在全球 III 期 CheckMate 816 研究中，与单独化疗相比，新辅助纳武单抗联合化疗可显着改善可切除非小细胞肺癌 (NSCLC) 患者的无事件生存期 (EFS) 和病理完全缓解 (pCR)。在这里，我们报告了本研究的中国亚人群的事后探索性疗效、安全性和手术结果。 IB-IIIA 期可切除 NSCLC 成人被随机接受纳武单抗 360 mg 加化疗或单独化疗，每 3 周一次，持续三个周期，然后外科手术。主要终点包括 EFS 和 pCR（均根据盲法独立审查）。 EFS 和 pCR 结果分别来自数据库锁定日期 2022 年 10 月 14 日和 2020 年 9 月 16 日。中国亚群包括 97 名患者（纳武单抗加化疗，44 例；化疗，53 例）。最短随访时间为 38.2 个月时，纳武单抗联合化疗组未达到中位 EFS [95% 置信区间 (CI) 23.4 个月 - 未达到]，化疗组为 13.9 个月（95% CI 8.3-34.3 个月） （风险比 0.47，95% CI 0.25-0.88）。 pCR 率分别为 25.0%（95% CI 13.2% 至 40.3%）和 1.9%（95% CI 0.0% 至 10.1%）（比值比 11.05；95% CI 1.41-86.49）。在 97 名中国患者中，纳武单抗联合化疗组中有 36 名患者 (82%) 和化疗组有 41 名患者 (77%) 接受了根治性手术。接受纳武单抗加化疗的 18/43 名患者（42%）和接受化疗的 22/53 名患者（42%）发生了 3-4 级治疗相关不良事件。与 CheckMate 816、新辅助治疗全球研究人群的结果一致与化疗相比，纳武单抗联合化疗改善了中国亚人群的 EFS 和 pCR，且不影响治疗耐受性或手术的可行性。这些发现支持使用纳武单抗联合化疗作为中国可切除 NSCLC 患者的标准新辅助治疗选择。版权所有 © 2023 作者。由爱思唯尔有限公司出版。保留所有权利。

Neoadjuvant nivolumab plus chemotherapy significantly improved event-free survival (EFS) and pathologic complete response (pCR) versus chemotherapy alone in patients with resectable non-small-cell lung cancer (NSCLC) in the global phase III CheckMate 816 study. Here, we report post hoc exploratory efficacy, safety, and surgical outcomes in the Chinese subpopulation of this study.Adults with stage IB-IIIA resectable NSCLC were randomized to receive nivolumab 360 mg plus chemotherapy or chemotherapy alone every 3 weeks for three cycles followed by surgery. Primary endpoints included EFS and pCR (both per blinded independent review). EFS and pCR results were from 14 October 2022, and 16 September 2020, database locks, respectively.The Chinese subpopulation comprised 97 patients (nivolumab plus chemotherapy, 44; chemotherapy, 53). At 38.2 months of minimum follow-up, median EFS was not reached [95% confidence interval (CI) 23.4 months-not reached] in the nivolumab plus chemotherapy arm and 13.9 months (95% CI 8.3-34.3 months) in the chemotherapy arm (hazard ratio 0.47, 95% CI 0.25-0.88). pCR rates were 25.0% (95% CI 13.2% to 40.3%) and 1.9% (95% CI 0.0% to 10.1%), respectively (odds ratio 11.05; 95% CI 1.41-86.49). Of 97 Chinese patients, 36 (82%) in the nivolumab plus chemotherapy arm and 41 (77%) in the chemotherapy arm underwent definitive surgery. Grade 3-4 treatment-related adverse events occurred in 18/43 patients (42%) treated with nivolumab plus chemotherapy and 22/53 patients (42%) treated with chemotherapy.Consistent with findings in the global study population of CheckMate 816, neoadjuvant nivolumab plus chemotherapy improved EFS and pCR versus chemotherapy in the Chinese subpopulation without impacting treatment tolerability or the feasibility of surgery. These findings support the use of nivolumab plus chemotherapy as a standard neoadjuvant treatment option for Chinese patients with resectable NSCLC.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.