Panitumumab

Roche has shed more light on its investigational KRAS G12C inhibitor's phase 3 victory over Amgen’s Lumakras and Bristol Myers Squibb’s Krazati. The open-label Krascendo 1 trial enrolled 338 people with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC). Patients who had already received a KRAS G12C inhibitor or pan-KRAS/RAS inhibitor were excluded from the trial. Participants received either divarasib once daily, Lumakras once daily or Krazati twice daily. Roche announced back in July that divarasib had demonstrated statistically significant improvements in progression-free survival (PFS) and overall survival (OS), meeting the trial’s primary and key secondary endpoints. But the Swiss pharma had been holding back the detailed data until now. At the European Society for Medical Oncology (ESMO) Congress in Madrid, Roche revealed that median OS for the 167 patients who received divarasib was 17.7 months, compared to 12 months for the 171 patients who received Lumakras or Krazati. The benefit was similarly clear when it came to median PFS, which stood at 9.8 months versus 5.7 months, respectively. A total of 44% of patients receiving divarasib were alive without disease progression at one year, compared to 24% of the control group, according to Roche’s presentation. It was a similar story for the objective response rate, which came in at 58% for divarasib versus 32% for the control group, while median duration of response was 11.9 months versus 6.9 months. Stefan Frings, M.D., Ph.D., deputy chief medical officer at Roche Pharma, told Fierce that the data made for a “very comprehensive, strong package, which should be convincing to health authorities.” “It’s an important advance for patients with lung cancer,” Frings said in an interview at a Madrid hotel during the conference. “It's a second-line setting, and patients who receive divarasib benefit compared to the current first-generation KRAS G12C inhibitors by having far longer overall survival,” he continued. “They live longer. They have better progression-free survival, better response rates, and with a safety profile which is—if [anything]—even better,” he said. According to Roche, 4.8% of patients receiving divarasib discontinued treatment due to treatment-related adverse events, compared to 11.7% in the control group. Serious treatment-related adverse events were also less common with divarasib, at 7.8% versus 15.2%. Roche’s confidence in divarasib had been building even before this phase 3 success. The candidate had already shown better potency and selectivity than the incumbent KRAS G12C inhibitors Krazati and Lumakras in preclinical tests. After cross-trial comparisons suggested that the edge translated into better clinical outcomes, Roche axed a study comparing divarasib to the chemotherapy docetaxel and went toe-to-toe with Lumakras and Krazati. “We designed the drug on purpose with higher potency and better selectivity,” Frings explained. “So, based on preclinical models, we clearly knew it would be superior to the first generation.” “It’s honestly not so frequent that pharma companies go head-to-head,” he added. “But if you want to make a point, if you want to convince payers, prescribers and patients … then a head-to-head win is rather rewarding.” While Amgen and BMS reached the regulatory finish line first for KRAS G12C-mutated, locally advanced or metastatic NSCLC in 2021 and 2022, respectively, they have struggled to capitalize on their head start. Krazati brought in $55 million for BMS in the second quarter , while Lumakras delivered $111 million to Amgen. For its part, Roche is aiming for peak divarasib sales of 1 billion to 2 billion Swiss francs ($1.2 billion to $2.5 billion), according to Frings. The Big Pharma is currently recruiting patients into a phase 3 trial comparing divarasib plus Keytruda against Keytruda plus chemotherapy in previously untreated advanced or metastatic nonsquamous KRAS G12C-mutated NSCLC. Roche has previously suggested that sales in metastatic disease would account for most of the forecast. Frings was tight-lipped on the exact timeline for a regulatory filing but said the Swiss pharma is “certainly keen to get this to as many patients as possible around the world.” Roche has more RAS drugs coming up behind divarasib. The pharma has already launched phase 1 trials of a pan-RAS inhibitor called RG6505 and a KRAS G12D inhibitor dubbed RG6620 in solid tumors. Roche’s partner Chugai Pharmaceutical is also testing a pan-KRAS inhibitor called AUBE00. Roche has made a “deliberate effort” to test a range of RAS drugs, Frings said. “If you have many rare mutations and you are scrambling to find sufficient patients, a pan-RAS inhibitor makes a lot of sense,” he explained.

