康方生物依沃西获批用于PD-L1阳性肺癌治疗

财中社
28 Apr

  4月27日,康方生物(09926)发布公告,宣布其自主研发的双特异性抗体依达方®(依沃西,PD-1/VEGF)获得中国国家药品监督管理局(NMPA)批准,用于一线治疗PD-L1阳性非小细胞肺癌(NSCLC)。

  这是依沃西获得的第二个适应症,标志着中国患者能够率先使用全球最优治疗方案。公告中提到,依沃西在临床研究中表现出显著的疗效,其与帕博利珠单抗的比较显示,中位无进展生存期(PFS)分别为11.14个月和5.82个月,依沃西组的疾病进展/死亡风险降低49%。

  此外,在中期分析中,依沃西相较于帕博利珠单抗显著降低死亡风险22.3%。此次批准不仅为NSCLC的治疗提供了新的选择,也显示了依沃西的潜力,成为全球首个在头对头研究中获得显著阳性结果的药物。

(文章来源:财中社)

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