Saha Aditi, Jhaveri Khushali, Sarfraz Humaira, Chavez Julio C
Department of Medicine/Hematology Oncology, University of South Florida, Tampa, FLUSA.
Department of Malignant Hematology, Moffitt Cancer Center, Tampa, FL USA.
Expert Opin Biol Ther. 2023 Jul-Dec;23(9):869-876. doi: 10.1080/14712598.2023.2248878. Epub 2023 Aug 20.
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.
替沙格赛定（tisagenlecleucel，tisa-cel）是一种抗CD19嵌合抗原受体T细胞（CAR-T）疗法，已在复发/难治性（R/R）大B细胞淋巴瘤和R/R B细胞急性淋巴细胞白血病中展现出临床活性。它在R/R滤泡性淋巴瘤（FL）中显示出特别高的疗效，且毒性特征易于管理。针对R/R FL的关键ELARA研究证实了这些发现，并促使美国食品药品监督管理局（FDA）在经过两线全身治疗后批准tisa-cel用于R/R FL。
我们首先介绍FL以及当前的治疗格局，重点是R/R情况。我们回顾CAR-T在R/R FL中的作用，重点关注现有产品。我们简要描述ELARA研究，以了解所治疗患者群体的情况。最后，我们讨论与产品选择相关的方面，以及鉴于双特异性抗体疗效相似，它们是否会挑战CAR-T在FL中的作用。
Tisa-cel是一种对经过大量预处理的R/R FL非常有效的疗法，其毒性特征为低级别且易于管理。在关键的ELARA研究中观察到了持久缓解（包括高危患者）。临床医生应考虑尽早将R/R FL患者转诊进行评估和讨论。
