NEW YORK – Cardiff Oncology on Tuesday said it has completed enrolling patients with advanced RAS-mutated colorectal cancer in a Phase II trial testing the activity of its PLK1 inhibitor onvansertib in the first-line setting.
The firm said it has reached its target of enrolling 90 colorectal cancer patients in the CRDF-004 trial. In order to participate in this study, patients had to have KRAS- or NRAS-mutant unresectable metastatic disease. Researchers are evaluating two dose levels of onvansertib given with standard-of-care FOLFIRI or FOLFOX chemotherapy plus Genentech's Avastin (bevacizumab) and comparing that against the standard regimen alone.
In a December data readout from this trial, the firm reported a 64 percent response rate among patients who received the onvansertib combo at the higher dose and a 50 percent response rate with the lower dose, compared to a 33 percent response rate among those who received just the standard-of-care regimen. Cardiff expects to report additional clinical data from the CRDF-004 trial in the first half of 2025 and is planning for potential regulatory discussions with the US Food and Drug Administration.
Cardiff began this trial in the first-line colorectal cancer setting after a previous study in the second-line setting suggested that patients who had not previously received Avastin responded better to the onvansertib combo. In that second-line study, the group who had not received prior Avastin therapy demonstrated a response rate of 73 percent and median progression-free survival of 25 months.
San Diego-based Cardiff is also studying onvansertib in pancreatic, small cell lung, and triple-negative breast cancer.