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单独和结合自抑制的细胞外调节激酶在转移性胰腺癌患者中的开放式II期试验

Rishi Surana¹, Micaela Morgado¹, Ashwin Somasundaram²

¹Department of Medical Oncology, Dana-Farber Cancer Institute and Harvard Medical School, Boston, MA.

JCO precision oncology

|September 2, 2025

概括

这项研究发现,将LY3214996 (一种ERK抑制剂) 与基 (HCQ) 结合使用并没有改善转移性胰腺癌患者的结果. 无论是组合还是单独的LY3214996在该患者群体中都没有显著的临床活性.

科学领域:

癌症学
分子生物学
癌症治疗方法

背景情况:

胰腺管腺癌 (PDAC) 经常存在瘤基因基尔斯鼠肉瘤病毒突变.
临床前研究表明,抑制PDAC细胞中激活蛋白激酶通路可以增加自流.

研究的目的:

评估结合细胞外调节激酶 (ERK) 抑制剂LY3214996与自抑制剂基 (HCQ) 的临床疗效.
在被诊断为转移性PDAC的患者中评估这种组合治疗.

主要方法:

一个安全引入阶段确定了LY3214996的最大耐受剂量.
患有转移性PDAC的患者被随机分配 (1:1) 接受LY3214996加HCQ或LY3214996单一治疗.
主要终点是疾病控制率 (DCR),次要终点是总生存率 (OS) 和无进展生存率 (PFS).

主要成果:

综合治疗组 (5%) 和单一治疗组 (5.3%) 的疾病控制率较低且相似.
组合治疗组的总生存时间中位数为2. 4个月,单一治疗组的总生存时间为4. 6个月.
组合治疗组的中位数无进展生存时间为1. 3个月,单一治疗组为1. 9个月. 探索性有机体研究没有支持协同效应.

结论:

在转移PDAC的患者中,LY3214996和HCQ的组合没有显示出临床活性.
在这一组患者中,单独治疗LY3214996的临床益处也有限.
这些发现不支持对PDAC的进一步研究.

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