In the phase II ELOQUENT-3 trial (ClinicalTrials.gov identifier: NCT02654132), elotuzumab combined with pomalidomide/dexamethasone (EPd) significantly improved progression-free survival (PFS) versus pomalidomide/dexamethasone (Pd) in patients with relapsed/refractory multiple myeloma (RRMM) previously treated with lenalidomide and a proteasome inhibitor (PI). Here, we present the final overall survival (OS) results.

Patients with RRMM who had received ≥ 2 prior lines of therapy, with disease refractory to last therapy and either refractory or relapsed and refractory to lenalidomide and a PI were randomly assigned (1:1) to receive EPd or Pd. The primary end point was PFS per investigator assessment. ORR and OS were secondary end points planned to be tested hierarchically.

A total of 117 patients were randomly assigned to EPd (n = 60) and Pd (n = 57). Among treated patients (EPd 60, Pd 55), there were 37 (61.7%) deaths in the EPd group and 41 (74.5%) in the Pd group, most commonly because of disease progression (EPd 41.7%, Pd 49.1%). Median (95% CI) OS was significantly improved with EPd (29.8 [22.9 to 45.7] months) versus Pd (17.4 [13.8 to 27.7] months), with a hazard ratio of 0.59 (95% CI, 0.37 to 0.93; P = .0217). OS benefit with EPd was observed in most patient subgroups. The safety profile of EPd was consistent with prior reports with no new safety signals detected.

EPd demonstrated a statistically significant improvement in OS versus Pd in patients with RRMM previously treated with lenalidomide and a PI who had disease refractory to last therapy. In this setting, ELOQUENT-3 is the first randomized study of a triplet regimen incorporating a monoclonal antibody and Pd to improve both PFS and OS significantly.

在 II 期 ELOQUENT-3 试验（ClinicalTrials.gov 标识符：NCT02654132）中，与泊马度胺/地塞米松 (Pd) 相比，elotuzumab 联合泊马度胺/地塞米松 (EPd) 显着改善了复发/难治性多发性骨髓瘤患者的无进展生存期 (PFS) (RRMM) 以前用来那度胺和蛋白酶体抑制剂 (PI) 治疗过。在这里，我们展示了最终的总体生存 (OS) 结果。

既往接受过 ≥ 2 线治疗的 RRMM 患者，其疾病对上次治疗难治，且对来那度胺和 PI 难治或复发且难治，被随机分配 (1:1) 接受 EPd 或 Pd。主要终点是研究者评估的 PFS。ORR 和 OS 是计划分层测试的次要终点。

共有 117 名患者被随机分配到 EPd（n = 60）和 Pd（n = 57）。在接受治疗的患者中（EPd 60，Pd 55），EPd 组有 37 例（61.7%）死亡，Pd 组有 41 例（74.5%）死亡，最常见的原因是疾病进展（EPd 41.7%，Pd 49.1%）。EPd（29.8 [22.9 至 45.7] 个月）与 Pd（17.4 [13.8 至 27.7] 个月）相比，中位（95% CI）OS 显着改善，风险比为 0.59（95% CI，0.37 至 0.93；P = .0217）。在大多数患者亚组中观察到 EPd 的 OS 获益。EPd 的安全性与之前的报告一致，没有检测到新的安全信号。

EPd 表明，在先前接受过来那度胺治疗的 RRMM 患者中，OS 与 Pd 相比具有统计学意义的显着改善，而 PI 的疾病对上次治疗难以治愈。在这种情况下，ELOQUENT-3 是第一个结合单克隆抗体和 Pd 的三联疗法显着改善 PFS 和 OS 的随机研究。