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SEC filingOncolytics Biotech announced FDA alignment on a randomized controlled pivotal study for pelareorep in second-line metastatic anal cancer, addressing an unmet need with no approved therapies.
On April 27, 2026, Oncolytics Biotech announced alignment with the FDA on the design of a pivotal clinical study for pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal (SCAC). The study will be a randomized controlled trial, which could potentially support both accelerated approval and full approval within the same study. This decision followed a Type C meeting and consideration of recent regulatory trends. The post-first-line SCAC setting has no FDA-approved therapies, representing a significant unmet need. In a prior study, pelareorep combined with a checkpoint inhibitor demonstrated a median duration of response of 15.5 months versus 9.5 months for standard of care, and 12-month survival of 82% versus 45.7%. The company plans to incorporate FDA feedback into the final protocol. This development is material as it de-risks the regulatory pathway and highlights the potential for pelareorep to address a high-need indication.