Blood:奥英妥珠单抗(InO)治疗儿童复发性/难治性CD22阳性急性淋巴细胞白血病

2020-10-20 星云 MedSci原创

奥英妥珠单抗(Inotuzumab ozogamicin,InO)是一种CD22抗体-药物偶联物(ADC),可识别人CD22。于2017年08月17日获FDA批准用于成人复发或难治性前B细胞急性淋巴细

奥英妥珠单抗(Inotuzumab ozogamicin,InO)是一种CD22抗体-药物偶联物(ADC),可识别人CD22。于2017年08月17日获FDA批准用于成人复发或难治性前B细胞急性淋巴细胞性白血病。在国内尚未上市。

近日,《Blood》杂志上发表了一项采用推荐的II期剂量(PR2D)的InO治疗复发性/难治性(R/R)-CD22阳性急性淋巴细胞白血病(ALL)儿童患者的I期临床试验结果。

受试患者(1-18岁)每疗程接受3次INO剂量(第1、8、15天)。基于第1疗程期间的剂量限制毒性(DLT)进行剂量递增。剂量水平1(DL1)=1.4 mg/m2(0.6-0.4-0.4 mg/m2),DL2=1.8 mg/m2(0.8-0.5-0.5 mg/m2)。次要终点包括安全性、抗白血病活性和药代动力学。

共招募了25名患者(23名可进行DLT评估)。在第1个疗程时,第一个队列中,1/6(DL1)和2/5(DL2)位患者经历了DLT;随后评估认为DL2的DLT是非剂量限制性。

将用药剂量降低到DL1,同时等待修改方案以重新评估第二个队列中的DL2。在第二个队列中,0/6(DL1)和1/6(DL2)位患者发生了DLT。

最常见的不良反应

23名患者发生了3-4级不良事件;2名患者在随后的化疗后报告了肝窦阻塞综合征。

无事件生存率(EFS)和总体生存率(OS)

第1个疗程后的总有效率为80%(20/25例患者;DL1=75%,DL2=85%);84%的应答者获得最小残留疾病阴性CR;12个月总生存率为40%。9名患者在InO治疗后接受了造血干细胞移植或嵌合抗原受体T细胞移植。

InO最大浓度中位数与模拟成人浓度相当。InO耐受性良好,在经过大量预处理的CD22阳性R/R ALL儿童中显示出抗白血病活性。RP2D被确定为1.8 mg/m2/疗程,与成人相同。

原始出处:

Brivio Erica,Locatelli Franco,Lopez-Yurda Marta et al. A Phase I study of inotuzumab ozogamicin in pediatric relapsed/refractory acute lymphoblastic leukemia (ITCC-059 study).[J] .Blood, 2020, undefined: undefined.

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    2020-10-25 刘煜

    阅读谢谢分享

    0

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    2020-10-22 freve
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    2020-10-20 易水河

    学习学习

    0

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    2020-10-20 刘煜

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