石药集团(01093)：安尼妥单抗联合多西他赛(白蛋白结合型)新辅助治疗HER2+乳腺癌Ⅲ期研究达到主要终点

智通财经03-31

智通财经APP讯，石药集团(01093)发布公告，本公司附属公司上海津曼特生物科技有限公司与江苏康宁杰瑞生物制药有限公司合作开发的安尼妥单抗注射液(KN026)，在联合集团自主研发的注射用多西他赛(白蛋白结合型)(HB1801)用于HER2阳性早期或局部晚期乳腺癌新辅助治疗的III期临床研究(研究方案号：KN026–004)中，达到预先设定的总体病理完全缓解率(tpCR)的主要终点，结果具有显著的...

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tpCR的患者，其无事件生存期(EFS)和总生存期(OS)均得到显著改善，尤其是在HER2阳性乳腺癌中。尽管如此，在接受标准新辅助治疗方案—曲妥珠单抗联合帕妥珠单抗和化疗(THP/TCbHP)后，仅约半数HER2阳性早期或局晚期乳腺癌患者能够获得tpCR。此外，新辅助治疗除了需提高tpCR，还旨在追求能够更早及时进行手术治疗。因此，临床上仍需探索更优且可更早实施手术的新辅助治疗方案。Neo-Healer(KN026–004)是一项随机、对照、开放、多中心、Ⅲ期临床研究，计划纳入约520例早期或局部晚期HER2阳性乳腺癌患者，按照1:1随机分配，旨在比较KN026联合HB1801±卡铂对比曲妥珠单抗联合帕妥珠单抗和多西他赛±卡铂新辅助治疗早期和局部晚期HER2 阳性乳腺癌的有效性和安全性，其主要研究终点为盲法独立评估委员会(BIRC)评估的tpCR。研究结果显示，与现有标准治疗相比，KN026联合HB1801±卡铂显著提高了患者的tpCR。该研究的详细数据将在近期国际学术会议上公布。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"1","news_tag":"dataReport","news_rank":0,"isVideo":false,"video":null,"symbols":[],"gpt_button":1,"need_auth":false,"need_login_tip":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like 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