Cardiff Oncology, Inc. announced positive initial data on December 10, 2024, from its randomized Phase 2 CRDF-004 clinical trial. This trial is evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). The efficacy and safety data were based on all evaluable patients as of a November 26, 2024, data cut-off.
The initial results demonstrated a robust efficacy signal, with the 30mg onvansertib dose arm achieving a 64% objective response rate (ORR), significantly higher than the 33% ORR observed in the control arm receiving SoC alone. A dose-dependent response was also noted, as the 30mg dose showed a higher ORR compared to the 20mg dose, which had a 50% ORR. Deeper tumor regression was observed in patients receiving the 30mg dose.
Onvansertib, when combined with chemotherapy and bevacizumab, was well-tolerated at both 20mg and 30mg doses, with no major or unexpected toxicities reported. This favorable safety profile is a key differentiator for onvansertib compared to previous generation PLK1 inhibitors. The company anticipates providing additional clinical updates from the CRDF-004 trial in the first half of 2025.
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