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Savolitinib in MET exon 14-mutated NSCLC: Phase 3b findings from China

  • Yongfeng Yu; Qisen Guo; Yongchang Zhang; Jian Fang; Diansheng Zhong; Baogang Liu; et al.

  • March 23, 2026

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Evidence before this study

The MET exon 14 mutation occurs in approximately 3%–4% of patients with non-small cell lung cancer (NSCLC) and is associated with aggressive disease and poor prognosis. Two selective MET inhibitors, capmatinib and tepotinib, have established efficacy in this setting, with pivotal studies reporting objective response rates of 68% and 44% for capmatinib and 57% and 45% for tepotinib in treatment-naïve and previously treated patients, respectively. In a Phase 2 pivotal study conducted in Chinese patients, savolitinib, a potent and highly selective MET inhibitor, demonstrated an Independent Review Committee-assessed objective response rate of 49% and median progression-free survival of 6·8 months, supporting conditional regulatory approval.

Added value of this study

This confirmatory Phase 3b trial is the first in China to comprehensively evaluate the long-term efficacy and safety of savolitinib across two distinct cohorts: previously treated and treatment-naïve patients with MET exon 14-mutated NSCLC. The final analysis confirms clinically meaningful and durable responses in both groups. The median overall survival was 25·3 months and 28·3 months in previously treated and treatment-naïve populations, respectively, demonstrating long-term survival benefit.

Implications of all the available evidence

Savolitinib is a promising treatment option for patients with MET exon 14-mutated NSCLC, a population with limited treatment options. These confirmatory findings supported its full approval in China in January 2025 and validate the clinical relevance of routine genomic profiling and targeted MET inhibition in NSCLC. Savolitinib showed encouraging activity in patients with brain metastases, a subgroup with poor outcomes.

Source: The Lancet Regional Health – Western Pacific

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