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Revolution Medicines’ RAS(ON) inhibitor daraxonrasib has shown robust activity in early and late-stage studies and is being fast-tracked into expanded access and registrational programs.
Phase I/II data published in the New England Journal of Medicine and presented at meetings reported response rates up to 35% in RAS G12–mutant pancreatic ductal adenocarcinoma at a 300 mg dose, with median progression-free survival around 8.5 months and median overall survival of 13.1–15.6 months in some cohorts.
Grade ≥3 treatment-related adverse events occurred in roughly 30% of patients, most commonly rash, diarrhea and mucositis; dose modifications were frequent but discontinuations for toxicity were uncommon.
Revolution Medicines reported top-line RASolute 302 phase III results showing a statistically significant and clinically meaningful improvement in PFS and OS versus chemotherapy, describing a 60% reduction in risk of death in the intent-to-treat population and median OS exceeding one year.
The FDA has issued a “safe to proceed” letter allowing an expanded access protocol; the company plans global regulatory filings and is accelerating additional registrational trials (RASolute 303–309) across pancreatic and lung cancers.








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