ABSTRACT

Introduction: Development within molecular medicine has given us an increased understanding of the pathophysiology of malignant diseases. This understanding has been the key to a development of a number of new effective target-specific drugs, including the PD-1/PD-L1 checkpoint inhibitors.

Areas covered: This review will focus on the clinical validation and utility of the commercially available IHC PD-L1 expression assays linked to the different PD-1/PD-L1 checkpoint inhibitors indicated for treatment of NSCLC. For the discussion of this subject, mainly data from studies where the PD-1/PD-L1 checkpoint inhibitors have been given as monotherapy will be reported.

Expert opinion: Although PD-L1 expression is not the perfect biomarker; the different IHC PD-L1 expression assays have had major impact on the clinical development of PD-1/PD-L1 checkpoint inhibitors for treatment of NSCLC. A number of clinical studies in NSCLC have shown that the efficacy of the PD-1/PD-L1 checkpoint inhibitors are positively correlated to the level of PD-L1 expression. Based on studies presented in this review, the recommendation is that monotherapy should mainly be used for treatment of NSCLC patients with a high PD-L1 expression, as defined by the cutoff values for the individual assays linked to the specific PD-1/PD-L1 checkpoint inhibitor.

摘要

简介：分子医学的发展使我们对恶性疾病的病理生理学有了更多的了解。这种认识一直是开发许多新的有效靶向特异性药物的关键，包括 PD-1/PD-L1 检查点抑制剂。

涵盖的领域：本综述将重点关注与用于治疗 NSCLC 的不同 PD-1/PD-L1 检查点抑制剂相关的市售 IHC PD-L1 表达测定的临床验证和实用性。对于该主题的讨论，将主要报告 PD-1/PD-L1 检查点抑制剂作为单一疗法的研究数据。

专家意见：虽然PD-L1表达不是完美的生物标志物；不同的 IHC PD-L1 表达测定对 PD-1/PD-L1 检查点抑制剂治疗 NSCLC 的临床开发产生了重大影响。多项针对 NSCLC 的临床研究表明，PD-1/PD-L1 检查点抑制剂的疗效与 PD-L1 表达水平呈正相关。根据本综述中提出的研究，建议单一疗法应主要用于治疗具有高 PD-L1 表达的 NSCLC 患者，如与特定 PD-1/PD- 相关的单个检测的临界值所定义L1 检查点抑制剂。