Austrian real-world experience with standard of care brexucabtagene autoleucel in patients with relapsed or refractory mantle-cell lymphoma.
[BACKGROUND] Mantle-cell lymphoma (MCL) represents a rare B-cell malignancy with a challenging treatment situation in the case of relapsed or refractory (r/r) disease.
APA
Koeck S, Rotter N, et al. (2026). Austrian real-world experience with standard of care brexucabtagene autoleucel in patients with relapsed or refractory mantle-cell lymphoma.. Transplantation and cellular therapy. https://doi.org/10.1016/j.jtct.2026.04.019
MLA
Koeck S, et al.. "Austrian real-world experience with standard of care brexucabtagene autoleucel in patients with relapsed or refractory mantle-cell lymphoma.." Transplantation and cellular therapy, 2026.
PMID
42002230
Abstract
[BACKGROUND] Mantle-cell lymphoma (MCL) represents a rare B-cell malignancy with a challenging treatment situation in the case of relapsed or refractory (r/r) disease. Brexu-cel as first approved chimeric antigen receptor T-cell (CART) therapy revolutionized the therapeutic landscape and outcome in r/r MCL patients.
[OBJECTIVE] This retrospective study analyzes the real world data of patients with r/r MCL enrolled into the CART program in Austria.
[STUDY DESIGN] In total, 33 patients in Austria were analyzed from 2021 to January 2025. Inclusion criteria comprised confirmed diagnosis of r/r MCL, an age ≥ 18 years and a confirmed enrollment into the CART program. Primary endpoints were the overall response rate (ORR), overall survival (OS) and progression-free survival (PFS). Further endpoints included the incidence and severity of CART-specific adverse events (AE) such as the cytokine-release-syndrome (CRS) and the immune effector cell-associated neurotoxicity syndrome (ICANS).
[RESULTS] Of all 33 patients enrolled into the CART program, 24 patients (72.7%) were treated with brexu-cel whereas nine patients (27.3%) received alternative treatments. Most common cause for alternative treatment was disease progression. The ORR for brexu-cel was 95.9%, with a 2-year OS- and PFS rate of 76.8% and 50.8%, respectively. In the alternative treatment group, the 2-year OS and PFS rates were 13.9% and 18.5%. Grade ≥2 CRS and ICANS occurred in 62.5% and 37.5%, respectively. There were no Grade 5 adverse events related to brexu-cel. Patients with a leukocyte count > 4.1 G/l at the time point of lymphodepletion had a significantly higher incidence of CRS grade ≥ 2, whereas a neutrophil count ≥ 4.75 G/l at the time point of lymphodepletion was associated with a higher incidence of ICANS grade ≥ 2.
[CONCLUSION] Our study provides first insights into the real-world trajectories and outcomes of r/r MCL patients intended for brexu-cel treatment in Austria. This analysis confirms the high rates of ORR and OS of Brexu-cel in MCL also in the real world setting. Exploratory analysis suggested that increased leukocyte and neutrophil counts at lymphodepletion may be associated with increased risk of CRS and ICANS, respectively.
[OBJECTIVE] This retrospective study analyzes the real world data of patients with r/r MCL enrolled into the CART program in Austria.
[STUDY DESIGN] In total, 33 patients in Austria were analyzed from 2021 to January 2025. Inclusion criteria comprised confirmed diagnosis of r/r MCL, an age ≥ 18 years and a confirmed enrollment into the CART program. Primary endpoints were the overall response rate (ORR), overall survival (OS) and progression-free survival (PFS). Further endpoints included the incidence and severity of CART-specific adverse events (AE) such as the cytokine-release-syndrome (CRS) and the immune effector cell-associated neurotoxicity syndrome (ICANS).
[RESULTS] Of all 33 patients enrolled into the CART program, 24 patients (72.7%) were treated with brexu-cel whereas nine patients (27.3%) received alternative treatments. Most common cause for alternative treatment was disease progression. The ORR for brexu-cel was 95.9%, with a 2-year OS- and PFS rate of 76.8% and 50.8%, respectively. In the alternative treatment group, the 2-year OS and PFS rates were 13.9% and 18.5%. Grade ≥2 CRS and ICANS occurred in 62.5% and 37.5%, respectively. There were no Grade 5 adverse events related to brexu-cel. Patients with a leukocyte count > 4.1 G/l at the time point of lymphodepletion had a significantly higher incidence of CRS grade ≥ 2, whereas a neutrophil count ≥ 4.75 G/l at the time point of lymphodepletion was associated with a higher incidence of ICANS grade ≥ 2.
[CONCLUSION] Our study provides first insights into the real-world trajectories and outcomes of r/r MCL patients intended for brexu-cel treatment in Austria. This analysis confirms the high rates of ORR and OS of Brexu-cel in MCL also in the real world setting. Exploratory analysis suggested that increased leukocyte and neutrophil counts at lymphodepletion may be associated with increased risk of CRS and ICANS, respectively.