Perioperative tislelizumab plus neoadjuvant chemotherapy for patients with resectable non-small-cell lung cancer: final analysis of the randomized RATIONALE-315 trial

作者：Chong Wang, Yang Wang, Hongrui Liu, Qi Chen, Chao Chen, Hong Li, Peng Zhang, Guohua Zhao, Fan Yang, Guorong Han, Bentong Yu, Yue Yang, Hao Chen, Jie Jiang, Lijie Tan, Shuangbing Xu, Ning Mao, Jian Hu, Li Zhang, Zhigang Zhang, Bo Yao, Shuxiao Wang, Shiang Jiin Leaw, K. Naicker, Wenxin Zheng, Changyuan Yu, Dongsheng Yue · 发表于：Annals of Oncology · 年份：2025 · DOI：10.1016/j.annonc.2025.11.017 · 被引用次数：12 · 研究领域：Cancer Immunotherapy and Biomarkers、Lung Cancer Diagnosis and Treatment、Lung Cancer Treatments and Mutations

BACKGROUND: Perioperative immunotherapy, particularly anti-programmed cell death protein 1 therapy, combined with neoadjuvant chemotherapy has emerged as one of the standard-of-care options for resectable non-small-cell lung cancer (NSCLC). We report the final analysis of RATIONALE-315, a randomized, double-blind, phase III trial evaluating the efficacy and safety of perioperative tislelizumab plus neoadjuvant chemotherapy versus neoadjuvant chemotherapy alone in patients with resectable, stage II-IIIA NSCLC. PATIENTS AND METHODS: Adult patients in China were randomized (1 : 1) to receive either perioperative tislelizumab or placebo in combination with neoadjuvant chemotherapy. The dual primary endpoints were event-free survival (EFS) and major pathological response, assessed by blinded independent central review. The secondary endpoints included pathological complete response, overall survival (OS), disease-free survival, and safety. RESULTS: In total, 453 patients were randomized (226 to tislelizumab and 227 to placebo). At the final analysis (median study follow-up of 38.5 months), patients in the tislelizumab group experienced statistically significantly improved OS versus those in the placebo group {hazard ratio (HR) 0.65 [95% confidence interval (CI) 0.45-0.93]; P = 0.009}. The median OS was not reached in either group. The 36-month OS rate was 79.3% in the tislelizumab group versus 69.3% in the placebo group. The median EFS was not reached in the tislelizumab group ver...