Oncolytics Biotech Announces Type C FDA Meeting to Discuss Pivotal Study for Pelareorep in Anal Cancer

Oncolytics Biotech Inc. announced that it has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) for April 16, 2026. The purpose of the meeting is to discuss a potential registrational development pathway for pelareorep in squamous cell anal carcinoma (SCAC). Specifically, the company intends to propose a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor for patients in the second-line or later treatment setting. The proposed study design involves approximately 60 to 70 patients, with the objective response rate (ORR) serving as the primary endpoint to support potential full approval. The initiative follows encouraging data from Cohort 4 of the GOBLET study, which demonstrated a 30% ORR and a median duration of response of 17 months in late-line patients—outperforming historical real-world outcomes. As there are currently no approved therapies for patients who have progressed on first-line chemotherapy and checkpoint inhibitors, Oncolytics believes this setting provides an efficient path to registration.