RASONQUE (Daraxonrasib (RMC-6236)) vs. Docetaxel - (RASolve-301)

Sept. 2, 2026: Revolution Medicines (NASDAQ: RVMD) said The New England Journal of Medicine published Phase 1/2 data for RASONQUE (daraxonrasib; trial RMC-6236-001, NCT05379985) in previously treated advanced RAS-mutant NSCLC excluding RAS G12C, supporting the ongoing Phase 3 RASolve 301 study.

The publication used a July 21, 2025 cutoff and included 136 patients with second-line-or-later NSCLC whose disease had progressed after, or who were intolerant to, platinum chemotherapy and anti-PD-(L)1 therapy. In a 160-220 mg subgroup of 38 docetaxel-naïve patients previously treated with first- or second-line platinum chemotherapy and anti-PD-(L)1 therapy, confirmed objective response rate was 42% (95% CI, 26%-59%), disease control rate was 89% (95% CI, 75%-97%), median progression-free survival was 8.3 months (95% CI, 4.0-12.5), and median overall survival was 16.0 months (95% CI, 9.5-not estimable). Grade 3 treatment-related adverse events occurred in 25%, most commonly rash (8%) and diarrhea (3%); no Grade 4 or 5 treatment-related adverse events were reported in this dose range.

The company said these results informed the design and initiation of RASolve 301 (NCT06881784), a global randomized open-label Phase 3 trial of RASONQUE versus docetaxel in previously treated locally advanced or metastatic RAS-mutant NSCLC.