在日本成年人患有复发性/耐药性扩散性大B细胞淋巴瘤的皮下epcoritamab单疗法
Koji Izutsu1, Takahiro Kumode2, Junichiro Yuda3
1Department of Hematology, National Cancer Center Hospital, Tokyo, Japan.
Cancer science
|November 3, 2023
概括
在日本患者中,epcoritamab在复发或耐火性扩散性大B细胞淋巴瘤 (DLBCL) 中表现出显著的疗效,显示出高响应率和持久的结果. 治疗耐受性良好,可管理的细胞因子释放综合征 (CRS).
科学领域:
- 在瘤学瘤学.
- 血液学 血液学 血液学
- 免疫治疗是一种免疫疗法.
背景情况:
- 针对CD3xCD20的双特异性抗体epcoritamab在治疗复发性或耐火性 (R/R) 扩散性大B细胞淋巴瘤 (DLBCL) 中表现有前途.
- 像EPCORE NHL-1这样的先前试验表明了深度和持久的反应,具有可管理的安全性.
研究的目的:
- 评估epcoritamab单一治疗在日本患者的疗效和安全性,这些患者患有R/R CD20+ B细胞非霍奇金淋巴瘤.
- 为了评估epcoritamab的响应率,响应的持续时间和以前未经治疗的人群的整体存活率.
主要方法:
- 一项I/II期临床试验 (EPCORE NHL-3) 涉及36名日本R/R DLBCL患者,他们先前接受过两种或更多种疗法.
- 在28天循环中,以特定的剂量计划,逐步增加剂量和细胞因子释放综合征 (CRS) 预防为48mg的皮下施用epcoritamab.
主要成果:
- 独立审查委员会的总体响应率 (ORR) 为55.6%,完整响应率 (CR) 为44.4%.
- 没有达到响应的中位持续时间,完整响应的持续时间和整体存活时间.
- 最常见的不良事件包括CRS (83.3%),注射部位反应 (69.4%) 和感染 (44.4%);CRS事件主要是低度和解决.
结论:
- 在日本的R/R DLBCL患者中,epcoritamab单一治疗显示出令人鼓舞的疗效和可管理的安全概况.
- 结果与之前的研究结果一致,支持对epcoritamab用于R/R DLBCL治疗的进一步临床评估.
- 这项研究支持epcoritamab在R/R DLBCL早期疗法中的潜在使用.
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