Real-World Outcomes of Brexucabtagene Autoleucel (Brexu-cel) for Relapsed or Refractory (R/R) Mantle Cell Lymphoma (MCL): A CIBMTR Subgroup Analysis of High-Risk Characteristics

Background: Patients (pts) with R/R MCL and TP53 mutation/deletion, or high Ki-67 proliferation index (PI), have historically had limited treatment options with dismal outcomes. Brexu-cel is a CAR T-cell therapy approved in the US for adults with R/R MCL. Real-world data has been consistent with tha...

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Published in:Blood 2023-11, Vol.142 (Supplement 1), p.107-107
Main Authors: Kambhampati, Swetha, Ahmed, Nausheen, Hamadani, Mehdi, Kim, Soyoung, Hemmer, Michael T., Grover, Natalie S., Shadman, Mazyar, Beitinjaneh, Amer, Budde, L. Elizabeth, Gerson, James, Jacobson, Caron A., Locke, Frederick L., Nasta, Dwivedy S., Wang, Michael L., Weng, Wen-Kai, Yan, Jiali, Nunes, Ana, Dalton, David, Wu, James J., Abdeldaim, Amina, Hu, Zhen-Huan, Pasquini, Marcelo, Herrera, Alex F.
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Language:English
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Summary:Background: Patients (pts) with R/R MCL and TP53 mutation/deletion, or high Ki-67 proliferation index (PI), have historically had limited treatment options with dismal outcomes. Brexu-cel is a CAR T-cell therapy approved in the US for adults with R/R MCL. Real-world data has been consistent with that of clinical trials (Kambhampati et al. 2023). In a 3-year follow-up of ZUMA-2 (Wang et al. 2022), outcomes were comparable across various high-risk subgroups (TP53 mutation, Ki-67 PI ≥ 30% or ≥ 50%). Here, we describe real-world outcomes of brexu-cel in R/R MCL by high-risk features, including deletion of TP53 or 17p, Ki-67 PI, and by ZUMA-2 eligibility. Methods : A total of 500 pts receiving brexu-cel for R/R MCL from 84 US centers between 07/2020−12/2022 were prospectively enrolled in the CIBMTR observational database for a post-authorization safety study. In this analysis, 446 pts were included, excluding pts with prior non-transplant cellular therapy, missing data for analysis, or no follow-up. Effectiveness outcomes were overall response rate (ORR), complete response (CR) rate, duration of response (DOR), progression-free survival (PFS), overall survival (OS) and relapse/progressive disease (REL/PD). Safety outcomes included cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), prolonged cytopenias, infections requiring treatment, subsequent neoplasms, and non-relapse mortality (NRM). Analyses conducted included univariate as well as multivariate logistic regression and Cox proportional hazard models fit to identify covariates with an impact on outcomes. Results : Of the 446 pts included and who had available data, 20% (44/220) had deletion of TP53/17p at diagnosis; Ki-67 PI ≥ 50% at diagnosis was seen in 42% (107/252). Pts with deletion of TP53/17p were less likely to undergo prior autologous hematopoietic cell transplant (11% vs 30%). Pts with Ki-67 PI ≥ 50% were more likely to receive Bruton's tyrosine kinase inhibitor (BTKi) (92% vs 81%) and bridging therapy (52% vs 37%), but less likely to receive bendamustine (47% vs 62%). Pts with either high-risk feature tended to have a shorter time from diagnosis to brexu-cel infusion. Overall, 67% (297/446) of pts would not have met ZUMA-2 eligibility criteria, mainly due to pulmonary impairment (33%), cardiac impairment (21%), prior malignancy (21%), low platelet count (20%), and no prior BTKi (18%). With a median follow-up of 12.2 mo, DOR, PFS and OS were evaluated a
ISSN:0006-4971
1528-0020
DOI:10.1182/blood-2023-179269