Oncolytics Biotech Inc. (Nasdaq: ONCY) announced updated data from Cohort 4 of its Phase 1/2 GOBLET study on October 27, 2026. The study is evaluating pelareorep in combination with atezolizumab (Tecentriq) for patients with second-line or later squamous cell anal cancer (SCAC).
The press release states that the median duration of response for the combination therapy is approximately 15 months. This figure compares favorably to historical results for the FDA-approved drug retifanlimab monotherapy, which showed a median duration of response of 9.5 months in a similar patient population.
Key details from the data include:
- Although median overall survival has not yet been reached, all patients who responded to the treatment survived beyond 12 months.
- Multiple patients survived for longer than 24 months.
The company noted that more than 90% of anal cancer cases are associated with human papillomavirus (HPV). Oncolytics stated that these results provide evidence that pelareorep enhanced the clinical benefit of checkpoint inhibition in advanced SCAC.
In response to recent FDA interactions and the receipt of Fast Track Designation, Oncolytics plans to explore additional clinical studies with a potential checkpoint inhibitor partner. The company believes the durable clinical responses may support an accelerated approval pathway, while overall survival data could support full approval, subject to FDA agreement.
The company also indicated a potential strategy to expand into HPV-associated head and neck squamous cell carcinoma. Pelareorep has previously demonstrated signals of antitumor activity in head and neck cancer studies, though it has not yet been evaluated in combination with a checkpoint inhibitor in this disease.
