Oncolytics schedules FDA meeting for pelareorep registrational path

Oncolytics (ONCY) announced it has scheduled a Type C meeting with the FDA on April 16, to discuss a potential registrational development path for pelareorep in anal cancer. “We believe this upcoming FDA meeting is a critical step in advancing pelareorep toward a potential registration pathway in anal cancer. 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,” said Jared Kelly, CEO of Oncolytics Biotech. 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. The company intends to discuss a study design enrolling approximately 60 to 70 patients with objective response rate as the primary endpoint to support a potential full approval.