BACKGROUND: MET exon 14 skipping is an oncogenic driver occurring in 3-4% of 
non-small cell lung cancer (NSCLC). The MET inhibitor tepotinib has demonstrated 
clinical efficacy in patients with MET exon 14 skipping NSCLC. Here, we present 
data from Japanese patients in the Phase II VISION study, evaluating the 
efficacy and safety of tepotinib.
METHODS: In the open-label, single-arm, Phase II VISION study, patients with 
advanced/metastatic NSCLC with MET exon 14 skipping received oral tepotinib 
500 mg once daily. The primary endpoint was objective response by independent 
review. Subgroup analyses of Japanese patients were preplanned.
RESULTS: As of 1 January 2020, 19 Japanese patients received tepotinib and were 
evaluated for safety, 15 of whom had ≥9 months' follow-up and were also analysed 
for efficacy. By independent review, objective response rate (ORR) was 60.0% 
(95% confidence interval [CI]: 32.3, 83.7), median duration of response was not 
reached (95% CI: 6.9, not estimable [ne]), and progression-free survival was 
11.0 months (95% CI: 1.4, ne). ORR in patients with MET exon 14 skipping 
identified by liquid biopsy (n = 8) was 87.5% (95% CI: 47.3, 99.7), and by 
tissue biopsy (n = 12) was 50.0% (95% CI: 21.1, 78.9). Patients' quality of life 
was maintained with tepotinib treatment. Among patients evaluated for safety, 
the most common treatment-related adverse events (any grade) were blood 
creatinine increase and peripheral oedema (12 and nine patients, respectively).
CONCLUSIONS: Tepotinib demonstrated robust and durable clinical efficacy in 
Japanese patients with advanced NSCLC harbouring MET exon 14 skipping, 
identified by either liquid or tissue biopsy. The main adverse events, blood 
creatinine increase and peripheral oedema, were manageable.