在耐火性多发性骨髓瘤中使用贝兰他马布 (Belantamab mafodotin,pomalidomide和dexamethasone):一个1/2阶段试验
Suzanne Trudel1, Arleigh McCurdy2, Martha L Louzada3
1Princess Margaret Cancer Centre, University Health Network, Toronto, Ontario, Canada. suzanne.trudel@uhn.ca.
Nature medicine
|January 4, 2024
概括
新型疗法对于复发性多发性骨髓瘤至关重要. 贝兰他马布 (Belantamab mafodotin) 加上波马利多米德和德克萨米,在三级耐火患者中显示了85.3%的整体反应率,提供了持久的反应和有希望的生存结果.
科学领域:
- 血液学 血液学 血液学
- 在瘤学瘤学.
- 临床试验 临床试验
背景情况:
- 多发性骨髓瘤治疗标准的不断变化导致很大一部分患者在复发时暴露于三重类,需要新的治疗策略.
- 针对B细胞成熟抗原 (BCMA) 的生物药物代表了复发性多发性髓瘤患者的有希望的新疗法.
研究的目的:
- 评估贝兰他马布 (belantamab mafodotin) - - 一种抗BCMA抗体 - - 药物结合物的安全性和有效性,与波马利多米德和德克萨米他结合使用.
- 确定推的第二部分剂量 (RP2D) 并评估复发多发性骨髓瘤患者的剂量限制毒性.
主要方法:
- ALGONQUIN试验 (NCT03715478) 是一项由两部分组成的研究,评估了贝兰他马布 (Belantamab) 的不同剂量和时间表,以及波马利多米德 (Pomalidomide) 和甲.
- 该研究包括了耐雷利多米德和暴露于蛋白酶体抑制剂的患者,其中55.2%是三级耐雷利的患者.
主要成果:
- 确定了RP2D,RP2D的整体响应率 (ORR) 为85.3% (n=38),≥非常好的部分响应率为75.7%.
- 预计两年无进展生存率为52.8%,随访时间中位数为13.9个月.
- 常见的不良事件包括最佳校正视敏度下降 (71.1%) 和角膜病变 (65.8%),这些都是可控的.
结论:
- 贝兰他马布 (Belantamab mafodotin) 与波马利多米德 (pomalidomide) 和甲 (dexamethasone) 结合,在复发性多发性骨髓瘤中显示出持久的反应和有希望的整体存活率.
- 组合疗法在RP2D表现出更好的耐受性与可管理的眼部不良事件,而不会影响疗效.
- 预计DREAMM-8研究的第三阶段将进一步证实这些发现.
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