Oncolytics Biotech Inc. reported that its investigational oncolytic virus pelareorep achieved a 33% objective response rate in a cohort of patients with KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer. The study, which combined pelareorep with bevacizumab and FOLFIRI chemotherapy, showed a 33% response rate versus the 6‑11% historical benchmark for bevacizumab plus FOLFIRI alone, and demonstrated more than a doubling of both progression‑free survival (median 16.6 months vs. 5.7 months) and overall survival (median 27.0 months vs. 11.2 months).
Translational analyses of tumor biopsies revealed that pelareorep treatment increased KRAS‑mutant–specific T‑cell populations, confirming the virus’s ability to convert immunologically “cold” tumors into “hot” ones. This mechanistic insight underpins the company’s plan to launch a sponsor‑led, controlled study to confirm the signal and support a potential regulatory submission for this indication.
The result is significant because KRAS‑mutant, microsatellite‑stable metastatic colorectal cancer has historically responded poorly to standard therapies, with an objective response rate of only 6‑11%. A 33% response rate triples the benchmark and addresses a large unmet need in a market projected to reach $20 billion by 2033. Oncolytics’ focus on this subgroup aligns with its broader gastrointestinal platform strategy, which also targets pancreatic and anal cancers, and positions pelareorep as a precision immunotherapy that could reshape treatment options for a difficult‑to‑treat population.
CEO Jared Kelly said, “Colorectal cancer is the core of our emerging GI tumor platform strategy for pelareorep, with a projected total addressable market of $20 billion by 2033. Pelareorep has clearly demonstrated the potential to become a transformational new treatment option in this underserved setting. With translational data supporting its unique activation of KRAS‑specific T cells, pelareorep has delivered a 33 percent response rate in KRAS‑mutant, MSS colorectal cancer.” Dr. Sanjay Goel, Professor of Medicine at Rutgers Cancer Institute of New Jersey, added, “These results are extremely encouraging. Achieving a 33 % ORR in KRAS‑mutant MSS colorectal cancer is highly unusual in this setting and warrants immediate further study. The translational findings strengthen the mechanistic rationale behind the clinical activity we are observing.”
Following the announcement, Oncolytics’ shares rose more than 5 percent, reflecting investor enthusiasm for the breakthrough data. The company’s stock had already experienced a 44 percent surge over the past six months, underscoring the market’s recognition of pelareorep’s potential to address a sizable, underserved patient population and to generate a new revenue stream within the company’s GI platform.
Oncolytics plans to initiate a sponsor‑led, controlled study to confirm the clinical benefit and to support a regulatory submission for pelareorep in KRAS‑mutant metastatic colorectal cancer. The company’s strategy to lead the trial, rather than rely on an investigator‑sponsored study, is intended to provide robust data for regulatory approval and to accelerate commercialization. The positive data also reinforce Oncolytics’ positioning as a leader in precision immunotherapy for KRAS‑mutant tumors, which are typically resistant to checkpoint inhibitors.
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