Oncolytics Biotech Inc. aligns with the U.S. Food and Drug Administration on a randomized pivotal trial design for pelareorep in metastatic anal cancer, aiming to support both accelerated and full approval.
Written By: Pharmacally Medical News Desk
Oncolytics Biotech Inc. has reached agreement with the U.S. Food and Drug Administration on the design of a pivotal clinical study evaluating pelareorep in patients with unresectable metastatic squamous cell carcinoma of the anal canal (SCAC), following a Type C meeting with the agency.
Pelareorep is an investigational immunotherapy administered systemically and designed to activate innate immune pathways. The planned study will be a randomized controlled trial intended to support both accelerated approval and full regulatory approval within a single protocol.
According to the company, the FDA’s guidance led to a shift from a potential single-arm study to a randomized design. This approach reflects recent regulatory expectations and is intended to meet evidentiary standards while allowing for multiple endpoint-based assessments over time.
Chief Executive Officer Jared Kelly indicated that the agency provided clear direction, enabling what the company views as a more efficient development pathway while maintaining rigorous clinical requirements.
SCAC is a rare gastrointestinal cancer, affecting more than 10,000 patients annually in the United States. Patients whose disease progresses after first-line chemotherapy and checkpoint inhibitor treatment currently have no FDA-approved therapies and limited options recommended by clinical guidelines.
Clinical data cited by the company suggest that combining pelareorep with a checkpoint inhibitor in second line and later SCAC may improve outcomes. In a recent study, the combination demonstrated a median duration of response of 15.5 months compared with 9.5 months for standard care, along with a 12-month survival rate of 82% versus 45.7%.
Dr. Van Morris of MD Anderson Cancer Center noted that the post–first line setting in SCAC remains an area of significant unmet need. He described pelareorep as having a strong scientific rationale for further evaluation and characterized the proposed trial design as appropriate for advancing new treatment options in this population.
Oncolytics plans to incorporate FDA feedback into the final study protocol. The company expects the single randomized trial to serve as the basis for regulatory submissions at different stages, depending on interim and final outcomes.
Reference
Oncolytics Aligns with FDA on Planned Pivotal Anal Cancer Study | Oncolytics Biotech Inc.