Final results of a multicenter confirmatory phase 3b study of savolitinib in Chinese patients with advanced MET exon 14-mutated NSCLC

The MET inhibitor savolitinib showed promising efficacy and tolerable safety in a phase 3 confirmatory trial for advanced NSCLC harboring MET exon 14 (METex14)-skipping mutations at 48 centers in China. Final results of the trial have now been published. The trial enrolled 166 patients from September 2021 through November 2024. Among previously treated patients (n=79), the median follow-up was 25.1 months, the median independent review committee (IRC) assessed overall response rate (ORR) was 42% (95% CI 31-53), the IRC-assessed median progression-free survival (PFS) was 13.7 months (8.3-17.9), and the median overall survival (OS) was 25.3 months (20.5-30.5). Among treatment-naïve patients (n=87), the median follow-up was 34.5 months, the ORR was 62% (95% CI 51-72), the median PFS was 13.7 months (8.5-16.6), and the median OS was 28.3 months (17.5-NE). Grade ≥ 3 treatment-related adverse events occurred in 62% of patients and were manageable. The authors conclude that savolitinib demonstrated robust and durable efficacy in patients with METex14-mutated advanced NSCLC.