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Real World Outcomes for Young Adult Patients Receiving CD19 CAR T-cell Therapy.

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Real World Outcomes for Young Adult Patients Receiving CD19 CAR T-cell Therapy. Blood advances Lust, H., Schultz, L. M., Kwon, S., Roloff, G. W., Aldoss, I., Baggott, C., John, S., Rossoff, J., McNerney, K. O., Fabrizio, V. A., Talano, J. A., Moskop, A., Curran, K. J., Phillips, C. L., Karras, N. A., Baumeister, S. H., Cooper, S., Hermiston, M. L., Satwani, P., Qayed, M., Raikar, S. S., MacMillan, M. L., Hall, E. M., Nguyen, K., Cassaday, R. D., Kopmar, N. E., Kota, V. K., Mathews, J., Shaughnessy, P. J., Schwartz, M. S., Ladha, A., Yaghmour, G., Kumaran, M., Bachanova, V., Tracy, S. I., Othman, T., Luskin, M. R., Chen, E. C., Advani, A. S., Jeyakumar, N., Miller, K., Zhang, A., Shah, B. D., Muffly, L. S., Faramand, R. G. 2025

Abstract

Tisagenlecleucel (tisa-cel) and brexucabtagene autoleucel (brexu-cel) are approved CD19 CAR T products for young adults (YAs) with relapsed/refractory B-ALL. A distinct analysis of YAs receiving commercial CD19 CAR T has not been reported. Utilizing retrospective data from the Pediatric Real-World CAR T Consortium and the Real-World Outcomes of CAR T in Adult ALL collaboration, we describe efficacy and safety of tisa-cel and brexu-cel in 70 young adults (18-26 years; tisa-cel: 50, brexu-cel: 20). Cytokine release syndrome (CRS) and immune-effector cell associated neurotoxicity syndrome (ICANS) were observed more frequently for brexu-cel vs tisa-cel (CRS= 85% vs 56%, p=0.01; ICANS= 40% vs 18%, p=0.05). CR rates were similar between products at 80% for brexu-cel and 88% for tisa-cel (p=0.39). Relapse free survival (RFS) at 12 months was 46% for brexu-cel (95% CI 31-81%) and 36% for tisa-cel (95% CI 26-52%, p=0.79). Durability of remission over 12 months was 61% for brexu-cel (95% CI 41-93%) vs 41% for tisa-cel (95% CI 27-61%, p=0.12). 12-month overall survival (OS) for brexu-cel was 84% (95% CI 81-100) vs 68% for tisa-cel (95% CI 56-85, HR 1.9, p=0.35). In multivariate analysis, low disease burden was associated with improved OS (HR 0.23, 95% CI 0.06-0.86, p=0.03), while inotuzumab pre-CAR T was associated with inferior outcomes (OS HR 6.32, 95% CI 1.48-27, p=0.01; RFS HR 3.65, 95% CI 1.41-9.46, p=0.008). This study demonstrates comparable real-world efficacy among young adults receiving CD19 CAR T therapy irrespective of CAR T construct, however, rates of toxicity appear higher with brexu-cel.

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