Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Department of Hematology, Seoul St. Mary's Hospital, Seoul, Republic of Korea.
Int J Hematol. 2022 Oct;116(4):553-562. doi: 10.1007/s12185-022-03378-w. Epub 2022 May 17.
In the phase 3 IKEMA study (NCT03275285), isatuximab (Isa) plus carfilzomib (K) and dexamethasone (d) significantly improved progression-free survival (PFS) in relapsed multiple myeloma (MM), compared with Kd. This IKEMA subgroup analysis evaluated efficacy and safety of Isa-Kd versus Kd among East Asian patients. Eligible patients had 1-3 prior lines of therapy and were stratified by number of prior lines and revised International Staging System. The primary endpoint was PFS. Key secondary endpoints included overall response, very good partial response or better (≥VGPR), minimal residual disease (MRD) negativity, and complete response (CR) rate. Forty-six East Asian patients (19 Japanese, 27 South Korean) were randomized to Isa-Kd (n = 25) or Kd (n = 21). Isa-Kd improved PFS (HR 0.64; 95% CI 0.23-1.76), ≥VGPR (80.0% vs 52.4%), MRD negativity rate (44.0% vs 9.5%), and CR (44.0% vs 23.8%). The rate of grade ≥ 3 treatment-emergent adverse events (TEAEs) was 79% for Isa-Kd versus 55% for Kd. The rate of serious TEAEs was 46% versus 50%, and the rate of TEAEs leading to treatment discontinuation was 4% versus 10%. Overall, Isa-Kd improved efficacy and safety versus Kd in East Asian patients with relapsed MM, consistent with the overall IKEMA population.
在 3 期 IKEMA 研究（NCT03275285）中，与 Kd 相比，伊沙妥昔单抗（Isa）联合卡非佐米（K）和地塞米松（d）显著改善了复发多发性骨髓瘤（MM）患者的无进展生存期（PFS）。这项 IKEMA 亚组分析评估了 Isa-Kd 与 Kd 在东亚患者中的疗效和安全性。符合条件的患者接受了 1-3 线治疗，按既往治疗线数和修订后的国际分期系统分层。主要终点是 PFS。关键次要终点包括总缓解率、非常好的部分缓解或更好（≥VGPR）、微小残留病（MRD）阴性率和完全缓解（CR）率。46 例东亚患者（19 例日本患者，27 例韩国患者）被随机分配至 Isa-Kd（n=25）或 Kd（n=21）组。Isa-Kd 改善了 PFS（HR 0.64；95%CI 0.23-1.76）、≥VGPR（80.0% vs 52.4%）、MRD 阴性率（44.0% vs 9.5%）和 CR（44.0% vs 23.8%）。Isa-Kd 的治疗相关不良事件（TEAEs）发生率≥3 级为 79%，而 Kd 为 55%。严重 TEAEs 的发生率分别为 46%和 50%，因 TEAEs 而停药的发生率分别为 4%和 10%。总体而言，在东亚复发 MM 患者中，与 Kd 相比，Isa-Kd 提高了疗效和安全性，与 IKEMA 总体人群一致。
