Division of Hematology and Medical Oncology, Washington University School of Medicine, St. Louis, MO, USA.
Division of Medical Oncology Section of Stem Cell Transplant and Leukemia, Center for Gene and Cellular Immunotherapy (CGCI), Washington University School of Medicine, St. Louis, MO, USA.
Expert Rev Anticancer Ther. 2022 Sep;22(9):903-914. doi: 10.1080/14737140.2022.2096009. Epub 2022 Aug 5.
Axicabtagene ciloleucel is an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell therapy that was recently approved for relapsed or refractory follicular lymphoma following progression on two or more lines of therapy including an anti-CD20 monoclonal antibody with an alkylating agent, providing a therapeutic breakthrough in a subset of indolent non-Hodgkin lymphoma associated with poor clinical outcomes.
In this article, we outline the drug profile of axicabtagene ciloleucel in comparison to currently approved agents and other CAR T-cell and T-cell redirecting therapies under investigation for the treatment of relapsed or refractory follicular lymphoma. We also review the efficacy, safety, and pharmacokinetic data from the ZUMA-5 phase II trial, which forms the basis of the recent approval of axicabtagene ciloleucel.
Axicabtagene ciloleucel is the first cellular therapy approved for relapsed or refractory follicular lymphoma, demonstrating high rates of durable responses and a manageable toxicity profile in heavily pre-treated patients.
Axicabtagene ciloleucel 是一种自体抗 CD19 嵌合抗原受体 (CAR) T 细胞疗法，最近在接受包括抗 CD20 单克隆抗体与烷化剂在内的两种或更多种治疗方案治疗后进展的复发性或难治性滤泡性淋巴瘤中获得批准，为与不良临床结局相关的亚组惰性非霍奇金淋巴瘤提供了治疗突破。
本文概述了 axi-cabtagene ciloleucel 的药物特征，与目前已批准的药物以及其他正在研究用于治疗复发性或难治性滤泡性淋巴瘤的 CAR T 细胞和 T 细胞重定向疗法进行了比较。我们还回顾了 ZUMA-5 期 II 期试验的疗效、安全性和药代动力学数据，该试验是 axi-cabtagene ciloleucel 最近获得批准的基础。
axi-cabtagene ciloleucel 是第一种获批用于复发性或难治性滤泡性淋巴瘤的细胞疗法，在经过大量预处理的患者中显示出持久反应率高和可管理的毒性特征。
