Supplemental Digital Content is available in the text. Since 2014, programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) checkpoint inhibitors have been approved by various regulatory agencies for the treatment of multiple cancers including melanoma, lung cancer, urothelial carcinoma, renal cell carcinoma, head and neck cancer, classical Hodgkin lymphoma, colorectal cancer, gastroesophageal cancer, hepatocellular cancer, and other solid tumors. Of these approved drug/disease combinations, a subset also has regulatory agency-approved, commercially available companion/complementary diagnostic assays that were clinically validated using data from their corresponding clinical trials. The objective of this document is to provide evidence-based guidance to assist clinical laboratories in establishing fit-for-purpose PD-L1 biomarker assays that can accurately identify patients with specific tumor types who may respond to specific approved immuno-oncology therapies targeting the PD-1/PD-L1 checkpoint. These recommendations are issued as 38 Guideline Statements that address (i) assay development for surgical pathology and cytopathology specimens, (ii) reporting elements, and (iii) quality assurance (including validation/verification, internal quality assurance, and external quality assurance). The intent of this work is to provide recommendations that are relevant to any tumor type, are universally applicable and can be implemented by any clinical immunohistochemistry laboratory performing predictive PD-L1 immunohistochemistry testing.

中文翻译：

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适用于免疫肿瘤学患者选择的 PD-L1 生物标记物测试


文本中提供了补充数字内容。自2014年以来，程序性细胞死亡蛋白1（PD-1）/程序性细胞死亡配体1（PD-L1）检查点抑制剂已被多个监管机构批准用于治疗多种癌症，包括黑色素瘤、肺癌、尿路上皮癌、肾细胞癌等。癌、头颈癌、经典霍奇金淋巴瘤、结直肠癌、胃食管癌、肝细胞癌和其他实体瘤。在这些批准的药物/疾病组合中，一部分还具有监管机构批准的、市售的伴随/补充诊断检测方法，这些检测方法使用相应临床试验的数据进行了临床验证。本文件的目的是提供基于证据的指导，协助临床实验室建立适合目的的 PD-L1 生物标志物测定，从而准确识别可能对特定已批准的针对 PD 的免疫肿瘤疗法产生反应的特定肿瘤类型患者-1/PD-L1 检查点。这些建议以 38 项指南声明的形式发布，涉及 (i) 外科病理学和细胞病理学标本的检测开发，(ii) 报告要素，以及 (iii) 质量保证（包括验证/验证、内部质量保证和外部质量保证）。这项工作的目的是提供与任何肿瘤类型相关、普遍适用且可由任何进行预测性 PD-L1 免疫组织化学检测的临床免疫组织化学实验室实施的建议。