Oncolytics Biotech (NASDAQ:ONCY) has scheduled a Type C meeting with the U.S. Food and Drug Administration (FDA) for April 16, 2026, to align on a formal registrational development path for its lead immunotherapy candidate, pelareorep, in patients with advanced anal cancer.
The meeting will focus on the design of a potential single-arm pivotal study evaluating pelareorep in combination with a checkpoint inhibitor for patients with second-line and later-stage squamous cell anal carcinoma (SCAC).
The proposed study targets a patient population that has already progressed on first-line chemotherapy and checkpoint inhibitors, a setting where no currently approved standard-of-care therapies exist.
Oncolytics intends to discuss a trial design enrolling approximately 60 to 70 patients, utilizing objective response rate (ORR) as the primary endpoint to support a potential filing for full regulatory approval.
The strategy follows encouraging data from the GOBLET study, where the combination therapy achieved a 30% ORR and a median duration of response of 17 months in late-line patients.
These figures significantly outperform historical real-world benchmarks, which typically show response rates between 10% and 14% with a 9.5-month median duration.
The anal cancer market is currently underserved, with approximately 54,000 cases diagnosed globally each year.
Analysts project the market for these treatments will double to $2.3 billion by 2035.
For Oncolytics, a successful Type C meeting would transition pelareorep from a mid-stage clinical asset into a late-stage registrational program with a high probability of meeting an unmet medical need.