Clinical TrialApr 27, 2026, 08:12 AM
ONCY Aligns with FDA on Pivotal Study Design for Pelareorep in SCAC
AI Summary
Oncolytics Biotech announced alignment with the U.S. Food and Drug Administration (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, aiming to support both accelerated and full approval within the same study. This development provides an efficient pathway for pelareorep in a disease with significant unmet medical need, leveraging strong durability and survival data from previous studies.
Key Highlights
- FDA aligned on pivotal clinical study design for pelareorep in metastatic SCAC.
- Study will be a randomized controlled trial, designed for both accelerated and full approval.
- Focuses on post-first-line SCAC patients, a population with no FDA-approved therapies.
- Previous study showed pelareorep combination achieved 15.5 months median duration of response vs. 9.5 months for standard of care.
- Previous study showed 12-month survival of 82% vs. 45.7% for standard of care.
- SCAC is a rare gastrointestinal malignancy affecting over 10,000 patients annually in the US.
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