再鼎医药(09688):安进贝玛妥珠单抗FORTITUDE-101 III期临床研究最新进展

智通财经
Yesterday

智通财经APP讯,再鼎医药(09688)发布公告,据安进公司,公司的合作伙伴和该项研究的申办方,评估贝玛妥珠单抗联合化疗(mFOLFOX6)用于一线胃癌治疗的 FORTITUDE-101 III 期临床研究已完成最终分析。

在该研究预设的中期分析(即主要分析)时,贝玛妥珠单抗联合化疗方案对比单独化疗在总生存期方面显示出具有显著统计学意义和临床意义的改善。然而,在最终分析中,此前观察到的生存获益幅度减弱。安进表示中期分析和最终分析的结果将在即将举行的主要医学会议上公布。

根据 FORTITUDE-101 研究的更新结果,公司计划在提交注册申请之前等待 FORTITUDE-102研究(其旨在评估贝玛妥珠单抗联合纳武利尤单抗及化疗用于相同的患者人群)的结果。预计FORTITUDE-102研究的数据将在2025年底或2026年上半年公布。

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