Tepotinib in NSCLC with MET Exon 14 Skipping Mutation (VISION Study)

2020 Year in Review: Non–Small-Cell Lung Cancer —February 6, 2021


Lung Cancer

The open-label, phase 2 VISION study evaluated the efficacy and safety of tepotinib, a highly selective oral MET inhibitor, in patients with advanced NSCLC with MET alterations.

MET exon 14 skipping mutations occur in approximately 3% to 4% of NSCLC cases and correlate with aggressive tumor behavior and poor clinical prognosis.1 Researchers reported the results of the open-label, phase 2 VISION study in patients with MET exon 14 skipping mutations.

The VISION study included 152 patients with advanced or metastatic disease who received tepotinib 500 mg once daily.1 The efficacy population consisted of 99 of the 152 patients with a follow-up of at least 9 months. The primary end point was the objective response by independent review in the efficacy population. Response rates were also analyzed according to whether the presence of MET exon 14 skipping mutation was detected by a liquid biopsy (N = 66) or tissue biopsy (N = 60). Secondary end points were investigator-assessed objective response, duration of response, progression-free survival (PFS), and overall survival (OS).

At a median follow-up of 17.4 months, the objective response rate by independent review was 46% (95% CI, 36-57; all partial responses) and was similar regardless of baseline characteristics and number of lines of previous therapy.1 The median duration of response was 11.1 months (95% CI, 7.2 months–not estimable) in the combined biopsy group, 9.9 months (95% CI, 7.2 months-not estimable) in the liquid biopsy group, and 15.7 months (95% CI, 9.7 months-not estimable) in the tissue biopsy group. The objective response rate was 48% (95% CI, 36-61) and 50% (95% CI, 37-63) in the liquid biopsy group and tissue biopsy group, respectively. The investigator-assessed objective response rate was 56% (95% CI, 45-66) and was similar regardless of the previous therapy received for advanced or metastatic disease.

Molecular response, as measured in circulating free DNA, was observed in 67% of the patients with matched liquid biopsy samples at baseline and during treatment.1 Median PFS by independent review was 8.5 months (95% CI, 6.7-11.0 months) in the efficacy population, 8.5 months (95% CI, 5.1=11.0 months) in the liquid biopsy group, and 11.0 months (95% CI, 5.1-17.1 months) in the tissue biopsy group. OS data were not mature (median duration of OS, 17.1 months; 95% CI, 12.0–26.8 months).

Overall, grade 3 or higher treatment-related adverse events were reported in 28% of the patients at a median follow-up of 11.8 months.1 Peripheral edema (7%,) was the most common treatment-related adverse event of grade 3 or higher. Serious treatment-related adverse events were reported in 15% of patients. Treatment-related adverse events led to permanent discontinuation of tepotinib in 11% of patients and dose reduction in 33% of patients. One death, which was due to respiratory failure and dyspnea secondary to interstitial lung disease, was considered related to treatment.


  1. Paik PK, Felip E, Veillon R, et al. Tepotinib in non-small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med. 2020;383:931-943.
Related Articles
American Cancer Society Cancer Action Network Releases Recommendations to Increase Cancer Biomarker Testing
Web Exclusives
The American Cancer Society Cancer Action Network has published data that demonstrate there are multiple barriers to biomarker testing access and released recommendations that address these barriers.
Sotorasib Demonstrates Efficacy in CodeBreaK 100 Phase 2 Study Results
Web Exclusives
Sotorasib has shown promising antitumor activity in phase 2 of a clinical trial of patients with heavily treated advanced NSCLC.
Results of an International Study Identify Barriers to Molecular Testing in NSCLC
Web Exclusives
Recently released survey responses identified multiple barriers to, and dissatisfaction with, the current state of molecular testing in lung cancer.
Last modified: February 8, 2021

Subscribe to the Journal of Oncology Navigation & Survivorship®

To sign up for our print publication or e-newsletter, please enter your contact information below.

  • First Name *
    Last Name *
    Profession or Role
    Primary Specialty or Disease State
  • Please enter your mailing address.

    Address Line 2
    Zip Code