European Commission Approves TEPMETKO ® (tepotinib) for Patients with Advanced NSCLC with MET ex14 Skipping Alterations

Merck, a leading science and technology company, today announced that the European Commission (EC) has approved once-daily oral TEPMETKO^® (tepotinib) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) harboring alterations leading to mesenchymal-epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy.

“The approval of TEPMETKO provides a much-needed targeted treatment option for patients with advanced non-small cell lung cancer with METex14 skipping alterations,” said Professor Egbert Smit, a VISION study investigator at the Netherlands Cancer Institute. “TEPMETKO has demonstrated durable and consistent response rates and has the potential to significantly help patients with this challenging cancer.”

The approval is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as monotherapy in patients with advanced NSCLC with METex14 skipping alterations. Data from the primary analysis of the VISION study were previously published online in The New England Journal of Medicine.¹

“The approval of TEPMETKO in Europe helps to address the need for targeted treatment options for people with lung cancer who have received prior treatment and whose tumors harbor METex14 skipping alterations,” said Dr. Anne-Marie Baird, President of Lung Cancer Europe. “It is vital that biomarker testing is made consistently available and utilized across Europe to ensure people with advanced lung cancer receive an accurate diagnosis and optimal treatment.”

In Europe, lung cancer is estimated to be the second most common cancer and the leading cause of cancer-related mortality, responsible for 388,000 deaths in 2018.² Alterations of the MET signaling pathway, including METex14 skipping alterations, are found in 3% to 4% of NSCLC cases and are associated with advanced disease and poor prognosis.^3-7

“With the European Commission’s approval of TEPMETKO, we are now able to bring this important medicine to more patients with this hard-to-treat and aggressive form of lung cancer,” said Andrew Paterson, Chief Marketing Officer for the Healthcare business sector of Merck. “As pioneers in the targeting of the MET signaling pathway, we will now be working on ways to bring this medicine to patients in Europe who may benefit.”

About the VISION Study

VISION (NCT02864992) is an ongoing pivotal Phase II, multicenter, multi-cohort, single-arm, non-randomized, open-label study investigating tepotinib as monotherapy. Based on the 01 February 2021 data cut, 275 patients with a median age of 72.6 years with advanced or metastatic NSCLC with METex14 skipping alterations have been analyzed.

About TEPMETKO^® (tepotinib)

TEPMETKO is a once-daily oral MET inhibitor that inhibits the oncogenic MET receptor signaling caused by MET (gene) alterations. Discovered and developed in-house at Merck, TEPMETKO 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.

TEPMETKO was the first oral MET inhibitor to receive a regulatory approval anywhere in the world for the treatment of advanced NSCLC harboring MET gene alterations, with its approval in Japan in March 2020. In February 2021, the U.S. Food and Drug Administration granted accelerated approval to TEPMETKO, making it the first and only once-daily oral MET inhibitor approved for patients in the U.S. with metastatic NSCLC with METex14 skipping alterations. Tepotinib is available in a number of countries, and under review by various other regulatory authorities globally. To meet an urgent clinical need, tepotinib is also available in a pilot zone of China in line with the government policy to drive early access for innovative medicines approved outside of China.

Merck is also investigating the potential role of tepotinib in treating patients with NSCLC and acquired resistance due to MET amplification in the Phase II INSIGHT 2 study of tepotinib in combination with osimertinib in MET amplified, advanced or metastatic NSCLC harboring activating EGFR mutations that has progressed following first-line treatment with osimertinib.

TEPMETKOSafety Profile from the EU Summary of Product Characteristics (SmPC)

The special warnings and precautions for use for TEPMETKO monotherapy include interstitial lung disease (ILD) or ILD-like adverse reactions including pneumonitis, increase of liver enzymes (ALT and AST), QTc prolongation, and embryo-foetal toxicity.

The most common adverse reactions in ≥ 20% of exposed to tepotinib at the recommended dose in the target indication are oedema, mainly peripheral oedema, nausea, hypoalbuminaemia, diarrhoea and increase in creatinine. The most common serious adverse reactions in ≥ 1% of patients are peripheral oedema, generalised oedema and ILD.

Commitment to Cancer

Merck is a science-led organization dedicated to delivering transformative medicines with the goal of making a meaningful difference in the lives of people affected by cancer. Our oncology research efforts aim to leverage our synergistic portfolio in oncogenic pathways, immuno-oncology, and DNA Damage Response (DDR) to tackle challenging tumor types in gastrointestinal, genitourinary, and thoracic cancers. Our curiosity drives our pursuit of treatments for even the most complex cancers, as we work to illuminate a path to scientific breakthroughs that transform patient outcomes. Learn more at www.merckgrouponcology.com.

References

1. Paik PK, Felip E, Veillon R, et al. Tepotinib in non–small-cell lung cancer with MET exon 14 skipping mutations. N Engl J Med 2020; 383:931-943.
2. Ferlay J, et al. Eur J Cancer. 2018;103:356–387.
3. Felip E, et al. WCLC 2021. Poster 170.
4. Reungwetwattana T, et al. Lung Cancer 2017;103:27-37.
5. Wolf J, et al. EORTC/NCI/AACR 2018. Poster 403.
6. Schrock AB, et al. J Thorac Oncol. 2016;11:1493–1502.
7. Tong JH, et al. Clin Cancer Res. 2016;22:3048–3056.8.
8. TEPMETKO^® (tepotinib) EU SmPC. http://www.ema.europa.eu/ema/. Accessed February 2022.

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About Merck

Merck, a leading science and technology company, operates across healthcare, life science and electronics. Around 58,000 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 2020, Merck generated sales of € 17.5 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 Electronics.

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