Oncolytics Biotech (US:ONCY) Prnewswire·2025-09-08 11:00Core Insights - Oncolytics Biotech Inc. has reported that pelareorep demonstrates a significant survival benefit in KRAS mutant metastatic colorectal cancer (mCRC), with median progression-free survival (PFS) of 16.6 months compared to 5.7 months for the current standard of care, and median overall survival (OS) of 27.0 months versus 11.2 months [6]. Group 1: Clinical Efficacy - In the REO 022 trial, pelareorep combined with FOLFIRI and bevacizumab showed promising results in platinum refractory 2L mCRC KRAS mutant patients [2]. - The GOBLET study's 3L mCRC Cohort 3 demonstrated that pelareorep combined with atezolizumab and TAS-102 met its predefined efficacy endpoint, achieving durable disease control and survival rates exceeding historical benchmarks [2]. Group 2: Mechanism of Action - Studies including REO 022 and REO 013 confirmed pelareorep's mechanism of action, showing viral replication and immune activation in mCRC tumors, including dendritic cell maturation and CD8+ T cell activation [3]. - The findings indicate that pelareorep can modify mCRC tumors to become immune responsive, making them more amenable to checkpoint inhibition [3]. Group 3: Future Development Plans - The company plans to initiate an investigator-sponsored trial to further explore pelareorep's potential in KRAS mutant mCRC, leveraging the robust immune activation and survival benefits observed in previous studies [4]. - Oncolytics aims to define a regulatory pathway for pelareorep and engage with leading investigators to establish a clear path to registration in mCRC, including the design of a confirmatory study [4].