SAN DIEGO, Sept. 28, 2026 /PRNewswire/ -- Equity Insider News Commentary - For most of the last four decades, RAS was the target oncology could not hit. That has changed quickly, and the commercial numbers are starting to follow. According to DelveInsight, the KRAS inhibitors market across the seven major markets was valued at approximately $526 million in 2025 and is projected to reach approximately $7.85 billion by 2034, a compound annual growth rate of roughly 35% over its 2024 to 2034 forecast period, with the United States expected to account for nearly 70% of the total. As the first generation of RAS-targeted drugs gives way to broader multi-selective inhibitors, the field's central question is shifting from whether RAS can be drugged to how long those responses can be made to last. Active Companies from around the markets with current developments this week include: Oncolytics Biotech® Inc. (Nasdaq: ONCY) , Revolution Medicines, Inc. (Nasdaq: RVMD) , Amgen Inc. (Nasdaq: AMGN) , Eli Lilly and Company (NYSE: LLY) , and Verastem Oncology (Nasdaq: VSTM) . Other forecasters size the category differently but point in the same direction. Roots Analysis projects the global KRAS market will grow from approximately $557 million in 2025 to approximately $3.98 billion by 2035, a CAGR of about 21%, and expects intravenously administered therapies to grow at a faster rate than the oral drugs that dominate the category today. The scale of the opportunity comes down to how common these mutations are. KRAS mutations account for approximately 85% of RAS-associated cancers in humans, including about 90% of pancreatic cancers, according to Eli Lilly and Company. In colorectal cancer, KRAS mutations appear in approximately 40% of all cases, according to Amgen, yet the G12C subtype that the first approved inhibitors were built to target is present in only about 3% to 5% of colorectal cancers. That gap is why the pipeline has moved toward multi-selective and mutation-specific agents aimed at G12D, G12V and other variants that drive pancreatic and colorectal disease. The clinical bar moved sharply in April 2026, when a Phase 3 trial of an oral RAS(ON) multi-selective inhibitor in previously treated metastatic pancreatic cancer reported a median overall survival of 13.2 months versus 6.7 months for chemotherapy, according to the sponsor's SEC filing. Results like that have changed the conversation. With RAS inhibition now showing it can extend survival in one of the hardest cancers to treat, attention is turning to what limits it: tumors that adapt, and responses that fade as resistance emerges. That is where combination strategies come in. Developers are pairing RAS blockade with EGFR antibodies, chemotherapy, immunotherapy and other agents in an effort to deepen responses and push resistance further out. Among the approaches being tested is whether an agent that engages the immune system through a different mechanism can work alongside RAS inhibition rather than against it. Oncolytics Biotech® Inc. (Nasdaq: ONCY) Announces Positive Preclinical Results Combining Pelareorep with a Pan-RAS Inhibitor in Colorectal Cancer Pelareorep activity was maintained in the presence of RAS inhibition, with no evidence of antagonism between the two therapies in a RAS-driven colorectal cancer model Findings support further evaluation of optimized pelareorep dosing with RAS inhibitors and the hypothesis that it could deepen or prolong responses to RAS-targeted therapy FDA written feedback in August 2026 aligned on a potential pivotal Part B expansion of the ongoing REO 033 colorectal cancer study Pelareorep holds FDA Fast Track designation in colorectal, anal and pancreatic cancer Oncolytics Biotech (Nasdaq: ONCY), a clinical-stage immunotherapy company developing pelareorep, announced positive preclinical results on September 10, 2026, from a study evaluating pelareorep in combination with a pan-RAS inhibitor in a RAS-driven colorectal cancer model. During the initial treatment period, when pelareorep was administered every other day, pelareorep, the pan-RAS inhibitor and the combination each reduced tumor growth compared to the control. The greatest tumor reductions were observed in the RAS inhibitor and combination groups, showing that pelareorep activity was maintained alongside RAS inhibition without evidence of antagonism. The Company was direct about the limits of the result. Following the transition to less frequent weekly pelareorep dosing, the incremental activity associated with pelareorep became less evident. Oncolytics said that, taken together, the findings support further evaluation of optimized pelareorep dosing with RAS inhibitors, and the hypothesis that sustained pelareorep activity could potentially deepen or prolong responses to RAS-targeted therapy and thereby delay the emergence of resistance. The Company also noted the findings are consistent with previously published independent research showing that RAS inhibitors do not interfere with the mechanism through which pelareorep selectively infects tumor cells. "These results provide an encouraging first look at combining pelareorep with one of the most important emerging classes of targeted cancer therapies," said Thomas Heineman, MD, PhD, Chief Medical Officer of Oncolytics. "We observed pelareorep activity during the initial intensive dosing period as well as biologic compatibility between pelareorep and RAS inhibition, supporting the continued evaluation of pelareorep/RAS inhibitor combination therapy. Because acquired resistance remains a major limitation of RAS-targeted therapies, we believe these findings provide a compelling rationale to investigate whether sustained pelareorep activity can deepen and prolong responses to RAS inhibition and potentially delay the emergence of resistance. Similarly, pelareorep, because of its unique mechanism