港股异动 | 康方生物(09926)涨超4% 卡度尼利联合化疗III期临床试验(AK104-302)的期中分析达到主要研究终点
康方生物(09926)涨超4%，截止发稿涨4.26%，报48.95港元，成交额7308万港元。
消息面上，公司发布公告，公司自主研发的全球首创双特异性抗体开坦尼®(卡度尼利，PD-1/CTLA-4)联合XELOX化疗方案(奥沙利铂和卡培他滨)一线治疗不可手术切除的局部晚期或转移性胃或胃食管结合部(GC/GEJC)腺癌患者的III期临床试验(AK104-302)的期中分析达到主要终点。独立数据监察委员会(IDMC)建议基于期中分析结果提前提交卡度尼利该新适应症上市申请(sNDA)。
期中分析结果显示，卡度尼利联合化疗延续了此前II期的各项疗效优势，全人群(无论PD-L1表达)长期生存获益突出：
(1)卡度尼利联合化疗显著降低全人群的死亡风险，包括PD-L1CPS≥5人群和PD-L1CPS<5人群。
(2)卡度尼利联合化疗在PD-L1CPS<5人群的OS同样具有显著疗效，显示卡度尼利联合化疗在PD-L1低表达及阴性人群中的疗效同样优异。
公司将按照IDMC建议继续高效推进该的进行，同时就该新适应症上市申请(sNDA)与国家药品监督管理局(NMPA)药品审评中心(CDE)积极进行沟通。
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