PR86894

DARMSTADT, Germany, Nov. 26, 2020 /PRNewswire＝KYODO JBN/--

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)[https://www.nejm.org/doi/full/10.1056/NEJMoa2004407 ] 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.

References

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]. (https://doi.org/10.1056/NEJMoa2004407)

3. Ferlay J, et al. Eur J Cancer. 2018;103:356–387. [https://www.ejcancer.com/article/S0959-8049(18)30955-9/fulltext ]

4. Reungwetwattana T, et al. Lung Cancer. 2017;103:27–37.

All Merck Press Releases are distributed by e-mail at the same time they become

available on the Merck Website. Please go to www.merckgroup.com/subscribe to

register online, change your selection or discontinue this service.

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.

Media Relations

gangolf.schrimpf@merckgroup.com

Phone: +49 6151 72-9591

Investor Relations

investor.relations@merckgroup.com

Phone: +49 6151 72-3321

Logo - https://mma.prnewswire.com/media/1136775/Merck_Logo.jpg

SOURCE: Merck