Outcomes of patients aged ≥26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials.

Autor: Minnema, Monique C., Yin, Xiang, Davi, Ruthanna, Keeping, Sam, Park, Julie E., Itani, Taha, Hadjivassileva, Tsveta, Castaigne, Jean-Gabriel, Damico Khalid, Rita, Zhou, Lang, Wu, James J., Shah, Bijal D.
Předmět:
Zdroj: Leukemia & Lymphoma; Oct2024, Vol. 65 Issue 10, p1438-1447, 10p
Abstrakt: Brexucabtagene autoleucel (brexu-cel) is an autologous anti-CD19 CAR T-cell therapy approved in the USA and European Union (EU) for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (R/R B-ALL; aged ≥26 years in EU). Here, outcomes for patients with R/R B-ALL aged ≥26 years in ZUMA-3 treated with brexu-cel were compared with historical standard-of-care (SOC) therapy. After median follow-up of 26.8 months, the overall complete remission (CR) rate among patients treated with brexu-cel in Phase 2 (N = 43) was 72% and median overall survival (OS) was 25.4 months (95% CI, 15.9-NE). Median OS was improved in Phase 2 patients versus matched historical SOC-treated patients. Compared with aggregate historical trial data, Phase 1 and 2 patients had improved OS versus blinatumomab, inotuzumab, and chemotherapy in a matching-adjusted indirect comparison (MAIC) study. These data demonstrate clinical benefit of brexu-cel relative to SOC in patients ≥26 years with R/R B-ALL. [ABSTRACT FROM AUTHOR]
Databáze: Complementary Index