Cardiff Oncology’s Onvansertib 30 mg with FOLFIRI/Bev Posts 72% ORR
Cardiff Oncology’s Phase 2 CRDF-004 trial showed onvansertib 30 mg plus FOLFIRI/bevacizumab achieved a 72.2% response rate versus 43.2% standard of care, with PFS hazard ratio 0.37 (p=0.048). The 30 mg regimen’s dose-dependent efficacy and safety prompted selection for a registrational first-line RAS-mutated mCRC trial later this year.
1. Stock Plunges After Leadership and Trial Focus Update
Cardiff Oncology’s shares closed down roughly 32% on January 27, 2026 following the company’s announcement of a sudden leadership transition and a narrowed focus on its onvansertib clinical program. Investors reacted to the departure of CEO Mark Erlander and CFO James Levine, as well as news that Cardiff would concentrate resources on late-stage development of its PLK1 inhibitor, onvansertib, in first-line RAS-mutated metastatic colorectal cancer, pausing broader investigator-initiated studies.
2. Executive Changes Signal Shift to Late-Stage Development
The board named Mani Mohindru, PhD, interim CEO effective immediately; Mohindru has served on the board since 2021 and brings drug-development, operational and capital-markets expertise. James Levine and Mark Erlander stepped down, while Brigitte Lindsay, a 14-year company veteran, was elevated to Chief Accounting Officer to maintain financial continuity. Cardiff has launched searches for permanent CEO and CFO positions, underscoring its intent to strengthen governance ahead of pivotal registrational milestones.
3. Phase 2 Data Support Registrational Program
In the randomized CRDF-004 trial (n=74 total), onvansertib plus FOLFIRI/bevacizumab produced a confirmed objective response rate of 72.2% (13/18 patients) versus 43.2% (16/37) for standard of care, with a median progression-free survival not reached at data cutoff compared with 10.97 months (95% CI 9.43–15.44) for control. Progression-free survival hazard ratio versus standard of care was 0.37 (p=0.048). Grade ≥3 neutropenia was the most common adverse event, without unexpected toxicities. Based on these results, Cardiff selected the 30 mg dose for a registrational trial slated to begin later in 2026, pending FDA consultation.