阿替唑单抗
医学
危险系数
肿瘤科
PD-L1
内科学
免疫组织化学
置信区间
化疗
子群分析
人口
肺癌
免疫疗法
癌症
彭布罗利珠单抗
环境卫生
作者
Jacek Jassem,Filippo de Marinis,Giuseppe Giaccone,A. Vergnenègre,Carlos H. Barrios,Masahiro Morise,Enriqueta Felip,Cristina Oprean,Young‐Chul Kim,Zoran Andrić,Simonetta Mocci,Ida Enquist,Kimberly M. Komatsubara,Mark L. McCleland,Hiroshi Kuriki,Monette Villalobos,See Phan,David R. Spigel,Roy S. Herbst
标识
DOI:10.1016/j.jtho.2021.06.019
摘要
IntroductionIMpower110 previously revealed significant overall survival (OS) benefit with atezolizumab versus chemotherapy in patients with treatment-naive EGFR- and ALK-negative (wild type [WT]) metastatic NSCLC with high programmed death-ligand 1 (PD-L1) expression (≥50% on tumor cells [TCs] or ≥10% on tumor-infiltrating immune cells [ICs], per SP142 immunohistochemistry assay; p = 0.0106). We present primary OS analyses in lower PD-L1 expression groups and an updated, exploratory analysis in the high PD-L1 expression group.MethodsThis open-label, phase 3 trial randomized patients with PD-L1 expression on greater than or equal to 1% of TC or IC to receive atezolizumab or platinum-based chemotherapy. The primary end point was OS, hierarchically tested in PD-L1 expression WT subgroups: first the high PD-L1 expression subgroup, then the high-or-intermediate PD-L1 expression subgroup (≥5% on TC or IC), and then the any PD-L1 expression subgroup (≥1% on TC or IC).ResultsThe any PD-L1 expression WT population included 554 patients (excluded 18 EGFR- or ALK-positive patients). With 17 months’ additional follow-up, OS improvement in the atezolizumab versus chemotherapy arm was not statistically significant in high-or-intermediate PD-L1 expression WT patients (n = 328; hazard ratio = 0.87, 95% confidence interval: 0.66–1.14, p = 0.3091; median = 19.9 versus 16.1 mo), precluding formal OS testing in any PD-L1 expression WT patients. Exploratory analysis in high PD-L1 expression WT patients (n = 205) revealed maintained OS benefit in the atezolizumab arm (hazard ratio = 0.76, 95% confidence interval: 0.54–1.09; median = 20.2 versus 14.7 mo). Updated safety data continued to favor atezolizumab.ConclusionsStatistical significance for OS was not revealed in the high-or-intermediate expression WT group, and, as a result, OS in the any PD-L1 expression WT group was not formally tested. No new safety signals were found. This updated analysis of IMpower110 supports using atezolizumab in treatment-naive, metastatic WT NSCLC with high PD-L1 expression.
科研通智能强力驱动
Strongly Powered by AbleSci AI