在123名来自德国的RRMM患者中对teclistamab的真实世界分析
C Riedhammer1, F Bassermann2, B Besemer3
1Department of Internal Medicine II, University Hospital of Würzburg, Würzburg, Germany.
Leukemia
|January 20, 2024
概括
与临床试验相比,teclistamab在现实世界复发性和耐火性多发性髓瘤患者中表现出类似的疗效和安全性. 这种双特异性抗体显示出有效性,尽管结果在特定的患者亚组中有所不同.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 免疫治疗是一种免疫疗法.
背景情况:
- 复发性和耐火性多发性骨髓瘤 (RRMM) 存在重大治疗挑战.
- 针对B细胞成熟抗原 (BCMA) × CD3的双特异性抗体,像特克利斯塔马布一样,提供了一种新的治疗方法.
- MAJESTEC-1试验证实了teclistamab的疗效,但现实世界的数据至关重要.
研究的目的:
- 为了追溯评估teclistamab在现实世界RRMM患者队列中的疗效和耐受性.
- 将现实结果与 MAJESTEC-1 试验中报告的结果进行比较.
- 为了确定潜在地对tclistamab.b.有不同的反应的患者子组.
主要方法:
- 在德国18个中心对123名RRMM患者进行了回顾性分析,这些患者接受了teclistamab治疗.
- 评估整体反应率 (ORR),无进展生存率 (PFS) 和不良事件.
- 亚组分析包括患有外骨髓性疾病,高ISS评分和之前的BCMA向治疗 (ide-cel) 的患者.
主要成果:
- 总体应答率 (ORR) 为59.3%,中位数无进展生存期 (PFS) 为8.7个月.
- 患有外骨髓性疾病,ISS第3阶段或之前的idecabtagene vicleucel (ide-cel) 的患者显示ORR和PFS较低.
- 在用ide-cel预先治疗的患者和未服用抗BCMA的患者中,响应的持续时间相似.
- 常见的不良事件包括感染和≥3级细胞衰竭.
结论:
- 在RRMM患者的现实环境中,特克利斯塔马布的疗效和安全性与MAJESTEC-1试验中观察到的相似.
- 现实世界的结果可能会受到疾病负担 (外骨髓性疾病,ISS阶段) 和先前治疗的影响.
- 德基利斯塔马布仍然是RRMM的可行的治疗选择,在仔细考虑患者特定因素的情况下.
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