Cardiff Oncology, Inc. announced new data from its lead clinical program evaluating onvansertib in combination with standard-of-care (SOC) FOLFIRI/bevacizumab for second-line treatment of patients with KRAS-mutated metastatic colorectal cancer (mCRC). Efficacy data in patients evaluable for disease response as of data cutoff date (July 2, 2021): Patients treated per protocol at the recommended Phase 2 dose (RP2D; 15 mg/m2) across both Phase 1b and Phase 2, 8 of 19 (42%) achieved an initial partial response (PR) as of the data cutoff date, 7 of 19 (37%) have achieved a confirmed PR (based on further follow-up of patients with an initial PR as of data cutoff date) Objective response rates observed in historical control trials in similar patient populations treated with standard of care are 5-13%. Patients evaluable for response treated at all dose levels (12 mg/m2, 15 mg/m2, 18 mg/m2) across both phases of the study,12 of 32 (38%) achieved an initial PR as of the data cutoff date, 10 of 32 (31%) have achieved a confirmed PR (based on further follow-up of patients with an initial PR as of data cutoff date). Median progression free survival (mPFS): mPFS has not yet been reached in patients treated per protocol at the RP2D, mPFS across all response-evaluable patients (n = 32) is 9.4 months (95% confidence interval: 7.8 – not yet reached) and mPFS of approximately 4.5-5.7 months has been reported in trials used as historical controls. Biomarker data as of data cutoff date across all patients: Partial responses (PRs) were observed across different KRAS mutation variants, including the 3 most common observed in colorectal cancer (G12D, G12V, G13D), Patients achieving a best response of PR showed the greater decreases in plasma KRAS mutant allelic frequency (MAF) after 1 cycle (28 days) of therapy. Safety data as of data cutoff date across all patients: The combination of onvansertib and FOLFIRI/bevacizumab was shown to be well-tolerated with only 10% (49/490) of reported treatment-emergent adverse events (TEAEs) being G3/G4, Most reported treatment-related adverse events (TRAEs) were manageable and reversible with supportive care.