About Hepatocellular Carcinoma
HCC is the most common type of primary liver cancer, accounting for 75–90% of all liver cancer cases.4,5 c-Met-positive tumors occur in approximately 45% of HCC patients.6 It occurs predominantly in patients with underlying chronic liver disease and cirrhosis.5 HCC is the third leading cause of cancer death worldwide, with over 500,000 people affected.7 Chronic liver disease due to hepatitis B virus or hepatitis C virus and alcohol accounts for the majority of HCC cases.8 HCC is frequently diagnosed at advanced stages and has a high mortality rate.9 Patients with HCC have limited treatment options and both the incidence and mortality of this disease has increased over the past 10 years.6,9
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,10 responsible for more deaths than colon, breast and prostate cancer combined.11 NSCLC is the most common type of lung cancer, accounting for 80 to 85% of all lung cancers.12 MET exon 14 skipping mutations occur in 3-4% of lung cancers.13,14 The five-year survival rate for people diagnosed with lung cancer that has spread (metastasized) to other areas of the body is 1%.15
Tepotinib is an investigational, small-molecule inhibitor of the c-Met receptor tyrosine kinase discovered in-house at Merck KGaA, Darmstadt, Germany. 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.
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.
1. Qin S, et al. Ann Oncol 2017;28(suppl 5):239,abstr 701P. ESMO 2017. Available at http://www.poster-submission.com/esmo2017/visitors/eposter/34259. Accessed June 2018.
2. Faivre SJ, et al. J Clin Oncol 2017;35(suppl):abstr e15676. ASCO 2017. Available at: https://meetinglibrary.asco.org/record/152613/abstract. Accessed June 2018.
3. Rebecca H, et al. MET exon 14 skipping in non-small cell lung cancer. Oncologist 2016;21:481-486. Available at: http://theoncologist.alphamedpress.org/content/21/4/481.full Accessed June 2-18.
4. Mayo Clinic. Liver Cancer. Available at: https://www.mayoclinic.org/diseases-conditions/hepatocellular-carcinoma/cdc-20354552. Accessed June 2018.
5. Wong MC, et al. International incidence and mortality trends of liver cancer: a global profile. Sci Rep 2017;7:45846. doi: 10.1038/srep45846.
6. American Association for Cancer Research. c-Met may be a biomarker for metastatic hepatocellular carcinoma. ScienceDaily 2010. Available at: www.sciencedaily.com/releases/2010/09/100928171422.htm Accessed June 2018.
7. Cicalese L. Hepatocellular carcinoma. Available at: https://emedicine.medscape.com/article/197319-overview. Accessed June 2018.
8. Ghouri YA, et al. Review of hepatocellular carcinoma: Epidemiology, etiology, and carcinogenesis. J Carcinog 2017;16:1. doi:10.4103/jcar.JCar916.
9. Bupathi M, et al. Hepatocellular carcinoma: Where there is unmet need. Mol Oncol 2015;9: 1501–1509.
10. American Cancer Society (2015) Global facts & figures third edition. Available at: www.cancer.org/acs/groups/content/@research/documents/document/acspc-044738.pdf. Accessed February 2018
11. American Cancer Society (2017) Key statistics for lung cancer. Available at: https://www.cancer.org/cancer/non-small-cell-lung-cancer/about/key-statistics.html. Accessed February 2018.
12. 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.
13. 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.
14. 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.
15. Cancer.net. Lung cancer – non-small cell: statistics. Available at: http://www.cancer.net/cancer-types/lung-cancer-non-small-cell/statistics. Accessed February 2018.
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About Merck KGaA, Darmstadt, Germany
Merck KGaA, Darmstadt, Germany, 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 KGaA, Darmstadt, Germany, generated sales of € 15.3 billion in 66 countries.
Founded in 1668, Merck KGaA, Darmstadt, Germany, is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck KGaA, Darmstadt, Germany, 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.