智通财经APP获悉,阿斯利康(AZN.US)和默沙东(MRK.US)今日公布了3期临床试验OlympiA的长期结果。研究显示,PARP抑制剂Lynparza(olaparib,奥拉帕利)在携带种系BRCA突变(gBRCAm)的HER2阴性高危早期乳腺癌患者中持续显著改善患者的总生存期(OS)、无侵袭性疾病生存期(IDFS)和无远处疾病生存期(DDFS)。
在中位随访时间达6.1年时,在已完成局部治疗及标准新辅助或辅助化疗的患者中,Lynparza与安慰剂相比,将死亡风险降低了28%(HR=0.72;95% CI:0.56-0.93)。此外,接受Lynparza治疗的患者中87.5%仍然存活,而安慰剂组这一数值为83.2%。
Lynparza则是一种“first-in-class"的PARP抑制剂,也是首个合成致死靶向治疗药物,用于靶向带有同源重组修复(HRR)缺陷的细胞/肿瘤(如携带BRCA1和/或BRCA2突变的细胞)。基于3期临床试验OlympiA的结果,Lynparza已在美国、欧盟、日本及许多其他国家和地区获批,用于治疗gBRCAm、HER2阴性高危早期乳腺癌。此外,它还获批在美国、欧盟、日本及许多其他国家和地区用于治疗gBRCAm、HER2阴性转移性乳腺癌。
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