Cardiff Oncology Inc. (CRDF), a clinical-stage biotechnology company, on Tuesday announced positive Phase 2 results for Onvansertib in combination with standard-of-care regimens in treating first-line RAS-mutated metastatic colorectal cancer (mCRC). The data was presented at the 2026 annual meeting of the American Society of Clinical Oncology (ASCO).
Onvansertib is a highly specific, oral PLK1 inhibitor developed for the treatment of RAS-mutated cancers.
The randomized, controlled Phase 2 CRDF-004 trial evaluated the safety and efficacy of Onvansertib across two different doses in combination with FOLFIRI/bevacizumab or FOLFOX/bevacizumab. The trial dosed 110 patients of KRAS or NRAS-mutated mCRC.
The primary endpoint was met, with an objective response rate (ORR) of 72.2% recorded in treated patients, compared to the ORR of 42.1% observed in those on the standard-of-care therapy. A median PFS could not be reported, as 14 patients currently remain in the trial. The drug was found to be well-tolerated in both combinations with chemotherapy.
Following the completion of an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the company achieved alignment on the design of a Phase 3 trial. The Phase 3 registrational study will evaluate the safety and efficacy of Onvansertib in combination with FOLFIRI/bevacizumab versus FOLFIRI/bevacizumab alone for patients with RAS-mutated mCRC.
Onvansertib is simultaneously being explored in studies for treating metastatic pancreatic ductal carcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).
CRDF is currently trading at $1.53, up 3.72%.
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