12:45 PM EST, 11/19/2025 (MT Newswires) -- Oncolytics Biotech ( ONCY ) said Wednesday it reached alignment with the US Food and Drug Administration on the design of its phase 3 trial testing pelareorep with standard chemotherapy for first-line treatment of metastatic pancreatic ductal adenocarcinoma.

The alignment was reached during a recent Type C meeting, where Oncolytics and the FDA agreed on key trial elements, paving the way for the immunotherapy study in this pancreatic cancer indication.

The study will compare chemotherapy alone to chemotherapy plus pelareorep, with an optional arm adding a checkpoint inhibitor. Overall survival will serve as the primary endpoint, and the trial may include an interim analysis to support an accelerated approval pathway.

Oncolytics said pelareorep has demonstrated compatibility with multiple checkpoint inhibitors and that it has begun study start-up activities, including protocol review and site selection.

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