研究动态
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Tisagenlecleucel: 用于复发或难治性滤泡性淋巴瘤成年患者的CAR-T细胞疗法。

Tisagenlecleucel: CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma.

发表日期:2023 Aug 20
作者: Aditi Saha, Khushali Jhaveri, Humaira Sarfraz, Julio C Chavez
来源: EXPERT OPINION ON BIOLOGICAL THERAPY

摘要:

Tisagenlecleucel (tisa-cel) 是一种抗CD19 CAR-T治疗,已在复发/难治性大B细胞淋巴瘤和复发/难治性B细胞急性淋巴细胞白血病中展示出临床活性。在复发/难治性滤泡性淋巴瘤 (FL) 中显示出特别高的疗效,且具有可控的毒副反应。关键ELARA研究在FL复发/难治性患者中证实了这些发现,并导致FDA批准tisa-cel用于经历两种系统性治疗后的FL复发/难治疗例。我们从引言开始介绍FL和当前治疗现状,并重点关注复发/难治性设置。我们回顾了CAR-T在复发/难治性FL中的作用,并重点介绍了当前可用的产品。我们以高层次描述ELARA研究,以便了解接受治疗的患者人群。最后,我们讨论与产品选择相关的问题,以及双特异抗体是否会挑战CAR-T在FL中的作用,鉴于它们具有相似的疗效。对于经过重度治疗的复发/难治性FL患者来说,tisa-cel是一种高效的治疗方法,具有低级别且可控的毒副反应。关键ELARA研究中观察到持久的缓解病情(包括高风险患者)。临床医生应考虑及早转诊复发/难治性FL患者进行评估和讨论。
Tisagenlecleucel (tisa-cel) is an anti CD19 CAR-T therapy that has demonstrated clinical activity in R/R large B-cell lymphoma and R/R B-cell acute lymphoblastic leukemia. It showed particularly high efficacy in R/R follicular lymphoma (FL) with a manageable toxicity profile. The pivotal ELARA study in R/R FL confirmed these findings and led to the FDA approval of tisa-cel in R/R FL after two lines of systemic therapies.We start with an introduction of FL and the current treatment landscape with emphasis on the R/R setting. We review the role of CAR-T in R/R FL with focus on currently available products. We describe the ELARA study at a high level to give a perspective of the patient population that was treated. Finally, we discuss aspects related to product selection and whether bispecific antibodies will challenge the role of CAR-T in FL given their similar efficacy.Tisa-cel is a highly effective therapy for heavily pretreated R/R FL with a toxicity profile that is low grade and manageable. Durable remissions (including high-risk patients) are seen in the pivotal ELARA study. Clinicians should consider early referral of R/R FL patients for assessment and discussion.