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Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer
SAN DIEGO, April 06, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech ® Inc. (Nasdaq: ONCY) (&#x...
About this update from Oncolytics Biotech Inc.
[{"type":"text","content":"Oncolytics Biotech® Announces Type C FDA Meeting to Discuss Single-arm Registrational Pathway for Pelareorep in Anal Cancer\nSAN DIEGO, April 06, 2026 (GLOBE NEWSWIRE) -- Oncolytics Biotech® Inc. (Nasdaq: ONCY) (“Oncolytics” or the “Company”), a clinical-stage immunotherapy company developing pelareorep, an investigational, systemically delivered immunotherapy that has been shown to activate innate immune-sensing pathways, today announced that it has scheduled a Type C meeting with the U.S. Food and Drug Administration (“FDA”) on April 16, 2026, to discuss a potential registrational development path in anal cancer. The meeting will focus on the potential to initiate a single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor in patients being treated with second-line and later therapy for squamous cell anal carcinoma (“SCAC”). Patients will have received a checkpoint inhibitor and chemotherapy in the first-line, which means all patients treated in this study would have no alternative approved therapies available at this stage of treatment. The Company intends to discuss a study design enrolling approximately 60 to 70 patients with objective response rate (“ORR”) as the primary endpoint to support a potential full approval. Pelareorep, in combination with a checkpoint inhibitor, has demonstrated encouraging clinical activity in SCAC. In Cohort 4 of the GOBLET study, the combination achieved approximately 30% ORR with a median duration of response in late-line patients of 17 months. These results compare favorably to real-world outcomes, where response rates are approximately 10-14% with a median duration of response of approximately 9.5 months in this setting.1 “We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer,” said Jared Kelly, Chief Executive Officer of Oncolytics. “Our goal is to align with the FDA on the statistical analysis plan and sample size for a potential pivotal single-arm study in second-line and later SCAC. In a setting with limited approved therapies, we believe the strength and durability of our data support this approach, and recent regulatory discussions in oncolytic virus development underscore t...