Overview
- Phase 3 RASolute 302 data published in the New England Journal of Medicine and presented at ASCO show median overall survival of 13.2 months with daraxonrasib versus about 6.6–6.7 months with investigator‑choice chemotherapy.
- In the RAS G12 subgroup the drug reduced the hazard of death by roughly 60% with a hazard ratio of 0.40, and it also roughly doubled progression‑free survival and raised objective response rates to about 33% versus ~12% for chemotherapy.
- The oral RAS(ON) inhibitor’s common toxicities included rash, stomatitis, diarrhea, and nausea, while grade 3 or higher events were reported less often than with chemotherapy and treatment discontinuations for toxicity were far lower with daraxonrasib.
- The trial was open‑label and operationally complex, with about 15% of patients randomized to chemotherapy not receiving it; investigators note those limits even as clinicians report surging patient demand and plan earlier‑line and combination trials.
- Revolution Medicines is preparing regulatory filings and the FDA has authorised expanded access and signalled accelerated review, a move that could widen patient access quickly if regulators grant approval.