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

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DARMSTADT, Germany, March 27, 2018 /PRNewswire=KYODO JBN/ --

     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-beta), 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 time they

become available on the Merck Website. Please go to

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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-cell/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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Source:  Merck