Revolution Medicines Starts Phase 3 Trial of Zoldonrasib Combination in NSCLC; RVMD Shares Rise 6.8%

Revolution Medicines Inc. (RVMD) said it has begun treating patients in the Phase 3 RASolve 308 trial of zoldonrasib combined with pembrolizumab and chemotherapy as first-line treatment for metastatic RAS G12D non-squamous non-small cell lung cancer. Shares rose 6.82% following the announcement, trading at $194.57. The global, randomized, double-blind trial will compare the three-drug regimen against placebo plus the same standard-of-care regimen in adults with previously untreated metastatic RAS G12D NSCLC. The primary endpoint is progression-free survival; key secondary endpoints include overall survival, objective response rate, duration of response, safety, tolerability and patient-reported outcomes. Zoldonrasib is an investigational oral RAS(ON) G12D-selective inhibitor targeting the active form of the cancer-driving mutation, which occurs in roughly 4% of NSCLC cases—a population with no approved targeted options. Revolution Medicines said preliminary data from the combination showed encouraging antitumor activity and a favorable safety profile. Zoldonrasib has not been approved for this indication.