- Revolution Medicines' zoldonrasib shows a 61% objective response rate in KRAS G12D mutant NSCLC patients.
- The Phase 1 trial demonstrated an 89% disease control rate and a favorable safety profile.
- Only 2% of patients experienced reversible Grade 3 adverse events.
Revolution Medicines, Inc. (RVMD, Financial) has unveiled promising early data for its RAS(ON) G12D-selective inhibitor, zoldonrasib (RMC-9805), used to treat KRAS G12D mutant non-small cell lung cancer (NSCLC). The results were showcased during the American Association for Cancer Research (AACR) Annual Meeting in Chicago.
In a Phase 1 study involving 90 patients with solid tumors, and specifically analyzing 18 efficacy-evaluable NSCLC patients, zoldonrasib achieved a noteworthy 61% objective response rate at a 1200 mg daily dosage. Additionally, the disease control rate was reported at 89%, with no dose-limiting toxicities and a 98% mean dose intensity, indicating sustained dosing adherence.
The safety profile was deemed acceptable, primarily presenting Grade 1 or 2 adverse events. The most frequent treatment-related adverse effects were nausea (39%), diarrhea (24%), vomiting (18%), and rash (12%). Notably, only 2% of participants experienced reversible Grade 3 events after adjusting the dosage.
Given that there are currently no approved targeted therapies for KRAS G12D mutant cancers, these findings offer significant hope. Despite the small sample size in this early trial phase, the initial efficacy signals are encouraging and suggest potential utility for zoldonrasib across various KRAS G12D-driven cancers. As Revolution Medicines advances its pipeline, the promising results underscore the potential of zoldonrasib and similar targeted therapies in addressing unmet medical needs in oncology.
