KRAS Inhibitor Market Projected to Reach $7.8 Billion by 2034

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.

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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.

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