Therapy Areas
Oncolytics reports strong efficacy signals for pelareorep in colorectal cancer
8 September 2025 -

Immunotherapy company Oncolytics Biotech Inc (NASDAQ: ONCY) on Monday announced positive clinical and translational findings from three metastatic colorectal cancer (mCRC) studies, highlighting pelareorep's potential in KRAS mutant and later-line settings.

In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab delivered median progression-free survival of 16.6 months and overall survival of 27.0 months in second-line KRAS mutant mCRC patients, compared with 5.7 months and 11.2 months, respectively, for the standard regimen.

In the GOBLET trial, pelareorep with atezolizumab and TAS-102 met its predefined endpoint in third-line mCRC, producing durable disease control and survival outcomes above historical benchmarks for TAS-102 monotherapy. Translational findings from REO 022 and REO 013 confirmed pelareorep's replication within CRC tumors and immune activation, including dendritic cell maturation and CD8+ T cell activity.

The company plans to define a regulatory pathway, advance discussions with investigators and establish an investigator-sponsored trial in KRAS mutant mCRC. Oncolytics is also pursuing broader development of pelareorep across gastrointestinal and breast cancers, with Fast Track designation already secured in pancreatic and breast cancer.

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