Darmstadt, Germany (ots/PRNewswire) - 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.
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.  2018;103:356-387.
4. Reungwetwattana T, et al. Lung Cancer. 2017;103:27-37.
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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 EUR 16.2 billion 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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