Daraxonrasib - (RASolute 309)

Oct. 05, 2026: Revolution Medicines (NASDAQ: RVMD) announced first-patient dosing in RASolute 309 (NCT07805954), a global, randomized, open-label Phase 3 trial of RASONQUE (daraxonrasib) plus zoldonrasib versus gemcitabine/nab-paclitaxel as first-line treatment for adults with metastatic RAS G12D pancreatic adenocarcinoma.

The dual primary endpoints are progression-free survival and overall survival; secondary endpoints include objective response rate, duration of response, safety/tolerability, pharmacokinetics, and patient-reported outcomes. The company said the Phase 3 design was informed by preclinical findings showing deeper and more sustained RAS pathway suppression and greater tumor control with the doublet than either agent alone, and by initial clinical data in previously treated metastatic PDAC that showed antitumor activity with manageable safety/tolerability.

The release also states that RASONQUE is FDA approved in the U.S. for adults with metastatic PDAC who have received at least one prior systemic therapy or are not candidates for multiagent systemic therapy, while outside the U.S. it remains investigational. Zoldonrasib is described as an investigational oral RAS(ON) G12D-selective inhibitor being studied alone and in combinations.