在先进的抗PD-1失败黑色素瘤 (IGNYTE) 中,RP1与尼沃卢马布结合使用
Michael K Wong1, Mohammed M Milhem2, Joseph J Sacco3,4
1Roswell Park Comprehensive Cancer Center, Buffalo, NY.
概括
与尼沃卢马布结合的RP1在以前抗PD-1治疗失败的黑色素瘤患者中显示出希望. 这种瘤性免疫疗法显示出持久的反应和良好的安全性,为晚期病例提供了新的希望.
科学领域:
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
- 病毒学 病毒学
背景情况:
- 晚期黑色素瘤免疫后检查点封锁失败的治疗选择有限.
- RP1 (vusolimogene oderparepvec) 是一种新型瘤性免疫疗法,源自简单疹病毒1型.
- 这项研究调查了RP1与尼沃卢马布联合治疗抗PD-1疗法耐药黑色素瘤患者的疗效和安全性.
研究的目的:
- 为了评估与尼沃卢马布结合RP1的客观响应率 (ORR) 在晚期黑色素瘤患者中,这些患者在抗PD-1治疗中进展.
- 评估注射和非注射病变中反应的深度,持续时间和动力学.
- 分析组合治疗的整体生存率和安全性概况.
主要方法:
- 一项临床试验涉及140名患有晚期黑色素瘤,不耐抗PD-1治疗的患者.
- 内注射RP1 (最多8剂量) 与尼沃卢马布 (最多2年) 结合使用.
- 目标响应率 (ORR) 由独立的中央审查评估,使用RECIST v1.1标准.
主要成果:
- 确定的ORR为32.9%,完全响应为15.0%.
- 反应是系统性的,影响了注射和非注射的病变,包括内脏转移.
- 响应的中位持续时间为33.7个月;1年和2年的整体存活率分别为75.3%和63.3%.
- 生物标志物分析表明CD8+T细胞透和PD-L1表达增加,表明免疫激活.
结论:
- RP1加尼沃卢马布为抗PD-1耐火性黑色素瘤患者提供了一个有前途的治疗策略,包括那些预后因素不佳的患者.
- 组合治疗产生了深度和持久的全身反应.
- 安全性概况是有利的,大多数与治疗相关的不良事件是低级的 (1/2).
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