Tepotinib in patients with NSCLC harbouring MET exon 14 skipping: Japanese subset analysis from the Phase II VISION

Hiroshi Sakai1, Masahiro Morise2, Terufumi Kato3

  • 1Department of Thoracic Oncology, Saitama Cancer Center, Ina, Japan.

Abstract

Insights

Tepotinib showed significant efficacy in Japanese patients with advanced non-small cell lung cancer (NSCLC) driven by MET exon 14 skipping. The treatment was well-tolerated and manageable for patients with this specific NSCLC subtype.

Area of Science:

  • Oncology
  • Medical Genetics
  • Pharmacology

Background:

  • MET exon 14 skipping mutations are key oncogenic drivers in 3-4% of non-small cell lung cancer (NSCLC).
  • The MET inhibitor tepotinib has shown promise in treating NSCLC patients with MET exon 14 skipping.
  • This study focuses on Japanese patients within the Phase II VISION trial, assessing tepotinib's efficacy and safety.

Purpose of the Study:

  • To evaluate the efficacy and safety of tepotinib in Japanese patients with advanced/metastatic NSCLC harboring MET exon 14 skipping mutations.
  • To analyze objective response rate (ORR), duration of response, and progression-free survival (PFS).
  • To assess the impact of tepotinib on patients' quality of life.

Main Methods:

  • An open-label, single-arm, Phase II clinical trial (VISION study).
  • Japanese patients with advanced/metastatic NSCLC and MET exon 14 skipping received oral tepotinib 500 mg daily.
  • Primary endpoint: objective response by independent review; subgroup analyses for Japanese patients were preplanned.

Main Results:

  • Objective response rate (ORR) was 60.0% in 15 evaluable Japanese patients.
  • ORR was higher in patients identified by liquid biopsy (87.5%) compared to tissue biopsy (50.0%).
  • Median duration of response and PFS were not reached; quality of life was maintained. Common adverse events included blood creatinine increase and peripheral edema.

Conclusions:

  • Tepotinib demonstrates robust and durable efficacy in Japanese patients with advanced NSCLC harboring MET exon 14 skipping.
  • The efficacy was observed regardless of whether the mutation was identified by liquid or tissue biopsy.
  • Adverse events associated with tepotinib were manageable.

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