Tepotinib Approved for MET Exon 14 Skipping Mutated Metastatic NSCLC

Tepotinib Approved for MET Exon 14 Skipping Mutated Metastatic NSCLC

Industry News & Regulatory Approvals
Feb 08, 2021
Regulatory Approval

February 3, 2021—Tepotinib was approved for treatment of patients with metastatic NSCLC who harbor MET exon 14 skipping alterations. Approval was based on data from the VISION trial (NCT02864992).

VISION, a multicenter, nonrandomized, open-label, multicohort trial, enrolled 152 patients with advanced or metastatic NSCLC and MET exon 14 skipping alterations. Patients received 450 mg of oral tepotinib once daily until unacceptable toxicity or disease progression. 

Of the 69 patients who had not received prior therapy, the overall response rate (ORR) was 43% (95% CI: 32%, 56%), with a median response duration of 10.8 months (95% CI: 6.9, NE). The ORR for the 89 previously treated patients also was 43% (95% CI: 33%, 55%), and the median response duration was 11.11 months (95% CI: 9.5, 18.5).

The most common adverse reactions experienced by > 20% of patients were edema, fatigue, nausea, diarrhea, musculoskeletal pain, and dyspnea. 

Watch Dr. Paul Paik present data from VISION at the WCLC 2020 during his presentation, “MA11.05 - Tepotinib in Patients with MET exon 14 (METex14) Skipping Advanced NSCLC: Updated Efficacy Results from VISION Cohort A.” Register or log in at wclc2020.iaslc.org. 
 

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