Cardiff Oncology, Inc. announced on June 2, 2025, positive data from an investigator-initiated Phase 1b clinical trial evaluating onvansertib in combination with paclitaxel in patients with metastatic triple-negative breast cancer (mTNBC). The results were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, held from May 30 to June 3, 2025.
The trial demonstrated a 40% objective response rate (ORR) at the highest dose of onvansertib in heavily pretreated mTNBC patients. Objective responses were observed only at the highest dose of onvansertib, indicating a dose-response relationship. Three of the four objective responses occurred in patients who had prior exposure to paclitaxel, suggesting potential synergy.
The combination of onvansertib and paclitaxel was well-tolerated, exhibiting a safe and manageable toxicity profile. Myelosuppression, a decrease in bone marrow activity, was noted as the most common side effect. These findings offer clinical validation of previously reported preclinical data, supporting onvansertib's potential across multiple cancer types beyond its primary focus in mCRC.
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