other material
confidence high
sentiment positive
materiality 0.50
Oncolytics: REO 033 CRC study sites nearly all activated; interim Part A data due year-end 2026
ONCOLYTICS BIOTECH INC
- Part A of randomized REO 033 to enroll ~60 patients with second-line RAS-mutant MSS metastatic colorectal cancer; ORR is primary endpoint, with PFS, OS, safety and biomarkers.
- Interim Part A data expected by year-end 2026, based on number of evaluable patients enrolled by end of October; multiple patients now on study.
- REO 022 prior data: ORR 33% vs ~6-11% historical benchmark; median PFS 16.6 months vs ~5.7; median OS 27.0 months vs ~11.2; median duration of response 19.5 months.
- FDA alignment on pivotal Part B expansion: potential accelerated approval on objective response rate; progression-free survival basis for full approval; Part A data to inform Part B.
- RO 033 tests pelareorep plus FOLFIRI and bevacizumab versus FOLFIRI and bevacizumab; COO John McAdory cites strong enrollment momentum.