Five-Year Survival Outcomes With Atezolizumab After Chemotherapy in Resected Stage IB-IIIA Non–Small Cell Lung Cancer (IMpower010): An Open-Label, Randomized, Phase III Trial

作者：Enriqueta Felip, Nasser K. Altorki, Caicun Zhou, Eric Vallières, Tibor Csőszi, Ihor Vynnychenko, Oleksandr Goloborodko, Achim Rittmeyer, Martin Reck, Alex Martínez‐Martí, Hirotsugu Kenmotsu, Yuh-Min Chen, Antonio Chella, Shunichi Sugawara, Chenqi Fu, Marcus Ballinger, Yu Deng, Minu K. Srivastava, Elizabeth L. Bennett, Barbara J. Gitlitz, Heather A. Wakelee, on behalf of the IMpower010 Study Investigators · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco-24-01681 · 被引用次数：44 · 研究领域：Cancer Immunotherapy and Biomarkers、Peptidase Inhibition and Analysis、Lung Cancer Treatments and Mutations

IMpower010 (ClinicalTrials.gov identifier: NCT02486718 ) previously showed that atezolizumab improved disease-free survival (DFS) versus best supportive care (BSC) after adjuvant chemotherapy in patients with resected non–small cell lung cancer (NSCLC). We report DFS final analysis, second overall survival (OS) interim analysis, and safety with a ≥5-year follow-up. Patients with completely resected stage IB-IIIA NSCLC were randomly assigned to atezolizumab (1,200 mg once every 3 weeks, 16 cycles) or BSC after platinum-based chemotherapy. At clinical cutoff (January 26, 2024), stratified hazard ratios (HRs; 95% CI) for DFS were 0.85 (95% CI, 0.71 to 1.01; P = .07) in the intention-to-treat (n = 1,005), 0.83 (95% CI, 0.69 to 1.00) in the all-randomized stage II-IIIA (n = 882), and 0.70 (95% CI, 0.55 to 0.91) in stage II-IIIA PD-L1 tumor cell (TC) ≥1% (n = 476) populations. Stratified HRs (95% CI) for OS were 0.97 (95% CI, 0.78 to 1.22), 0.94 (95% CI, 0.75 to 1.19), and 0.77 (95% CI, 0.56 to 1.06), respectively. The unstratified HRs (95% CI) in the stage II-IIIA PD-L1 TC ≥50% population (n = 229) were 0.48 (95% CI, 0.32 to 0.72) for DFS and 0.47 (95% CI, 0.28 to 0.77) for OS, and the unstratified HRs in the stage II-IIIA PD-L1 TC ≥50% without EGFR / ALK alterations (n = 209) population were 0.49 (95% CI, 0.32 to 0.75) and 0.44 (95% CI, 0.26 to 0.74). No new safety signals were reported. IMpower010 is the first study to report survival outcomes with a ≥5-year follow-up and contin...