{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T23:29:05Z","timestamp":1789687745188,"version":"4.0.1"},"reference-count":33,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2024,2,25]],"date-time":"2024-02-25T00:00:00Z","timestamp":1708819200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Science"],"published-print":{"date-parts":[[2024,4]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Tepotinib is a highly selective MET tyrosine kinase inhibitor (TKI) that has demonstrated robust and durable clinical activity in patients with <jats:italic>MET<\/jats:italic> exon 14 (<jats:italic>MET<\/jats:italic>ex14) skipping non\u2013small\u2010cell lung cancer (NSCLC). In the Phase II VISION study, patients received oral tepotinib 500\u2009mg once daily. The primary endpoint was an objective response by an independent review committee (IRC) according to RECIST v1.1 criteria. The secondary endpoints included duration of response (DOR), progression\u2010free survival (PFS), overall survival (OS), and safety. Here we report the analysis of the efficacy and safety of tepotinib in all Japanese patients with advanced <jats:italic>MET<\/jats:italic>ex14 skipping NSCLC from VISION (<jats:italic>n<\/jats:italic>\u2009=\u200938) with &gt;18\u2009months' follow\u2010up. The median age of the Japanese patients was 73\u2009years (range 63\u201388), 39.5% of patients were \u226575\u2009years old, 68.4% were male, 55.3% had a history of smoking, 76.3% had adenocarcinoma, and 10.5% of patients had known brain metastases at baseline. Overall, the objective response rate (ORR) was 60.5% (95% confidence interval (CI): 43.4, 76.0) with a median DOR of 18.5\u2009months (95% CI: 8.3, not estimable). ORR in treatment\u2010na\u00efve patients (<jats:italic>n<\/jats:italic>\u2009=\u200918) was 77.8% (95% CI: 52.4, 93.6), and in patients aged \u226575\u2009years (<jats:italic>n<\/jats:italic>\u2009=\u200915), ORR was 73.3% (95% CI: 44.9, 92.2). The most common treatment\u2010related adverse event (AE) with any grade was blood creatinine increase (65.8%), which resolved following tepotinib discontinuation. Other common treatment\u2010related AEs were peripheral edema (60.5%), hypoalbuminemia (34.2%), diarrhea (28.9%), and nausea (15.8%). In summary, tepotinib demonstrated robust and durable clinical activity irrespective of age or therapy line, with a manageable safety profile in Japanese patients with <jats:italic>MET<\/jats:italic>ex14 skipping NSCLC enrolled in VISION.<\/jats:p>","DOI":"10.1111\/cas.16107","type":"journal-article","created":{"date-parts":[[2024,2,25]],"date-time":"2024-02-25T23:06:45Z","timestamp":1708902405000},"page":"1296-1305","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":14,"title":["Long\u2010term experience with tepotinib in Japanese patients with <scp><i>MET<\/i><\/scp> exon 14 skipping <scp>NSCLC<\/scp> from the Phase <scp>II VISION<\/scp> study"],"prefix":"10.1111","volume":"115","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-6576-3349","authenticated-orcid":false,"given":"Masahiro","family":"Morise","sequence":"first","affiliation":[{"name":"Department of Respiratory Medicine Nagoya University Graduate School of Medicine  Nagoya Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5853-1424","authenticated-orcid":false,"given":"Terufumi","family":"Kato","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Kanagawa Cancer Center  Yokohama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shingo","family":"Matsumoto","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology National Cancer Center Hospital East  Kashiwa Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takako","family":"Inoue","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Osaka International Cancer Institute  Osaka Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomohiro","family":"Sakamoto","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine Tottori University Hospital  Yonago City Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Takaaki","family":"Tokito","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Kurume University School of Medicine  Kurume City Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shinji","family":"Atagi","sequence":"additional","affiliation":[{"name":"Health Management Center JCHO Yamatokoriyama Hospital  Yamatokoriyama Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toshiyuki","family":"Kozuki","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology and Medicine National Hospital Organization Shikoku Cancer Center  Matsuyama City Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroaki","family":"Takeoka","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine NHO Kyushu Medical Center  Fukuoka City Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kenichi","family":"Chikamori","sequence":"additional","affiliation":[{"name":"Department of Oncology NHO Yamaguchi \u2010 Ube Medical Center  Ube City Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Naofumi","family":"Shinagawa","sequence":"additional","affiliation":[{"name":"Department of Respiratory Medicine, Faculty of Medicine and Graduate School of Medicine Hokkaido University  Sapporo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Tanaka","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Niigata Cancer Center Hospital  Niigata City Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eisuke","family":"Horii","sequence":"additional","affiliation":[{"name":"Medical Department Merck Biopharma Co., Ltd. (an affiliate of Merck KGaA)  Tokyo Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Svenja","family":"Adrian","sequence":"additional","affiliation":[{"name":"Global Clinical Development Merck Healthcare KGaA  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rolf","family":"Bruns","sequence":"additional","affiliation":[{"name":"Department of Biostatistics Merck Healthcare KGaA  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andreas","family":"Johne","sequence":"additional","affiliation":[{"name":"Global Clinical Development Merck Healthcare KGaA  Darmstadt Germany"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul K.","family":"Paik","sequence":"additional","affiliation":[{"name":"Department of Medicine, Thoracic Oncology Service Memorial Sloan\u2010Kettering Cancer Center  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroshi","family":"Sakai","sequence":"additional","affiliation":[{"name":"Department of Thoracic Oncology Saitama Cancer Center  Kitaadachi\u2010gun Japan"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2024,2,25]]},"reference":[{"key":"e_1_2_12_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2017.04.031"},{"key":"e_1_2_12_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.lungcan.2016.12.001"},{"key":"e_1_2_12_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2016.05.016"},{"key":"e_1_2_12_5_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-22-1749"},{"key":"e_1_2_12_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2015.10.005"},{"key":"e_1_2_12_7_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyab072"},{"key":"e_1_2_12_8_1","doi-asserted-by":"publisher","DOI":"10.1093\/jjco\/hyaa042"},{"key":"e_1_2_12_9_1","doi-asserted-by":"publisher","DOI":"10.1111\/bcp.14807"},{"key":"e_1_2_12_10_1","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa2004407"},{"key":"e_1_2_12_11_1","doi-asserted-by":"publisher","DOI":"10.1158\/1078-0432.CCR-21-2733"},{"key":"e_1_2_12_12_1","doi-asserted-by":"publisher","DOI":"10.1001\/JAMAONCOL.2023.1962"},{"key":"e_1_2_12_13_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jtho.2022.07.024"},{"key":"e_1_2_12_14_1","volume-title":"The 62nd Annual Meeting of the Japan Lung Cancer Society","author":"Kato T","year":"2021"},{"key":"e_1_2_12_15_1","volume-title":"The 63rd Annual Meeting of the Japan Lung Cancer Society","author":"Kato T","year":"2022"},{"key":"e_1_2_12_16_1","unstructured":"KatoT OguraT SatoM et\u00a0al.Post marketing surveillance of Tepotinib (kinase inhibitor for unresectable advanced or recurrent NSCLC with METex14 skipping alterations)_ final analysis. 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