Revolution Medicines Announces First Patient Dosed in Phase 3 Study Evaluating RMC-6236 in Previously Treated Patients with Metastatic Pancreatic Ductal Adenocarcinoma

Core Insights - Revolution Medicines has initiated dosing for the first patient in the Phase 3 RASolute 302 study, evaluating RMC-6236 for metastatic pancreatic ductal adenocarcinoma (PDAC) [1][3] Company Overview - Revolution Medicines is a clinical-stage oncology company focused on developing targeted therapies for RAS-addicted cancers, with a pipeline that includes RMC-6236, RMC-6291, and RMC-9805 [6] Study Design and Objectives - RASolute 302 is a global, randomized, open-label Phase 3 study aimed at assessing the safety and efficacy of RMC-6236 monotherapy compared to standard chemotherapy in approximately 460 patients with previously treated metastatic pancreatic cancer [2] - The study targets a core population with RAS mutations at position 12 and an expanded population including various RAS mutations and those without identified targetable mutations [2] Cancer Context - Pancreatic cancer, particularly PDAC, is one of the most lethal cancers, with an estimated 60,000 diagnoses and 50,000 deaths in the U.S. in 2024 [3][4] - PDAC accounts for about 92% of pancreatic cancer cases, with over 90% of patients harboring RAS mutations, leading to a five-year survival rate of approximately 3% [4] Drug Mechanism - RMC-6236 is an oral, direct RAS(ON) multi-selective inhibitor designed to block RAS signaling by inhibiting its interaction with downstream effectors, targeting various oncogenic RAS mutations [5]