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Brexucabtagene autoleucel (brexu-cel) is an autologous CD19-directed chimeric antigen receptor (CAR) T-cell therapy approved for relapsed/refractory mantle cell lymphoma (MCL). It is the first CAR approval for MCL and its manufacture differs from other CAR T-cells in having an additional T-cell enrichment phase to remove circulating tumor cells from the leukapheresis material. This therapy was approved on the basis of the single-arm phase II , which showed best overall and complete response rates of 91% and 68%, respectively.
In a study in the , the U.S. Lymphoma CAR T Consortium analyzed the outcomes of brexu-cel in the real-world setting with the outcomes of 189 patients in this multicenter retrospective study. Of the 189 who underwent leukapheresis, 168 (89%) received brexu-cel infusion. The outcomes are quite similar to the pivotal study, with best overall and complete response rates of 90% and 82%, respectively.
It is important to note that of leukapheresed patients, 79% would not have met ZUMA-2 eligibility criteria. Patients ineligible for ZUMA-2 because of disease status or comorbidities were older and had poorer ECOG Performance Status, higher Ki-67, and more prior lines of therapy compared with patients eligible for ZUMA-2 and did not have a statistically significant difference in outcomes.
At a median follow-up of 14.3 months after infusion, the estimates for 6- and 12-month progression-free survival were 69% and 59%, respectively. The study particularly noted a higher risk of infectious deaths than previously observed in pivotal trials as well as indicated that recent bendamustine exposure may contribute to inferior outcomes.
While this is a retrospective analysis, it demonstrates reassuring outcomes and toxicity profile in a real-world cohort of MCL patients receiving brexu-cel.
Sairah Ahmed, MD, is associate professor in the Department of Lymphoma/Myeloma and director of the CART Program at the University of Texas MD Anderson Cancer Center in Houston.
Read the study here and an interview about it here.
Primary Source
Journal of Clinical Oncology
Source Reference: