Merck KGaA Subsidiary EMD Serono Receives FDA Priority Review for Tepotinib in METex14 Skipping NSCLC

Today, EMD Serono, a business of Merck KGaA, announced that the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for the oral MET inhibitor tepotinib and granted it Priority Review designation. The indication is for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 (METex14) skipping mutations. This application is currently under review as part of the FDA’s Real-Time Oncology Review (RTOR) pilot program, which aims to establish a more efficient review process to bring safe and effective therapies to patients sooner.

Lung cancer is the most common type of cancer globally and the leading cause of cancer-related deaths. There are 1.9 million lung cancer deaths worldwide each year. NSCLC accounts for approximately 85% of all lung cancer cases. Alterations in the MET signaling pathway, including MET exon 14 (METex14) skipping alterations and MET amplification, occur in 3% to 5% of NSCLC cases.

Tepotinib is an oral MET inhibitor designed to suppress oncogenic MET receptor signaling caused by MET gene alterations. It was previously granted Breakthrough Therapy Designation by the U.S. FDA. In March this year, it was approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with unresectable, advanced, or recurrent non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping mutations. This also marks the first regulatory approval of a MET inhibitor worldwide.

This application is based on the results of the pivotal Phase 2 clinical trial, VISION. The trial results demonstrated consistent response rates and durable antitumor activity across different lines of therapy, including in patients with brain metastases and those assessed via liquid biopsy (LBx) and tissue biopsy (TBx). Data from the preliminary analysis of the VISION study were published in the New England Journal of Medicine (NEJM) on May 29, 2020, and presented in the American Society of Clinical Oncology (ASCO) ASCO20 Virtual Scientific Program. The overall response rate (ORR), as assessed by an Independent Review Committee (IRC), was 46%, and the median duration of response (DOR) was 11.1 months.

References:

[1] FDA Accepts Filing of New Drug Application for Tepotinib for the Treatment of Patients with Metastatic NSCLC with METex14 Skipping Alterations. Retrieved August 25, 2020, from https://www.prnewswire.com/news-releases/fda-accepts-filing-of-new-drug-application-for-tepotinib-for-the-treatment-of-patients-with-metastatic-nsclc-with-metex14-skipping-alterations-301117906.html

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