智通财经APP获悉,阿斯利康(AZN.US)今日宣布CAPItello-281临床3期试验的积极结果。分析显示,对于PTEN缺陷型转移性激素敏感性前列腺癌(mHSPC)患者,阿斯利康的Truqap(capivasertib)联合阿比特龙(abiraterone)和雄激素剥夺疗法(ADT)与阿比特龙和ADT联合安慰剂相比,在放射学无进展生存期(rPFS)的主要终点方面表现出统计学上显著并具临床意义的改善。根据报道,Truqap组合是被证实对这种特定亚型前列腺癌有益的首个AKT抑制剂组合。
在进行本分析时,总生存期(OS)数据尚不成熟;然而Truqap联合疗法与安慰剂组相比,显示出OS改善的早期趋势。试验将按计划继续进行,以进一步评估关键次要终点OS的结果。Truqap在CAPItello-281试验中与阿比特龙和ADT联合使用的安全性与每种药物的已知安全性大致一致。
Truqap为一款具选择性、靶向3种AKT激酶异形体(AKT1/2/3)的腺苷三磷酸(ATP)竞争性抑制剂。此口服药品在许多临床项目中接受检验,治疗PI3K/AKT/PTEN信号通路变异的肿瘤。去年11月,该疗法获FDA批准用以与fulvestrant联合使用,治疗激素受体(HR)阳性、人表皮生长因子受体2(HER2)阴性的晚期或转移性乳腺癌成年患者。
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