Real-world outcomes of brexucabtagene autoleucel for relapsed or refractory mantle cell lymphoma: a CIBMTR analysis
Brexucabtagene autoleucel (brexu-cel) is a chimeric antigen receptor T-cell therapy approved for relapsed/refractory mantle cell lymphoma (R/R MCL). Here, we report real-world effectiveness and safety outcomes of brexu-cel in a prospective study of patients with R/R MCL, including subgroups based on prior treatment with Bruton's tyrosine kinase inhibitor, bendamustine, or autologous hematopoietic cell transplant (auto-HCT) and number of prior therapy lines, using Center for International Blood and Marrow Transplant Research registry data. A total of 476 patients with R/R MCL who received brexu-cel between July 2020 and December 2022 were included in the analysis. With a median follow-up of 13.5 months, the overall response rate was 91% and complete response rate was 82%. One-year overall survival and progression-free survival rates were 76% and 63%, respectively. One-year cumulative incidence of nonrelapse mortality was 8%. Prior auto-HCT was associated with better duration of response within 6 months after infusion (hazard ratio [HR], 0.49; 95% confidence interval [CI], 0.28-0.85) but greater risk of immune effector cell-associated neurotoxicity syndrome (odds ratio [OR], 1.66; 95% CI, 1.06-2.60). Prior bendamustine was associated with increased risk of prolonged thrombocytopenia (OR, 1.90; 95% CI, 1.13-3.21). In patients with 1 to 2 prior therapy lines, relapse or progression was less frequent compared with those with ≥3 prior lines (HR, 0.64; 95% CI, 0.42-1.00). Collectively, our results suggest that real-world outcomes with brexu-cel were consistent with those of the ZUMA-2 trial, regardless of prior therapy type or number of prior therapy lines.
Authors
- Matthew Bye (ORCID: https://orcid.org/0009-0004-6903-6156)
- Mehdi Hamadani (ORCID: https://orcid.org/0000-0001-5372-510X)
- Mohamed A. Kharfan‐Dabaja (ORCID: https://orcid.org/0000-0001-7394-5185)
- Frederick Lundry Locke (ORCID: https://orcid.org/0000-0001-9063-6691)
- Ioana Kloos
- Zhen‐Huan Hu (ORCID: https://orcid.org/0000-0002-3303-8991)
- Matthew J. Frank (ORCID: https://orcid.org/0000-0002-2356-3354)
- Alex Francisco Herrera (ORCID: https://orcid.org/0000-0002-9665-7415)
- Craig S. Sauter (ORCID: https://orcid.org/0000-0002-5316-8785)
- Sairah Ahmed (ORCID: https://orcid.org/0000-0001-7302-8299)
- Peiman Hematti (ORCID: https://orcid.org/0000-0001-5836-4497)
- James N. Gerson (ORCID: https://orcid.org/0000-0002-4736-187X)
- Mazyar Shadman (ORCID: https://orcid.org/0000-0002-3365-6562)
- Natalie Sophia Grover (ORCID: https://orcid.org/0000-0002-1346-3157)
- Lihua E. Budde (ORCID: https://orcid.org/0000-0003-1464-5494)
- Marcelo C. Pasquini (ORCID: https://orcid.org/0000-0003-1579-2293)
- Amy Moskop (ORCID: https://orcid.org/0000-0002-5110-004X)
- Hairong Xu
- Nausheen Ahmed (ORCID: https://orcid.org/0000-0003-4336-4982)
- Cameron J. Turtle (ORCID: https://orcid.org/0000-0002-4722-4461)
- Soyoung Kim (ORCID: https://orcid.org/0000-0003-1404-0575)
- Michael L. Wang (ORCID: https://orcid.org/0000-0001-9748-5486)
- Daniel Y. Lee (ORCID: https://orcid.org/0000-0001-9106-9342)
- Ana Nunes
- Swetha Kambhampati (ORCID: https://orcid.org/0000-0002-5776-3274)
- Brent R. Logan
- Daniel P. Dalton
Institutions
- University of North Carolina at Chapel Hill (US)
- The University of Sydney (AU)
- City Of Hope National Medical Center (US)
- Cleveland Clinic (US)
- Memorial Sloan Kettering Cancer Center (US)
- The University of Texas MD Anderson Cancer Center (US)
- Medical College of Wisconsin (US)
- Jacksonville College (US)
- University of Vermont Medical Center (US)
- WinnMed (US)
- Moffitt Cancer Center (US)
- Nemours Children’s Clinic (US)
- Fred Hutch Cancer Center (US)
- The University of Kansas Cancer Center (US)
- City of Hope (US)
- Versiti Blood Center of Wisconsin (US)
- Gilead Sciences (Australia) (AU)
- Kite (United States) (US)
- Mayo Clinic in Florida (US)
- Nemours Children's Clinic (US)
- UNC Lineberger Comprehensive Cancer Center
- Stanford University (US)
Publication Details
- Journal
- Blood Advances
- Published
- 2025-07-24
- DOI
- https://doi.org/10.1182/bloodadvances.2024015014
- Citations
- 8
- Primary Topic
- CAR-T cell therapy research
- Type
- article
- Field-Weighted Citation Impact
- 8.36
Funders
- Gateway for Cancer Research
- Amgen
- Bristol-Myers Squibb
- Eli Lilly and Company
- Astellas Pharma US
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Gilead Sciences
- Alexion Pharmaceuticals
- Spectrum Pharmaceuticals
- Celgene
- HistoGenetics
- CSL Behring
- Actinium Pharmaceuticals
- Jazz Pharmaceuticals
- Society for Immunotherapy of Cancer
- Mallinckrodt Pharmaceuticals
- Atara Biotherapeutics
- CareDx
- bluebird bio
- Adaptive Biotechnologies
- BeiGene
- Incyte
- Seagen
- Kiadis Pharma
- Astellas Pharma
- Aptitude Health
- Health Resources and Services Administration
- Genentech
- Kite Pharma
- Pharmacyclics
- Juno Therapeutics
- Legend Biotech
- National Heart, Lung, and Blood Institute
- Office of Naval Research
- National Cancer Institute
- National Institute of Allergy and Infectious Diseases
- Eurostars