强生(JNJ.US)/艾伯维(ABBV.US)遇劲敌!礼来(LLY.US)BTK抑制剂三期临床达主要终点

智通财经
Jul 29, 2025

智通财经APP获悉,礼来(LLY.US)周二宣布,其经美国食品药品监督管理局(FDA)批准的布鲁顿酪氨酸激酶抑制剂Jaypirca在针对慢性淋巴细胞白血病(CLL)或小淋巴细胞淋巴瘤(SLL)患者的三期头对头临床试验中,达到了主要研究终点,成功挑战了强生(JNJ.US)与艾伯维(ABBV.US)的同类重磅药物Imbruvica。

这项名为BRUIN CLL-314的三期研究直接比较了Jaypirca(吡妥布替尼)与Imbruvica(伊布替尼)在初诊或未接受过BTK抑制剂治疗的CLL/SLL患者中的疗效。根据公布的顶线数据,吡妥布替尼在总体缓解率(ORR)方面展现出统计学优势,无论是针对预先治疗组还是意向治疗人群,均达到非劣效性主要终点。

礼来指出,虽然无进展生存期(PFS)这一次要终点的数据尚未成熟,但已显示出有利于吡妥布替尼的趋势。这家总部位于印第安纳州的制药巨头表示,后续分析将进一步验证PFS优势。在安全性方面,Jaypirca的表现与既往研究结果一致。公司计划在今年晚些时候的医学会议上公布详细数据。

目前,Jaypirca与Imbruvica均是美国FDA批准的口服靶向药物,获批适应症包括CLL和SLL等血液系统恶性肿瘤。

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