Cardiff Oncology’s Onvansertib Shows Promising Results in First-Line RAS-Mutated Metastatic Colorectal Cancer Trial
Positive Initial Data:
Cardiff Oncology announced positive initial data from its Phase 2 CRDF-004 trial evaluating onvansertib combined with standard-of-care (SoC) in first-line RAS-mutated metastatic colorectal cancer (mCRC) patients13.
Objective Response Rate (ORR):
The trial demonstrated a 64% ORR in the 30mg onvansertib dose arm, significantly outperforming both the control arm (33% ORR) and the 20mg dose arm (50% ORR)13.
Tumor Regression:
The 30mg dose showed deeper tumor regression compared to the 20mg dose, with the drug being well-tolerated at both doses13.
Study Design:
The CRDF-004 trial is a randomized Phase 2 study enrolling patients with mCRC who have a documented KRAS or NRAS mutation, combining onvansertib with FOLFIRI plus bevacizumab or FOLFOX plus bevacizumab13.
Future Data:
Additional clinical data from the CRDF-004 trial is expected in the first half of 2025, which will be crucial for partnership discussions and market validation13.
Market Potential:
The positive results position onvansertib as a compelling first-line therapy option, particularly given its clean safety profile and compatibility with existing treatment regimens, targeting a significant commercial opportunity in the 50,000 annual US patient population1.
Sources:
1. https://www.stocktitan.net/news/CRDF/cardiff-oncology-announces-positive-initial-data-from-first-line-ras-nhqkyxqo5m7y.html
3. https://investors.cardiffoncology.com/news-releases/news-release-details/cardiff-oncology-announces-positive-initial-data-first-line-ras