Merck Presents Update on Tepotinib in Advanced Lung Cancer at ASCO 2018

PR73828

DARMSTADT, Germany, June 3, 2018, /PRNewswire=KYODO JBN/--

ASCO Abstract #

Tepotinib (c-Met kinase inhibitor): 9082, 9016; M7824 (TGF-ß trap/anti-PD-L1):

3007, 9017, 2566; M2698 (dual p70S6k/Akt inhibitor): 2584; M6620 (ATR

inhibitor): 2549; M3814 (DNA-PK): 2518

Not intended for UK- or US-based media

Data from an ongoing Phase II tepotinib study show anti-tumor clinical activity

in patients with advanced non-small cell lung cancer harboring MET exon 14

skipping mutations  

Patients with advanced lung cancer harboring MET exon 14 mutations currently

have a poor prognosis and limited treatment options  

Safety data are consistent with data previously reported, with no new safety

signals identified  

Merck, a leading science and technology company, today announced that the

investigational, targeted therapy tepotinib[*] has shown clinical activity in

an ongoing Phase II study of patients with advanced non-small cell lung cancer

(NSCLC) harboring MET exon 14 skipping mutations. Data from the VISION trial

will be presented during the American Society of Clinical Oncology (ASCO) 2018

Annual Meeting in Chicago, June 1-5, 2018.

"Patients living with advanced non-small cell lung cancer harboring MET exon 14

skipping mutations have limited treatment options available to them and

typically face poor clinical outcomes," said investigator Enriqueta Felip,

M.D., Medical Oncologist, Vall d'Hebron Institute of Oncology (VHIO). "More

than half of the patients in the Phase II VISION study had an

investigator-assessed confirmed response, demonstrating the potential of

tepotinib and the need to further evaluate this precision medicine option."

Initial data from the Phase II VISION study of tepotinib in patients living

with advanced NSCLC harboring MET exon 14 skipping mutations will be presented

today at ASCO during the "Lung Cancer-Non-Small Cell Metastatic" poster

discussion session, 11:30 a.m. - 12:45 p.m. CDT. Treatment with tepotinib led

to a confirmed complete response (CR) or confirmed partial response (PR) in

53.6% (15/28) and stable disease (SD) in 17.9% (5/28) of patients based on

investigator assessment. Based on independent assessment of updated data from

28 patients (patients with at least 2 post-baseline assessments or who

discontinued for any reason), 42.9% (12/28) had a PR and 21.4% (6/28) had SD.

In this ongoing study, the safety data are consistent with that observed in

previous studies; no new safety signals have been identified to date. A total

of 26 out of 38 patients with data available experienced treatment-related

adverse events (TRAEs), most commonly Grade 1/2 peripheral edema (13 patients)

and diarrhea (10 patients). Seven patients reported Grade 3 TRAEs, including

asymptomatic amylase increase (2 patients) and one instance each of: asthenia,

generalized edema, aspartate aminotransferase increase, gamma-glutamyl

transferase increase, lipase increase, hyperkalemia, dizziness and pneumonia.

Four patients experienced serious TRAEs, with one instance of pneumonia,

generalized edema, asthenia and dizziness, and interstitial lung disease. The

VISION study is continuing to enroll patients harboring MET exon 14 skipping

mutations from Europe, United States and Japan.

"These data support our plans to continue with the clinical development of

tepotinib in this particularly aggressive, advanced lung cancer. Patients with

this form of non-small cell lung cancer currently have a poor prognosis and

limited treatment options," said Luciano Rossetti, M.D., Executive Vice

President, Global Head of Research & Development at the biopharma business of

Merck. "Tepotinib is an important late-stage investigational therapy and a key

part of our strategic focus on innovative precision medicines."

Tepotinib, discovered in-house at Merck, is an investigational 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 has been designed with the potential to

improve outcomes in aggressive tumors that have a poor prognosis and harbor

these specific mutations. In March, the Japanese Ministry of Health, Labour and

Welfare granted SAKIGAKE 'fast-track' designation to tepotinib in patients with

NSCLC harboring MET exon 14 skipping mutations.

                                              Presentation Date

    Title             Lead Author Abstract #    / Time (CDT)       Location

    Tepotinib

    Poster Sessions

    Can duration of

    response be used

    as a surrogate

    endpoint for

    overall survival

    in advanced

    non-small cell    Boris M                 Sun, Jun 03, 8:00

    lung cancer?      Pfeiffer    9082        a.m. - 11:30 a.m.     Hall A

    Poster Discussion

    Tepotinib in

    patients with

    advanced

    non-small cell

    lung cancer

    (NSCLC) harboring

    MET exon

    14-skipping

    mutations: Phase  Enriqueta               Sun, Jun 03, 11:30   

    II trial.         Felip, M.D. 9016        a.m. - 12:45 p.m.     Arie Crown

Theater

In addition to tepotinib, Merck is sharing data from across its oncology and

immuno-oncology pipeline at ASCO 2018, including investigational immunotherapy

M7824 and updates from its DNA Damage Response portfolio. Merck is committed to

exploring an array of targets and taking creative scientific approaches to

developing novel therapies for hard-to-treat cancers.

*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

Globally, lung cancer is the most common cause of cancer-related deaths in men

and the second most common in women,[1] responsible for more deaths than colon,

breast and prostate cancer combined.[2] NSCLC is the most common type of lung

cancer, accounting for 80 to 85% of all lung cancers.[3] MET exon 14 skipping

mutations occur in 3-4% of lung cancers.[5],[6] The five-year survival rate for

people diagnosed with lung cancer that has spread (metastasized) to other areas

of the body is 1%.[4]

About Tepotinib

Tepotinib is an investigational, small-molecule inhibitor of the c-Met receptor

tyrosine kinase discovered in-house at Merck. 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 currently

being investigated in a Phase II study in NSCLC.

About SAKIGAKE

SAKIGAKE designation is granted by the Japanese Ministry of Health, Labour and

Welfare, promoting research and development in Japan and aiming at early

practical application for innovative pharmaceutical products, medical devices

and regenerative medicines. SAKIGAKE designation can reduce a drug's review

period down from 12 months to a target of 6 months.

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.

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

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About Merck

Merck is a leading science and technology company in healthcare, life science

and performance materials. Almost 53,000 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 € 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.

References

American Cancer Society (2015) Global facts & figures third edition. Available

from:

http://www.cancer.org/acs/groups/content/@research/documents/document/acspc-044738.pdf.

Accessed February 2018

American Cancer Society (2017) Key statistics for lung cancer. Available from:

https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/key-statistics.html.

Accessed February 2018.

American Cancer Society (2016) What is non-small cell lung cancer? Available

from:

https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/what-is-non-small-cell-lung-cancer.html.

Accessed February 2018.

Cancer.net. Lung cancer - non-small cell: statistics. Available from:

http://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics.

Accessed February 2018.

Lutterbach B et al. Lung cancer cell lines harboring MET gene amplification are

dependent on Met for growth and survival. Cancer Res. (2007) 67(5):2081-8.

Wong MCS, et al. Incidence and mortality of lung cancer: global trends and

association with socioeconomic status. Sci. Rep. (2017) 7:143000: doi:

10.1038/s41598-017-14513-7.

Contact: Brenda Mulligan +978-821-5345

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Source: Merck