在患有扩散阶段小细胞肺癌的患者中Ifinatamab Deruxtecan:第二阶段IDeate-Lung01试验的初级分析
Charles M Rudin1, Melissa L Johnson2, Luis Paz-Ares3
1Memorial Sloan Kettering Cancer Center, New York, NY.
概括
伊菲纳塔马布德鲁克斯泰干 (I-DXd) 显示出对扩散阶段小细胞肺癌 (ES-SCLC) 患者有希望的疗效. 治疗显示了48.2%的客观反应率,并有可控的副作用.
科学领域:
- 在瘤学瘤学.
- 药理学 药理学是指药理学的学科.
- 临床试验 临床试验
背景情况:
- 扩散阶段小细胞肺癌 (ES-SCLC) 对复发性或进展性疾病的治疗选择有限.
- 需要新的治疗策略来改善先前治疗的ES-SCLC患者的治疗结果.
研究的目的:
- 为了评估ifinatamab deruxtecan (I-DXd) 的疗效和安全性,ifinatamab deruxtecan是一种B7同源的3导抗体-药物结合物.
- 为了确定I-DXd的最佳剂量和响应率,先前治疗ES-SCLC的患者.
主要方法:
- 一项II期随机试验,涉及183名先前接受治疗的ES-SCLC患者.
- 患者接受了每3周一次静脉注射8或12毫克/公斤的I-DXd,主要终点是客观反应率 (ORR).
- 根据RECIST,版本1.1,使用盲目独立中央审查来分析数据.
主要成果:
- 12毫克/公斤剂量的确定的ORR为48.2% (95% CI,39.6至56.9),响应的中位持续时间为5.3个月.
- 无进展生存时间的中位数为4.9个月,9个月的整体生存估计为59.1%.
- 与治疗相关的不良事件 (TRAEs) 在89.8%的患者中发生;恶心,贫血和中性质减退是最常见的. 级别≥3的TRAE发生在36.5%的人群中.
结论:
- 伊菲纳塔马布德鲁克斯泰坎 (I-DXd) 每3周服用12毫克/公斤,在先前治疗的ES-SCLC中显示出有前途的疗效.
- 安全性概况与先前的研究一致,没有发现新的安全问题.
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