新辅助抗程序性细胞死亡蛋白-1 (PD-1) 疗法在治疗可切除的非小细胞肺癌 (NSCLC) 方面表现出潜力。此前，我们已经报道了该试验的3年临床结果，表明新辅助信迪利单抗单药治疗的有效性和可行性。然而，接受新辅助单一免疫治疗的患者的长期预后尚未阐明。对于IA-IIIB期NSCLC患者，在新辅助治疗中静脉注射两剂信迪利单抗（200mg）。在这些更新的结果中评估了 5 年无事件生存期 (EFS)、无病生存期 (DFS) 和总生存期 (OS)。还探讨了特定生物标志物在新辅助免疫治疗中的预测作用。中位随访时间为61.0个月，接受R0切除的患者的5年DFS和OS率分别为65.7%和80.4%。程序性死亡配体1（PD-L1）阳性表达患者的5年DFS和OS率分别为71.9%和90.9%。 PD-L1 阳性（肿瘤比例评分≥1%）的存在显示出有希望预后的趋势（OS、HR，0.143；95% CI：0.027 至 0.743），特别是对于那些未达到病理完全缓解（pCR）的患者）。此外，肿瘤突变负荷与良好的预后呈正相关。 5 年随访期间共发现 10 例复发和 5 例随后死亡，其中肺转移为主。这些更新的分析首次揭示了新辅助信迪利单抗单药治疗的 5 年生存获益，暗示了其潜在价值PD-1 抑制剂在新辅助治疗中的应用。© 作者（或其雇主）2024。根据 CC BY-NC 允许重复使用。禁止商业再利用。请参阅权利和权限。英国医学杂志出版。

Neoadjuvant anti-programmed cell death protein-1 (PD-1) therapy exhibits potential in treating resectable non-small cell lung cancer (NSCLC). Previously, we have reported the 3-year clinical outcomes of this trial, implying the effectiveness and feasibility of neoadjuvant sintilimab monotherapy. However, the long-term prognosis of patients receiving neoadjuvant mono-immunotherapy has yet to be elucidated.For patients with stage IA-IIIB NSCLC, two doses of sintilimab (200 mg) were administered intravenously in the neoadjuvant setting. The 5-year event-free survival (EFS), disease-free survival (DFS), and overall survival (OS) were assessed in these updated results. The predictive role of specific biomarkers in neoadjuvant immunotherapy was also explored.With a median follow-up of 61.0 months, 5-year DFS and OS rates of patients who underwent R0 resection were 65.7% and 80.4%, respectively. The 5-year DFS and OS rates of patients with positive programmed death-ligand 1 (PD-L1) expression were 71.9% and 90.9%, respectively. The presence of PD-L1 positivity (tumor proportion score ≥1%) showed a tendency toward the promising prognosis (OS, HR, 0.143; 95% CI: 0.027 to 0.743), especially for those who did not achieve pathological complete response (pCR). In addition, tumor mutation burden was positively correlated with a favorable prognosis. A total of 10 recurrences and 5 subsequent deaths were identified within the 5-year follow-up, with lung metastasis being the predominant.These updated analyses were the first to unveil the 5-year survival benefits of neoadjuvant sintilimab monotherapy, implying the potential value of PD-1 inhibitors in neoadjuvant therapy.© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.