National Hospital Organization Okayama Medical Center, Okayama, Japan.
Shizuoka Cancer Center, Shizuoka, Japan.
Clin Lymphoma Myeloma Leuk. 2022 Aug;22(8):e751-e761. doi: 10.1016/j.clml.2022.04.005. Epub 2022 Apr 8.
In the pivotal phase III, randomized, multicenter ICARIA-MM study (NCT02990338), isatuximab plus pomalidomide and dexamethasone (Isa-Pd) improved progression-free survival and overall response rate versus pomalidomide and dexamethasone (Pd) in the overall population of patients with relapsed/refractory multiple myeloma.
In this predefined subgroup analysis, efficacy, and safety between East Asian patients and the overall population were assessed.
In total, 36 East Asian patients were included (Japanese, n = 13; Korean, n = 9; Taiwanese, n = 14). At a median follow-up of 11.6 months, median progression-free survival was not reached (95% confidence interval [CI] 5.80-not calculable) in the Isa-Pd arm and was 7.9 months (95% CI 2.90-not calculable) in the Pd arm. The hazard ratio for the between-group difference was 0.52 (95% CI 0.19-1.39), which was similar to the overall population (hazard ratio, 0.60; 95% CI 0.44-0.82). No new safety signals were observed, except that a higher proportion of patients in the East Asian population experienced Grade ≥ 3 neutropenia compared with the overall population.
These results confirm the efficacy of Isa-Pd in East Asian patients with relapsed/refractory multiple myeloma, and the related safety data are consistent with those observed in the overall population and are manageable.
在关键性的 III 期、随机、多中心 ICARIA-MM 研究（NCT02990338）中，与泊马度胺和地塞米松（Pd）相比，伊沙佐米联合泊马度胺和地塞米松（Isa-Pd）改善了复发/难治性多发性骨髓瘤患者的无进展生存期和总缓解率。
在这项预先设定的亚组分析中，评估了东亚患者与总体人群之间的疗效和安全性。
共纳入 36 例东亚患者（日本人，n=13；韩国人，n=9；台湾人，n=14）。在中位随访 11.6 个月时，Isa-Pd 组中位无进展生存期未达到（95%置信区间[CI] 5.80-不可计算），而 Pd 组为 7.9 个月（95%CI 2.90-不可计算）。组间差异的风险比为 0.52（95%CI 0.19-1.39），与总体人群相似（风险比，0.60；95%CI 0.44-0.82）。未观察到新的安全性信号，除东亚人群中更高比例的患者发生≥3 级中性粒细胞减少症外，与总体人群相比。
这些结果证实了 Isa-Pd 在东亚复发/难治性多发性骨髓瘤患者中的疗效，相关安全性数据与总体人群观察到的一致，且可管理。
