Oncolytics Fast Tracked for Pelareorep in 2L KRAS-Mutant MSS Metastatic Colorectal Cancer

Oncolytics (Nasdaq: ONCY) announced the FDA granted Fast Track Designation for pelareorep plus bevacizumab and FOLFIRI in 2L KRAS‑mutant MSS metastatic colorectal cancer. Clinical signals cited include a 33% ORR, median PFS 16.6 months and median OS 27 months, versus SOC benchmarks of ~10% ORR, 5.7‑month PFS and 11.2‑month OS. The company plans a controlled 2L study, first site activation in March, up to 11 sites, with interim data expected by year‑end 2026. The Fast Track may enable more FDA engagement and possible accelerated pathways.

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