Oncolytics Biotech updated efficacy from the Phase 1 REO 022 trial, reporting a 19.5-month median duration of response and a 33% overall response rate for pelareorep combined with bevacizumab and FOLFIRI in second-line RAS-mutant, MSS metastatic colorectal cancer. The company said the outcomes numerically exceed historical SOC benchmarks. The company also indicated discussions with the FDA on a potential accelerated approval pathway for pelareorep (Reolysin) in this setting. Oncolytics described the dataset as demonstrating a durability signal in a patient population with limited options. For drug developers and investors, the key question remains whether the updated durability and response rates will translate into a regulatory strategy acceptable for accelerated review in a challenging biomarker-defined subtype.
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