Arvinas和辉瑞(PFE.US)蛋白降解组合疗法临床结果积极 患者临床获益率超62%

智通财经
11 Dec 2024

智通财经APP获悉,Arvinas和辉瑞公司(PFE.US)今日宣布了正在进行的1b期临床试验TACTIVE-U子研究的初步数据。该试验评估蛋白降解剂vepdegestrant与CDK4/6抑制剂abemaciclib联用,治疗局部晚期或转移性雌激素受体阳性(ER+)/人表皮生长因子受体2阴性(HER2-)乳腺癌患者的效果和安全性。所有患者均接受过CDK4/6抑制剂的治疗。来自1b期子研究的16名患者的初步结果显示,abemaciclib(150 mg,每日两次)与3期临床试验推荐剂量(200 mg,每日一次)vepdegestrant联用具有可接受的安全性,患者临床获益率达到62.5%。

Vepdegestrant是一种具有口服生物利用度的在研蛋白降解剂,旨在靶向降解雌激素受体,作为单药或组合疗法的一部分,用于治疗ER+/HER2-乳腺癌患者。

组合疗法耐受性总体上与abemaciclib的已知安全性特征,以及vepdegestrant在其它临床试验中先前观察到的结果一致。最常见的任何级别治疗伴发不良事件(TEAE)为腹泻、恶心和疲劳。没有观察到剂量限制毒性,也没有4级或5级的TEAE。

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