Inotuzumab ozogamicin (InO) is a targeted treatment for adults with relapsed or refractory B-cell acute lymphoblastic leukemia (ALL). InO was previously studied in INO-VATE, an international, open-label, randomized phase 3 trial comparing InO against standard of care (SoC). In the present subgroup analysis, we evaluated outcomes in the 55 Asian patients who were randomized in INO-VATE (31 InO and 24 SoC). Complete remission (CR) or CR with incomplete hematologic recovery (CRi) was achieved in 22/31 patients treated with InO versus 5/24 treated with SoC. In the InO arm, more of the patients achieving CR/CRi were minimal residual disease (MRD)-negative (17/22 versus 1/5), and more patients proceeded directly to hematopoietic stem cell transplantation (15/31 versus 3/24). Median overall survival for the respective arms was 5.8 versus 3.9 months (hazard ratio 0.67; 97.5% CI 0.28, 1.62). In the safety analysis (n = 51), the most common adverse events were hematologic. Sinusoidal obstruction syndrome was reported in five InO patients and one SoC patient. In conclusion, Asian patients with relapsed or refractory B-cell ALL experienced improved efficacy with InO versus SoC, with an efficacy and safety profile consistent with results of the overall INO-VATE population.Clinical trial registration: ClinicalTrials.gov identifier: NCT01564784.

中文翻译：

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在患有复发性/难治性急性淋巴细胞白血病的亚洲患者中，依托珠单抗奥佐米星与标准治疗的比较。

伊诺单抗ozogamicin（InO）是针对复发或难治性B细胞急性淋巴细胞白血病（ALL）的成年人的靶向治疗。InO之前曾在INO-VATE中进行过研究，INO-VATE是一项将InO与护理标准（SoC）进行比较的国际性，开放标签，随机第3期试验。在本亚组分析中，我们评估了55例在INO-VATE中随机分组的亚洲患者（31个InO和24个SoC）的结局。使用InO治疗的22/31患者与使用SoC治疗的5/24患者达到了完全缓解（CR）或血液学不完全恢复（CRi）。在InO组中，更多获得CR / CRi的患者为最小残留疾病（MRD）阴性（17/22对1/5），并且更多患者直接进行了造血干细胞移植（15/31对3/24） ）。各个组的总中位生存期分别为5.8和3。9个月（危险比0.67; 97.5％CI 0.28，1.62）。在安全性分析中（n = 51），最常见的不良事件是血液学。5例InO患者和1例SoC患者报告了正弦阻塞综合征。总之，亚洲人复发或难治性B细胞ALL患者与SoC相比使用InO的疗效有所提高，其有效性和安全性与整个INO-VATE人群的结果一致。临床试验注册：ClinicalTrials.gov标识符：NCT01564784。