Merck Receives Fast-Track Designation for Tepotinib in Non-Small Cell Lung Cancer in Japan

Darmstadt, Germany (ots/PRNewswire) -

Not intended for UK- or US-based media

- Japanese Ministry of Health, Labour and Welfare Grants SAKIGAKE
designation for tepotinib, Merck's investigational highly
selective c-Met receptor tyrosine kinase inhibitor
- First regulatory designation for tepotinib
- SAKIGAKE designation encompasses the possibility for a target
review period of 6 months

Merck, a leading science and technology company, today announced
that the Japanese Ministry of Health, Labour and Welfare (MHLW) has
granted SAKIGAKE 'fast-track' designation for its investigational
molecule tepotinib* for patients with advanced non-small cell lung
cancer (NSCLC) harboring MET exon 14 skipping mutations. SAKIGAKE
designation promotes research and development in Japan, aiming at
early practical application for innovative pharmaceutical products,
medical devices, and regenerative medicines, and can reduce a drug's
review period down from 12 months to a target of 6 months. This is
the first regulatory designation granted to tepotinib.

"This fast-track designation in Japan recognizes the progress we
are making with tepotinib as part of our strategic focus on
delivering innovative precision medicines to oncology patients," said
Luciano Rossetti, M.D., Global Head of Research & Development at the
Biopharma business of Merck. "Tepotinib is a highly selective small
molecule that - if supported by the outcome of further studies - may
have the potential to provide particular benefit to NSCLC patients
with this genetic mutation."

The SAKIGAKE Designation System is a core component of the MHLW's
"Strategy of SAKIGAKE". The system's objective is to designate drugs
that have the potential of prominent effectiveness against serious
and life-threatening diseases in order to make them available to
patients in Japan ahead of the rest of the world.

Tepotinib, discovered in-house at Merck, is an investigational
inhibitor of the c-Met receptor tyrosine kinase. The designation
consultation on the clinical development program for tepotinib
includes a Phase II study exploring the potential of this small
molecule in patients with advanced NSCLC harboring MET exon 14
skipping mutations - a population that currently has no approved
therapies available. Data from this study will be presented at an
upcoming medical congress.

Merck's oncology and immuno-oncology pipeline includes
high-quality, selective small molecules, antibodies and antibody-drug
conjugates with strong translational research data supporting each
drug's clinical development. In addition to tepotinib, the oncology
pipeline includes M7824, an investigational bifunctional
immunotherapy, designed to simultaneously block two immunoinhibitory
pathways (programmed death ligand-1 and transforming growth
factor-?), as well as a number of anti-DNA Damage Response molecules
(including inhibitors of DNA-PK, ATR and ATM).

*Tepotinib is the recommended International Nonproprietary Name (INN)
for the c-Met kinase inhibitor (MSC 2156119J). Tepotinib is currently
under clinical investigation and not approved for any use anywhere in
the world.

About Non-Small Cell Lung Cancer (NSCLC)

Lung cancer (both small cell and non-small cell) has been the most
common cancer in the world for several decades.[1] Globally, lung
cancer is responsible for approximately 1 in every 5 deaths from
cancer.[1] The five-year survival rate for people diagnosed with lung
cancer that has spread (metastasized) to other areas of the body is
1%.[2] NSCLC is the most common type of lung cancer, accounting for
80 to 85% of all lung cancers.[2] MET Exon 14 skipping mutations
occur in 2-3% of lung cancers.[3]

About Tepotinib

Tepotinib is an investigational, highly selective small-molecule
inhibitor of the c-Met receptor tyrosine kinase. Alterations of the
c-Met signaling pathway are found in various cancer types and
correlate with aggressive tumor behavior and poor clinical prognosis.
Tepotinib is being investigated in a Phase II study in non-small cell
lung cancer.

About Merck

Merck is a leading science and technology company in healthcare,
life science and performance materials. Around 50,000 employees work
to further develop technologies that improve and enhance life - from
biopharmaceutical therapies to treat cancer or multiple sclerosis,
cutting-edge systems for scientific research and production, to
liquid crystals for smartphones and LCD televisions. In 2017, Merck
generated sales of EUR 15.3 billion in 66 countries.

Founded in 1668, Merck is the world's oldest pharmaceutical and
chemical company. The founding family remains the majority owner of
the publicly listed corporate group. Merck holds the global rights to
the Merck name and brand. The only exceptions are the United States
and Canada, where the company operates as EMD Serono, MilliporeSigma
and EMD Performance Materials.

All Merck Press Releases are distributed by e-mail at the same
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References

1. International Agency for Research on Cancer (IARC). GLOBOCAN 2012:
Estimated Cancer Incidence, Mortality and Prevalence Worldwide in
2012; Lung Cancer. Available from:
http://globocan.iarc.fr/Pages/fact_sheets_cancer.aspx. Last
accessed: March 2018.
2. Cancer.net. Lung cancer - non-small cell: statistics. Available
from: http://www.cancer.net/cancer-types/lung-cancer-non-small-cel
l/statistics. Last accessed: March 2018.
3. Reungwetwattana T, Liang Y, et al. The race to target MET exon 14
skipping alterations in non-small cell lung cancer: The Why, the
How, the Who, the Unknown, and the Inevitable. Lung Cancer.
2017;103:27-37.

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ots Originaltext: Merck KGaA
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