Oncolytics Biotech Launches Phase 2 REO 033 Trial Targeting $3-5 B Colorectal Cancer Market
Oncolytics Biotech has initiated its randomized Phase 2 REO 033 trial combining pelareorep with bevacizumab and FOLFIRI in second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer, addressing a $3-5 billion market. Earlier data showed 27- and 16.6-month overall and progression-free survival versus 11.2 and 5.7 months, with a 33% response rate versus ~10%.
1. Phase 2 REO 033 Trial Initiation
Oncolytics Biotech has launched the randomized Phase 2 REO 033 trial to evaluate pelareorep in combination with bevacizumab and FOLFIRI in second-line RAS-mutated, microsatellite-stable metastatic colorectal cancer. The study will enroll 60 patients randomized 1:1 between the pelareorep arm and control arm of bevacizumab plus FOLFIRI, with objective response rate as the primary endpoint.
2. Compelling Prior Data
Earlier clinical data demonstrated that pelareorep combined with bevacizumab and FOLFIRI achieved a median overall survival of 27 months and progression-free survival of 16.6 months versus 11.2 and 5.7 months for standard therapy. The regimen delivered a 33% objective response rate compared with approximately 10% for the standard of care and received FDA Fast Track Designation.
3. Market Potential
The global market for second-line treatment in KRAS-mutant, microsatellite-stable metastatic colorectal cancer is estimated between $3 billion and $5 billion annually. This segment represents a significant opportunity as current therapies offer limited benefit and new immuno-oncology approaches are in high demand.
4. Next Steps and Timeline
Oncolytics expects to open the first REO 033 study site later this month and to add additional clinical centers shortly thereafter. Preliminary data from the trial are anticipated by year-end 2026, which could support regulatory registration and reshape treatment options in this difficult-to-treat population.