Merck updates on Phase 2 trial for aggressive tumor med at ASCO

• Alterations of the MET signaling pathway are present in 3-5% of non-small cell lung cancer patients and correlate with poor prognosis
• New interim data from Phase II VISION study (all lines of treatment) show tepotinib induced objective responses, as assessed by independent review, in 50.0% of patients identified by liquid biopsy (LBx) and 45.1% for patients identified by tissue biopsy (TBx) 
• Median duration of response was 12.4 months for LBx-identified patients and 15.7 months for TBx-identified patients
• Safety results for tepotinib are consistent with those reported in previous studies; most treatment-related adverse events (TRAEs) were Grade 1 and 2, and no Grade 4 or 5 TRAEs were observed

Merck KGaA, Darmstadt, Germany, a leading science and technology company, which operates its biopharmaceutical business as EMD Serono in the US and Canada, today presented updated results from the potentially registrational Phase II VISION 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 (NSCLC) patients harboring MET exon 14 skipping mutations detected by liquid biopsy (LBx) or tissue biopsy (TBx). Data were shared in an oral presentation today at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, IL, US.

“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.”

Discovered in-house at Merck KGaA, Darmstadt, Germany, tepotinib is an investigational, highly potent and selective¹ oral MET kinase inhibitor that is designed to inhibit the oncogenic signaling caused by MET (gene) alterations, including both MET exon 14 skipping mutations and MET amplifications, or MET protein overexpression. Alterations of the MET signaling pathway are found in various cancer types, including 3-5% of NSCLC cases, and correlate with aggressive tumor behavior and poor clinical prognosis.^2-4

“Patients with this NSCLC molecular subtype lack treatment options that have the potential to significantly improve clinical outcomes,” said Paul K. Paik, M.D., primary study investigator and Clinical Director, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center. “It is noteworthy to see data that are consistent with tepotinib’s previously reported efficacy findings in this patient population, and that also provide valuable new insight into its durable clinical activity across various treatment lines.”

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