Article ; Online: Efficacy and safety of CD19-directed CAR-T cell therapies in patients with relapsed/refractory aggressive B-cell lymphomas: Observations from the JULIET, ZUMA-1, and TRANSCEND trials.
American journal of hematology
2021 Volume 96, Issue 10, Page(s) 1295–1312
Abstract: Chimeric antigen receptor (CAR)-T cell therapies have improved the outcome for many patients with relapsed or refractory aggressive B-cell lymphomas. In 2017, axicabtagene ciloleucel and soon after tisagenlecleucel became the first approved CAR-T cell ... ...
Abstract | Chimeric antigen receptor (CAR)-T cell therapies have improved the outcome for many patients with relapsed or refractory aggressive B-cell lymphomas. In 2017, axicabtagene ciloleucel and soon after tisagenlecleucel became the first approved CAR-T cell products for patients with high-grade B-cell lymphomas or diffuse large B-cell lymphoma (DLBCL) who are relapsed or refractory to ≥ 2 prior lines of therapy; lisocabtagene maraleucel was approved in 2021. Safety and efficacy outcomes from the pivotal trials of each CAR-T cell therapy have been reported. Despite addressing a common unmet need in the large B-cell lymphoma population and utilizing similar CAR technologies, there are differences between CAR-T cell products in manufacturing, pivotal clinical trial designs, and data reporting. Early reports of commercial use of axicabtagene ciloleucel and tisagenlecleucel provide the first opportunities to validate the impact of patient characteristics on the efficacy and safety of these CAR-T cell therapies in the real world. Going forward, caring for patients after CAR-T cell therapy will require strategies to monitor patients for sustained responses and potential long-term side effects. In this review, product attributes, protocol designs, and clinical outcomes of the key clinical trials are presented. We discuss recent data on patient characteristics, efficacy, and safety of patients treated with axicabtagene ciloleucel or tisagenlecleucel in the real world. Finally, we discuss postinfusion management and preview upcoming clinical trials of CAR-T cell therapies. |
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MeSH term(s) | Antigens, CD19/adverse effects ; Antigens, CD19/therapeutic use ; Biological Products ; Clinical Trials as Topic ; Humans ; Immunotherapy, Adoptive/adverse effects ; Lymphoma, Large B-Cell, Diffuse/therapy ; Neoplasm Recurrence, Local/therapy ; Receptors, Antigen, T-Cell/therapeutic use ; Treatment Outcome |
Chemical Substances | Antigens, CD19 ; Biological Products ; Receptors, Antigen, T-Cell ; tisagenlecleucel (Q6C9WHR03O) ; axicabtagene ciloleucel (U2I8T43Y7R) |
Language | English |
Publishing date | 2021-08-13 |
Publishing country | United States |
Document type | Journal Article ; Research Support, Non-U.S. Gov't ; Review |
ZDB-ID | 196767-8 |
ISSN | 1096-8652 ; 0361-8609 |
ISSN (online) | 1096-8652 |
ISSN | 0361-8609 |
DOI | 10.1002/ajh.26301 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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