Cardiff Oncology announces data from CRDF-004 trial

Cardiff Oncology (CRDF) announced data from the ongoing CRDF-004, a randomized, Phase 2 clinical trial evaluating onvansertib in combination with standard-of-care in patients with first-line RAS-mutated metastatic colorectal cancer. Efficacy data represents intent-to-treat patients as of a July 8 data cut-off, and is determined by blinded, independent central review (BICR) of each patient’s tumor scans. Both the 20mg and 30mg onvansertib arms demonstrated an early separation of the PFS curves compared to the control arm at a median follow up time of 6 months. While the median PFS has not been reached, there was a dose dependent effect in favor of the 30mg onvansertib dose. The safety analysis was conducted for the 104 patients who were dosed in the trial. Onvansertib in combination with chemo/bevacizumab was well-tolerated and there were no major or unexpected toxicities observed. Grade 3 or higher adverse events were infrequent, with neutropenia being the most common treatment-emergent adverse event associated with onvansertib.