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伴随性诊断和针对HER2的抗体-药物联合体

Jan Trøst Jørgensen¹, Kristian Egebjerg²

¹Medical Science, Dx-Rx Institute, Fredensborg, Denmark.

Expert review of molecular diagnostics

|November 7, 2025

概括

高HER2表达显著改善了治疗HER2向抗体-药物合物 (ADCs) 的患者的结果. 免疫组织化学 (IHC) 建议作为患者选择的主要伴随诊断 (CDx) 试验.

科学领域:

在瘤学瘤学.
药理学药理学是指药理学的学科.
诊断诊断诊断诊断

背景情况:

针对HER2的抗体-药物联合体 (ADC) 在治疗表达HER2的固体瘤方面显示出显著的前景.
抗药剂的有效性取决于诸如抗体特征,链接技术,有效载荷强度,药物与抗体的比率以及向抗原表达水平等因素.

研究的目的:

本综述侧重于向抗原表达和伴随诊断 (CDx) 试验在患者选择HER2向ADCs中的作用.
它评估了FDA批准的HER2向抗药剂 (trastuzumab emtansine和trastuzumab deruxtecan) 的关键试验,以评估与HER2表达水平相关的疗效数据.
此外,还评估了目前FDA批准的HER2 CDx测定对患者资格的临床实用性.

主要方法:

对特拉斯图祖马布埃姆坦辛 (T-DM1) 和特拉斯图祖马布德鲁克斯坦 (T-DXd) 的关键临床试验的文献综述.
对试验数据的分析,以将HER2表达水平与治疗疗效结果相关联.
评估目前FDA批准的HER2伴侣诊断试验的性能和临床效用.

主要成果:

高HER2表达 (IHC 3+) 与各种固体瘤中T-DM1和T-DXd的增强疗效密切相关.
目前的证据支持使用免疫组织化学 (IHC) 作为选择患者接受HER2向ADC治疗的首要CDx测定.
这与作用机制一致,在这种情况下,更高的HER2密度会增强受体介导的内细胞分裂.

结论:

免疫组织化学 (IHC) 是推的首要伴随诊断 (CDx) 试验,用于在HER2向ADC治疗中选择患者.
高HER2表达是治疗T-DM1和T-DXd等ADC的成功的一个关键决定因素.
通过准确的HER2评估优化患者选择对于最大限度地提高固体瘤中ADC疗效至关重要.

关键词:

伴随诊断系统是指伴随诊断系统.在HER2中,HER2是HER2.抗体 - 药物联合体免疫组织化学免疫组织化学特拉斯图祖马布可以脱.特拉斯图祖马布 (Trastuzumab) 是一种素.

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