Merck KGaA says tepotinib shows 'durable anti-tumor clinical activity'
Merck KGaA presented updated results from the potentially registrational Phase II Visoin study, showing "durable anti-tumor clinical activity" for the investigational targeted therapy tepotinib across different lines of treatment in advanced non-small cell lung cancer patients harboring MET exon 14 skipping mutations detected by liquid biopsy or tissue biopsy. "Tepotinib has been designed to potentially improve outcomes in aggressive tumors that have a poor prognosis and harbor these specific alterations," said Luciano Rossetti, Global Head of Research & Development for the Biopharma business of Merck KGaA, Darmstadt, Germany. "Tepotinib is an important part of our strategic focus on precision medicine, and both the proportion of patients responding and the duration of anti-tumor clinical activity demonstrate the potential of this investigational therapy." Results from the ongoing Phase II Vision study in 73 efficacy-evaluable patients with NSCLC with MET exon 14 skipping mutations identified by LBx or TBx demonstrate overall objective response rate of 50.0% for LBx-identified patients as assessed by Independent Review Committee, and 55.3% as assessed by investigators. The ORR for TBx-identified patients was 45.1% and 54.9%, respectively. The overall median duration of response was 12.4 months and 17.1 months among LBx-identified patients, as assessed by IRC and investigators, respectively, while among TBx-identified patients, 15.7 and 14.3 months were observed, respectively. Most treatment-related adverse events were Grade 1 and 2, Merck KGaA said in a statement.