Merck Announces FDA Breakthrough Therapy Designation for Investigational Therapy Tepotinib in Patients with Metastatic NSCLC with METex14 Skipping Alterations - Seite 3

clinically significant endpoint(s). The FDA's granting of the
Breakthrough Therapy Designation for advanced NSCLC does not alter
the standard regulatory requirement to establish the safety and
effectiveness of a drug through adequate and well-controlled studies
to support approval.

About Non-Small Cell Lung Cancer

With 2 million cases diagnosed annually, lung cancer (including
trachea, bronchus and lung) is the most common type of cancer
worldwide, and the leading cause of cancer-related death, with 1.7
million mortality cases worldwide.[1] Alterations of the MET
signaling pathway, including MET exon 14 skipping alterations and MET
amplifications, occur in 3-5% of NSCLC cases.[2],[3],[4]

About Tepotinib

Tepotinib, discovered in-house at Merck, is an investigational
oral MET inhibitor that is designed to inhibit the oncogenic MET
receptor signaling caused by MET (gene) alterations, including both
MET exon 14 skipping alterations and MET amplifications, or MET
protein overexpression. It has been designed to have 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.

Tepotinib is currently being investigated in NSCLC and Merck is
actively assessing the potential of investigating tepotinib in
combination with novel therapies and in other tumor indications.

References

[1] Bray F, et al. CA Cancer J Clin. Global cancer statistics 2018:
GLOBOCAN estimates of incidence and mortality worldwide for 36
cancers in 185 countries. 2018;68(6):394-424.
https://doi.org/10.3322/caac.21492 PMID:30207593.
[2] Reungwetwattana T, et al. Lung Cancer 2017;103:27-37.
[3] Mo HN, et al. Chronic Dis Transl Med 2017; 3(3):148-153.
[4] Lutterbach B, et al. Cancer Res 2007;67:2081-8.
[5] Bladt, F, et al. Clin Cancer Res 2013;19:2941-2951.
[6] Paik P, et al. J Clin Oncol 2019;37: (suppl; abstr 9005).

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About Merck

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healthcare, life science and performance materials. Around 52,000
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From advancing gene editing technologies and discovering unique ways
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sales of EUR14.8 billion in 66 countries.

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