Savolitinib is effective in patients with MET-mutated NSCLC

The final results of a phase 2 study confirmed the selective MET tyrosine kinase inhibitor savolitinib to be effective in patients with MET exon 14 skipping-mutated non-small cell lung cancer (NSCLC), irrespective of the subgroup.

A MET exon 14 skipping mutation is present in about 3% of patients with NSCLC [1]. Savolitinib is a highly selective MET tyrosine kinase inhibitor that is approved in China for the treatment of MET exon 14 skipping-mutated NSCLC based on (interim) results of a phase 2 study (NCT02897479) [2]. Dr Shun Lu (Shanghai Chest Hospital, China) presented the final results of this study [3].

This multicentre, open-label, phase 2 trial, enrolled 70 patients with unresectable or metastatic MET exon 14 skipping-mutated NSCLC; 25 patients were diagnosed with pulmonary sarcomatoid carcinoma (PSC) and 45 with other types of NSCLC, 28 patients were treatment-naïve and 42 were pre-treated, 15 patients had CNS lesions. Participants were treated with savolitinib 600 or 400 mg once daily, depending on body weight, in 21-day cycles until disease progression or unacceptable toxicity. The primary endpoint was objective response rate (ORR), secondary endpoints included progression-free survival (PFS), overall survival (OS), and safety. At data cut-off, 20% of participants were ≥18 months on treatment; median follow-up was 28.4 months.

Savolitnib demonstrated promising activity in MET exon 14 skipping-mutated NSCLC, regarding both PFS and OS (see Table).

Table: PFS and OS in subgroups of participants



With respect to safety, the most common treatment-related adverse events of any grade were peripheral oedema (57%), nausea (53%), hypoalbuminemia (41%), and increased ALT/AST (both 39%). Most common grade ≥3 treatment-related adverse events were increased AST (13%), increased ALT (10%), and peripheral oedema (9%).

1. Fujino T, et al. Lung Cancer (Auckl). 2021;12:35–50.
2. Lu S, et al. Abstract 9519. ASCO Annual Meeting 2020, 29–31 May.
3. Lu S, et al. Final OS results and subgroup analysis of savolitinib in patients with MET exon 14 skipping mutations (METex14+) NSCLC. Abstract 2MO. ELCC 2022 Virtual Meeting, 30 March–02 April.

 

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Posted on 25 May 202222 February 2024