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在高风险切除性黑色素瘤中使用新辅助剂vidutolimod和nivolumab:前性II期试验

Diwakar Davar¹, Robert M Morrison¹, Amiran K Dzutsev²

¹Division of Hematology-Oncology, Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA; University of Pittsburgh Medical Center Hillman Cancer Center, Pittsburgh, PA, USA; Department of Computational and Systems Biology, University of Pittsburgh, Pittsburgh, PA, USA.

|November 1, 2024

概括

结合TLR9agonistvidutolimod和anti-PD-1nivolumab的新辅助疗法在高风险黑色素瘤患者中显示出55%的主要病理反应. 这种免疫疗法组合激活了广泛的抗瘤免疫反应,并与特定的肠道细菌有关.

科学领域:

免疫学免疫学免疫学
在瘤学瘤学.
微生物组研究的研究.

背景情况:

结合免疫检查点抑制剂 (如抗编程死亡-1 (anti-PD-1) 疗法) 的内托尔类受体9 (TLR9) 激动剂,在癌症治疗中表现有前途.
高风险切除性黑色素瘤患者通常需要新的新辅助策略来改善结果.

研究的目的:

评估新辅助药维多利莫德 (TLR9激动剂) 与尼沃卢马布 (抗PD-1) 结合在患有高风险切除性黑色素瘤的患者中的疗效和与免疫相关的影响.
确定与治疗反应相关的生物标志物.

主要方法:

一个单臂临床研究,涉及31名高风险切除性黑色素瘤的可评估患者.
评估病理反应,包括主要病理反应 (MPR).
对瘤微环境 (TME) 和外围免疫细胞种群,基因表达概况和肠道微生物群组成的分析.

主要成果:

组合疗法实现了55%的MPR率,达到主要终点.
在TME中,MPR与增加的瘤缩,黑色细胞,CD8+瘤透性淋巴细胞和血细胞状树突细胞 (pDCs) 相相关.
周围免疫分析显示Ki67+ CD8+ T细胞增加,基线基因特征表明神经质细胞,免疫细胞,pDCs,细胞化和巨细胞激活在响应者中.
响应者的肠道微生物群显示了格拉姆阴性细菌的丰富,包括Bacteroidaceae和Enterobacteriaceae家族.

结论:

视图利莫德和尼沃卢马布的组合显示出显著的临床活性,并在高风险黑色素瘤中诱导广泛的抗瘤免疫反应.
显著的基线髓质基因特征和肠道微生物群概况与治疗反应有关,这表明潜在的预测生物标志物.

关键词:

ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI IC1 ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI ICI IC1 IC1 IC1 IC1 IC1 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC1 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 IC2 which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which which 在PD-1中使用PD-1.在TLR9中,免疫疗法免疫疗法内在的激动剂是天生的激动剂.巨细胞是一个巨细胞.黑色素瘤是一种黑色素瘤.这是一种新辅助剂.在pDCDC中,pDC是在视频中使用了limod.

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