文章：

达雷妥尤单抗、来那度胺和地塞米松治疗东亚复发或难治性多发性骨髓瘤患者：III期POLLUX研究亚组分析

Daratumumab, lenalidomide, and dexamethasone in East Asian patients with relapsed or refractory multiple myeloma: subgroup analyses of the phase 3 POLLUX study

原文发布日期：2018-05-01

DOI: 10.1038/s41408-018-0071-x

类型: Article

开放获取: 是

英文摘要：

In the phase 3 POLLUX study, daratumumab plus lenalidomide and dexamethasone (DRd) significantly reduced the risk of progression/death and induced deeper responses vs. lenalidomide and dexamethasone alone (Rd) in patients with relapsed/refractory multiple myeloma (RRMM). We report a subgroup analysis of East Asian (Japanese, Korean, and Taiwanese) patients from POLLUX based on a longer follow-up of 24.7 months. Median progression-free survival was not reached (NR) for DRd vs. 13.8 months for Rd (hazard ratio [HR], 0.42; 95% confidence interval [CI], 0.23–0.76), and overall response rates were higher for DRd vs. Rd (90.2 vs. 72.1%). DRd extended the median duration of response vs. Rd (NR vs. 20.2 months), and minimal residual disease–negative rates at the 10–5 sensitivity threshold were 21.2 vs. 9.1% for DRd vs. Rd. No new safety signals were observed. Similar efficacy and safety were observed in the smaller subgroup of Japanese patients treated with DRd vs. Rd. These results demonstrate favorable efficacy and safety of DRd vs. Rd in East Asian patients and also in the Japanese-only patient subgroup that are consistent with findings in the overall patient population of POLLUX.

摘要翻译： 

在3期POLLUX研究中，对于复发/难治性多发性骨髓瘤（RRMM）患者，达雷妥尤单抗联合来那度胺和地塞米松（DRd）与单用来那度胺和地塞米松（Rd）相比，显著降低了疾病进展/死亡风险并诱导了更深层次的应答。本文基于24.7个月的更长随访时间，报告POLLUX研究中东亚（日本、韩国和台湾）患者的亚组分析。DRd组的中位无进展生存期未达到（NR），而Rd组为13.8个月（风险比[HR]为0.42；95%置信区间[CI]为0.23–0.76），且DRd组的总缓解率高于Rd组（90.2% vs. 72.1%）。与Rd相比，DRd延长了中位缓解持续时间（NR vs. 20.2个月），并且在10^-5灵敏度阈值下，DRd与Rd的微小残留病阴性率分别为21.2%和9.1%。未观察到新的安全信号。在接受DRd与Rd治疗的日本患者较小亚组中，观察到类似的疗效和安全性。这些结果表明，在东亚患者以及仅日本患者亚组中，DRd与Rd相比具有更优的疗效和安全性，这与POLLUX总体患者群体的研究结果一致。

原文链接：

Daratumumab, lenalidomide, and dexamethasone in East Asian patients with relapsed or refractory multiple myeloma: subgroup analyses of the phase 3 POLLUX study