Data on Tepotinib for metastatic non–small cell lung cancer presented at ESMO Asia 2019

·         Abstracts highlight data on investigational therapy tepotinib in locally advanced or metastatic non-small cell lung cancer

Singapore, November 25, 2019 – Merck, a leading science and technology company, today announced the presentation of multiple abstracts on tepotinib* at the European Society for Medical Oncology (ESMO) Asia Congress 2019 in Singapore.

Discovered in-house at Merck, tepotinib is an investigational oral MET kinase inhibitor that is designed to be highly potent and selective^[1] and to inhibit the oncogenic signaling caused by MET (gene) alterations, including both MET exon 14 skipping alterations and MET amplifications, or MET protein overexpression. This month, tepotinib was granted orphan drug designation (ODD) in Japan for patients with non-small cell lung cancer (NSCLC) harboring MET gene alterations.

Earlier in September, tepotinib was granted Breakthrough Therapy Designation (BTD) by the US Food and Drug Administration (FDA) in patients with metastatic non-small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who progressed following platinum-based cancer therapy. In March 2018, tepotinib’s potential was also recognized by the Japanese Ministry of Health, Labour and Welfare (MHLW), which granted SAKIGAKE ’fast-track’ designation for tepotinib in advanced NSCLC harboring MET exon 14 skipping alterations.

“Our development program for tepotinib is focused on precision medicine. We are leveraging innovative, non-invasive liquid biopsies to identify patients in Asia who might benefit from this treatment,” Dr Rajiv Rana, Head, Medical Affairs – APAC, Merck Biopharma.

“Lung cancer is the most common type of cancer in Asia^[2]. Our extensive Asia-focused research on tepotinib demonstrates our commitment to developing new therapeutic options for people currently living with this disease in the region,” said Andre Musto, Regional Vice President – APAC, Merck Biopharma.

Merck presented the following studies at the conference:

1. Mini Oral Session Presentation #477O: Tepotinib plus gefitinib in patients with MET-amplified EGFR-mutant NSCLC: long-term outcomes of the INSIGHT study

1. Mini Oral Session Presentation #62O: Tepotinib in NSCLC patients harboring METex14 skipping: Cohort A of phase II VISION study

1. Poster Display: 536TiP - INSIGHT 2: Tepotinib plus osimertinib in patients with EGFR-mutant NSCLC having acquired resistance to EGFR TKIs due to MET-amplification: a phase II trial in progress study

1. Poster Display: 67P - Pooled safety analysis of tepotinib in Asian patients with advanced solid tumors

[1] Bladt, F, et al. Clin Cancer Res 2013;19:2941-2951. Paik P, et al. J Clin Oncol 2019;37: (suppl; abstr 9005).

[2] Pakzad, R., Mohammadian-Hafshejani, A., Ghoncheh, M., Pakzad, I., & Salehiniya, H. (2015). The incidence and mortality of lung cancer and their relationship to development in Asia. Translational lung cancer research, 4(6), 763–774. doi:10.3978/j.issn.2218-6751.2015.12.01

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.³ Alterations of the MET signaling pathway, including MET exon 14 skipping alterations and MET amplifications, occur in 3-5% of NSCLC cases.^4-6

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 mutations 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.

About Merck

Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 56,000 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 2018, Merck generated sales of € 14.8 billion 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.