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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.