Cardiff Oncology, Inc. announced on October 30, 2024, the publication of data from its Phase 2 trial evaluating onvansertib in combination with FOLFIRI and bevacizumab (bev) for the second-line treatment of KRAS mutant metastatic colorectal cancer (mCRC). The findings were published in the peer-reviewed Journal of Clinical Oncology, the flagship publication of the American Society of Clinical Oncology (ASCO). This publication underscores the clinical activity and tolerability of the onvansertib combination in a cancer indication that has lacked new treatment options for decades.
A post hoc analysis from the trial revealed a 7.7-fold higher clinical benefit in bevacizumab-naïve patients, demonstrating an objective response rate (ORR) of 77% and a median Progression-Free Survival (mPFS) of 14.9 months. In contrast, bevacizumab-exposed patients showed an ORR of 10% and an mPFS of 6.6 months. These results highlight a significant differentiation in efficacy based on prior bevacizumab exposure.
The compelling data from this trial, coupled with translational studies, provided the scientific rationale for Cardiff Oncology to strategically shift its clinical development program for onvansertib to the first-line RAS-mutant mCRC setting. In this first-line setting, all patients are bevacizumab-naïve, aligning with the observed robust responses. The company anticipates releasing initial data from its first-line RAS-mutant mCRC CRDF-004 trial in the second half of 2024.
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