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Revolution Medicines Announces First Patient Dosed in Phase 3 Clinical Trial Evaluating Daraxonrasib in Previously Treated Patients with RAS Mutant Non-Small Cell Lung Cancer
REDWOOD CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted
About this update from Revolution Medicines, Inc.
[{"type":"text","content":"REDWOOD CITY, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced the first patient has been dosed in RASolve 301, a global, randomized, open-label Phase 3 clinical trial. RASolve 301 will evaluate the safety and efficacy of daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor, in patients with previously treated, locally advanced or metastatic RAS mutant non-small cell lung cancer (NSCLC) compared to docetaxel chemotherapy. RASolve 301 is anticipated to enroll approximately 420 patients with NSCLC worldwide who have received one to two prior lines of therapy for the treatment of advanced disease including an anti-PD-1/anti-PD(L)-1 agent and platinum-based chemotherapy. The pivotal clinical trial is designed to include a core population of patients with NSCLC carrying RAS mutations at position G12 (G12X), and an expanded population that also includes patients with tumors carrying other specific RAS mutations. The dual primary endpoints are progression-free survival (PFS) and overall survival (OS) in the core patient population. Key secondary endpoints include PFS, OS and objective response rate (ORR) in the expanded population. “We are pleased that dosing is underway in the RASolve 301 Phase 3 clinical trial, an important step in developing daraxonrasib, a highly innovative compound that targets a diverse array of RAS mutations that drive tumor growth in 30% of NSCLC cases,” said Mark A. Goldsmith M.D., Ph.D., chief executive officer and chairman of Revolution Medicines. “For the vast majority of these RAS cancer drivers, there are currently no approved targeted drugs that can be used in place of chemotherapy. In this trial we are collaborating with physicians globally to evaluate the potential of daraxonrasib as a new therapy for people living with RAS mutant lung cancer.” The company’s decision to evaluate daraxonrasib as a monotherapy in this NSCLC setting was informed by early evidence from a single-arm trial showing the compound had an acceptable safety profile and encouraging antitumor activity. Daraxonrasib is also being evaluated in the RASolute 302 clinical trial, which is a global, randomized Phase 3 trial evaluating daraxonrasib versus standard of care che...