在CheckMate 227第1部分（NCT02477826）中，一线应用尼伐替尼加艾匹利莫抗体与化疗相比，不论肿瘤中程序化死配体-1（PD-L1）的表达如何，均表现出长期持久的总生存（OS）益处。我们在接受≥5年随访的日本患者中报告了结果。成人非小细胞肺癌（NSCLC）患者中Stage IV/复发性并且没有EGFR/ALK异常的患者按1:1:1被随机分组为尼伐替尼加艾匹利莫抗体组，尼伐替尼单独组，或化疗（PD-L1≥1%患者），或尼伐替尼加艾匹利莫抗体组，尼伐替尼加化疗组，或化疗（PD-L1<1%患者）。五年期效果和安全性在日本患者中进行评估。在最少随访62.1个月后，143名PD-L1≥1% 或<1%的日本患者被随机分为尼伐替尼加艾匹利莫抗体组（n=66）或化疗组（n=77）。尼伐替尼加艾匹利莫抗体组的五年生存率为46%，而化疗组为34%（PD-L1≥1%）和36%对19%（PD-L1<1%）。反应持续时间中位数为59.1个月对7.1个月（PD-L1≥1%）和17.3个月对3.0个月（PD-L1<1%）。在接受尼伐替尼加艾匹利莫抗体治疗的五年生存者（PD-L1≥1%和<1%；n=27）中，59%（95%CI，39%至75%）的患者在≥3年内没有接受后续治疗。未观察到新的安全信号。在五年随访中，尼伐替尼加艾匹利莫抗体相对于化疗在无论肿瘤PD-L1的表达如何方面持续显示出长期持久的临床益处。与全球人群的发现一致，这些数据支持尼伐替尼加艾匹利莫抗体在日本转移性NSCLC患者中作为一线治疗的使用。©2023。作者（经日本临床肿瘤学会独家授权）

In CheckMate 227 Part 1 (NCT02477826), first-line nivolumab plus ipilimumab demonstrated long-term durable overall survival (OS) benefit versus chemotherapy in patients with metastatic non-small cell lung cancer (NSCLC), regardless of tumor programmed death ligand 1 (PD-L1) expression. We report results in Japanese patients with ≥ 5-year follow-up.Adults with stage IV/recurrent NSCLC without EGFR/ALK aberrations were randomized 1:1:1 to nivolumab plus ipilimumab, nivolumab alone, or chemotherapy (patients with tumor PD-L1 ≥ 1%), or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (patients with tumor PD-L1 < 1%). Five-year efficacy and safety were assessed in Japanese patients.At 62.1 months' minimum follow-up, 143 Japanese patients with PD-L1 ≥ 1% or < 1% were randomized to nivolumab plus ipilimumab (n = 66) or chemotherapy (n = 77). Five-year OS rates were 46% with nivolumab plus ipilimumab versus 34% with chemotherapy (PD-L1 ≥ 1%) and 36% versus 19% (PD-L1 < 1%). Median duration of response was 59.1 versus 7.1 months (PD-L1 ≥ 1%) and 17.3 versus 3.0 months (PD-L1 < 1%). Among 5-year survivors treated with nivolumab plus ipilimumab (PD-L1 ≥ 1% and < 1%; n = 27), 59% (95% CI, 39%-75%) were off treatment for ≥ 3 years without receiving subsequent therapy. No new safety signals were observed.At 5-year follow-up, nivolumab plus ipilimumab continued to show long-term durable clinical benefit versus chemotherapy, regardless of tumor PD-L1 expression. Consistent with findings for the global population, these data support the use of nivolumab plus ipilimumab as first-line treatment in Japanese patients with metastatic NSCLC.© 2023. The Author(s) under exclusive licence to Japan Society of Clinical Oncology.