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ASCO 2026 | CRDF-004: interim data of onvansertib and chemotherapy in 1L RAS-m mCRC
Heinz-Josef Lenz, MD, FACP, University of Southern California, Los Angeles, CA, discusses interim results from the Phase II CRDF-004 trial (NCT06106308) of onvansertib, a selective PLK1 inhibitor, combined with standard-of-care chemotherapy and bevacizumab in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Results demonstrated improved antitumor activity and a manageable safety profile with the addition of onvansertib, supporting further confirmatory Phase III evaluation of this combination in this patient population. This interview took place during the 2026 American Society of Clinical Oncology (ASCO) Meeting in Chicago, IL.
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Transcript
The data we’re presenting is from a randomized phase 2 clinical trial, randomized inpatient to standard of care, which is either FOLFOX or FOLFIRI plus bevacizumab versus two doses of Onvansertib, 20 milligrams or 30 milligrams, in combination with either FOLFIRI or FOLFOX plus bevacizumab as a backbone. The reason this study was designed is that Onvansertib has shown pre-clinically to have significant synergism with irinotecan and bevacizumab...
The data we’re presenting is from a randomized phase 2 clinical trial, randomized inpatient to standard of care, which is either FOLFOX or FOLFIRI plus bevacizumab versus two doses of Onvansertib, 20 milligrams or 30 milligrams, in combination with either FOLFIRI or FOLFOX plus bevacizumab as a backbone. The reason this study was designed is that Onvansertib has shown pre-clinically to have significant synergism with irinotecan and bevacizumab. Phase 1b as well as phase 2 studies proved that the interaction with FOLFIRI plus bevacizumab and Onvansertib showed a significant increased response rate and progression-free survival. So this study was designed to prove prospectively the efficacy of the combination with FOLFIRI plus bevacizumab. And the study clearly validated the high response rate of 72% in patients treated with FOLFIRI plus bevacizumab and Onvansertib. There was a dose dependency. The 30 milligrams is more effective than the 20 milligrams. The PFS has not been even reached in the treatment experimental arms, but the hazard ratio is about 0.53 or 0.55, depending on central review or local assessment per investigators, indicating that the data were validated from earlier clinical trials, setting the stage for a randomized phase three registration study. The combination with Onvansertib and FOLFOX did not improve the outcome, which we pre-clinically assumed, but we wanted to have a prospective testing of this done. So this is going, we are going to present showing that the efficacy of Onvansertib with FOLFIRI plus bevacizumab showed very promising response rate over 70 percent and PFS not reached with a hazard ratio of 0.5 compared to standard of care treatments.
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