On March 2, 2026 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported the initiation of a metastatic colorectal cancer ("mCRC") Phase 2 study that will be referred to as REO 033.
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In this trial, second-line ("2L") RAS-mutated (which includes KRAS), microsatellite-stable ("MSS") mCRC patients will be randomized to a control arm of bevacizumab (Avastin) and fluorouracil, leucovorin, irinotecan ("FOLFIRI") or an experimental arm of pelareorep, bevacizumab, and FOLFIRI. The study is powered for statistical significance, with each study arm expected to enroll 30 patients. All participants will have failed their initial treatment with platinum-based chemotherapy. The primary endpoint of the study is objective response rate ("ORR"), with progression-free survival ("PFS"), overall survival ("OS"), safety, and biomarker analysis as other endpoints. The trial will be sponsored by Oncolytics with Sanjay Goel, M.D., M.S., FASCO, Professor of Medicine at Rutgers Cancer Institute of New Jersey, as the Lead Investigator. The Company is expecting to initiate the first study site later this month and provide preliminary data by year-end.
"I am honored to lead this study as I have a long track record working with pelareorep and have witnessed its ability to improve patient outcomes in a meaningful way," said Dr. Goel. "The colorectal cancer data we recorded in the REO 022 study continues to be compelling to this day, as evidenced by the Fast Track Designation, and I hope we can generate additional exciting data in this new trial to support registration."
The previous REO 022 clinical study of pelareorep, bevacizumab, and FOLFIRI in this population demonstrated a median OS of 27 months and a median PFS of 16.6 months, both of which substantially exceed the median 11.2- and 5.7-month OS and PFS, respectively, observed for standard-of-care therapy. Similarly, ORR in the same study was 33% for pelareorep-containing therapy compared to approximately 10% for standard-of-care treatment.1-2 Last month, the Company announced that pelareorep in combination with bevacizumab and FOLFIRI was granted Fast Track Designation by the U.S. Food & Drug Administration in 2L KRAS-mutant, MSS mCRC.
"The potential to improve clinical outcomes compared to the standard-of-care in the second-line setting would have the potential to benefit patients around the world who are affected by colorectal cancer," said Dr. Van Morris, Associate Professor in the Department of Gastrointestinal Medical Oncology at The University of Texas MD Anderson Cancer Center in Houston, TX, and member of the Oncolytics Biotech Gastrointestinal Scientific Advisory Board. "An immunotherapy with the potential to improve outcomes would improve treatment options in colorectal cancer and would be highly welcomed, especially as we are seeing more and more younger patients being diagnosed with colorectal cancer."
(Press release, Oncolytics Biotech, MAR 2, 2026, View Source [SID1234663180])