CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
ZUMA-3 与历史试验中年龄 ≥26 岁复发/难治性 B 细胞急性淋巴细胞白血病患者的结局
英文原题：Outcomes of patients aged ≥26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials.
查看英文原题
Outcomes of patients aged ≥26 years with relapsed or refractory B-cell acute lymphoblastic leukemia in ZUMA-3 and historical trials.
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中文摘要
Brexucabtagene autoleucel（brexu-cel）是一种自体抗 CD19 CAR-T 细胞疗法，已在美国和欧盟获批用于复发/难治性 B 细胞急性淋巴细胞白血病（R/R B-ALL）成人患者（欧盟适用年龄为 26 岁及以上）。本文将 ZUMA-3 研究中年龄至少 26 岁、接受 brexu-cel 治疗患者的结局与历史标准治疗（SOC）进行比较。中位随访 26.8 个月后，II 期接受 brexu-cel 治疗患者（N=43）的总完全缓解（CR）率为 72%，中位总生存期（OS）为 25.4 个月（95% CI，15.9–未达到）。II 期患者的中位 OS 优于匹配的历史 SOC 治疗患者。与汇总的历史试验数据相比，在匹配调整间接比较（MAIC）研究中，I 期和 II 期患者的 OS 均优于接受 blinatumomab、inotuzumab 或化疗者。这些数据表明，对于年龄至少 26 岁的 R/R B-ALL 患者，brexu-cel 相较 SOC 可带来临床获益。
展开英文摘要原文
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.
论文信息
- 作者
- Minnema MC、Yin X、Davi R、Keeping S、Park JE、Itani T、Hadjivassileva T、Castaigne JG
- 第一作者单位
- University Medical Center Utrecht, Utrecht, Netherlands.Netherlands
- 通讯作者单位
- Moffitt Cancer Center, Tampa, FL, USA.United States
- 文献类型
- 非美国政府资助研究
- 期刊
- Leukemia & lymphoma2024 Oct
- 原文标识
- PubMed 38785408 · DOI 10.1080/10428194.2024.2353877