Revolution Medicines, Inc. announced on April 27, 2025, new clinical data for zoldonrasib (RMC-9805), its RAS(ON) G12D-selective inhibitor, as monotherapy in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC). These results were highlighted in a late-breaking oral presentation at the American Association for Cancer Research (AACR) Annual Meeting.
The Phase 1 RMC-9805-001 study, with a December 2, 2024 data cutoff, evaluated 90 solid tumor patients treated with 1200 mg once daily, the candidate recommended Phase 2 dose. Zoldonrasib demonstrated an acceptable safety profile, generally consistent with previously reported data in pancreatic cancer, with most treatment-related adverse events being Grade 1 or 2.
Preliminary antitumor activity was assessed in 18 efficacy-evaluable NSCLC patients, showing an objective response rate (ORR) of 61% and a disease control rate (DCR) of 89%. These encouraging results support further evaluation of zoldonrasib as monotherapy and in combinations, addressing a high unmet need as there are currently no approved targeted therapies for any RAS G12D mutant cancer.
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