贝林妥欧单抗对比化疗治疗晚期急性淋巴细胞白血病
Blinatumomab versus Chemotherapy for Advanced Acute Lymphoblastic Leukemia
贝林妥欧单抗是一种双特异性抗体，能让T细胞识别并杀灭带CD19的白血病细胞，此前仅凭单臂试验获批。这项多中心3期试验将405例经多线治疗的成人B细胞前体急性淋巴细胞白血病患者按2:1随机分入贝林妥欧单抗组或标准化疗组，主要终点是总生存。贝林妥欧单抗组中位总生存7.7个月，化疗组4.0个月；12周内完全缓解率也更优（34%对16%），无事件生存和缓解持续时间同样更好，两组严重不良事件比例相近。这为贝林妥欧单抗在复发难治患者中的疗效提供了随机对照证据。
为什么推荐给您：双特异性抗体首个关键3期随机试验阳性，会改变复发难治B-ALL临床实践。
不需要生物学背景，多打比方
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摘要Abstract
BACKGROUND: Blinatumomab, a bispecific monoclonal antibody construct that enables CD3-positive T cells to recognize and eliminate CD19-positive acute lymphoblastic leukemia (ALL) blasts, was approved for use in patients with relapsed or refractory B-cell precursor ALL on the basis of single-group trials that showed efficacy and manageable toxic effects.
METHODS: In this multi-institutional phase 3 trial, we randomly assigned adults with heavily pretreated B-cell precursor ALL, in a 2:1 ratio, to receive either blinatumomab or standard-of-care chemotherapy. The primary end point was overall survival.
RESULTS: Of the 405 patients who were randomly assigned to receive blinatumomab (271 patients) or chemotherapy (134 patients), 376 patients received at least one dose. Overall survival was significantly longer in the blinatumomab group than in the chemotherapy group. The median overall survival was 7.7 months in the blinatumomab group and 4.0 months in the chemotherapy group (hazard ratio for death with blinatumomab vs. chemotherapy, 0.71; 95% confidence interval [CI], 0.55 to 0.93; P=0.01). Remission rates within 12 weeks after treatment initiation were significantly higher in the blinatumomab group than in the chemotherapy group, both with respect to complete remission with full hematologic recovery (34% vs. 16%, P<0.001) and with respect to complete remission with full, partial, or incomplete hematologic recovery (44% vs. 25%, P<0.001). Treatment with blinatumomab resulted in a higher rate of event-free survival than that with chemotherapy (6-month estimates, 31% vs. 12%; hazard ratio for an event of relapse after achieving a complete remission with full, partial, or incomplete hematologic recovery, or death, 0.55; 95% CI, 0.43 to 0.71; P<0.001), as well as a longer median duration of remission (7.3 vs. 4.6 months). A total of 24% of the patients in each treatment group underwent allogeneic stem-cell transplantation. Adverse events of grade 3 or higher were reported in 87% of the patients in the blinatumomab group and in 92% of the patients in the chemotherapy group.
CONCLUSIONS: Treatment with blinatumomab resulted in significantly longer overall survival than chemotherapy among adult patients with relapsed or refractory B-cell precursor ALL. (Funded by Amgen; TOWER ClinicalTrials.gov number, NCT02013167 .).