Abstract
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.
Original language | English |
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Pages (from-to) | 1438-1447 |
Number of pages | 10 |
Journal | Leukemia & lymphoma |
Volume | 65 |
Issue number | 10 |
Early online date | 24 May 2024 |
DOIs | |
Publication status | Published - Oct 2024 |
Keywords
- B-cell acute lymphoblastic leukemia
- brexucabtagene autoleucel
- CAR T-cell therapy
- CD-19
- SCHOLAR-3
- ZUMA-3