一线纳武利尤单抗联合伊匹单抗治疗晚期 NSCLC：CheckMate 227 亚组分析在亚洲患者中的结果。
First-line nivolumab + ipilimumab in advanced NSCLC: CheckMate 227 subpopulation analyses in Asian patients.
机构信息
Princess Alexandra Hospital and Queensland University of Technology, Brisbane, Australia.
Chungbuk National University Hospital, Cheongju-si, Republic of Korea.
出版信息
ESMO Open. 2022 Feb;7(1):100394. doi: 10.1016/j.esmoop.2022.100394. Epub 2022 Feb 12.
BACKGROUND
Nivolumab plus ipilimumab demonstrated clinically meaningful improvement in efficacy versus chemotherapy with a manageable safety profile in patients with advanced non-small cell lung cancer (NSCLC) and tumor programmed death-ligand 1 (PD-L1) expression ≥1% or <1% in Part 1 of CheckMate 227. Here we report efficacy and safety results for the Asian subpopulation.
METHODS
Patients with stage IV/recurrent NSCLC were randomized 1 : 1 : 1 to nivolumab plus ipilimumab, nivolumab monotherapy, or chemotherapy (PD-L1 ≥1%) or nivolumab plus ipilimumab, nivolumab plus chemotherapy, or chemotherapy (PD-L1 <1%). Overall survival (OS), progression-free survival, objective response rate, duration of response, and safety were evaluated among patients in Japan, South Korea, and Taiwan.
RESULTS
In the Asian subpopulation with PD-L1 ≥1%, 81 patients received nivolumab plus ipilimumab and 81 received chemotherapy. Median OS was not reached with nivolumab plus ipilimumab versus 24.8 months with chemotherapy; 3-year OS rate was 53% versus 37% [hazard ratio (HR), 0.72; 95% confidence interval (CI) 0.47-1.11]. The 3-year progression-free survival rate was 26% versus 7% (HR, 0.65; 95% CI 0.45-0.96), objective response rate was 56% versus 37%, and median duration of response was 29.0 months (95% CI 15.0 months-not reached) versus 6.9 months (95% CI 3.9-11.1 months). Similar results were observed regardless of tumor PD-L1 expression and in Japanese patients. Grade 3-4 treatment-related adverse events occurred in 40% of patients receiving nivolumab plus ipilimumab and 36% receiving chemotherapy, in the overall Asian subpopulation (tumor PD-L1 expression ≥1% and <1%); no new safety signals were identified.
CONCLUSIONS
At 3-year follow-up, nivolumab plus ipilimumab provided durable long-term efficacy benefits versus chemotherapy regardless of tumor PD-L1 expression in the Asian subpopulation, including Japanese patients. Consistent with findings for all randomized patients, these data support the use of nivolumab plus ipilimumab as first-line treatment of Asian patients with advanced NSCLC.
背景
纳武利尤单抗联合伊匹单抗在晚期非小细胞肺癌（NSCLC）患者中表现出优于化疗的临床疗效改善，且安全性可管理，这些患者的肿瘤程序性死亡配体 1（PD-L1）表达≥1%或<1%，这在 CheckMate 227 研究的第 1 部分中得到证实。在此，我们报告了亚洲亚组人群的疗效和安全性结果。
方法
在这项研究中，患者按照 1:1:1 的比例随机分配，分别接受纳武利尤单抗联合伊匹单抗、纳武利尤单抗单药或化疗（PD-L1≥1%）或纳武利尤单抗联合伊匹单抗、纳武利尤单抗联合化疗或化疗（PD-L1<1%）。在日本、韩国和中国台湾地区的患者中评估了总生存期（OS）、无进展生存期、客观缓解率、缓解持续时间和安全性。
结果
在 PD-L1≥1%的亚洲亚组中，81 例患者接受纳武利尤单抗联合伊匹单抗治疗，81 例患者接受化疗。纳武利尤单抗联合伊匹单抗组的中位 OS 尚未达到，而化疗组为 24.8 个月；3 年 OS 率为 53%，而化疗组为 37%[风险比（HR），0.72；95%置信区间（CI）0.47-1.11]。3 年无进展生存率为 26%，而化疗组为 7%（HR，0.65；95%CI 0.45-0.96），客观缓解率为 56%，而化疗组为 37%，中位缓解持续时间为 29.0 个月（95%CI 15.0 个月-无进展），而化疗组为 6.9 个月（95%CI 3.9-11.1 个月）。无论肿瘤 PD-L1 表达如何，在日本患者中均观察到类似的结果。在整个亚洲亚组（肿瘤 PD-L1 表达≥1%和<1%）中，纳武利尤单抗联合伊匹单抗治疗组和化疗组的患者发生 3-4 级治疗相关不良事件的比例分别为 40%和 36%。未发现新的安全性信号。
结论
在 3 年随访时，纳武利尤单抗联合伊匹单抗在亚洲亚组患者中，无论肿瘤 PD-L1 表达如何，均提供了持久的长期疗效获益，包括日本患者。与所有随机患者的结果一致，这些数据支持将纳武利尤单抗联合伊匹单抗作为晚期 NSCLC 亚洲患者的一线治疗。
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