Song Lianxi, Zeng Liang, Yan Huan, Xu Qinqin, Xia Qing, Lei Jian, Chen Xiaoyan, Hu Xiaoping, Wang Zhan, Liu Hong, Yang Nong, Zhang Yongchang
Department of Medical Oncology, Lung Cancer and Gastrointestinal Unit, Hunan Cancer Hospital/The Affiliated Cancer Hospital of Xiangya School of Medicine, Central South University, Changsha, 410013, China.
Graduate Collaborative Training Base of Hunan Cancer Hospital, Hengyang Medical School, University of South China, Hengyang, 421001, China.
Commun Med (Lond). 2022 Nov 1;2(1):137. doi: 10.1038/s43856-022-00206-4.
The programmed death-ligand 1 (PD-L1) 22C3 assay is one of the approved companion diagnostic assays for receiving anti-programmed cell death ligand 1 (PD-L1) therapy. Our study evaluated the performance of E1L3N and 22C3 antibodies in estimating PD-L1 expression in non-small cell lung cancer (NSCLC).
Our retrospective study included 46 patients diagnosed with unresectable EGFR/ALK/ROS1-negative NSCLC who received first-line pembrolizumab therapy between 2018 and 2021. PD-L1 immunohistochemistry of baseline tissue biopsy samples was performed using PDL1-E1L3N and PDL1-22C3 antibodies. The concordance between the PD-L1 assays and the treatment outcomes was assessed.
Using a tumor proportion score (TPS) cutoff of ≥1%, 67.4% of patients are evaluated to be positive using PDL1-E1L3N and 73.9% using PDL1-22C3. Using a TPS of ≥50% as the cutoff, 26.1% of patients are positive using PDL1-E1L3N and 30.4% using PDL1-22C3. The PDL1-22C3 and PDL1-E1L3N assays are highly concordant and reveal a correlation coefficient of 0.925 (p < 0.0001). Patients with PDL1-E1L3N TPS > 50% have a significantly higher objective response rate than patients with PDL1-E1L3N TPS < 1% (p = 0.047), with a similar trend observed for PDL1-22C3 (p = 0.051). Consistent with PDL1-22C3, patients with higher PDL1-E1L3N expression (≥50%, 1-49%) have longer progression-free survival than those with PDL1-E1L3N TPS < 1%.
Our study provides clinical evidence on the concordance of PD-L1 TPS scores between clones E1L3N and 22C3. Moreover, the treatment responses to pembrolizumab are also comparable between the PDL1-E1L3N and PDL1-22C3. These findings indicate that E1L3N is a reliable and cost-effective assay and may serve as an alternative to 22C3.
程序性死亡配体1（PD-L1）22C3检测是获批用于接受抗程序性细胞死亡配体1（PD-L1）治疗的伴随诊断检测方法之一。我们的研究评估了E1L3N和22C3抗体在评估非小细胞肺癌（NSCLC）中PD-L1表达的性能。
我们的回顾性研究纳入了46例在2018年至2021年间被诊断为不可切除的表皮生长因子受体（EGFR）/间变性淋巴瘤激酶（ALK）/ROS1阴性NSCLC且接受一线帕博利珠单抗治疗的患者。使用PDL1-E1L3N和PDL1-22C3抗体对基线组织活检样本进行PD-L1免疫组化。评估PD-L1检测与治疗结果之间的一致性。
使用肿瘤比例评分（TPS）临界值≥1%时，使用PDL1-E1L3N评估为阳性的患者占67.4%，使用PDL1-22C3评估为阳性的患者占73.9%。以TPS≥50%为临界值时，使用PDL1-E1L3N评估为阳性的患者占26.1%，使用PDL1-22C3评估为阳性的患者占30.4%。PDL1-22C3和PDL1-E1L3N检测高度一致，相关系数为0.925（p<0.0001）。PDL1-E1L3N TPS>50%的患者客观缓解率显著高于PDL1-E1L3N TPS<1%的患者（p=0.047），PDL1-22C3也观察到类似趋势（p=0.051）。与PDL1-22C3一致，PDL1-E1L3N表达较高（≥50%，1-49%）的患者无进展生存期长于PDL1-E1L3N TPS<1%的患者。
我们的研究提供了关于克隆E1L3N和22C3之间PD-L1 TPS评分一致性的临床证据。此外，PDL1-E1L3N和PDL1-22C3对帕博利珠单抗的治疗反应也具有可比性。这些发现表明E1L3N是一种可靠且具有成本效益的检测方法，可作为22C3的替代方法。
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