Oncolytics' Pelareorep Yields 19.5-Month Median Response in KRAS-Mutant MSS Colorectal Cancer
Pelareorep-based therapy achieved a 19.5-month median duration of response in second-line KRAS-mutant MSS colorectal cancer, compared with a 4–6 month historical benchmark. The combination also produced a 33% objective response rate versus 6–11% standard therapy, and the company is engaging FDA on an accelerated approval path.
1. REO 022 Study Results
In the REO 022 trial, second-line KRAS-mutant MSS colorectal cancer patients treated with pelareorep plus bevacizumab and FOLFIRI achieved a median duration of response of 19.5 months, compared with the standard 4–6 months historically. The regimen also produced a 33% objective response rate, more than triple the 6–11% seen with standard care.
2. Regulatory Engagement
Oncolytics is actively engaging the FDA to explore an accelerated approval pathway based on the observed durability and time-to-event outcomes. Discussions aim to align on key endpoints and leverage the strength of the response data for potential early market access.
3. Ongoing Phase 2 Randomized Study
The company is enrolling patients in a randomized Phase 2 study evaluating pelareorep in combination with FOLFIRI and bevacizumab in second-line RAS-mutant MSS colorectal cancer. Results from this trial will inform confirmatory studies and support a potential registrational strategy.
4. Pelareorep Mechanism and Market Potential
Pelareorep is an intravenously delivered immunotherapeutic designed to convert ‘cold’ tumors ‘hot’ by activating innate and adaptive immunity. With Fast Track designation in colorectal cancer and significant unmet need in RAS-mutant MSS mCRC, the therapy targets a major oncology market where durable responses are scarce.