Revolution Medicines, Inc. announced on October 23, 2024, updated clinical safety, tolerability, and activity data for RMC-6236, its RAS(ON) multi-selective inhibitor, in patients with previously treated metastatic pancreatic ductal adenocarcinoma (PDAC). These results, from the Phase 1 RMC-6236-001 study with a July 23, 2024 data cutoff, were presented at the EORTC-NCI-AACR Symposium.
For patients with KRAS G12X mutations in the second-line (2L) setting, RMC-6236 demonstrated a median progression-free survival (PFS) of 8.5 months and a median overall survival (OS) of 14.5 months. Patients with any RAS mutation in the 2L setting achieved a median PFS of 7.6 months and a median OS of 14.5 months. The objective response rate (ORR) for KRAS G12X mutations was 29% in the 2L group and 22% in the third-line and beyond (3L+) group.
The safety profile was consistent with previously reported results, showing RMC-6236 to be generally well tolerated at doses from 160 mg to 300 mg once daily. The most common treatment-related adverse events were rash and gastrointestinal-related toxicities, primarily Grade 1 or 2 in severity, with no treatment discontinuations due to these events. These data reinforce the potential of RMC-6236 as a therapeutic option for advanced PDAC and support the ongoing Phase 3 RASolute 302 study.
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