第2阶段,开放标签,多中心研究尼利托利莫德与布利祖马布结合在抗PD-1治疗中-先进黑色素瘤未经治疗
Antoni Ribas1, Mohammed M Milhem2, Christopher J Hoimes3
1University of California, Los Angeles, Los Angeles, CA, United States.
概括
内利托利莫德与布罗利祖马布结合,在晚期黑色素瘤患者中显示出有前途的抗瘤活性. 这种组合疗法,特别是2毫克尼利托利莫德剂量,实现了高的客观反应率,需要进一步调查.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 黑色素瘤研究 黑色素瘤研究
背景情况:
- 尼利托利莫德是一种托尔类受体9激动剂.
- 晚期黑色素瘤患者通常需要新的治疗策略.
- 之前的抗编程细胞死亡蛋白1 (PD-1) /编程细胞死亡联体1 (PD-L1) 治疗可能会影响治疗结果.
研究的目的:
- 为了评估内口内尼利托利莫德与pembrolizumab结合的疗效.
- 评估晚期黑色素瘤中抗瘤活性的增强.
- 在未接受过抗PD-1/PD-L1治疗的患者中研究这种组合.
主要方法:
- 晚期黑色素瘤患者通过内注射接受了2毫克或8毫克的尼利托利莫德.
- 布罗利祖马布每3周一次静脉注射,与尼利托利莫德同时使用.
- 用客观反应率 (ORR) 和无进展生存期 (PFS) 来评估治疗反应.
主要成果:
- 客观反应率 (ORR) 在2毫克尼利托利莫德组为76%,在8毫克组为49%.
- 在18个月后,无进展生存率为2毫克组的62%,为8毫克组的40%.
- 在PD-L1-阳性和PD-L1-阴性瘤以及远程转移患者中观察到反应.
结论:
- 尼利托利莫德加上潘布罗利祖马布在未经治疗的先进黑色素瘤中显示出显著的抗瘤活性.
- 组合疗法,特别是2mg剂量,需要进一步的临床研究.
- 即使在患有PD-L1-阴性瘤的患者中,也实现了客观反应.
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