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Revolution Medicines to Present Updated Phase 1 Clinical Data for Zoldonrasib in Patients with Previously Treated KRAS G12D Non-Small Cell Lung Cancer at the 2026 AACR Annual Meeting

RVMD
  • Revolution Medicines announced updated Phase 1 clinical data for zoldonrasib, an oral RAS(ON) G12D-selective inhibitor, targeting patients with previously treated KRAS G12D non-small cell lung cancer (NSCLC).
  • Results were presented as a plenary oral presentation on April 19, 2026, at the American Association for Cancer Research (AACR) Annual Meeting.
  • The data analyzed 40 patients with KRAS G12D NSCLC treated with the recommended Phase 2 dose of 1200 mg once daily, with efficacy assessments conducted in a subset of 27 patients previously treated with immune checkpoint inhibitors & platinum chemotherapy without prior docetaxel.
  • Zoldonrasib demonstrated a favorable safety profile with a mean dose intensity of 94%, where Grade 3 treatment-related adverse events occurred in 13% of patients & treatment discontinuation due to adverse events occurred in 5%.
  • Most treatment-related adverse events were Grade 1, with the most common (occurring in at least 15% of patients) being nausea (43%), vomiting (33%), diarrhea (30%), & rash (18%).
  • In the efficacy subset of 27 patients, the confirmed objective response rate was 52% & the disease control rate was 93%.
  • Median time to response was 1.4 months, median progression-free survival was 11.1 months, & the estimated 12-month progression-free survival rate was 48%.
  • Estimated 12-month overall survival was 73%, though overall survival data remained immature at the time of the December 1, 2025 data cutoff.
  • Zoldonrasib is a tri-complex inhibitor designed to selectively recognize & inhibit the active RAS G12D mutant, addressing a population where historical chemotherapy options have offered limited benefit.
  • The company plans to advance zoldonrasib in monotherapy & combination settings, including with daraxonrasib (RMC-6236), for lung cancer & other RAS G12D-driven cancers.