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The overall response rate was 24%; complete response (CR), 6%; partial response, 18%. The response rates were 33.3% in the systemic therapy\u2010na\u00efve and 15.4% in the prior\u2010treatment groups, and 16.1% for patients who were treated with first\u2010line anti\u2010programmed death 1 antibody monotherapy followed by second\u2010line N\u2009+\u2009I therapy after progression of the disease. The response rate for cutaneous melanoma was 32.7%, and 47.8% in the na\u00efve group. Response rates for non\u2010acral, acral, and mucosal melanoma were 34.9%, 25%, and 16.7%, respectively. The median progression\u2010free survival (PFS) for all patients was 3.25\u2009months (6.5 and 2.5\u00a0months in the na\u00efve and prior\u2010treatment groups, respectively). Median overall survival (OS) was 14.5\u00a0months (25.25 and 7.5\u00a0months in the na\u00efve and prior\u2010treatment groups, respectively). There were no significant differences in PFS or OS for patients with non\u2010acral, acral, or mucosal melanoma. The 3\u2010year PFS and OS were both 100% in patients who achieved CR with combination therapy. Adverse events occurred in 89% and were grade three or higher in 56% of cases. Although direct comparisons cannot be made due to different patient backgrounds, N\u2009+\u2009I combination therapy in Japanese patients in clinical practice tended to be inferior when compared to global study and non\u2010Asian patients in clinical practice. The highest response rate was in the cutaneous melanoma therapy\u2010na\u00efve group. The best tumor response was associated with survival outcome, and the PFS and OS were good in cases where CR was obtained. The proportion of grade three and four adverse events was as high as that in the global study.<\/jats:p>","DOI":"10.1111\/1346-8138.16669","type":"journal-article","created":{"date-parts":[[2022,12,14]],"date-time":"2022-12-14T07:17:24Z","timestamp":1671002244000},"page":"525-535","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":23,"title":["Updated analysis of nivolumab and ipilimumab combination therapy in Japanese patients with advanced melanoma"],"prefix":"10.1111","volume":"50","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9304-7590","authenticated-orcid":false,"given":"Akira","family":"Takahashi","sequence":"first","affiliation":[{"name":"Department of Dermatologic Oncology National Cancer Center Hospital East  Chiba Japan"},{"name":"Department of Dermatologic Oncology National Cancer Center Hospital  Tokyo 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