Overview
- Daraxonrasib’s first-in-human Phase 1/2 results, published Wednesday in The New England Journal of Medicine, showed tumor control for about eight months and overall survival near 13 to 16 months at the 300 mg dose.
- Revolution Medicines says its Phase 3 RASolute 302 trial doubled median overall survival versus chemotherapy, with reported results of 13.2 months on the combo versus 6.7 months on chemo alone, pending full data at ASCO.
- Side effects were frequent yet usually manageable, with about 30% of patients having severe events and common problems including rash, diarrhea, and mouth sores treated with supportive care and dose adjustments.
- The FDA has allowed daraxonrasib to be provided outside trials through an expanded access program, and the drug holds Breakthrough Therapy and Orphan Drug designations for previously treated metastatic disease.
- Daraxonrasib is a pill that binds active RAS through a “molecular glue” pairing with cyclophilin A, a mechanism that could reach many RAS‑mutant tumors, though researchers want biomarker and resistance data before changing routine care.