On November 19, 2025 Oncolytics Biotech Inc. (Nasdaq: ONCY) ("Oncolytics" or the "Company"), a clinical-stage immunotherapy company developing pelareorep, reported alignment with the U.S. Food and Drug Administration ("FDA") regarding the design of its pivotal study of pelareorep in combination with standard-of-care therapy for the first-line treatment of metastatic pancreatic ductal adenocarcinoma (mPDAC).
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The Company and the FDA completed a recent Type C meeting and have agreed on the key elements of the Phase 3 trial, which will evaluate pelareorep in combination with chemotherapy with or without a checkpoint inhibitor ("CPI") compared to chemotherapy alone. As a result, Oncolytics now has a clear path to launch what it believes will be the only such pivotal study of an immunotherapy in mPDAC, an indication for which immunotherapies have provided very little benefit.
"We now have regulatory clarity to allow us to start a pivotal study and ultimately the chance to bring the first approved immunotherapy treatment option to the pancreatic cancer treatment landscape," said Jared Kelly, Chief Executive Officer of Oncolytics Biotech. "The data speaks for itself, but we want to sincerely thank the FDA for its great work in helping us clear this initial regulatory hurdle. Although we still have work to do, we are laser-focused on bringing potential treatments to pancreatic cancer patients who desperately need more options."
The pivotal trial design includes a control arm of gemcitabine plus nab-paclitaxel (GnP), an experimental arm evaluating GnP plus pelareorep and an additional optional experimental arm evaluating GnP plus pelareorep plus a CPI. The primary endpoint of the study is overall survival. Progression-free survival and objective response rate are secondary endpoints. The trial will be statistically powered to demonstrate a clinically meaningful survival benefit and will potentially incorporate an interim analysis to support the option for an accelerated registration timeline. Either experimental arm or potentially both could meet the required success criteria.
The study protocol also permits flexibility in CPI selection for the triple-combination arm. Pelareorep has been combined successfully with multiple checkpoint inhibitors—including atezolizumab, pembrolizumab, nivolumab, and retifanlimab—in gastrointestinal and other tumor types. The final CPI choice will reflect ongoing discussions internally and with potential partners.
Dr. Thomas Heineman, Chief Medical Officer of Oncolytics, stated, "The FDA’s feedback confirms that our design is appropriate to support registration if successful. We are now completing the administrative activities necessary to initiate the study, including finalizing the protocol, generation of supporting documents, and site selection. We also plan to announce the lead principal investigator once these preparations are complete."
The Company is engaged in study start-up activities, including protocol review and site selection, and will provide periodic updates on the trial initiation process.
(Press release, Oncolytics Biotech, NOV 19, 2025, View Source [SID1234660089])