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Plain Language Summary
What is this summary about?
This plain language summary provides an overview of two of the main clinical studies that led to tepotinib’s approval, the phase I first-in-human study and the phase II VISION study.
What is tepotinib?
Tepotinib is a targeted anti-cancer treatment taken orally (by mouth). It is available in many countries for people with advanced or metastatic non-small cell lung cancer (NSCLC), where the tumor contains a genetic mutation (alteration) called ‘MET exon 14 skipping’. Tumor cells rely on this mutation to grow and survive, so targeted blocking of the effect of this mutation is an important treatment approach. MET exon 14 skipping occurs in approximately 3–4% of people with NSCLC. These people are usually of older age. This subtype of NSCLC is associated with poor outcomes. Before treatments that specifically target this MET mutation were developed, only general treatments such as chemotherapy were available for this type of cancer. Because chemotherapy attacks all rapidly dividing cells in a person’s body and is administered intravenously (through a vein), it can often cause unwanted side effects. Cancer cells grow and divide rapidly because of defects, often involving proteins called ‘tyrosine kinases’. Specific tyrosine kinase inhibitors (TKIs) were therefore developed to slow or stop cancer growth by targeting these proteins. Tepotinib is a MET TKI. This means that it blocks the activity of the MET pathway that is overactive in MET exon 14 skipping NSCLC. Doing this, may slow down cancer growth.
What were the results from the clinical studies of tepotinib?
In the studies summarized here, people with MET exon 14 skipping NSCLC who took tepotinib had their tumor growth stopped or their tumor shrunk for a period of time, and they mostly experienced side effects that they could tolerate.
Clinical Trial Registration: NCT01014936 (tepotinib first-in-human), NCT02864992 (VISION), NCT03940703 (INSIGHT 2) (ClinicalTrials.gov)
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Acknowledgments
Merck Healthcare KGaA, Darmstadt, Germany would like to thank the participants and their families who took part in the tepotinib clinical trials. Medical writing and editorial assistance in the development of this article were provided by Rebecca Hurst of Syneos Health Communications, London, UK, funded by Merck Healthcare KGaA, Darmstadt, Germany.
The authors note with sadness the death of our co-author, John Hallick, on 4 March 2023, prior to publication of this manuscript after peer review. We are grateful for his deep insight and collaboration.
Financial & competing interests disclosure
John Hallick: grants or contracts from EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA; honoraria for advisory and speaker activities from Merck Healthcare KGaA, Darmstadt, Germany and EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA; travel expenses from Biomarker Collaborative, Inc; leadership role at MET Crusaders, Inc and Biomarker Collaborative, Inc. Anne-Marie Baird: honoraria (self) from Roche; leadership role at Lung Cancer Europe; funding (to institution) from Amgen, AstraZeneca, Bayer, Blueprint Medicines, Bristol Myers Squibb, Boehringer Ingelheim, Daiichi-Sankyo, Lilly, Merck Healthcare KGaA, Darmstadt, Germany, Merck Sharpe & Dohme, Novartis, Pfizer, Regeneron, Roche, Sanofi, Takeda, Janssen, Novocure and ThermoFisher. Gerald Falchook: royalties (self) from Wolters Kluwer; advisory role (to institution) for Fujifilm, Silicon, Navire, Turning Point, Predicine, Inspirna, Regeneron, Jubilant, BostonGene; advisory role (self) for EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA; speakers honorarium for CME from Total Health Conferencing, Rocky Mountain Oncology Society; travel expenses (self, for work and/or research related to institution) from Bristol Myers Squibb, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Fujifilm, Millennium, Sarah Cannon Research Institute (employer, at least once yearly); research funding (to institution) from 3-V Biosciences, Abbisko, AbbVie, ABL Bio, ADC Therapeutics, Accutar, Agenus, Aileron, American Society of Clinical Oncology, Amgen, ARMO/Eli Lilly, Artios, AstraZeneca, BeiGene, Bioatla, Bioinvent, Biothera, Bicycle, Black Diamond, Boehringer Ingelheim, Celgene, Celldex, Ciclomed, Curegenix, Curis, Cyteir, Daiichi, DelMar, eFFECTOR, Eli Lilly, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, Epizyme, Erasca, Exelixis, Freenome, Fujifilm, Genmab, GlaxoSmithKline, Hutchison MediPharma, IGM Biosciences, Ignyta, ImmunoGen/MacroGenics, Incyte, Jacobio, Jounce, Jubilant, Kolltan, Loxo/Bayer, MedImmune, Merck Sharpe & Dohme, Metabomed, Millennium, miRNA Therapeutics, Molecular Templates, National Institutes of Health, Navire, NiKang, Novartis, OncoMed, Oncorus, Oncothyreon, Poseida, Precision Oncology, Prelude, PureTech, Pyramid, RasCal, Regeneron, Relay, Rgenix, Ribon, Samumed, Sapience, Seagen, Silicon, Simcha, Sirnaomics, Strategia, Syndax, Synthorx/Sanofi, Taiho, Tallac, Takeda, Tarveda, Teneobio, Tesaro, Tocagen, Turning Point, U.T. MD Anderson Cancer Center, Vegenics, Xencor. Xiuning Le: consulting/advisory role at Sanofi Aventis, Merck Sharpe & Dohme, Takeda, Amgen and Boehringer Ingelheim. Santiago Viteri: consulting or advisory role at AbbVie, BMS, Roche, Takeda, AstraZeneca, Merck Sharpe & Dohme; speaker’s bureau fees from BMS, Merck Sharpe & Dohme, Roche, AstraZeneca; travel expenses from Roche, OSE Pharma, BMS, Merck Sharpe & Dohme, Merck Healthcare KGaA, Darmstadt, Germany, Puma Biotechnology and Janssen Cilag. Jo Raskin: advisory role at Pfizer, Eli Lilly; invited speaker at Boehringer Ingelheim, BMS; travel expenses from Roche. Niels Reinmuth: honoraria – scientific meetings (self) and travelling support (self) from BMS, Merck Sharpe & Dohme, AstraZeneca, Roche, Takeda, Boehringer Ingelheim and Pfizer; advisory board honoraria (self) from BMS, Merck Sharpe & Dohme, AstraZeneca, Roche, Takeda, Boehringer Ingelheim and Pfizer; honoraria for advisory and speaker activities from: Amgen, AstraZeneca, Bristol Myers Squibb, Boehringer Ingelheim, Hoffmann-La Roche, Merck Sharpe & Dohme, Merck Healthcare KGaA, Darmstadt, Germany, Pfizer, Sanofi and Takeda. Soetkin Vlassak and Mihaela Militaru: employees of Merck N.V.-S.A., Belgium, an affiliate of Merck KGaA, Darmstadt, Germany. Paul K Paik: advisory or consultancy role at Calithera, Takeda, Xencor, CrownBio, Bicara, Mirati, and EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA; research institution has received research expenses from Bicara, Boehringer Ingelheim and EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA.
Disclaimer
This summary shows the results of a first-in-human study and the VISION study. Other studies may have different findings. The results of many studies are needed to understand how a medicine works. No healthcare decisions should be made based on the results of a single study. If you are a study participant and have any questions regarding the study, please talk to the study doctors at your study center. The VISION study is still ongoing; therefore, the final outcomes of this study may differ from the outcomes described in this summary.
Tepotinib is currently approved for the treatment of advanced/metastatic NSCLC with MET exon 14 skipping in the EU, Japan, United States, Argentina, Australia, Brazil, Canada, Taiwan, Republic of Korea, Singapore, Great Britain, Hong Kong, Israel, Switzerland, India and Malaysia.