{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,1]],"date-time":"2026-08-01T01:51:44Z","timestamp":1785549104903,"version":"3.56.0"},"reference-count":26,"publisher":"Springer Science and Business Media LLC","issue":"4","license":[{"start":{"date-parts":[[2025,2,7]],"date-time":"2025-02-07T00:00:00Z","timestamp":1738886400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2025,2,7]],"date-time":"2025-02-07T00:00:00Z","timestamp":1738886400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","award":["honoraria"],"award-info":[{"award-number":["honoraria"]}],"id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100013170","name":"Ono Pharmaceutical","doi-asserted-by":"publisher","award":["honoraria"],"award-info":[{"award-number":["honoraria"]}],"id":[{"id":"10.13039\/501100013170","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Bristol Myers Squibb","award":["research funding"],"award-info":[{"award-number":["research funding"]}]},{"DOI":"10.13039\/100030831","name":"Novartis Pharma K.K","doi-asserted-by":"crossref","award":["research funding"],"award-info":[{"award-number":["research funding"]}],"id":[{"id":"10.13039\/100030831","id-type":"DOI","asserted-by":"crossref"}]},{"name":"GSK","award":["research funding"],"award-info":[{"award-number":["research funding"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Int J Clin Oncol"],"published-print":{"date-parts":[[2025,4]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Background<\/jats:title>\n            <jats:p>A BRAF inhibitor, encorafenib, combined with a MEK inhibitor, binimetinib, was approved in Japan in early 2019 for the treatment of <jats:italic>BRAF<\/jats:italic> V600-mutant, unresectable malignant melanoma based on results of the global phase III trial, COLUMBUS, conducted in various countries including Japan. This post-marketing surveillance (PMS) assessed the combination in real-world clinical practice in Japan.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>We performed a prospective, multicentre, 12-month PMS of the safety and effectiveness of encorafenib plus binimetinib for radically unresectable, <jats:italic>BRAF<\/jats:italic>-mutant malignant melanoma in Japan.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>Among 174 survey forms collected from 85 centres between February 2019 and August 2020, 172 were included for safety and effectiveness analysis. Patients (male [52.3%], median age 62.0\u00a0years) had Eastern Cooperative Oncology Group Performance Status 0 or 1 (91.8%) and comorbidities (55.2%). Respective encorafenib and binimetinib median dosages were 450\u00a0mg\/day and 90\u00a0mg\/day; median treatment duration, 24.1 and 24.2\u00a0weeks, and discontinuation, 71.5% for each, primarily for disease progression (56.9%) and adverse drug reactions (ADRs, 38.2%). Safety assessment ADRs occurred in 99 patients (57.6%), including eye disorders (40.7%), hepatic dysfunction (20.3%), rhabdomyolysis (4.7%), haemorrhage (2.3%), palmar-plantar erythrodysaesthesia syndrome (1.7%), and hypertension (1.7%); 19.8% were grade\u2009\u2265\u20093, none were grade 5, most resolved with\/without treatment modification. At 12\u00a0months, the objective response rate was 48.8% (95% CI 41.2, 56.6; complete [19.2%], partial [29.7%]), overall survival was 40.1%.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusion<\/jats:title>\n            <jats:p>The safety and effectiveness of encorafenib plus binimetinib in Japanese patients with <jats:italic>BRAF<\/jats:italic>-mutant malignant melanoma were similar to data reported in COLUMBUS; no new safety concerns were identified.<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s10147-025-02693-6","type":"journal-article","created":{"date-parts":[[2025,2,7]],"date-time":"2025-02-07T15:50:08Z","timestamp":1738943408000},"page":"814-823","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Post-marketing surveillance of encorafenib in combination with binimetinib in Japanese patients with BRAF-mutant melanoma"],"prefix":"10.1007","volume":"30","author":[{"given":"Naoya","family":"Yamazaki","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hidenori","family":"Sakata","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Osamu","family":"Iida","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teruaki","family":"Katayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-5391-3397","authenticated-orcid":false,"given":"Hisashi","family":"Uhara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,7]]},"reference":[{"key":"2693_CR1","doi-asserted-by":"crossref","first-page":"495","DOI":"10.1001\/jamadermatol.2022.0160","volume":"158","author":"M Arnold","year":"2022","unstructured":"Arnold M, Singh D, Laversanne M et al (2022) Global burden of cutaneous melanoma in 2020 and projections to 2040. 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HS, OI and TK are employees of Ono Pharmaceutical Co., Ltd., HU has received honoraria from Ono Pharmaceutical Co., Ltd.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}}]}}