将免疫肿瘤生物标志物转化为诊断测试：监管视角

Translating Immuno-oncology Biomarkers to Diagnostic Tests: A Regulatory Perspective.

作者信息

Li You, Veeraraghavan Janaki, Philip Reena

机构信息

OHT7/ Office of In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality, Center for Diagnostics and Radiological Health, U.S. Food and Drug Administration, Silver Spring, MD, USA.

出版信息

Methods Mol Biol. 2020;2055:701-716. doi: 10.1007/978-1-4939-9773-2_31.

DOI:10.1007/978-1-4939-9773-2_31

PMID:31502175

Abstract

The rapid development of effective immunotherapy using immune-checkpoint inhibitors (ICIs) against many different cancer types opened a new front in cancer treatment. Immunotherapy is undoubtedly one of the biggest breakthroughs in cancer therapy within the past decade. The identification of predictive biomarkers to select the patients most likely to respond to ICI monotherapies or emerging combination therapies remains one of the major unmet needs for the oncology community.This chapter provides an overview of existing and emerging biomarkers associated with ICI response. Additionally, using several case studies of FDA approved or authorized in vitro diagnostic oncology devices, this chapter also provides an overview of analytical and clinical validation considerations of diagnostic tests for immuno-oncology biomarkers.

摘要

使用免疫检查点抑制剂（ICI）针对多种不同癌症类型的有效免疫疗法的迅速发展，为癌症治疗开辟了新的战线。免疫疗法无疑是过去十年癌症治疗领域最大的突破之一。确定预测性生物标志物以选择最有可能对ICI单药疗法或新兴联合疗法产生反应的患者，仍然是肿瘤学界主要未满足的需求之一。本章概述了与ICI反应相关的现有和新兴生物标志物。此外，通过几个美国食品药品监督管理局（FDA）批准或授权的体外诊断肿瘤学设备的案例研究，本章还概述了免疫肿瘤学生物标志物诊断测试的分析和临床验证考量。