Outcomes of brexucabtagene autoleucel in patients with relapsed/refractory acute lymphoblastic leukemia with CNS involvement.
СтатьяМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Muhsen Ibrahim N, Roloff Gregory W, Faramand Rawan, Othman Tamer, Valtis Yannis, Kopmar Noam E, Dekker Simone E, Connor Matthew, Mercadal Santiago, O'Connor Timothy E, Dykes Kaitlyn C, Ahmed Mohamed, Jeyakumar Nikeshan, Zhang Amy, Miller Katharine, Sutherland Katherine C, Guzowski Caitlin, Gupta Vishal K, Majhail Navneet, Battiwalla Minoo, Solh Melhem M, Malik Shahbaz A, Mathews John, Oliai Caspian H, Shaughnessy Paul, Mountjoy Luke, Lee Catherine J, Logan Aaron C, Tsai Stephanie B, Leonard Jessica T, Schwartz Marc, Sasine Joshua P, Kumaran Muthu, Frey Noelle, Park Jae H, Koura Divya, Cassaday Ryan D, Shah Bijal D, Aldoss Ibrahim, Muffly Lori S, Hill LaQuisa C
Аннотация
Patients with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL) with central nervous system (CNS) involvement (CNS B-ALL) have poor outcomes and were frequently excluded from CD19-targeting chimeric antigen receptor (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 patients with CNS B-ALL using data from the ROCCA (Real-World Outcomes Collaborative for CAR T in ALL) consortium. Of 189 patients who received infusion, 31 had CNS-2 (presence of blasts in cerebrospinal fluid with <5 white blood cells [WBCs] per μL) or CNS-3 (presence of blasts with >5 WBCs per μL and/or clinical signs/symptoms) disease before apheresis and are the focus of this report. The median age was 46.5 years (range, 24-76), and 58.1% were male. Most (87.1%) received bridging therapy. After brexu-cel, 21 of 24 patients with CNS restaging (87.5%) achieved CNS-1. Additionally, 28 of 30 evaluable patients achieved marrow complete remission; 25 were measurable residual disease negative. No statistically significant differences were seen in progression-free survival or overall survival after brexu-cel among patients with or without CNS involvement. Similarly, grade 3/4 immune effector cell-associated neurotoxicity syndrome occurred similarly in patients with (35.5%) and without (30%) CNS disease. In conclusion, our data suggest that brexu-cel results in high response rates in patients with CNS B-ALL, with toxicity comparable with that in patients without CNS involvement.