智通财经APP讯，康宁杰瑞制药-B(09966)发布公告，本公司与石药集团有限公司(01093)附属公司上海津曼特生物科技有限公司合作开发的KN026(KN026- 001)联合化疗二线及以上治疗HER2阳性GC(包括GEJ)的II/III期临床试验已完成首个期中分析及期中分析结果达到PFS主要终点。
KN026-001的第2部分是一项随机、双盲、安慰剂对照的III期研究，旨在评估 KN026联合化疗用于一线标准治疗失败的HER2阳性晚期不可切除或转移性GC(包括GEJ)患者的疗效。该研究的主要终点为经独立评审委员会(IRC)评估的PFS 和总生存期(OS)。
KN026-001研究第2部分的首个PFS期中分析结果已由独立数据监察委员会 (IDMC)审查，结果显示达到预先设定的PFS的主要终点，具有统计学显著性和临床意义。PFS期中分析结果显示，与现有标准治疗相比，KN026联合化疗显著改善了患者的PFS，降低了疾病进展╱死亡的风险，并具有OS获益趋势。该研究的详细数据将在近期国际学术会议上公布。
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