在移植不合格的复发性/耐药DLBCL中,Epcoritamab加Gemox:来自EPCORE NHL-2试验的结果
Joshua D Brody1, Judit Jørgensen2, David Belada3
1Department of Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY.
Blood
|January 10, 2025
概括
埃普科利他马布加Gemox为复发性或耐火性扩散性大B细胞淋巴瘤 (DLBCL) 患者提供了一个有前途的新疗法,不符合干细胞移植的条件,显示高响应率和持久的结果.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- 复发性或耐火性扩散性大B细胞淋巴瘤 (R/R DLBCL) 在采用标准救援疗法后,带来了不良结果的重大挑战.
- 目前用于R/R DLBCL的救援方案,如凝胺加氧沙 (GemOx),表现出有限的疗效,完全响应率 (CR) 低,总生存率 (OS) 中位数短.
- 针对CD3和CD20的双特异性抗体epcoritamab已被批准用于R/R DLBCL后多重疗法,并且已在组合治疗中显示出潜力.
研究的目的:
- 评估epcoritamab与Gemox结合的安全性和有效性,用于自身干细胞移植 (ASCT) 患者,不符合R/R DLBCL.
- 确定整体响应率 (ORR) 作为这种组合治疗的主要终点.
- 在这个患者群体中评估epcoritamab加Gemox的响应的持久性,整体存活率和安全性.
主要方法:
- 进行了一项1b/2期临床试验 (EPCORE NHL-2),招募了103名ASCT不合格的R/R DLBCL患者.
- 患者接受皮下epcoritamab (48毫克后逐步剂量) 直到疾病进展或不可接受的毒性,结合GemOx化疗每两周服用八次剂量.
- 该研究监测了治疗出现的不良事件,包括细胞因子释放综合征 (CRS),并评估了ORR和CR率等疗效终点.
主要成果:
- 在具有挑战性的R/RDLBCL患者队列中,epcoritamab加Gemox的组合实现了高的整体响应率 (ORR) 85%和61%的完整响应率 (CR).
- 响应是持久的,CR的中位持续时间为23.6个月,平均整体存活时间 (OS) 为21.6个月.
- 治疗出现的不良事件,主要是细胞衰竭和细胞因子释放综合征 (CRS),是可控的;CRS事件大多是低级的,并且在不停止治疗的情况下得到解决.
结论:
- 埃普科里塔马布加Gemox显示出显著的疗效,在ASCT不合格的R/R DLBCL患者中产生深度和持久的反应.
- 这种组合为具有历史不良预后的患者群体提供了有利的长期结果和可管理的安全概况.
- 这些发现支持epcoritamab加Gemox作为R/R DLBCL患者不适合ASCT的有前途的治疗选择.
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