RASOLUTE-302

NCT06625320 📎

Regimen

Experimental
Daraxonrasib (RMC-6236) 300 mg PO QD
Control
Investigator's choice of standard-of-care: mFOLFIRINOX, NALIRIFOX, gem/nab-paclitaxel, or FOLFOX (1:1 randomization)

Population

Previously treated (1 prior line metastatic) metastatic PDAC, ECOG 0-1, enrolled KRAS G12X + non-G12 RAS + RAS WT; primary efficacy population = KRAS G12X mutation (G12D/G12V/G12C/G12R/G12A/G12S) confirmed by local or central testing. Global sites.

Key finding

First positive phase 3 in biomarker-selected KRAS-mutant metastatic PDAC. Near-doubling of median OS in ITT population vs SoC chemotherapy in the 2L setting where FOLFOX/NALIRIFOX-1 benchmark mOS is 5-7 mo. Selected for FDA Commissioner's National Priority Voucher pilot program. If confirmed in final analysis, establishes daraxonrasib as new 2L standard and validates pan-KRAS G12X as a therapeutic category.