强生(JNJ.US)单抗疗法达到3期临床主要终点 显著延缓高风险SMM进展

智通财经
06 Nov 2024

智通财经APP获悉,美国血液学会(ASH)公布了2024年会上部分研究的摘要。其中,强生(JNJ.US)公司开发的抗CD38抗体Darzalex(daratumumab)在名为Aquila的3期临床试验中达到主要终点,显著延缓高风险冒烟性多发性骨髓瘤(SMM)患者的疾病进展。

摘要指出,Darzalex单药治疗耐受性良好,与积极监测相比,在预防或延缓高风险SMM患者进展为活动性MM方面显示出统计显著且具有临床意义的益处。

公开资料显示,SMM是多发性骨髓瘤(MM)的前期无症状阶段,可能发展为活动性多发性骨髓瘤,目前尚无获批的治疗方案。不过新近研究显示,有高风险进展为MM的患者可能从早期治疗中获益。Darzalex是一款靶向CD38的人源化单克隆抗体,已经获批治疗复发/难治性MM,并与标准治疗联用一线治疗初治MM患者。Aquila研究旨在确定Darzalex与积极监测相比,是否更有效地延缓MM的进展。

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