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DARMSTADT, GERMANY-- December 20, 2021 -- Merck, a leading science and technology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of once-daily oral TEPMETKO® (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in the first quarter of 2022.

“TEPMETKO has demonstrated important clinical benefits and a manageable safety profile in the treatment of this aggressive form of lung cancer, and has the potential to advance the treatment of this type of tumor,” said Danny Bar-Zohar, M.D., Global Head of Development for the Healthcare business sector of Merck. “We look forward to the European Commission decision, and bringing the first oral MET inhibitor in NSCLC to patients in Europe.”

The positive opinion is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as a once-daily oral monotherapy treatment for patients with advanced NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were previously published in The New England Journal of Medicine, and showed TEPMETKO demonstrated consistent and durable responses in both treatment naïve and previously treated adult patients with advanced NSCLC harboring alterations leading to METex14 skipping. Additional data from the VISION study presented at IASLC 2021 World Conference on Lung Cancer include results for 123 patients from Cohort C with follow-up of at least 3 months from the start of treatment and provide additional evidence supporting the clinically meaningful responses demonstrated in the primary analysis.

In Europe, lung cancer is estimated to be the second most common cancer, and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018.[2] Alterations of the MET signaling pathway, including METex14 skipping alterations, are found in 3% to 4% of NSCLC cases, and are associated with having advanced disease and poor prognosis

TEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020. In February 2021, the U.S. Food and Drug Administration granted accelerated approval to TEPMETKO, making it the first and only once-daily oral MET inhibitor approved for patients in the U.S. with metastatic NSCLC with METex14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Tepotinib is available in a number of countries, and under review by various other regulatory authorities globally. To meet an urgent clinical need, tepotinib is also available in a pilot zone of China in line with the government policy to drive early access for innovative medicines approved outside of China.