Cardiff Oncology's Onvansertib Phase 2 mCRC Trial Shows 72.2% ORR
Cardiff Oncology, Inc. announced positive results from its Phase 2 CRDF-004 clinical trial evaluating onvansertib in first-line RAS-mutated metastatic colorectal cancer (mCRC). The trial successfully achieved its primary goal, with the 30 mg onvansertib + FOLFIRI/bevacizumab arm demonstrating a 72.2% overall response rate (ORR) compared to 42.1% for standard-of-care (SoC), and median progression-free survival (PFS) not yet reached. Onvansertib was well-tolerated with no new toxicities, leading the company to plan a registrational trial in first-line RAS-mutated mCRC following a successful End-of-Phase 2 meeting with the FDA. An investor webcast is scheduled for June 3, 2026, to discuss the data and future plans.
Key Highlights
- Phase 2 CRDF-004 trial achieved primary goal of selecting efficacious and safe dose for registrational program.
- 30 mg onvansertib + FOLFIRI/bevacizumab arm showed 72.2% confirmed ORR vs 42.1% for SoC.
- Median PFS not reached in 20 or 30 mg onvansertib + FOLFIRI/bevacizumab arms.
- Onvansertib was safe and well-tolerated with no overlapping or new toxicities.
- Registrational trial planned in first-line RAS-mutated mCRC following successful FDA meeting.
- Investor webcast scheduled for June 3, 2026, to review Phase 2 data and registrational plans.
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