of action, may offer a treatment option for patients who become resistant to RAS inhibitors." Oncolytics plans to expand its preclinical evaluation of pelareorep with RAS inhibitors across additional dosing schedules and RAS-driven tumor models, designed to further characterize pelareorep's contribution to the combination, including its potential impact on the depth and durability of tumor response and the development of resistance. Pelareorep is an intravenously delivered, systemically active, investigational immunotherapy with a dual mechanism of action: it selectively replicates in tumor cells while activating both innate and adaptive anti-tumor immune responses. It has been administered to over 1,200 patients, and the Company is advancing it in combination with chemotherapy and/or checkpoint inhibitors in metastatic gastrointestinal cancers. The preclinical work sits alongside a colorectal program already moving toward a registrational decision. On August 18, 2026, Oncolytics announced it had received written feedback from the FDA on the design of a potential pivotal Part B expansion of REO 033, its ongoing randomized study of pelareorep with FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab alone in second-line RAS-mutant, microsatellite stable metastatic colorectal cancer. The Company said the feedback represents important alignment on a pathway in which objective response rate could support potential accelerated approval and progression-free survival could support full approval. The FDA also suggested an End-of-Phase meeting to reach final agreement on key elements of the registration program. "We are thrilled with the response provided by the FDA and believe this feedback could support a highly efficient path to potentially transition REO 033 from its ongoing randomized Part A directly into a pivotal Part B," said Jared Kelly, Chief Executive Officer of Oncolytics. "Importantly, the feedback provides alignment around the potential use of response rate to support an accelerated approval pathway and progression-free survival to support full approval." The ongoing Part A enrolls 60 patients, and the Company intends to decide whether to launch the pivotal expansion once initial clinical data from Part A are available. Elsewhere in the portfolio, pelareorep received Fast Track designation in July 2026 in combination with a checkpoint inhibitor for second-line and later squamous cell anal cancer, following April 2026 FDA alignment on a pivotal study design in that indication. Oncolytics has also secured a new U.S. patent covering key aspects of pelareorep's commercial manufacturing process, which the Company expects to provide protection into 2044. There are several risks associated with the Company's plans. The RAS combination findings are preclinical results from a single colorectal cancer model, and preclinical results may not be predictive of results in clinical studies; the Company itself reported that pelareorep's incremental contribution became less evident under weekly dosing. No clinical data combining pelareorep with a RAS inhibitor have been reported. Pelareorep is investigational and has not been approved by the FDA or any other regulator for any indication. FDA written feedback and Fast Track designation do not guarantee approval, the End-of-Phase meeting has not yet been held, and the decision to launch REO 033 Part B depends on Part A data that are not yet available. As a clinical-stage company, Oncolytics will require additional capital to advance its programs and is pursuing strategic partnerships that may not materialize. Readers should review the Company's filings on EDGAR and SEDAR+ and the forward-looking statements in its releases. Read this and more news for Biotech Sector at: In other industry developments and happenings in the market this week include: Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company focused on RAS-addicted cancers, announced that the FDA accepted for review its New Drug Application for daraxonrasib, an oral RAS(ON) multi-selective inhibitor, for previously treated metastatic pancreatic ductal adenocarcinoma. The application is supported by the Phase 3 RASolute 302 trial, in which daraxonrasib delivered a median overall survival of 13.2 months versus 6.7 months for chemotherapy, with a hazard ratio of 0.40, and the drug was selected for the FDA Commissioner's National Priority Voucher pilot program. In its second quarter 2026 update, Revolution Medicines reported that the FDA also granted daraxonrasib Breakthrough Therapy Designation for certain patients with previously treated metastatic RAS-mutant non-small cell lung cancer, and that it opened an FDA-cleared Expanded Access Program in May. The company continues to advance daraxonrasib into earlier lines of pancreatic cancer through the global Phase 3 RASolute 303 and RASolute 304 studies in the first-line metastatic and adjuvant settings. Amgen Inc. (Nasdaq: AMGN) markets LUMAKRAS® (sotorasib), one of the first approved KRAS G12C inhibitors, which is approved in combination with its anti-EGFR antibody Vectibix® (panitumumab) for previously treated KRAS G12C-mutated metastatic colorectal cancer. In its second quarter 2026 results, Amgen reported LUMAKRAS/LUMYKRAS sales up 23% year-over-year to $111 million, primarily on volume growth, while total revenues rose 10% to $10.1 billion. Amgen is pushing the colorectal program into the first-line setting through CodeBreaK 301, a Phase 3 study of LUMAKRAS in combination with Vectibix and FOLFIRI in patients with first-line KRAS G12C-mutated metastatic colorectal cancer, alongside CodeBreaK 202 in first-line KRAS G12C-mutated, PD-L1 negative non-small cell lung cancer. Eli Lilly and Company (NYSE: LLY) announced that the FDA granted Breakthrough Therapy designation to olomorasib, an investigational next-generation KRAS G12C