blinatumomab 的疗效和安全性：亚洲复发/难治性 B 细胞前体急性淋巴细胞白血病成人患者的事后汇总分析。
Efficacy and safety of blinatumomab: Post hoc pooled analysis in Asian adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia.
机构信息
National Cancer Center Hospital, Tokyo, Japan.
International University of Health and Welfare, Mita Hospital, Tokyo, Japan.
出版信息
Asia Pac J Clin Oncol. 2022 Jun;18(3):311-318. doi: 10.1111/ajco.13609. Epub 2021 Jun 29.
BACKGROUND
Global studies have demonstrated the efficacy and safety of blinatumomab-a BiTE (bispecific T-cell engager) targeted immuno-oncology therapy that mediates the lysis of cells expressing CD19 in patients with relapsed/refractory acute lymphoblastic leukemia (R/R ALL). Because limited data are available in Asian patients, we conducted a post hoc pooled analysis in 45 Asian adult patients with R/R ALL-19 from the blinatumomab arm of TOWER (NCT02013167) and 26 from Study 265, a phase 1b/2 study in Japanese adults (NCT02412306).
METHODS
Patients received a maximum of two cycles of induction blinatumomab for 4 weeks by continuous intravenous infusion (cycle 1/week 1: 9 μg/day; cycle 1/weeks 2-4: 28 μg/day) followed by 2 weeks of no blinatumomab (each 6-week cycle); patients received 28 μg/day blinatumomab in subsequent cycles.
RESULTS
Twenty of 45 patients enrolled (44%) achieved complete remission with full or partial hematologic recovery compared with 44% in TOWER and 80% and 38% in phase 1b and phase 2, respectively, of Study 265. The Kaplan-Meier (KM) median overall survival was 11.9 months (95% confidence interval [CI], 9.9-17.1) and the KM median duration of relapse-free survival was 8.9 months (95% CI, 3.8-10.7). Ninety-three percent of patients had grade ≥ 3 treatment-emergent adverse events (AEs) compared with 87% in TOWER and 80% and 100% in phase 1b and phase 2, respectively, of Study 265. Five patients (11.4%) had fatal AEs.
CONCLUSIONS
The safety and efficacy of blinatumomab in Asian patients were comparable with those reported in previous global studies with no new safety signals.
背景
全球研究已经证实了blinatumomab（一种双特异性 T 细胞衔接器）的疗效和安全性，该药靶向免疫肿瘤学治疗，可介导表达 CD19 的细胞溶解，用于治疗复发/难治性急性淋巴细胞白血病（R/R ALL）患者。由于亚洲患者的数据有限，我们对 TOWER 研究中blinatumomab 治疗组的 45 例亚洲成年 R/R ALL 患者（来自 NCT02013167）和日本成年患者的 265 号研究（NCT02412306）的 1 期/2 期研究中的 26 例患者进行了事后汇总分析。
方法
患者接受最多两个周期的诱导blinatumomab 治疗，持续静脉输注，为期 4 周（第 1 周期/第 1 周：9 μg/天；第 1 周期/第 2-4 周：28 μg/天），然后无 blinatumomab 2 周（每个 6 周周期）；随后的周期中患者接受 28 μg/天的 blinatumomab。
结果
45 例入组患者中有 20 例（44%）与 TOWER 研究中的 44%和 265 号研究的 1 期/2 期研究中的 80%和 38%相比，实现完全缓解，伴有完全或部分血液学恢复。Kaplan-Meier（KM）中位总生存期为 11.9 个月（95%置信区间[CI]，9.9-17.1），KM 中位无复发生存期为 8.9 个月（95%CI，3.8-10.7）。93%的患者发生了≥3 级治疗相关不良事件（AE），与 TOWER 研究中的 87%和 265 号研究的 1 期/2 期研究中的 80%和 100%相比。有 5 例患者（11.4%）发生了致命的 AE。
结论
blinatumomab 在亚洲患者中的安全性和疗效与以前的全球研究报告一致，没有新的安全性信号。
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