Updated phase 1 results of zoldonrasib for KRAS-G12D-mutant non-small cell lung cancer

Approximately 4% of patients with non-small cell lung cancer (NSCLC) harbor KRAS^G12D mutations. No FDA-approved therapies for this isoform exist. Updated results from a phase 1 trial presented at the AACR Annual Meeting in San Diego, CA, demonstrate that zoldonrasib could be a safe and effective option. Forty patients with KRAS^G12D-mutant NSCLC who had already been treated with platinum chemotherapy and immune checkpoint inhibitors received zoldonrasib daily. Among the 27 patients who received the 1,200 mg dose, the objective response rate was 52% after a median follow-up of 13.1 months. The disease control rate was 93%, the median progression-free survival was 11.1 months, and the overall survival rate at 12 months was 73%. Most treatment-related adverse events were grade 1 or 2; only 13% of patients experienced grade 3 TRAEs, and there were no grade 4 or 5 TRAEs. The authors conclude that zoldonrasib showed promising activity and favorable safety among patients with KRAS^G12D-mutant NSCLC.