inhibitor, as a monotherapy for adults with advanced pancreatic cancer who have received at least one prior systemic therapy and have a KRAS G12C mutation. It is the second Breakthrough Therapy designation for olomorasib, following a September 2025 designation in combination with pembrolizumab for first-line KRAS G12C-mutant non-small cell lung cancer with high PD-L1 expression. "Pancreatic cancer has historically been one of the most difficult-to-treat cancers and people whose tumors harbor a KRAS G12C mutation face limited options once their disease progresses," said Jacob Van Naarden, executive vice president, and president of Lilly Oncology. Lilly noted there are currently no approved therapies that specifically target KRAS G12C-mutant pancreatic cancer, and olomorasib is also being studied in the pivotal SUNRAY-01 and SUNRAY-02 lung cancer studies. Verastem Oncology (Nasdaq: VSTM), which focuses on RAS/MAPK pathway-driven cancers, announced it will host an investor event on October 14, 2026 to present initial efficacy and updated safety and tolerability data for VS-7375, its investigational oral KRAS G12D (ON/OFF) inhibitor, in pancreatic, lung and colorectal cancers from the TARGET-D clinical program. VS-7375 has FDA Fast Track Designation in KRAS G12D-mutated metastatic pancreatic cancer in both the first-line and previously treated settings, and in previously treated KRAS G12D-mutated non-small cell lung cancer. Verastem already has a commercial RAS pathway product in AVMAPKI® FAKZYNJA® CO-PACK, approved for KRAS-mutated recurrent low-grade serous ovarian cancer. In its second quarter 2026 results, the company reported net product revenue of $25.1 million for the co-pack and said first patients had been dosed in all three registration-directed TARGET-D Phase 2 trials, including TARGET-D 203 in metastatic colorectal cancer. Track the Signals Before the Crowd The best positioning happens before the crowd catches on. Eagle Eye is a real-time investor signal-intelligence platform that surfaces sentiment shifts, news flow, and trending tickers as they form, so you see attention building instead of chasing it. Watch it live at eagle-eye.dev. Contact Information: Equity Insider Media Contact: [email protected] DISCLAIMER: Nothing in this publication should be considered personalized financial advice. We are not licensed under securities laws to address your particular financial situation, and no communication from us should be deemed personalized financial advice. Please consult a licensed financial advisor before making any investment decision. 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Pelareorep is an investigational product candidate that has not been approved by the U.S. Food and Drug Administration or any other regulatory authority for any indication and has not been demonstrated to be safe or effective. The pelareorep and pan-RAS inhibitor findings referenced in this article are preclinical results from a single colorectal cancer model; preclinical results may not be predictive of results in clinical studies, and no clinical data combining pelareorep with a RAS inhibitor have been reported. Fast Track designation does not guarantee approval or a shortened review. FDA written feedback on the design of a potential pivotal study does not constitute agreement on a registration program, which the FDA has suggested be finalized at an End-of-Phase meeting that has not yet been held. Any decision to initiate REO 033 Part B depends on Part A data that are not yet available. Other companies' product candidates referenced in this article are likewise investigational unless stated to be approved. Referenced Companies and Market Data: References to Revolution Medicines, Inc., Amgen Inc., Eli Lilly and Company and Verastem Oncology are provided solely as market and sector context. Those companies are not peers, competitors, or financial comparables of Oncolytics Biotech Inc., were not involved in the preparation of this article, and their results are not indicative of Oncolytics Biotech Inc.'s prospects. The pan-RAS inhibitor used in the Oncolytics preclinical study was not identified by the Company, and nothing in this article implies it is a product of any company named herein. No partnership, affiliation, or endorsement is implied. Market-size figures are third-party projections by DelveInsight and Roots Analysis, are not addressable revenue for any company named in this article, and may not be realized. Eagle Eye Disclosure: Eagle Eye is an investor signal-intelligence platform affiliated with the publisher of this article, and any reference to it constitutes promotion of an affiliated product. Eagle Eye is not a broker-dealer, and nothing in the platform or in this article is financial, investment, tax, or legal advice. Data provided in the platform is for informational purposes only and may be delayed. Always do your own research before making any investment decision. Forward-Looking Statements: This publication contains forward-looking information which is subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ from those projected in the forward-looking statements. Forward-looking statements in this publication include statements regarding the potential of pelareorep in combination with RAS inhibitors, the design, timing and outcome of current and future clinical and preclinical studies, potential regulatory pathways and approvals, anticipated patent protection, and the size and growth of the KRAS inhibitor market. These forward-looking statements are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and are subject to risks and uncertainties including regulatory outcomes, trial execution, financial resources, access to capital markets, and market dynamics. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of publication. 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