ABSTRACT
INTRODUCTION:
Large
B-cell lymphomas (LBCL) are the most frequently aggressive B-
cell non-Hodgkin
lymphomas. Anti-CD19
chimeric antigen receptor (
CAR)-
T cell therapy has emerged as a new, powerful
treatment for relapsed or refractory (R/R)
disease. Two
CAR-
T cell products, tisagenlecleucel (tisa-cel,) and axicabtagene ciloleucel (axi-cel), are reimbursed in
Belgium for R/R LBCL beyond second line. OBJECTIVES AND
METHODS:
We conducted a retrospective
cohort study to
report the outcome with tisa-cel and axi-cel for R/R LBCL beyond second line in the years 2019-2023 at the
University Hospitals Leuven for 79
patients selected for
apheresis and
CAR-T infusion.
RESULTS:
Eleven
patients (14%) did not proceed to
CAR-
T cell infusion. For infused
patients (n = 68), the best overall response rate (ORR)/complete response (CR) rate was 64%/49% for tisa-cel and 88%/66% for axi-cel (p = 0.04 for ORR). After a median follow-up of 13.8 months,
progression-free survival (PFS) and overall
survival (OS) at 1 year were 30% and 43% for tisa-cel and 48% and 62% for axi-cel.
Cytokine release syndrome (CRS) (all grades/grade ≥3) occurred in 82%/9% after tisa-cel and in 97%/0% after axi-cel. Immune effector
cell-associated
neurotoxicity syndrome (ICANS) (all grades/grade ≥3) occurred in 24%/18% after tisa-cel and in 54%/40% after axi-cel. The non-
relapse mortality in the infusion cohort was 13%.
CONCLUSION:
Our real-world data show high and durable response rates, with a non-significant trend towards a higher
efficacy and higher
toxicity for axi-cel compared to tisa-cel. Our results are in line with other real-world
registries except for a shorter median OS and more high-grade ICANS.
