Cardiff Oncology has announced positive initial data from its Phase II clinical trial evaluating onvansertib in combination with standard-of-care (SoC) in patients with first-line RAS-mutated metastatic colorectal cancer (mCRC). The data, presented on December 10, 2024, led to a 50% surge in the company's stock price.
The Phase II trial (NCT06106308) randomized 30 evaluable patients in a 1:1:1 ratio to receive either 20mg of onvansertib plus SoC, 30mg of onvansertib plus SoC, or SoC alone. The primary endpoint was objective response rate (ORR), with secondary endpoints including progression-free survival (PFS), duration of response (DOR), and safety.
Efficacy and Safety Results
The 30mg dose arm demonstrated a 64% ORR, compared to 50% in the 20mg arm, and 33% ORR in the control arm. The data also indicated deeper tumor regression in the 30mg arm. According to Fairooz Kabbinavar, chief medical officer of Cardiff Oncology, the 64% ORR in the 30mg dose arm was "significantly higher" than the 33% ORR observed in the control arm.
Onvansertib was reportedly well-tolerated by patients at both the 30mg and 20mg doses, with similar safety profiles.
Future Plans and Financials
Cardiff Oncology plans to share additional clinical data from the trial in the first half of 2025. Subject to positive results from the Phase II CRDF-004 study, the company intends to initiate a Phase III CRDF-005 registrational study for the onvansertib/SoC combination in first-line RAS-mutated mCRC.
The FDA has agreed that an interim analysis of ORR in the planned registrational study could provide the basis for an accelerated approval application. Progression-free survival (PFS) and overall survival data would then serve as endpoints for full approval.
Following the positive data release, Cardiff Oncology announced the pricing of an underwritten offering of 15,384,619 shares of its common stock at $2.60 per share, resulting in an oversubscribed offering of approximately $40 million. The company plans to use the net proceeds to fund clinical costs for onvansertib in first-line RAS-mutated mCRC, as well as for working capital and other general corporate purposes.
Onvansertib's Potential in Oncology
Cardiff Oncology is also investigating onvansertib in other ongoing studies, including trials in relapsed small cell lung cancer, metastatic pancreatic ductal adenocarcinoma, and triple-negative breast cancer. These studies are evaluating onvansertib in combination with various other therapies.
