Revolution Medicines Begins Patient Treatment In Global Phase 3 RASolute 303 Trial Of Daraxonrasib For Metastatic Pancreatic Cancer

Revolution Medicines announced that it has begun treating patients in RASolute 303, its global Phase 3 clinical trial evaluating daraxonrasib both as a standalone therapy and in combination with chemotherapy for individuals with previously untreated metastatic pancreatic ductal adenocarcinoma (PDAC). This cancer type is largely driven by oncogenic RAS variants, and the study is designed to enroll patients regardless of their specific tumor RAS genotype.

Alan Sandler, M.D., chief development officer at the company, said that initiating treatment in the RASolute 303 study marks a significant step forward for the daraxonrasib development program and for patients facing metastatic pancreatic cancer, a disease for which treatment options remain limited. 

He explained that the trial is examining two scientifically grounded strategies—using daraxonrasib alone and using it together with chemotherapy—to explore their potential to improve outcomes. He added that this effort reflects the company’s ongoing commitment to moving RAS(ON) inhibition into earlier treatment settings where it may offer meaningful clinical benefit.

RASolute 303 (NCT07491445) is a global, randomized, open-label Phase 3 study comparing daraxonrasib as monotherapy or combined with gemcitabine and nab-paclitaxel against the current standard-of-care regimen of gemcitabine and nab-paclitaxel. The trial is enrolling patients who have not previously received systemic therapy for metastatic disease. 

Its primary endpoints are progression-free survival and overall survival, while secondary endpoints include additional assessments of antitumor activity, safety, tolerability, and patient-reported outcomes. Daraxonrasib is currently being studied in four global Phase 3 registrational trials, three of which focus on patients with PDAC and one on individuals with non-small cell lung cancer.