Cardiff Oncology’s Onvansertib Shows 72.2% ORR and H1 2026 Filing Plans
Cardiff Oncology’s Phase 2 CRDF-004 trial reported a 72.2% objective response rate for 30 mg onvansertib plus FOLFIRI/bevacizumab versus 43.2% for combined standard regimens, with a PFS hazard ratio of 0.37 (p<0.05). The company ended 2025 with $58.3 million cash to fund operations into Q1 2027 and aims for registrational filings in H1 2026.
1. Phase 2 Trial Results
The randomized Phase 2 CRDF-004 trial evaluated onvansertib at a 30 mg dose combined with FOLFIRI/bevacizumab in first-line RAS-mutated metastatic colorectal cancer and achieved a confirmed objective response rate of 72.2% versus 43.2% for combined standard-of-care arms. The combination also demonstrated a significant progression-free survival benefit (hazard ratio 0.37, p<0.05) with no meaningful increase in toxicity.
2. Registrational Program and Timeline
Based on the robust efficacy data, Cardiff Oncology plans to advance the 30 mg onvansertib plus FOLFIRI/bevacizumab regimen into a registrational program. Detailed Phase 2 data and a formal registrational plan will be shared following discussions with regulatory authorities in the first half of 2026.
3. Full Year 2025 Financial Position
As of December 31, 2025, the company held $58.3 million in cash, cash equivalents and short-term investments, which it expects will fund operations into the first quarter of 2027. Total operating expenses for 2025 were $49.6 million, driven by R&D activity, SG&A costs and stock-based compensation.
4. Leadership Changes
In January 2026, the board appointed Mani Mohindru, PhD, as interim Chief Executive Officer to guide the transition into late-stage development. Brigitte Lindsay was promoted to Chief Accounting Officer, and searches are underway for permanent CEO and CFO positions.