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快速整体生物标记程序的合理性和可行性,以告知免疫瘤学临床试验:ADVISE试验

Jason J Luke¹, Katherine Bever², F Stephen Hodi³

¹UPMC, Pittsburgh, Pennsylvania, USA lukejj@upmc.edu.

Journal for immunotherapy of cancer

|May 19, 2025

概括

生物标志物适应免疫瘤学 (I-O) 治疗选择是可行的,但开发PD-1耐火性癌症的新生物标志物仍然具有挑战性. 在12天内,ADVISE试验成功地将大多数患者分配给I-O组合.

科学领域:

在瘤学瘤学.
免疫治疗是一种免疫疗法.
临床试验临床试验

背景情况:

在ADVISE (ADaptiVe生物标志物试验,以告知治疗的演变) 试验 (NCT03335540) 调查了生物标志物适应的方法,用于组合免疫瘤学 (I-O) 治疗选择.
免疫组织化学 (IHC) 用于评估瘤组织中的各种生物标志物,以指导治疗决策.

研究的目的:

评估生物标志物驱动战略的可行性,以选择组合I-O疗法.
建立基于患者活检结果的IO治疗选择算法.

主要方法:

在瘤样本上进行信使RNA表达分析和IHC,以评估IO相关基因和蛋白质表达.
根据他们的生物标志物概况,患者被分配到特定的I-O组合疗法.
主要终点是成功完成在12个工作日内进行生物标志物分析以分配治疗.

主要成果:

相关性分析揭示了PD-1/L1和其他IO基因之间的各种关联,在瘤中表现出低/中等PD-L1表达的明显的免疫标志物上调.
IHC分析证实了在低至中等炎症瘤中免疫标的上调.
主要终点得到满足,87%的符合条件的患者在12天窗口内被分配并接受治疗.
没有观察到治疗反应,大多数患者接受了cabiralizumab.

结论:

一个针对患者的I-O组合治疗选择策略是可行的.
开发用于PD-1-耐火性癌症的新生物标志物值提出了重大挑战.
将生物标志物的发展从免疫疗法原始生物标本转化为PD-1耐药患者的选择是困难的.

关键词:

生物标志物生物标志物活检是为了检查生物质.免疫治疗是一种免疫疗法.

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