Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma
Elotuzumab Therapy for Relapsed or Refractory Multiple Myeloma
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DOI：
10.1056/nejmoa1505654
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发表时间：
2015-08-13
影响因子：
158.5
通讯作者：
Richardson, Paul
中科院分区：
文献类型：
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作者：
Lonial, Sagar;Dimopoulos, Meletios;Richardson, Paul
研究背景罗妥珠单抗是一种靶向信号淋巴细胞活化分子F7（SLAMF 7）的免疫刺激性单克隆抗体，在复发或难治性多发性骨髓瘤患者的1b-2期研究中与来那度胺和地塞米松联合显示出活性。我们将患者随机分配接受埃罗妥珠单抗联合来那度胺和地塞米松治疗，（埃罗妥珠单抗组）或单独的来那度胺和地塞米松（对照组）。共同主要终点为无进展生存期和总缓解率。共同主要终点的最终结果是在计划的无进展生存期中期分析的基础上报告的。总的来说，321名患者被分配到埃罗妥珠单抗组，325名患者被分配到对照组。在中位随访24.5个月后，埃罗妥珠单抗组1年的无进展生存率为68%，而对照组为57%; 2年的无进展生存率分别为41%和27%。埃罗妥珠单抗组的中位无进展生存期为19.4个月，对照组为14.9个月（埃罗妥珠单抗组进展或死亡的风险比为0.70; 95%置信区间为0.57至0.85; P
BACKGROUNDElotuzumab, an immunostimulatory monoclonal antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7), showed activity in combination with lenalidomide and dexamethasone in a phase 1b-2 study in patients with relapsed or refractory multiple myeloma.METHODSIn this phase 3 study, we randomly assigned patients to receive either elotuzumab plus lenalidomide and dexamethasone (elotuzumab group) or lenalidomide and dexamethasone alone (control group). Coprimary end points were progression-free survival and the overall response rate. Final results for the coprimary end points are reported on the basis of a planned interim analysis of progression-free survival.RESULTSOverall, 321 patients were assigned to the elotuzumab group and 325 to the control group. After a median follow-up of 24.5 months, the rate of progression-free survival at 1 year in the elotuzumab group was 68%, as compared with 57% in the control group; at 2 years, the rates were 41% and 27%, respectively. Median progression-free survival in the elotuzumab group was 19.4 months, versus 14.9 months in the control group (hazard ratio for progression or death in the elotuzumab group, 0.70; 95% confidence interval, 0.57 to 0.85; P