Cardiff Oncology Inc. (NASDAQ: CRDF) has announced new findings from its flagship clinical program evaluating the combination of onvansertib with the standard of care FOLFIRI/bevacizumab for second-line therapy in KRAS mutated metastatic colorectal cancer patients. Dr. Heinz-Josef Lenz, principal investigator, USC Norris Comprehensive Cancer Center, will discuss a sample of these findings in a poster at the American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) on Saturday, January 22, 2022.
Cardiff increased the number of patients evaluated in the study
Chief Medical Officer of Cardiff Oncology Katherine Ruffner said, “As we have increased the number of patients evaluated and the duration of follow-up, our Phase 1b/2 trial has consistently generated data suggesting that onvansertib provides meaningful clinical benefits when added to SOC. The objective response rate and median progression-free survival observed substantially exceed what would be expected with SOC alone, and five patients receiving onvansertib have been able to pursue potentially curative metastasis-directed treatments. We also observed a complete, confirmed response, which is exciting given the difficult-to-treat nature of second-line mCRC patients.
CEO of Cardiff Oncology, Mark Erlander, commented, “These impressive results show radiographic responses across multiple KRAS mutation variants when onvansertib is combined with the standard of care regimen of FOLFIRI-Bev and demonstrate a substantial increase in disease response relative to historical controls. We believe the data presented today further validate the potential of onvansertib to provide a meaningful improvement in the treatment outcome of a large patient population that has limited available treatment options. Looking forward, and with our strong cash position, we have the ability to explore the full potential of onvansertib.”
Enrolment ongoing in the study
This single-arm, multi-center Phase 1b/2 study evaluates the preliminary efficacy and safety of onvansertib combined with standard-of-care FOLFIRI and Avastin® (bevacizumab) in the second-line care of KRAS-mutated mCRC patients. Patients with histologically confirmed metastatic and unresectable colorectal carcinoma containing a KRAS mutation are being enrolled in the “A Phase 1b/2 Study of Onvansertib (PCM-075) in Combination with FOLFIRI and Bevacizumab for Second-Line Treatment of Metastatic Colorectal Cancer in Patients with a KRAS Mutation.”
