康宁杰瑞制药-B(09966):安尼妥单抗(KN026)新辅助治疗BC的III期临床研究结果于2026 ASCO年会以LBA口头报告形式呈列

智通财经
Jun 01

智通财经APP讯,康宁杰瑞制药-B(09966)发布公告,与石药集团附属公司津曼特生物合作开发的安尼妥单抗(商品名:恩尼妥®,研发代号:KN026)联合注射用多西他赛(白蛋白结合型)(HB1801)新辅助治疗HER2+ BC的III期临床研究(研究编号:KN026-004)的显著性结果已于2026 ASCO年会以LBA口头报告形式呈列。

KN026-004是一项随机、对照、开放、多中心III期临床研究,旨在评估安尼妥单抗联合HB1801±卡铂对比曲妥珠单抗联合帕妥珠单抗及多西他赛±卡铂在早期及局部晚期HER2+ BC新辅助治疗中的疗效与安全性,主要终点为由BIRC评估的 tpCR。早期或局部晚期HER2+ BC患者按照1:1的比例随机入组,分别接受6周期安尼妥单抗联合HB1801±卡铂(安尼妥单抗组)或曲妥珠单抗联合帕妥珠单抗及多西他赛±卡铂(THP±Cb组)治疗。患者根据(i)临床分期;(ii)激素受体状态;(iii)是否计划使用卡铂进行分层。

在早期或局部晚期HER2 + BC患者新辅助治疗中,安尼妥单抗联合 HB1801 ± 卡铂方案,相较现有标准双重HER2阻断联合化疗方案,显著提升了tpCR率,且安全性可控。该等结果支持以安尼妥单抗为基础的治疗方案有望成为早期或局部晚期HER2 + BC新辅助治疗的全新标准疗法。

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