Among 38 previously treated patients with RAS-mutant NSCLC in the 160–220 mg dose group, the objective response rate was 42%, median progression-free survival 8.3 months and median overall survival 16 months.
On September 2, 2026 the New England Journal of Medicine published Phase 1/2 results of daraxonrasib in previously treated patients with RAS-mutant non-small cell lung cancer.
Among 38 patients treated in the Phase 3 dose range (160–220 mg once daily), the objective response rate was 42%, median duration of response 11.5 months, median progression-free survival 8.3 months and median overall survival 16 months.
Grade ≥3 adverse events occurred in 51% of patients. The most common adverse events were rash (90%; grade ≥3 in 8%), diarrhoea (73%), nausea (62%) and vomiting (54%); 71% of patients required dose modification and 10% discontinued because of adverse events. The investigators considered the toxicities largely manageable compared with the available second-line options.
These results support the ongoing Phase 3 RASolve 301 trial (daraxonrasib vs docetaxel, approximately 420 patients), led by Prof. Ferdinandos Skoulidis of MD Anderson Cancer Center.