Oncolytics Biotech (US:ONCY) Prnewswire·2025-10-28 11:30Core Insights - The combination of pelareorep and atezolizumab achieved a 30% objective response rate (ORR) in patients with second-line or later squamous cell anal carcinoma (SCAC), significantly higher than the historical benchmark of 13.8% for the only FDA-approved treatment [1][2] - The median duration of response for this combination therapy was 15.5 months, compared to 9.5 months for the current standard of care [3] - Oncolytics Biotech plans to discuss a single-arm accelerated approval study with the FDA in Q1 2026 [1][6] Efficacy Results - Among 20 evaluable patients, six achieved a response, resulting in a 30% ORR, which is more than double the historical benchmark [2] - Two durable complete responses were observed, with one lasting over two years and another lasting 15 months; an additional patient has an ongoing response at 64 weeks [3] - The results indicate the potential for pelareorep to provide durable immunologic tumor control in gastrointestinal tumors without chemotherapy [4] Company Strategy - The SCAC cohort is part of the broader GOBLET study, which evaluates pelareorep in combination with checkpoint inhibitors and standard therapies across multiple gastrointestinal cancer indications [5] - Oncolytics intends to engage with the FDA regarding a potential single-arm study for accelerated approval in SCAC, with a possible launch in the first half of 2026 [6] - The GOBLET study includes multiple treatment groups targeting various gastrointestinal cancers, assessing both efficacy and safety [7][8] Company Background - Oncolytics Biotech is a clinical-stage biotechnology company focused on developing pelareorep, an investigational immunotherapeutic agent designed to activate immune responses against cancer [10] - The company is advancing pelareorep in combination with chemotherapy and/or checkpoint inhibitors in various cancer types, including pancreatic and breast cancers [11]