MERCK
Merck, a leading science and technology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of 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 (MET ex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum-based chemotherapy. The CHMP positive opinion will now be reviewed by the European Commission (EC), with a decision expected in the first quarter of 2022.
“TEPMETKO has demonstrated important clinical benefits and a manageable safety profile in the treatment of this aggressive form of lung cancer, and has the potential to advance the treatment of this type of tumor,” said Danny Bar-Zohar, M.D., Global Head of Development for the Healthcare business sector of Merck. “We look forward to the European Commission decision, and bringing the first oral MET inhibitor in NSCLC to patients in Europe.”
The positive opinion is based on results from the pivotal Phase II VISION study evaluating TEPMETKO as a once-daily oral monotherapy treatment for patients with advanced NSCLC with MET ex14 skipping alterations. Data from the primary analysis of the VISION study were previously published in The New England Journal of Medicine , and showed TEPMETKO demonstrated consistent and durable responses in both treatment naïve and previously treated adult patients with advanced NSCLC harboring alterations leading to MET ex14 skipping. Additional data from the VISION study presented at IASLC 2021 World Conference on Lung Cancer include results for 123 patients from Cohort C with follow-up of at least 3 months from the start of treatment and provide additional evidence supporting the clinically meaningful responses demonstrated in the primary analysis.1
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 MET ex14 skipping alterations, are found in 3% to 4% of NSCLC cases, and are associated with having advanced disease and poor prognosis.1,3-6
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 MET ex14 skipping alterations. This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. 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.
About VISION Study
VISION (NCT02864992) is an ongoing pivotal Phase II, multicenter, multi-cohort, single-arm, non-randomized, open-label study investigating tepotinib as monotherapy in 275 patients with a median age of 72.6 years with advanced or metastatic NSCLC with MET
ex14 skipping alterations.
About TEPMETKO®
(tepotinib)
TEPMETKO is an 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.
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.
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. Felip E, et al. WCLC 2021.
Poster 170.
2. Ferlay J, et al. Eur J Cancer.
2018;103:356–387.
3. Reungwetwattana T, et al. Lung Cancer
2017;103:27-37.
4. Wolf J, et al. EORTC/NCI/AACR 2018. Poster 403.
5. Schrock AB, et al. J Thorac Oncol
. 2016;11:1493–1502.
6. Tong JH, et al. Clin Cancer Res
. 2016;22:3048–3056.8.
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 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20211216005685/en/
Link:
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
SES Receives All Required Regulatory Approvals to Complete Intelsat Acquisition14.7.2025 22:15:00 CEST | Press release
SES received the final regulatory approvals for the SES-Intelsat transaction, including the US Federal Communications Commission. On 30 April 2024, SES and Intelsat announced an agreement for SES to acquire Intelsat for a cash consideration of $3.1 billion (€2.8 billion). The transaction was subject to receipt of relevant regulatory clearances and other relevant requirements which all have now been obtained. As a result, SES plans to close the transaction on or about Thursday, 17 July 2025. Once closing has occurred, a press release will be published to confirm that the transaction has successfully closed. Follow us on: Twitter | Facebook | YouTube | LinkedIn | Instagram Read our Blogs > Visit the Media Gallery > About SES SES has a bold vision to deliver amazing experiences everywhere on Earth by distributing the highest quality video content and providing seamless data connectivity services around the world. As a provider of global content and connectivity solutions, SES owns and ope
Loomis Sayles Celebrates 15 Years of Growth Equity Strategies Team Under Leadership of Aziz V. Hamzaogullari14.7.2025 22:05:00 CEST | Press release
Loomis, Sayles & Company: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714614048/en/ 90.7 160 1 BILLION IN ASSETS UNDER MANAGEMENT COMBINED YEARS OF INVESTMENT EXPERIENCE INVESTMENT PHILOSOPHY GES Team As of 5/31/2025 GES Team As of 5/31/2025 Supported by a seven-step research framework Loomis, Sayles & Company proudly celebrates the 15-year anniversary of a differentiated approach to growth equity investing under the leadership of Aziz V. Hamzaogullari, CFA, the founder, chief investment officer and portfolio manager of the Loomis Sayles Growth Equity Strategies (GES) Team. Aziz is also an executive vice president and a member of the firm’s Board of Directors. GES is a cohesive team with nearly 19 years of alpha generation and a long-term, private equity approach to investing. Under Aziz Hamzaogullari’s leadership since 2010, assets under management for GES have grown from $1.9 billion to nearly $91 billion as of 31 Ma
Cessna Skyhawk Soars With Enhanced Efficiency: Solid-State Dual Electronic Ignition System Introduced to the Industry-leading Piston14.7.2025 18:00:00 CEST | Press release
The industry-leading training aircraft, the Cessna Skyhawk, now features a dual electronic ignition system (dual EIS), enhancing maintenance, efficiency and overall operation of the single-engine, high-wing piston. The dual Lycoming electronic ignition system is now standard on all new Cessna Skyhawk aircraft. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714759359/en/ Cessna Skyhawk soars with enhanced efficiency: solid-state dual electronic ignition system introduced to the industry-leading piston (Photo Credit: Textron Aviation) The Cessna Skyhawk is designed and produced by Textron Aviation Inc., a Textron Inc. (NYSE: TXT) company. The dual EIS replaces the previous dual magneto ignition system on the Skyhawk, incorporating advanced electronic components and reducing the number of internal moving parts to optimize operation. This solid-state electronic technology improves maintenance intervals, fuel efficiency and en
The 2025 Empire State Building Run-Up Returns Oct. 814.7.2025 17:48:00 CEST | Press release
Presented by NYU Langone Health and Powered by the Challenged Athletes FoundationLottery Opens July 14 The Empire State Building (ESB) announced today general lottery registration for the annual Empire State Building Run-Up (ESBRU) on Oct. 8, 2025, at 8 p.m. ESB also announced the ESBRU will be presented by NYU Langone Health and powered by the Challenged Athlete’s Foundation. General lottery registration will be open from July 14 through July 28, 2025. In the 47th annual Run-Up, 225 runners will race up the iconic building’s 1,576 stairs to the world-famous Observatory. This year’s heats will include elite men and women, media, celebrities, New York City real estate brokers, building tenants, CAF athletes, members of the NYPD and FDNY, and the public, among others. On July 30, registered runners will be notified of their race status with participation costs of $175 per runner to be charged only upon acceptance from the lottery. “We are delighted to welcome NYU Langone Health as our ne
Taicang: A Model for China-Europe ESG Cooperation14.7.2025 16:11:00 CEST | Press release
Located in the Yangtze River Delta, Taicang City in Jiangsu Province is known as the “Hometown of German Enterprises in China.” At the recent 2nd Sino-European Corporate ESG Best Practice Conference, Taicang received the prestigious “Zero-Carbon City” Best Practice Award, further solidifying its reputation as a benchmark for green urban transformation. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250714458209/en/ A glimpse of Taicang City, Jiangsu Province, China. According to the jury, “By integrating ESG indicators into its urban development strategy, Taicang has demonstrated visionary leadership and has become a model for sustainable city and industrial development.” In response to the global challenges of climate change and sustainable growth, Taicang has proactively aligned with China’s “dual carbon” strategy. It has positioned itself as a modern garden city driven by green development, integrating ESG principles into
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom