在复发性或耐火性卵泡淋巴瘤 (inMIND) 中使用tafasitamab,lenalidomide和rituximab: 全球3期随机对照试验
Laurie H Sehn1, Kai Hübel2, Stefano Luminari3
1BC Cancer Centre for Lymphoid Cancer and The University of British Columbia, Vancouver, BC, Canada.
Lancet (London, England)
|December 8, 2025
概括
在复发性或耐受性卵泡淋巴瘤患者中,添加tafasitamab与lenalidomide和rituximab显著改善了无进展的生存期. 这种组合显示出良好的安全性,表明它可能成为新的护理标准.
科学领域:
- 血液学
- 癌症学
- 免疫疗法
背景情况:
- 毛囊性淋巴瘤 (FL) 是一种复发性缓解性淋巴瘤,需要多次治疗.
- 莱纳利多米德加上利图西玛是复发性或耐药性FL的标准免疫疗法.
- 针对CD19的抗体tafasitamab被研究为其增强这种组合治疗的潜力.
研究的目的:
- 在复发性或耐火性FL患者中评估添加tafasitamab与lenalidomide和rituximab的疗效和安全性.
- 评估对无进展生存 (PFS) 和整体安全性的影响.
主要方法:
- 一个第三阶段,双盲,随机,安慰剂对照试验 (inMIND) 涉及210个全球中心的548名患者.
- 患者接受了tafasitamab或安慰剂,与lenalidomide和rituximab结合使用长达12个周期.
- 主要终点是研究人员评估的无进展生存期 (PFS).
主要成果:
- 添加tafasitamab显著降低了进展,复发或死亡的风险 (HR 0.43, p< 0. 0001).
- 与安慰剂相比,tafasitamab的PFS中位数为22. 4个月.
- 各组的不良反应相似 (99%), 中性质衰竭和腹是最常见的; 没有发生与tafasitamab治疗相关的死亡.
结论:
- 在复发性/ 耐药性FL中,tafasitamab与lenalidomide和rituximab结合提供了具有统计学意义和临床意义的PFS改善.
- 这种组合显示出可接受的安全性.
- 这种治疗方案为这种患者群体提供了潜在的新标准治疗.
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