来自 III 期 IMpower010 研究的肿瘤样本用于比较两种程序性死亡配体 1 (PD-L1) 免疫组织化学检测（VENTANA SP263 和 Dako 22C3），以鉴定 PD-L1 患者亚组（阴性、阳性、低表达和高表达） ）以及与最佳支持治疗（BSC）相比，辅助阿特珠单抗在可切除的早期非小细胞肺癌（NSCLC）中的预测价值。PD-L1 表达通过 SP263 测定进行评估，该测定测量肿瘤细胞的百分比任何膜性 PD-L1 染色，以及 22C3 测定，对显示部分或完全膜性 PD-L1 染色的活肿瘤细胞的百分比进行评分。检查 PD-L1 阳性阈值的一致性时（SP263：肿瘤细胞 (TC)） ≥1%；22C3：肿瘤比例评分（TPS）≥1%），83% 样品的检测结果一致。同样，在 PD-L1 高截止值（SP263：TC≥50%；22C3：TPS≥50%）处，92% 的样品的检测结果一致。 atezolizumab 相对于 BSC 的无病生存获益在 PD-L1 阳性检测之间具有可比性（SP263 的 TC≥1%：HR，0.58（95% CI：0.40 至 0.85）与 22C3 的 TPS≥1%：HR， 0.65（95% CI：0.45 至 0.95））和 PD-L1 高（SP263 的 TC≥50%：HR，0.27（95% CI：0.14 至 0.53）与 22C3 的 TPS≥50%：HR，0.31（95 % CI：0.16 至 0.60)) 亚组。SP263 和 22C3 检测显示阿特珠单抗在经过验证的 PD-L1 阈值下具有高度一致性和可比较的临床预测值，表明这两种检测可以识别最有可能受益的早期 NSCLC 患者来自佐剂 atezolizumab.NCT02486718.© 作者（或其雇主）2023。根据 CC BY-NC 允许重复使用。不得商业再利用。请参阅权利和权限。英国医学杂志出版。

Tumor samples from the phase III IMpower010 study were used to compare two programmed death-ligand 1 (PD-L1) immunohistochemistry assays (VENTANA SP263 and Dako 22C3) for identification of PD-L1 patient subgroups (negative, positive, low, and high expression) and their predictive value for adjuvant atezolizumab compared with best supportive care (BSC) in resectable early-stage non-small cell lung cancer (NSCLC).PD-L1 expression was assessed by the SP263 assay, which measured the percentage of tumor cells with any membranous PD-L1 staining, and the 22C3 assay, which scored the percentage of viable tumor cells showing partial or complete membranous PD-L1 staining.When examining the concordance at the PD-L1-positive threshold (SP263: tumor cell (TC)≥1%; 22C3: tumor proportion score (TPS)≥1%), the results were concordant between assays for 83% of the samples. Similarly, at the PD-L1-high cut-off (SP263: TC≥50%; 22C3: TPS≥50%), the results were concordant between assays for 92% of samples. The disease-free survival benefit of atezolizumab over BSC was comparable between assays for PD-L1-positive (TC≥1% by SP263: HR, 0.58 (95% CI: 0.40 to 0.85) vs TPS≥1% by 22C3: HR, 0.65 (95% CI: 0.45 to 0.95)) and PD-L1-high (TC≥50% by SP263: HR, 0.27 (95% CI: 0.14 to 0.53) vs TPS≥50% by 22C3: HR, 0.31 (95% CI: 0.16 to 0.60)) subgroups.The SP263 and 22C3 assays showed high concordance and a comparable clinical predictive value of atezolizumab at validated PD-L1 thresholds, suggesting that both assays can identify patients with early-stage NSCLC most likely to experience benefit from adjuvant atezolizumab.NCT02486718.© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.