Cardiff Oncology Achieves 72% ORR with Onvansertib in RAS-Mutant mCRC
Cardiff Oncology reported a 72% overall response rate for its PLK1 inhibitor onvansertib in RAS-mutant metastatic colorectal cancer patients presented at the Oppenheimer conference, with predominantly low-grade neutropenia and gastrointestinal events. The company plans to launch chemo combination cohorts and accelerate its Phase 1b/2 expansion.
1. Data Highlights
Cardiff Oncology’s onvansertib delivered a 72% overall response rate in RAS-mutant mCRC patients, showcasing durable tumor shrinkage. Safety was manageable, with mostly grade 1–2 neutropenia and mild gastrointestinal side effects and no grade 4 or 5 events reported.
2. Trial Design
The ongoing Phase 1b/2 study enrolls patients who progressed after standard therapy, testing ascending monotherapy doses of onvansertib to establish safety and efficacy in a genetically defined cohort. Preliminary pharmacokinetics support twice-weekly oral dosing.
3. Next Steps
Based on these results, Cardiff Oncology will open combination cohorts pairing onvansertib with irinotecan-based chemotherapy and explore additional targeted partners. Discussions are underway to define a registrational path and initiate Phase 2 expansion by mid-year.