BACKGROUND Nivolumab plus ipilimumab or nivolumab alone resulted in longer progression-free and overall survival than ipilimumab alone in a trial involving patients with advanced melanoma. We now report 5-year outcomes in the trial. METHODS We randomly assigned patients with previously untreated advanced melanoma to receive one of the following regimens: nivolumab (at a dose of 1 mg per kilogram of body weight) plus ipilimumab (3 mg per kilogram) every 3 weeks for four doses, followed by nivolumab (3 mg per kilogram every 2 weeks); nivolumab (3 mg per kilogram every 2 weeks) plus ipilimumab-matched placebo; or ipilimumab (3 mg per kilogram every 3 weeks for four doses) plus nivolumab-matched placebo. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group, as compared with the ipilimumab group. RESULTS At a minimum follow-up of 60 months, the median overall survival was more than 60.0 months (median not reached) in the nivolumab-plus-ipilimumab group and 36.9 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.52; hazard ratio for death with nivolumab vs. ipilimumab, 0.63). Overall survival at 5 years was 52% in the nivolumab-plus-ipilimumab group and 44% in the nivolumab group, as compared with 26% in the ipilimumab group. No sustained deterioration of health-related quality of life was observed during or after treatment with nivolumab plus ipilimumab or with nivolumab alone. No new late toxic effects were noted. CONCLUSIONS Among patients with advanced melanoma, sustained long-term overall survival at 5 years was observed in a greater percentage of patients who received nivolumab plus ipilimumab or nivolumab alone than in those who received ipilimumab alone, with no apparent loss of quality of life in the patients who received regimens containing nivolumab. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505.).

中文翻译：

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Nivolumab和Ipilimumab联合治疗晚期黑色素瘤的五年生存期。

背景在一项涉及晚期黑色素瘤患者的试验中，与单独使用ipilimumab相比，与单独使用ipilimumab相比，Nivolumab加ipilimumab或单独使用nivolumab导致更长的无进展生存期和总体生存期。现在，我们在试验中报告了5年的结果。方法我们随机分配先前未接受治疗的晚期黑色素瘤患者接受以下治疗方案之一：每3周一次nvolumab（以每千克体重1 mg的剂量）加ipilimumab（每千克体重3 mg），共四剂，然后是nivolumab （每2周每公斤3毫克）；尼古鲁单抗（每2周每公斤3毫克）加依匹莫单抗匹配的安慰剂；或ipilimumab（每3周每公斤3毫克，共4剂）加上nivolumab匹配的安慰剂。这两个主要终点是nivolumab-plus-ipilimumab组和nivolumab组的无进展生存期和总生存期，与伊匹木单抗组相比。结果在至少60个月的随访中，nivolumab加ipilimumab组的中位总生存期超过60.0个月（中位数未达到），nivolumab组的中位总生存期超过36.9个月，而ipilimumab组的中位总生存期为19.9个月（尼古鲁单抗加依普利单抗与依普利单抗的死亡危险比为0.52；尼古鲁单抗与依普利珠单抗有关的死亡的危险比为0.63）。尼古鲁单抗联合依匹莫单抗组5年总生存率为52％，尼古鲁单抗组为44％，依普利单抗组为26％。在使用nivolumab加ipilimumab或单独使用nivolumab治疗期间或之后，未观察到健康相关生活质量的持续恶化。没有发现新的晚期毒性作用。结论在晚期黑色素瘤患者中，与单独接受伊匹单抗的患者相比，接受尼武单抗加伊匹木单抗或尼武单抗的患者中观察到的5年持续长期总体生存率更高，并且接受含尼武单抗方案的患者的生活质量没有明显下降。（由Bristol-Myers Squibb等人资助； CheckMate 067 ClinicalTrials.gov编号，NCT01844505。）。