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匹配调整间接治疗比较:评估 Ciltacabtagene Autoleucel 在 CARTITUDE-1 中与 Belantamab Mafodotin 在 DREAMM-2 中、Selinexor-地塞米松在 STORM 第 2 部分中及 Melphalan Flufenamide-地塞米松在 HORIZON 中用于治疗三类暴露的复发/难治性多发性骨髓瘤患者的比较疗效

英文原题:Matching-Adjusted Indirect Treatment Comparison to Assess the Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 Versus Belantamab Mafodotin in DREAMM-2, Selinexor-Dexamethasone in STORM Part 2, and Melphalan Flufenamide-Dexamethasone in HORIZON for the Treatment of Patients With Triple-Class Exposed Relapsed or Refractory Multiple Myeloma.

查看英文原题

Matching-Adjusted Indirect Treatment Comparison to Assess the Comparative Efficacy of Ciltacabtagene Autoleucel in CARTITUDE-1 Versus Belantamab Mafodotin in DREAMM-2, Selinexor-Dexamethasone in STORM Part 2, and Melphalan Flufenamide-Dexamethasone in HORIZON for the Treatment of Patients With Triple-Class Exposed Relapsed or Refractory Multiple Myeloma.

PubMed 2022/05/23(内容时间) Clin Lymphoma Myeloma Leuk Q1 · IF 4.1(JCR 2025)

分数与星级只用于站内排序 —— 不代表疗效、安全性或个人适用性。

研究概要

cilta-cel 在所有结局上均较各对照药显示出更优疗效,表明其有望成为三类药物暴露的 RRMM 患者的有效治疗。

中文摘要

采用配对匹配调整间接治疗比较(MAIC),使用CARTITUDE-1中cilta-cel患者级数据及各对照试验的汇总数据(DREAMM-2中2.5 mg/kg队列、STORM第2部分改良意向治疗人群、HORIZON中三类药物难治患者)。纳入CARTITUDE-1中符合对照试验条件的患者,并对重要预后因素不平衡进行校正。估算cilta-cel相较各疗法的总缓解率、完全缓解或以上比例、无进展生存期和总生存期。

校正后,cilta-cel患者获得总缓解或完全缓解及以上的可能性至少分别增加3.1倍和10.3倍,疾病进展或死亡风险至少降低74%,死亡风险至少降低47%;这些结果均具有统计学意义。

在所有结局指标上,cilta-cel疗效均优于各对照方案,显示其有望成为治疗三类药物暴露RRMM患者的有效疗法。

展开英文摘要原文

Pairwise matching-adjusted indirect treatment comparisons (MAICs) were conducted using patient-level data for cilta-cel from CARTITUDE-1 and summary level data for each comparator (2.5 mg/kg cohort in DREAMM-2, modified intention-to-treat population in STORM Part 2, and triple-class refractory patients in HORIZON). Treated patients from CARTITUDE-1 who satisfied the eligibility of the comparator trial were included. MAICs adjusted for imbalances in important prognostic factors between CARTITUDE-1 and the comparator populations. Comparative efficacy of cilta-cel versus each therapy was estimated for overall response rate, complete response or better rate, progression-free survival, and overall survival.

After adjustment, patients treated with cilta-cel demonstrated at least a 3.1-fold and at least a 10.3-fold increase in the likelihood of achieving an overall response or complete response or better, respectively, at least a 74% reduction in the risk of disease progression or death, and at least a 47% reduction in the risk of death. These results were statistically significant.

Cilta-cel showed improved efficacy over each comparator for all outcomes, demonstrating its potential as an efficacious treatment for patients with triple-class exposed RRMM.

论文信息

作者
Weisel K、Krishnan A、Schecter JM、Vogel M、Jackson CC、Deraedt W、Yeh TM、Banerjee A
单位
University Medical Center Hamburg-Eppendorf, Hamburg, Germany. Electronic address: k.weisel@uke.de.Germany
文献类型
临床试验 · 非美国政府资助研究
期刊
Clinical lymphoma, myeloma & leukemia2022 Sep
原文标识
PubMed 35764490 · DOI 10.1016/j.clml.2022.04.025