Success for Phase II VISION trial of tepotinib to treat NSCLC harboring MET exon 14 skipping mutations.- Merck KGaA.

Merck KGaA, announced that the investigational, targeted therapy tepotinib has shown clinical activity in an ongoing Phase II study of patients with advanced non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. Data from the VISION trial was presented during the American Society of Clinical Oncology (ASCO) 2018 Annual Meeting in Chicago, June 1-5, 2018.

Treatment with tepotinib led to a confirmed complete response (CR) or confirmed partial response (PR) in 53.6% (15/28) and stable disease (SD) in 17.9% (5/28) of patients based on investigator assessment. Based on independent assessment of updated data from 28 patients (patients with at least 2 post-baseline assessments or who discontinued for any reason), 42.9% (12/28) had a PR and 21.4% (6/28) had SD. In this ongoing study, the safety data are consistent with that observed in previous studies; no new safety signals have been identified to date. A total of 26 out of 38 patients with data available experienced treatment-related adverse events (TRAEs), most commonly Grade 1/2 peripheral edema (13 patients) and diarrhea (10 patients). Seven patients reported Grade 3 TRAEs, including asymptomatic amylase increase (2 patients) and one instance each of: asthenia, generalized edema, aspartate aminotransferase increase, gamma-glutamyl transferase increase, lipase increase, hyperkalemia, dizziness and pneumonia. Four patients experienced serious TRAEs, with one instance of pneumonia, generalized edema, asthenia and dizziness, and interstitial lung disease.

The VISION study is continuing to enroll patients harboring MET exon 14 skipping mutations from Europe, United States and Japan. Merck will now expand the VISION trial considerably with a view to using it as a registrational trial for seeking regulatory approval for tepotinib. VISION would therefore recruit up to 120 patients who have NSCLC with MET exon 14 skipping mutations.