Cardiff Oncology Presents Positive Phase 2 Data for Onvansertib in mCRC
Cardiff Oncology, Inc. has announced positive interim results from its Phase 2 CRDF-004 trial for onvansertib in combination with chemotherapy and bevacizumab for first-line RAS-mutated metastatic colorectal cancer (mCRC). The presentation highlighted a 72% Objective Response Rate (ORR) with the 30 mg dose of onvansertib plus FOLFIRI/bevacizumab, a 30% improvement over the standard of care (SoC). Median Progression-Free Survival (PFS) was not reached in the onvansertib arm compared to 12.2 months for SoC. The company has selected the 30 mg onvansertib + FOLFIRI/bev combination for its registrational study, CRDF-005, which will have dual primary endpoints of ORR and PFS and is designed for potential accelerated approval. The safety profile was deemed clean, with no new or unexpected toxicities.
Key Highlights
- Cardiff Oncology presented Phase 2 CRDF-004 data for onvansertib in first-line RAS-mutated mCRC.
- Onvansertib 30 mg + FOLFIRI/bev showed a 72% ORR, a 30% improvement over SoC.
- Median PFS was not reached for onvansertib + FOLFIRI/bev vs. 12.2 months for SoC.
- 9 of 14 remaining patients are on onvansertib + SoC chemo/bev treatment.
- The company selected 30 mg onvansertib + FOLFIRI/bev for the registrational study.
- A Phase 3 trial (CRDF-005) is planned with dual primary endpoints of ORR and PFS.
- Onvansertib showed a clean safety profile, with no unexpected toxicities when added to chemotherapy.
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