Business Wire

TEPMETKO® (tepotinib) Receives Positive CHMP Opinion for Patients with Advanced NSCLC with METex14 Skipping Alterations

Share

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 (METex14) 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 METex14 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 METex14 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 METex14 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 METex14 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 METex14 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.

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Media Relations
gangolf.schrimpf@merckgroup.com
Phone: +49 151 1454-9591

Investor Relations
investor.relations@merckgroup.com
Phone: +49 6151 72-3321

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Kyowa Kirin Receives European Commission Approval for Use of CRYSVITA®▼(burosumab) for the Treatment of Tumour-Induced Osteomalacia (TIO)19.8.2022 11:30:00 EEST | Press release

Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin) today announced that the European Commission (EC) approved CRYSVITA® (burosumab) for the treatment of FGF23-related hypophosphataemia in Tumour-Induced Osteomalacia (TIO) associated with phosphaturic mesenchymal tumours (PMTs) that cannot be curatively resected or localised in children and adolescents aged 1 to 17 years and in adults.1 CRYSVITA is also already licensed in the EU for use in the rare disease X-Linked Hypophosphataemia (XLH), for children and adolescents between 1 and 17 years of age with radiographic evidence of bone disease, and in adults.2 Also known as oncogenic osteomalacia, TIO is an acquired disorder caused by typically small, slow-growing, benign PMTs.3,4 It is a rare condition with fewer than 1000 cases reported in the medical literature,4 which mainly affects adults and with a mean onset age of 40 – 45 years.3,5 TIO is associated with progressive and debilitating musculoskeletal deficits,6,7 ultimately having a detr

Kapruvia® approved in Switzerland with additional regulatory decisions expected in H2 202219.8.2022 08:00:00 EEST | Press release

Vifor Fresenius Medical Care Renal Pharma (VFMCRP) and Cara Therapeutics, Inc. (Nasdaq: CARA) today announced that they have received approval for Kapruvia® from the Swiss Agency for Therapeutic Products (Swissmedic). Kapruvia® will be the first therapy available for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adult hemodialysis patients. Swissmedic approval for Kapruvia® follows approvals by the U.S. Food and Drug Administration, by the European Medicines Agency, by the UK Medicines and Healthcare products Regulatory Agency, as well as by Health Canada. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005552/en/ “The approval of Kapruvia® in Switzerland is the next step on our journey to bring this breakthrough treatment to hemodialysis patients living with CKD-associated pruritus around the world,” said Dr. Klaus Henning Jensen, Chief Medical Officer of CSL Vifor. “There is a

Dermaliq Therapeutics announces first patient dosed in Phase 1b/2 trial evaluating DLQ02 for treatment of plaque psoriasis18.8.2022 19:27:00 EEST | Press release

Dermaliq Therapeutics, Inc. (Dermaliq), a private, clinical stage pharmaceutical company with a focus on dermatology, today announced first patient dosed in a Phase 1b/2a trial with DLQ02, a topical calcineurin inhibitor. The trial is designed to evaluate the safety, systemic absorption, pharmacodynamics, and clinical efficacy of DLQ02 in patients with plaque psoriasis. “DLQ02 evaluates for the first time hyliQTM, a novel platform technology in dermatology to create best in-class topical therapies with superior bioavailability,” said Betsy Hughes-Formella, PhD, Chief Scientific Officer at Dermaliq. “Calcineurin inhibitors for the treatment of psoriasis are a standard of care when given orally, albeit being associated with significant risk for systemic side effects. DLQ02 is designed to overcome the challenges of topical delivery of this drug class with reduced risk profiles. We are convinced DLQ02 has the potential to transform topical psoriasis therapy for millions of patients.” The r

Aero Secures $65M in Series B Financing to Accelerate the Future of Premium Air Travel18.8.2022 19:00:00 EEST | Press release

Aero Technologies, Inc. the next-generation premium air travel company, which serves routes in both the US and Europe, today announced a $65M capital raise, $50M in Series B funding and $15M in convertible notes, for a total post-money valuation of $300M. The funding round was co-led by AlbaCore Capital Group, one of Europe’s leading alternative investment firms, and returning investors Expa and Keyframe Capital, with new investment from Capital One Ventures. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005095/en/ (Photo: Business Wire) Inspired by the golden age of aviation and designed for modern life, Aero is redefining semi-private air travel. Aero serves premium leisure travelers through private terminals, enriching the experience with personalized Concierge services - from booking to touchdown. With its fleet of sleek, black planes, Aero offers elevated, effortless guest experiences to curated destinations with

Methane Electrolysis Can Decarbonize LNG/LPG Imports and Achieve EU’s Climate Targets18.8.2022 15:00:00 EEST | Press release

To become independent of Russian natural gas imports by 2027, the European Union is increasing near-term imports of US or Azerbaijan liquefied natural gas (LNG) or liquefied petroleum gas (LPG). The main element of LNG, methane, is the second leading greenhouse gas contributing to climate change. Environmental organizations warn that long-term supply contracts for the fossil LNG will undermine the European Green Deal. The German company Graforce has developed a methane electrolysis technology (plasmalysis) that uses LNG or LPG to produce hydrogen and solid carbon for dioxide-free energy generation. Compared to water electrolysis, plasmalysis requires only one fifth the energy to produce the same amount of hydrogen. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20220818005013/en/ Graforce has developed methane electrolysis plants. Errected at LNG terminals or other decentralized locations, they can decarbonize energy supply, a

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