Revolution Medicines presents initial data from RMC-9805 study

Revolution Medicines (RVMD) announced preliminary safety and antitumor data for RMC-9805, its RAS G12D-selective inhibitor, in patients with previously treated pancreatic ductal adenocarcinoma, or PDAC. These initial results were presented during the late-breaking oral session at the EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in Barcelona on October 25. The RMC-9805-001 Phase 1/1b study is a multicenter, open-label, dose-escalation and dose-expansion study designed to evaluate RMC-9805 in patients with advanced solid tumors harboring a KRAS G12D mutation. As of the September 2 data cutoff date, 179 patients were treated with escalating doses of RMC-9805. Study patients had received a median of two prior therapies and all had previously been treated with standard of care. As of the data cutoff date, RMC-9805 demonstrated an encouraging safety profile and was generally well tolerated across dose levels. For patients receiving 1200 mg of RMC-9805 daily, the most common treatment-related adverse events, or TRAEs, occurring in greater than 10% of patients were GI-related toxicities and rash that were primarily Grade 1 in severity and typically of limited duration. One Grade 3 TRAE of ALT elevation was reported, and no Grade 4 or 5 TRAEs were observed. Four patients experienced TRAEs that led to dose reduction and no patients discontinued treatment as a result of TRAEs. No dose limiting toxicities were observed and the maximum tolerated dose was not reached. Preliminary efficacy was assessed in PDAC patients. At a candidate recommended Phase 2 dose of 1200 mg daily, patients who received a first dose of RMC-9805 at least 14 weeks prior to the data cutoff date achieved a 30% objective response rate, with a disease control rate of 80%.