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CD19 CAR-T 细胞在二线大 B 细胞淋巴瘤中的作用:来自 III 期试验的经验教训——美国移植与细胞治疗学会专家小组意见

英文原题:Role of CD19 Chimeric Antigen Receptor T Cells in Second-Line Large B Cell Lymphoma: Lessons from Phase 3 Trials. An Expert Panel Opinion from the American Society for Transplantation and Cellular Therapy.

查看英文原题

Role of CD19 Chimeric Antigen Receptor T Cells in Second-Line Large B Cell Lymphoma: Lessons from Phase 3 Trials. An Expert Panel Opinion from the American Society for Transplantation and Cellular Therapy.

PubMed 2022/06/26(内容时间) Transplant Cell Ther Q1 · IF 4.7(JCR 2025)

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中文摘要

自2017年以来,三种靶向CD19的嵌合抗原受体(CAR)T细胞疗法——阿基仑赛、替沙仑赛和利基迈仑赛——已获批用于接受过两线治疗后复发/难治的侵袭性弥漫性大B细胞淋巴瘤。近期开展的三项前瞻性III期随机临床试验比较各CAR-T 产品与当前标准治疗,以确定最佳二线方案:阿基仑赛的ZUMA-7、替沙仑赛的BELINDA及利基迈仑赛的TRANSFORM。三项试验所研究的问题大体相同,但结果不同:ZUMA-7和TRANSFORM显示,二线CD19 CAR-T 较标准治疗显著改善结局,而BELINDA未显示获益。美国FDA现已批准阿基仑赛和利基迈仑赛用于一线化学免疫治疗难治或一线治疗后12个月内复发的大B细胞淋巴瘤。针对这些改变临床实践的研究结果,美国移植与细胞治疗学会召集专家组全面回顾三项试验,强调其潜在差异,并分享这些结果对B细胞淋巴瘤治疗新时代临床实践的意义。

展开英文摘要原文

Since 2017, 3 CD19-directed chimeric antigen receptor (CAR) T cell therapies-axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel-have been approved for relapsed/refractory aggressive diffuse large B cell lymphoma after 2 lines of therapy. Recently, 3 prospective phase 3 randomized clinical trials were conducted to define the optimal second-line treatment by comparing each of the CAR T cell products to the current standard of care: ZUMA-7 for axicabtagene ciloleucel, BELINDA for tisagenlecleucel, and TRANSFORM for lisocabtagene maraleucel. These 3 studies, although largely addressing the same question, had different outcomes, with ZUMA-7 and TRANSFORM demonstrating significant improvement with CD19 CAR T cells in second-line therapy compared with standard of care but BELINDA not showing any benefit.

The US Food and Drug Administration has now approved axicabtagene ciloleucel and lisocabtagene maraleucel for LBCL that is refractory to first-line chemoimmunotherapy or relapse occurring within 12 months of first-line chemoimmunotherapy.

Following the reporting of these practice changing studies, here a group of experts convened by the American Society for Transplantation and Cellular Therapy provides a comprehensive review of the 3 studies, emphasizing potential differences, and shares perspectives on what these results mean to clinical practice in this new era of treatment of B cell lymphomas.

论文信息

作者
Perales MA、Anderson LD Jr、Jain T、Kenderian SS、Oluwole OO、Shah GL、Svoboda J、Hamadani M
单位
Adult Bone Marrow Transplantation Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York; Department of Medicine, Weill Cornell Medical College, New York, New York. Electronic address: peralesm@mskcc.org.United States
文献类型
临床实践指南 · 综述
期刊
Transplantation and cellular therapy2022 Sep
原文标识
PubMed 35768052 · DOI 10.1016/j.jtct.2022.06.019