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Oncolytics Biotech® Announces Promising Efficacy and Translational Data Supporting Pelareorep in KRAS-Mutant Metastatic Colorectal Cancer

33% ORR achieved in second-line KRAS-mutant MSS colorectal cancer—triple historical response rates for Avastin + FOLFIRI of 6-11% Translational analysis

articleOncolytics Biotech Inc.December 16, 20253/company/oncolytics-biotech-inc/news/oncolytics-biotechr-announces-promising-efficacy-and-translational-data-supporting-pelareorep-in-kras-mutant-metastatic-colorectal-cancer
Oncolytics Biotech® Announces Promising Efficacy and Translational Data Supporting Pelareorep in KRAS-Mutant Metastatic Colorectal Cancer

About this update from Oncolytics Biotech Inc.

[{"type":"text","content":"\n33% ORR achieved in second-line KRAS-mutant MSS colorectal cancer—triple historical response rates for Avastin + FOLFIRI of 6-11%\n\nTranslational analysis shows pelareorep enhances KRAS-mutant–specific T-cell activity, providing mechanistic support for clinical responses\n\nData strengthen pelareorep’s potential to transform a multi–billion dollar underserved colorectal cancer market\n\n SAN DIEGO--(BUSINESS WIRE)--\nOncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, today announced clinical and translational findings supporting the development of pelareorep in second-line metastatic colorectal cancer (“mCRC”), specifically in patients with KRAS-mutant, microsatellite-stable (“MSS”) disease. This represents one of the most difficult-to-treat and least responsive subgroups within colorectal cancer.\n\nIn a previously completed clinical study evaluating pelareorep in combination with standard-of-care therapy, 33% of KRAS-mutant MSS patients achieved an objective response, compared to the well-established historical objective response rate (“ORR”) of approximately 6–11% for Avastin® (bevacizumab) + FOLFIRI in second-line mCRC.1, 2 In that same study, patients receiving the pelareorep, bevacizumab, and FOLFIRI treatment regimen more than doubled progression-free survival and overall survival compared to those receiving bevacizumab and FOLFIRI (click here for the PR).\n\nIn addition to the clinical activity, a separate translational analysis of paired tumor biopsies revealed that treatment with pelareorep led to a notable increase in KRAS-mutant–specific T-cell populations, indicating that pelareorep may directly enhance anti-tumor immune recognition in this genetically defined subgroup. These findings provide strong biological support for pursuing pelareorep as a precision immunotherapy capable of addressing a patient population that rarely benefits from checkpoint inhibitors or other immunotherapies. A complete analysis of the translational data will be presented at an upcoming medical meeting.\n\n“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,”3 said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. “Pelareorep has clearly demons...

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