Lisocabtagene Maraleucel治疗复发或难治性弥漫性大B细胞淋巴瘤:证据是什么?

Mohamed A Kharfan-Dabaja, Farah Yassine, Muhamad Alhaj Moustafa, Madiha Iqbal, Hemant Murthy
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引用次数: 5

摘要

Lisocabtagene maraleucel (liso- cell)是一种自体cd19定向嵌合抗原受体(CAR) T细胞产品,具有CD3ζ活化结构域连接到4-1BB共刺激结构域。与其他两种获批产品(axicabtagene ciloleucel和tisagenlecleucel)不同,Liso-cel是分别从CD4和CD8 T细胞中分离制造的,然后以等靶剂量连续输注这两种成分。liso-cel的批准是基于Transcend NHL 001的结果,该试验是一项单臂、开放标签、多中心、无缝设计的试验,入组了344名患者,其中269名患者接受了符合标准的liso-cel治疗。最常见的组织学为弥漫性大B细胞淋巴瘤(DLBCL NOS;n = 137, 51%),其次是惰性淋巴瘤转化的DLBCL (n = 78, 29%)。令人鼓舞的结果报告,所有剂量水平的客观反应率为73%[完全缓解(CR) = 53%], 1年的估计反应持续时间为所有患者的55%和达到CR的患者的65% .估计12个月的总生存率为所有患者的58%和达到CR的患者的86% .细胞因子释放综合征和神经系统不良事件分别为42%和30%。本文综述了关于liso- cell的安全性和有效性的证据,从而使其加入到目前复发或难治性大B细胞淋巴瘤的治疗方案中。
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Lisocabtagene Maraleucel in Relapsed or Refractory Diffuse Large B Cell Lymphoma: What is the Evidence?

Lisocabtagene maraleucel (liso-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T cell product, with a CD3ζ activatory domain connected to 4-1BB costimulatory domain. Liso-cel, unlike the other two approved products-axicabtagene ciloleucel and tisagenlecleucel-is manufactured separately from CD4 and CD8 T cells and then administered as a sequential infusion of the two components at equal target doses. The approval of liso-cel was based on the results of Transcend NHL 001, a single-arm, open-label, multicenter, seamless design trial that enrolled 344 patients, of whom 269 received conforming liso-cel. The most common histology was diffuse large B cell lymphoma, not otherwise specified (DLBCL NOS; n = 137, 51%) followed by DLBCL transformed from indolent lymphomas (n = 78, 29%). Encouraging results were reported, yielding an objective response rate across all dose levels of 73% [complete remission (CR) = 53%], with an estimated duration of response at 1 year of 55% for all patients and 65% for those achieving a CR. The estimated 12-month overall survival was 58% for all patients and 86% for those achieving a CR. Cytokine release syndrome and neurological adverse events were reported in 42% and 30%, respectively. This review summarizes the evidence on the safety and effectiveness of liso-cel, resulting in its addition to the current treatment armamentarium of relapsed or refractory large B cell lymphoma.

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来源期刊
CiteScore
4.30
自引率
0.00%
发文量
0
审稿时长
27 weeks
期刊介绍: Hematology Oncology and Stem Cell Therapy is an international, peer-reviewed, open access journal that provides a vehicle for publications of high-quality clinical as well as basic science research reports in hematology and oncology. The contents of the journal also emphasize the growing importance of hematopoietic stem cell therapy for treatment of various benign and malignant hematologic disorders and certain solid tumors.The journal prioritizes publication of original research articles but also would give consideration for brief reports, review articles, special communications, and unique case reports. It also offers a special section for clinically relevant images that provide an important educational value.
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