumab alone. Part A is expected to randomize about 60 patients, with objective response rate as the primary endpoint and progression-free survival, overall survival, safety and biomarkers as additional endpoints. The study builds on REO 022, a smaller non-randomized trial in which the same pelareorep combination produced a 33% objective response rate, median progression-free survival of 16.6 months and median overall survival of 27.0 months. Oncolytics has said it aligned with the FDA on the concept of a potential pivotal Part B expansion, with a proposed accelerated approval path based on response rate and progression-free survival as the basis for potential full approval. Pelareorep holds FDA Fast Track designation in colorectal, anal and pancreatic cancer and has been administered to more than 1,200 patients. "Given the current pace of enrollment, we expect to have the ability to report interim data from Part A by year-end," said John McAdory, Chief Operating Officer. The company has also been adding scientific support around the program. In September it reported preclinical results combining pelareorep with a pan-RAS inhibitor in a RAS-driven colorectal cancer model, in which the combination showed no evidence of antagonism, and it announced a peer-reviewed publication in the Proceedings of the National Academy of Sciences showing that pelareorep changed the liver tumor microenvironment from immunologically inactive to active in preclinical models. CONTINUED... Read more oncology sector coverage at: Equity Insider In other industry developments and happenings in the market this week include: Revolution Medicines, Inc. (NASDAQ: RVMD) Revolution Medicines announced on August 26 that the FDA approved RASONQUE (daraxonrasib), a once-daily oral tablet, for adults with metastatic pancreatic cancer who have received at least one prior systemic therapy or cannot receive multiagent therapy. In the Phase 3 RASolute 302 trial, median overall survival was 13.2 months with daraxonrasib versus 6.7 months with chemotherapy. The company has said it expects to share updated colorectal cancer data and strategy in the fourth quarter of 2026. "The FDA approval of RASONQUE is a monumental step forward for patients with pancreatic cancer and for the oncology field," said Mark A. Goldsmith, M.D., Ph.D., Chief Executive Officer and Chairman. Eli Lilly and Company (NYSE: LLY) Lilly announced on October 2 that the FDA approved Jaypirca (pirtobrutinib) for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma without a known 17p deletion. In the BRUIN CLL-313 trial, Jaypirca reduced the risk of progression or death by 80% compared with bendamustine plus rituximab, with an overall response rate of 94% versus 81%. Genmab A/S (NASDAQ: GMAB) Genmab and AbbVie announced on October 5 that the Phase 3 EPCORE DLBCL-2 trial of epcoritamab plus R-CHOP met its primary endpoint in newly diagnosed diffuse large B-cell lymphoma, reducing the risk of progression or death by 51% compared with R-CHOP alone. The companies plan to present the data at a future medical meeting and to engage with global regulators. Exelixis, Inc. (NASDAQ: EXEL) Exelixis disclosed that the FDA extended its review of zanzalintinib in combination with atezolizumab for metastatic colorectal cancer by three months after the company submitted updated safety and efficacy information, which the agency classed as a major amendment. The new target action date is March 3, 2027. Know Which Biotech Names Are Moving First Clinical readouts and FDA decisions can reprice a stock in minutes. 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This is an independent market commentary published on a non-paid basis. MEL has not been paid any fee by any company mentioned in this article for its production or distribution. MEL was previously paid a fee by Oncolytics Biotech, Inc. for advertising and digital media services under an arrangement that has since expired. MEL and/or its owners, operators, directors, and affiliates own shares of Oncolytics Biotech, Inc. purchased in the open market, and reserve the right to buy and sell shares of Oncolytics Biotech, Inc. at any time without any further notice. The prior compensation and this share ownership constitute a conflict of interest as to our ability to remain objective in our communication regarding Oncolytics Biotech, Inc. Because of this conflict, individuals are strongly encouraged not to use this publication as the basis for any investment decision. 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iStock, Jian Fan While BNT113 failed to improve progression-free survival in patients with a type of head and neck cancer during a Phase 3 trial, BioNTech is holding out hope for an overall survival win—but analysts say that outcome is now “less likely.” BioNTech’s recent run of bad luck with its mRNA cancer immunotherapy pipeline continued Tuesday, as the company reported that one candidate, BNT113, failed to significantly improve progression-free survival in patients with a type of head and neck cancer in a closely watched Phase 3 trial. “Results add to a growing list of recent mRNA cancer vaccine setbacks including two discontinuations for autogene cevumeran in bladder cancer and colorectal cancer,” BMO Capital Markets wrote in a note to investors Tuesday morning. BioNTech halted a Phase 2 trial of autogene cevumeran in colorectal cancer in August due to futility following a recommendation by an independent data safety monitoring board. This followed the discontinuation earlier this year of a Phase 2 trial for the asset in bladder cancer “due to the rapidly emerging treatment landscape and shifting standard of care,” the company said. The most recent miss, announced on Tuesday , comes from the Phase 2/3 AHEAD-MERIT trial , which is testing the mRNA immunotherapy in combination with Merck’s Keytruda vs. Keytruda alone for the first-line treatment of metastatic HPV16-positive head and neck squamous cell carcinoma (HNSCC). The trial, which has enrolled 358 patients, has dual primary endpoints: progression-free survival (PFS) and overall survival (OS). BioNTech shares wobbled upon market open on Tuesday, falling 5% to $90.88. Cancer BioNTech halts mid-stage trial of personalized mRNA vaccine in colorectal cancer Shares of Germany-based BioNTech were down as much as 8% Friday after announcing a Phase 2 trial of autogene cevumeran would be discontinued for futility. The news follows Merck and Moderna’s Phase 3 win last week for their cancer vaccine plus Keytruda in melanoma. August 28, 2026 · 2 min read · Heather McKenzie Read more Despite the PFS miss, the German biotech isn’t giving up hope on the trial just yet, suggesting that a positive readout on OS could still render the trial a success. The trial will therefore continue on to evaluate OS, “completing the assessment with the potential of this treatment approach to help patients live longer,” BioNTech said in its press release. “Under the trial’s pre-specified statistical design, a statistically significant improvement in overall survival would establish a positive trial outcome, even if the progression-free survival dual primary endpoint was not met,” the company clarified in its announcement. This is in line with the recommendation of an independent data monitoring committee, BioNTech added. BMO agreed that overall survival could still be achieved despite the PFS miss but said so with “significantly reduced confidence.” The firm noted, “While improvement in overall survival is still possible, we view such a scenario as less likely given today’s PFS miss.” Around one-third of HNSCC cases are associated with HPV infection, with the majority linked to HPV16, BioNTech said in its release, adding that there are currently no HPV-targeted treatments approved. BioNTech is hoping to change that with BNT113, which encodes a fixed set of antigens to specifically target two HPV16-derived antigens that are frequently expressed on HPV16+ tumor cells. BMO noted that as an mRNA vaccine, BNT113 is designed to induce an immune response against those target proteins. “This response may take longer to fully deepen, supporting the possibility that AHEAD-MERIT misses on PFS improvement, but an overall survival benefit can still materialize over time.” BNT113 and autogene cevumeran are part of BioNTech’s personalized cancer immunotherapy pipeline that also includes BNT116, which is currently in Phase 2 development for metastatic non-small cell lung cancer (NSCLC) and Phase 1 for NSCLC. Autogene cevumeran scored a win in a small Phase 1 trial in April. The study showed that nearly 90% of participants with pancreatic cancer whose immune systems responded to the immunotherapy plus Roche’s checkpoint inhibitor Tecentriq and chemotherapy were still alive up to six years after receiving the last treatment. The combo is currently in a Phase 2 study , which is expected to be complete in January 2031.