Cardiff Oncology's Onvansertib Shows Strong Phase 2 Results in RAS-Mutated mCRC
Event summary
- Cardiff Oncology's Phase 2 trial of onvansertib in first-line RAS-mutated mCRC met its primary endpoint, selecting a 30 mg dose for the registrational program.
- The 30 mg onvansertib + FOLFIRI/bevacizumab arm showed a 72.2% confirmed ORR vs. 42.1% for standard-of-care alone.
- Median PFS not reached in the 30 mg onvansertib arm, with nine of 14 patients remaining on treatment.
- Onvansertib was well-tolerated with no new or overlapping toxicities when added to standard-of-care.
- Company plans a Phase 3 registrational trial following a successful End-of-Phase 2 meeting with the FDA.
The big picture
Cardiff Oncology's positive Phase 2 data for onvansertib in RAS-mutated mCRC positions the company to address a significant unmet need in oncology, where treatment options for this patient population have seen little advancement in decades. The successful End-of-Phase 2 meeting with the FDA clears a critical path for the registrational trial, potentially setting the stage for a new therapeutic standard in this indication. The results also highlight the growing role of PLK1 inhibition in precision oncology.
What we're watching
- Regulatory Pathway
- Whether the FDA's alignment on the Phase 3 trial design will expedite approval for onvansertib in RAS-mutated mCRC.
- Clinical Validation
- How the durability of responses in the Phase 2 trial will translate into the planned Phase 3 study.
- Competitive Positioning
- The pace at which Cardiff Oncology can establish onvansertib as a new standard-of-care in a field with limited therapeutic progress.
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