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Tepotinib granted FDA priority review for METex14 NSCLC

MET TKIs have been in clinical studies for almost a decade, without much success. Prospects improved when METex14 skipping was identified as an actionable mutation in 3-4% of NSCLC.

Several MET TKIs jumped into the race to market, including EMD Serono’s tepotinib. The VISION study includes 3 separate cohorts: METex14 skipping (Cohort A), MET amplification (Cohort B), and METex14 skipping (Cohort C, confirmatory for Cohort A). Tepotinib was granted FDA BTD in 2019 based on preliminary data from Cohort A.

Tepotinib will be the 2nd MET TKI to market, just months after capmatinib (Tabrecta, Novartis). In May 2020, capmatinib received accelerated FDA approval based on phase 2 data from the multi-cohort GEOMETRY-Mono-1 study.

Ongoing development is focused on MET amplification associated with acquired resistance to EGFR TKIs. Tepotinib, capmatinib, and
savolitinib (AZ) all have pivotal studies ongoing in this NSCLC segment.

VISION: NCT02864992
Awad et al., JCO. 2016 (PMID: 26729443)
Paik et al., NEJM. 2020 (PMID: 32469185)