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Outcomes of Brexucabtagene Autoleucel in Relapsed/Refractory Acute Lymphoblastic Leukemia Patients with CNS Involvement.

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Outcomes of Brexucabtagene Autoleucel in Relapsed/Refractory Acute Lymphoblastic Leukemia Patients with CNS Involvement. Blood advances Muhsen, I. N., Roloff, G. W., Faramand, R. G., Othman, T., Valtis, Y. K., Kopmar, N. E., Dekker, S. E., Connor, M., Mercadal, S., O'Connor, T. E., Dykes, K. C., Ahmed, M., Jeyakumar, N., Zhang, A., Miller, K., Sutherland, K. C., Guzowski, C., Gupta, V. K., Majhail, N. S., Battiwalla, M., Solh, M. M., Malik, S. A., Mathews, J., Oliai, C., Shaughnessy, P. J., Mountjoy, L., Lee, C. J., Logan, A. C., Tsai, S. B., Leonard, J. T., Schwartz, M. S., Sasine, J. P., Kumaran, M., Frey, N. V., Park, J. H., Koura, D., Cassaday, R. D., Shah, B. D., Aldoss, I., Muffly, L. S., Hill, L. C. 2025

Abstract

Relapsed/Refractory (r/r) B-cell acute lymphoblastic leukemia patients with central nervous system involvement (CNS B-ALL) have poor outcomes and were frequently excluded from CD19-targeting chimeric antigen receptor T-cell (CAR T-cell) clinical trials. The efficacy and safety of brexucabtagene autoleucel (brexu-cel) in adults with r/r B-ALL was established by the ZUMA-3 trial, which excluded patients with advanced or symptomatic CNS involvement. In this retrospective multicenter analysis, we investigated the safety and efficacy of brexu-cel in CNS B-ALL patients utilizing data from the Real-World Outcomes Collaborative for CAR T in ALL (ROCCA) consortium. Of 189 patients infused, 31 had CNS-2 (presence of blasts in CSF with < 5 WBC/uL) or CNS-3 (presence of blasts with >5 WBC/uL and/or clinical signs/symptoms) disease pre-apheresis and are the focus of this report. The median age was 46.5 years (range, 24-76), and 58.1% were males. Most (87.1%) received bridging therapy. Following brexu-cel, 21 of 24 with CNS restaging (87.5%) achieved CNS-1. Additionally, 28 of 30 evaluable patients achieved marrow complete remission (CR); 25 were MRD-negative. No statistically significant differences were seen in progression-free survival (PFS) or overall survival (OS) following brexu-cel among patients with or without CNS involvement. Similarly, grade 3-4 immune effector cell associated neurotoxicity syndrome (ICANS) occurred similarly in patients with (35.5%) and without CNS disease (30%). In conclusion, our data suggest that brexu-cel results in high response rates in CNS B-ALL patients with toxicity comparable to patients without CNS involvement.

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