Revolution Medicines, Inc. announced on October 21, 2024, that the first patient has been dosed in RASolute 302, a global, randomized, open-label Phase 3 registrational study. This trial evaluates RMC-6236, a RAS(ON) multi-selective inhibitor, in patients with previously treated, metastatic pancreatic ductal adenocarcinoma (PDAC). The study is designed to assess the safety and efficacy of RMC-6236 monotherapy against standard of care chemotherapy.
The RASolute 302 study is anticipated to enroll approximately 460 patients worldwide who have received one prior line of therapy. The trial focuses on a core population of patients with PDAC harboring RAS G12X mutations, with an expanded population including RAS G13X or Q61X mutations, or those without identified targetable mutations.
Dual primary endpoints for the study are progression-free survival (PFS) and overall survival (OS) in the core patient population. This advancement into a pivotal Phase 3 trial represents a significant step towards potentially addressing the high unmet medical need in metastatic PDAC, a highly lethal malignancy.
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