Cardiff Oncology, Inc. (CRDF) Reports 40% Response Rate in mTNBC Trial of Onvansertib + Paclitaxel

Cardiff Oncology, Inc. (NASDAQ:CRDF) announced groundbreaking Phase 1b clinical trial results for its PLK1 inhibitor onvansertib, combined with paclitaxel in metastatic triple-negative breast cancer (mTNBC) at the 2025 ASCO Annual Meeting.

The therapy demonstrated a 40% objective response rate at the highest dose (18mg/m²) in heavily pretreated patients, who had received a median of three prior chemotherapy lines.

Cardiff Oncology, Inc. (CRDF) Reports 40% Response Rate in mTNBC Trial of Onvansertib + Paclitaxel

A researcher in a lab coat analyzing the effects of PD-L1 on GITR Expressing Cells to advance the targeted oncology.

Notably, three of four responders had prior paclitaxel exposure, suggesting the combination may overcome resistance to standard taxane therapy. The drug pairing showed a clear dose-response relationship, with responses observed exclusively at the highest onvansertib dose. Safety data revealed a manageable profile, with myelosuppression as the most common adverse event. Dr. Fairooz Kabbinavar, Cardiff Oncology, Inc. (NASDAQ:CRDF)’s Chief Medical Officer, made the following comment:

“These results validate preclinical synergy between onvansertib and paclitaxel, offering hope for one of oncology’s most challenging malignancies.”

The trial, led by Dana-Farber Cancer Institute, achieved its primary endpoint of establishing a recommended Phase 2 dose (18mg/m²).

mTNBC lacks targetable receptors and accounts for 10-15% of breast cancers, often relapsing rapidly after initial treatment. Cardiff Oncology, Inc. (NASDAQ:CRDF) plans further development of the combination, which could become a critical option for patients with limited therapeutic alternatives.

Cardiff Oncology, Inc. (NASDAQ:CRDF) is a clinical-stage biotech focused on PLK1 inhibition to develop cancer therapies. Its lead drug, onvansertib, is being tested with standard treatments for RAS-mutated metastatic colorectal cancer and in trials for pancreatic, lung, and triple-negative breast cancers. The company aims to overcome treatment resistance and improve outcomes.

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