Capmatinib in Japanese patients with MET exon 14 skipping–mutated or MET-amplified advanced NSCLC: GEOMETRY mono-1 study

Takashi Seto, Kadoaki Ohashi, Shunichi Sugawara, Makoto Nishio, Masayuki Takeda, Keisuke Aoe, Sanae Moizumi, Satoshi Nomura, Takeshi Tajima, Toyoaki Hida

Research output: Contribution to journalArticlepeer-review

1 Citation (Scopus)

Abstract

MET mutations leading to exon 14 skipping (METΔex14) are strong molecular drivers for non–small-cell lung cancer (NSCLC). Capmatinib is a highly potent, selective oral MET inhibitor that showed clinically meaningful efficacy and a manageable safety profile in a global phase II study (GEOMETRY mono-1, NCT02414139) in patients with advanced METΔex14-mutated/MET-amplified NSCLC. We report results of preplanned analyses of 45 Japanese patients according to MET status (METΔex14-mutated or MET-amplified) and line of therapy (first- [1L] or second-/third-line [2/3L]). The starting dose was 400 mg twice daily. The primary endpoint was the objective response rate (ORR) assessed by a blinded independent review committee. A key secondary endpoint was duration of response (DOR). Among METΔex14-mutated patients, in the 1L group, one patient achieved partial response (DOR of 4.24 months) and the other had stable disease. In the 2/3L group, the ORR was 36.4% (95% confidence interval [CI] 10.9%-69.2%), median DOR was not evaluable, and progression-free survival was 4.70 months. One patient (2/3L group) showed partial resolution of brain lesions per independent neuroradiologist review. In MET-amplified patients with a MET gene copy number of ≥10, the ORR was 100% (2/2 patients) in the 1L group and 45.5% (5/11 patients) in the 2/3L group, with DOR of 8.2 and 8.3 months, respectively. Common treatment-related adverse events among the 45 Japanese patients were blood creatinine increased (53.3%), nausea (35.6%), and oedema peripheral (31.1%); most were grade 1/2 severity. In conclusion, capmatinib was effective and well tolerated by Japanese patients with METΔex14/MET-amplified NSCLC, consistent with the overall population.

Original languageEnglish
Pages (from-to)1556-1566
Number of pages11
JournalCancer Science
Volume112
Issue number4
DOIs
Publication statusPublished - Apr 2021

Keywords

  • MET receptor tyrosine kinase
  • capmatinib
  • non–small-cell lung cancer
  • response
  • safety

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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