Cardiff Oncology’s onvansertib shows efficacy in Phase 2 colorectal cancer trial

Cardiff Oncology (CRDF) announced positive initial data from CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care in patients with first-line RAS-mutated metastatic colorectal cancer, or mCRC. Efficacy and safety data are for all evaluable patients as of a November 26, 2024 data cut-off date. The CRDF-004 phase 2 trial is currently enrolling patients with mCRC who have a documented KRAS or NRAS mutation. Onvansertib is added to SoC consisting of FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab. The primary endpoint is objective response rate – ORR -, and the secondary endpoints include progression-free survival – PFS -, duration of response – DOR – and safety. Spider Plots, displaying the change in tumor size from baseline for each patient over time, demonstrate deeper responses observed in patients receiving the 30mg dose of onvansertib in combination with the SoC compared to both the control arms and 20mg dose of onvansertib arms. Onvansertib in combination with chemo/bevacizumab was well-tolerated and there have been no major or unexpected toxicities observed. Additional clinical data from CRDF-004 trial expected in 1H 2025.