Cardiff Oncology, Inc. announced positive updated data on July 29, 2025, from its ongoing CRDF-004, a randomized Phase 2 clinical trial. The trial is evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). Efficacy data, based on an intent-to-treat population of 110 patients as of a July 8, 2025, data cut-off, was determined by blinded, independent central review.
The data demonstrated a 49% confirmed objective response rate (ORR) in the 30mg onvansertib dose arm, representing a substantial 19% improvement over the 30% confirmed ORR observed in the control arm. Early progression-free survival (PFS) data also showed a favorable trend for the 30mg dose arm compared to the control arm at a median follow-up time of 6 months. Onvansertib continued to be well-tolerated, with a dose-dependent response observed across all efficacy endpoints, including early tumor shrinkage and depth of response.
The safety analysis, conducted for 104 patients dosed in the trial, indicated that onvansertib in combination with chemotherapy and bevacizumab was well-tolerated, with no major or unexpected toxicities. Neutropenia was the most common Grade 3 or higher treatment-emergent adverse event associated with onvansertib. These strong results position Cardiff Oncology to engage in discussions with the FDA regarding its registrational CRDF-005 trial, with an update on the first-line mCRC program expected by Q1 2026.
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