Clinical-stage biotechnology developer Cardiff Oncology announced updated clinical data for its lead oncology compound onvansertib in patients with metastatic colorectal cancer on November 13. All active patients enrolled in the thirty-milligram combination trial cohort have now exceeded twenty-one months of continuous therapy without disease progression. The longest ongoing patient on the thirty-milligram daily dosing regimen has surpassed twenty-nine months of durable treatment response; historical median progression-free survival for standard second-line metastatic colorectal cancer regimens ranges between ten and eleven months.
Onvansertib functions as a selective oral inhibitor of polo-like kinase 1, an enzymatic driver frequently overexpressed in cancer cells with KRAS or NRAS mutations. Trial clinicians noted an overall response rate of forty-four percent within the evaluated combination cohort, alongside favorable tolerability profiles. Dose reductions due to hematological adverse events occurred in less than eight percent of participants throughout the extended monitoring period. The medical publication Clinical Trial Vanguard reported the durability milestone in its clinical oncology update: "Every patient still enrolled in the 30 mg onvansertib plus FOLFIRI/bevacizumab arm of Cardiff Oncology's Phase 2 trial has now passed 21 months on treatment".
Cardiff Oncology reported thirty-three point eight million dollars in available cash reserves, providing operational runway through the third quarter of 2027. The company is completing preparations for a pivotal Phase 3 registration trial scheduled to commence patient enrollment in early 2027; the registration trial will focus on patients presenting with frontline KRAS-mutated colorectal malignancies across clinical sites in North America. Oncologists emphasize that therapeutic options for RAS-mutant metastatic colorectal cancer have remained constrained over the past two decades. Cardiff Oncology executives plan to present complete biomarker correlative datasets at upcoming medical congresses.
