文章：

埃洛妥珠单抗、来那度胺和地塞米松治疗复发/难治性多发性骨髓瘤（RRMM）：Ⅲ期随机ELOQUENT-2研究的最终总生存结果

Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study

原文发布日期：2020-09-04

DOI: 10.1038/s41408-020-00357-4

类型: Article

开放获取: 是

英文摘要：

Prolonging overall survival (OS) remains an unmet need in relapsed or refractory multiple myeloma (RRMM). In ELOQUENT-2 (NCT01239797), elotuzumab plus lenalidomide/dexamethasone (ERd) significantly improved progression-free survival (PFS) versus lenalidomide/dexamethasone (Rd) in patients with RRMM and 1–3 prior lines of therapy (LoTs). We report results from the pre-planned final OS analysis after a minimum follow-up of 70.6 months, the longest reported for an antibody-based triplet in RRMM. Overall, 646 patients with RRMM and 1–3 prior LoTs were randomized 1:1 to ERd or Rd. PFS and overall response rate were co-primary endpoints. OS was a key secondary endpoint, with the final analysis planned after 427 deaths. ERd demonstrated a statistically significant 8.7-month improvement in OS versus Rd (median, 48.3 vs 39.6 months; hazard ratio, 0.82 [95.4% Cl, 0.68–1.00]; P = 0.0408 [less than allotted α of 0.046]), which was consistently observed across key predefined subgroups. No additional safety signals with ERd at extended follow-up were reported. ERd is the first antibody-based triplet regimen shown to significantly prolong OS in patients with RRMM and 1–3 prior LoTs. The magnitude of OS benefit was greatest among patients with adverse prognostic factors, including older age, ISS stage III, IMWG high-risk disease, and 2–3 prior LoTs.
 

摘要翻译： 

延长总生存期（OS）仍然是复发或难治性多发性骨髓瘤（RRMM）领域未满足的临床需求。在ELOQUENT-2研究（NCT01239797）中，对于既往接受过1-3线治疗（LoTs）的RRMM患者，与来那度胺/地塞米松（Rd）方案相比，埃罗妥珠单抗联合来那度胺/地塞米松（ERd）显著改善了无进展生存期（PFS）。本文报告了经过至少70.6个月（目前RRMM中基于抗体的三联疗法最长随访记录）随访后预先计划的最终OS分析结果。研究共纳入646例既往接受1-3线治疗的RRMM患者，按1:1随机分配至ERd组或Rd组。PFS和总缓解率是共同主要终点，OS是关键次要终点，最终分析计划在427例死亡事件发生后进行。与Rd组相比，ERd组OS显著延长8.7个月（中位OS：48.3个月 vs 39.6个月；风险比0.82[95.4%置信区间0.68-1.00]；P=0.0408[低于分配的α值0.046]），这一获益在所有关键预设亚组中均一致观察到。延长随访期间未报告ERd新的安全信号。ERd是首个在既往接受1-3线治疗的RRMM患者中显示显著延长OS的基于抗体的三联方案。在伴有不良预后因素的患者中（包括高龄、ISS分期III期、IMWG高危疾病以及既往接受2-3线治疗），OS获益幅度最为显著。

原文链接：

Elotuzumab, lenalidomide, and dexamethasone in RRMM: final overall survival results from the phase 3 randomized ELOQUENT-2 study