Country for PR: United Kingdom
Contributor: PR Newswire Europe
Friday, November 27 2020 - 04:27
European Medicines Agency Validates Application for Tepotinib for the Treatment of Advanced NSCLC with METex14 Skipping Alterations
DARMSTADT, Germany, Nov. 26, 2020 /PRNewswire-AsiaNet/--

Merck, a leading science and technology company, today announced that the 
European Medicines Agency (EMA) has validated for review, the application for 
tepotinib for the treatment of adult patients with advanced non-small cell lung 
cancer (NSCLC) harboring mesenchymal-epithelial transition factor gene (MET) 
exon 14 (METex14) skipping alterations. With this validation, the application 
is complete, and the EMA will now begin the review procedure. 

Tepotinib is a highly selective oral MET inhibitor that is administered once 
daily.1 The application to the EMA is based on results from the pivotal Phase 
II VISION study (NCT02864992) evaluating tepotinib as monotherapy in patients 
with advanced NSCLC with METex14 skipping alterations, prospectively assessed 
by liquid biopsy or tissue biopsy. In the ongoing study, the patient population 
is generally characterized as elderly, with a median age of 74.0 years, and as 
having poor clinical prognosis typical of NSCLC with METex14 skipping 
alterations. Data from the primary analysis of the VISION study were published 
in The New England Journal of Medicine 
(NEJM)[] on May 29, 2020.2

Lung cancer is estimated to be the second most common cancer in Europe, and the 
leading cause of cancer-related mortality, responsible for 388,000 deaths in 
2018.3 METex14 skipping occurs in approximately 3–4% of NSCLC cases and 
correlates with aggressive tumor behavior and poor clinical prognosis.4 
Currently, there are no treatments available in Europe for patients with 
advanced NSCLC harboring METex14 skipping alterations.

Tepotinib became the first oral MET inhibitor indicated for the treatment of 
advanced NSCLC harboring MET gene alterations to receive a regulatory approval 
globally, with its approval in Japan in March 2020 through the SAKIGAKE 
program. Recently, the FDA granted Orphan Drug Designation (ODD) to tepotinib 
and the FDA is reviewing the application under Priority Review and through the 
Real-Time Oncology Review pilot program. 

About Tepotinib
Tepotinib is an oral MET inhibitor that inhibits the oncogenic MET receptor 
signaling caused by MET (gene) alterations. Discovered and developed in-house 
at Merck, it has a highly selective mechanism of action, with the potential to 
improve outcomes in aggressive tumors that have a poor prognosis and harbor 
these specific alterations.1 

Additional Clinical Investigations: Tepotinib is also being investigated in the 
Phase II INSIGHT 2 study in combination with osimertinib in MET amplified, 
advanced or metastatic NSCLC harboring activating EGFR mutations that has 
progressed following first-line treatment with osimertinib, and in the Phase II 
PERSPECTIVE study in combination with cetuximab in RAS/BRAF wild-type 
left-sided metastatic colorectal cancer patients having acquired resistance to 
anti-EGFR antibody targeting therapy due to MET amplification.

1. Bladt F, et al. Clin Cancer Res. 2013;19:2941-2951. 
2. Paik PK et al. Tepotinib in non–small-cell lung cancer with MET exon 14 
skipping mutations. N Engl J Med 2020 May 29; [e-pub]. 
3. Ferlay J, et al. Eur J Cancer. 
4. Reungwetwattana T, et al. Lung Cancer. 2017;103:27–37.

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About Merck
Merck, a leading science and technology company, operates across healthcare, 
life science and performance materials. Around 57,000 employees work to make a 
positive difference to millions of people's lives every day by creating more 
joyful and sustainable ways to live. From advancing gene editing technologies 
and discovering unique ways to treat the most challenging diseases to enabling 
the intelligence of devices – the company is everywhere. In 2019, Merck 
generated sales of 16.2 billion Euros in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to 
Merck's technological and scientific advances. This is how Merck has thrived 
since its founding in 1668. The founding family remains the majority owner of 
the publicly listed company. Merck holds the global rights to the Merck name 
and brand. The only exceptions are the United States and Canada, where the 
business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma 
in life science, and EMD Performance Materials.

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