Medical University of Gdańsk, Gdansk, Poland.
European Institute of Oncology, Istituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.
J Thorac Oncol. 2021 Nov;16(11):1872-1882. doi: 10.1016/j.jtho.2021.06.019. Epub 2021 Jul 12.
INTRODUCTION: IMpower110 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. METHODS: This 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). RESULTS: The 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. CONCLUSIONS: Statistical 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.
介绍：IMpower110 此前显示，与化疗相比，在治疗初治 EGFR 和 ALK 阴性（野生型 [WT]）转移性 NSCLC 患者中，肿瘤细胞 [TCs] 上高程序性死亡配体 1（PD-L1）表达 [≥50%（SP142 免疫组化检测）；p = 0.0106] 或肿瘤浸润免疫细胞 [ICs] 上高 PD-L1 表达（≥10%）的患者中，atezolizumab 具有显著的总生存（OS）获益。我们报告了较低 PD-L1 表达组的主要 OS 分析结果，并对高 PD-L1 表达组进行了更新的探索性分析。 方法：这是一项开放标签、III 期试验，将 PD-L1 表达大于或等于 1%的 TC 或 IC 的患者随机分配至 atezolizumab 或铂类化疗组。主要终点为 OS，按 PD-L1 WT 亚组进行分层检验：首先是高 PD-L1 表达亚组，然后是高或中 PD-L1 表达亚组（TC 或 IC 上≥5%），然后是任何 PD-L1 表达亚组（TC 或 IC 上≥1%）。 结果：任何 PD-L1 表达 WT 人群包括 554 例患者（排除 18 例 EGFR 或 ALK 阳性患者）。在额外的 17 个月随访中，高或中 PD-L1 表达 WT 患者（n=328）中，atezolizumab 组与化疗组的 OS 改善无统计学意义（风险比=0.87，95%置信区间：0.66-1.14，p=0.3091；中位值：19.9 与 16.1 mo），因此排除了任何 PD-L1 表达 WT 患者的正式 OS 检验。高 PD-L1 表达 WT 患者（n=205）的探索性分析显示，atezolizumab 组的 OS 获益仍保持（风险比=0.76，95%置信区间：0.54-1.09；中位值：20.2 与 14.7 mo）。更新的安全性数据继续有利于 atezolizumab。 结论：高或中表达 WT 组的 OS 未达到统计学意义，因此，任何 PD-L1 表达 WT 组的 OS 未进行正式检验。未发现新的安全性信号。IMpower110 的这项更新分析支持在高 PD-L1 表达的治疗初治、转移性 WT NSCLC 中使用 atezolizumab。
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