智通财经APP获悉,2月27日,阿斯利康(AZN.US)宣布,3期临床试验SERENA-6的中期分析显示,其在研口服选择性雌激素受体降解剂(SERD)camizestrant与CDK4/6抑制剂联用,在主要终点无进展生存期(PFS)上显示出统计学显著且具有临床意义的改善。
该试验评估了在一线治疗激素受体(HR)阳性、HER2阴性晚期乳腺癌患者过程中,当肿瘤出现新发ESR1突变时,将治疗方案从芳香化酶抑制剂(AI)联合CDK4/6抑制剂转换为camizestrant联合同一CDK4/6抑制剂,与继续使用标准治疗方案相比的效果。
据了解,SERENA-6是首个采用循环肿瘤DNA(ctDNA)检测,发现肿瘤内分泌耐药性的出现并在疾病进展前提示治疗转换的全球性3期临床试验。在SERENA-6试验中,camizestrant联合CDK4/6抑制剂的安全性与各药物已知的安全性一致,未发现新的安全性问题,两组的停药率均非常低且相似。
Camizestrant是一种效力强劲的新一代口服SERD及雌激素受体完全拮抗剂,目前正在3期试验中接受评估,用于治疗HR阳性乳腺癌。Camizestrant已在一系列临床前模型中展示出抗癌活性,包括那些具有雌激素受体激活性突变的模型。
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