Brexu-cel Clinical Practice Safety Report by Lymphoma CAR T Consortium
Hackensack University Medical Center Among Centers Reporting Positive Results at American Society of Hematology Meeting
At the 2021 American Society of Hematology meeting, the U.S. Lymphoma CAR T Consortium reported positive safety and efficacy evaluation of brexu-cel in standard of care practice for relapsed/refractory (R/R) mantle cell lymphoma (MCL) among 14 of its participant centers.
Brexucabtagene autoleucel (brexu-cel) was FDA approved for R/R MCL mid-2020 based on results of the ZUMA-2 study, which recorded an objective response rate of 93% and a complete response rate of 67%. The study maintained stringent eligibility criteria, including prior treatment with a BTK inhibitor (BTKi), and only allowed BTKi and/or corticosteroid for bridging therapy.
As follow-up, fourteen consortium centers participated in this retrospective study to examine whether these results are replicable in a real-world clinical setting. The evaluation demonstrated encouraging safety and efficacy data of brexu-cel in R/R MCL in clinical practice. The CRS and ICANS incidences were comparable to those reported in ZUMA-2, though the use of tocilizumab and steroid was more frequent than in ZUMA-2. Although 73% of the patients would have been ineligible for ZUMA-2, the ORR and CR rate were comparable to those reported in ZUMA-2.
While extended follow-up is necessary to confirm long-term safety and efficacy, these initial results offer promising real-world validation of the ZUMA-2 study findings.
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