智通财经APP获悉，8月17日，阿斯利康(AZN.US)和第一三共联合宣布Enhertu(德曲妥珠单抗)单药一线治疗非小细胞肺癌(NSCLC)的III期DESTINY-Lung04研究取得了高水平的积极结果。
该研究是一项全球性、随机、多中心、开放标签临床试验(n=454)，评估了Enhertu对比标准治疗(帕博利珠单抗联合含铂双药化疗)一线治疗携带HER2外显子19或外显子20突变的不可切除的局部晚期或转移性非鳞状NSCLC患者的有效性和安全性。研究的主要终点是无进展生存期(PFS)。
结果显示，Enhertu组患者的PFS较标准治疗组实现了统计学显著且临床意义显著的改善。该研究将按计划继续进行，以评估包括总生存期(OS)在内的次要终点。
值得一提的是，Enhertu是第一个在III期研究中成功证明单药相较标准治疗作为一线治疗方案能够改善NSCLC患者的PFS的ADC药物。
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