The most compelling results emerged from the cohort receiving 30 mg of onvansertib in combination with FOLFIRI and bevacizumab. Although the primary end point of ORR narrowly missed statistical significance (P =.051), the clinical signal was reinforced by PFS data. The trial also compared combinations with FOLFOX chemotherapy, showing that onvansertib provided a more robust benefit when paired with FOLFIRI rather than FOLFOX. Accordingly, the agent holds a fast track designation from the FDA for second-line treatment of KRAS-mutant mCRC, awarded in May 2020. Cardiff Oncology announces positive update from its randomized Phase 2 trial of onvansertib in first-line RAS-mutated mCRC.