Safety of axicabtagene ciloleucel for the treatment of relapsed or refractory large B-cell lymphoma

Abstract Background Diffuse large B-cell lymphoma (DLBCL) is the most common type of non-Hodgkin’s lymphoma (NHL). Recent advances in immunotherapy have resulted in development of chimeric antigen receptor (CAR) T-cell therapy, such as axicabtagene ciloleucel (axi-cel). However, axi-cel administration is not without risk of toxicity. Methods This retrospective study of 37 patients with relapsed or refractory DLBCL evaluated incidence and severity of common and severe safety events following axi-cel treatment in a real-world setting. Patients Ninety percent of patients had received three or more prior lines of therapy (median prior therapies 3, range 2-7) prior to receiving CAR T-cells and 32.4% had relapsed after prior stem cell transplant. Results All but one patient experienced cytokine release syndrome (CRS) of any grade (97.3%). Of those 36 patients, 83.3% experienced maximum CRS grade of 1 or 2, occurring after a median of 27 hours and persisting for a median of six days. Twenty-seven (73.0%) patients experienced neurotoxicity of any grade. Of those 27 patients, 96.3% experienced maximum neurotoxicity grade of 2 or higher, occurring after a median of 145 hours (6 days) and persisting for a median of seven days. All ten patients age 65 or older had neurotoxicity of grade 2 or higher, compared to 59.3% (11/27) under age 65 (p=0.02). Patients with baseline Eastern Cooperative Oncology Group (ECOG) score of 2 were significantly more likely to have shorter time to neurotoxicity compared to patients with ECOG of 0 (p=0.01). Conclusion With more real-life experience and data, we will be able to define and refine management of these unique toxicities.