信達生物(01801.HK):達伯舒®聯合達攸同®一線治療晚期肝癌III期ORIENT-32研究達到主要研究終點
格隆匯 9 月 28日丨信達生物(01801.HK)發佈公告,達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗生物類似藥)用於晚期肝癌一線治療的III期臨牀研究(ORIENT-32)在期中分析達到無進展生存期(“PFS”)及總生存期(“OS”)的主要研究終點。這是全球首個公佈達到主要研究終點的程序性細胞死亡蛋白1(“PD-1”)抑制劑聯合治療用於晚期肝癌一線治療的III期研究。
基於獨立數據監察委員會(“IDMC”)進行的期中分析,達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗生物類似藥)對比索拉非尼作為單藥治療,顯着延長了PFS及OS,達到預設的優效性標準。安全性特徵與既往報道的達伯舒®(信迪利單抗注射液)和達攸同®(貝伐珠單抗生物類似藥)的研究結果一致,無新的安全性信號。相關研究結果將在近期的學術會議上予以公佈。根據IDMC的建議,公司計劃就遞交達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗生物類似藥)用於晚期肝癌一線治療的新適應症上市申請(“sNDA”)與國家藥品監督管理局(“NMPA”)藥品審評中心進行溝通。
根據披露,目前,肝癌是中國發病率第四位、死亡率第二位的惡性腫瘤,全球每年大約一半的新發和死亡肝癌病例發生在中國。中國約85%的肝癌患者具有乙肝病毒感染的背景,與歐美國家有很大的不同。因此,針對中國肝癌患者開展臨牀研究意義重大。目前,中國批准的晚期肝癌一線治療手段索拉非尼、侖伐替尼和化療療效有限。ORIENT-32研究的結果證明信迪利單抗聯合貝伐珠單抗在中國晚期肝癌一線治療中可延長患者的OS與PFS。公司預期達伯舒®(信迪利單抗注射液)聯合達攸同®(貝伐珠單抗生物類似藥)可以惠及更多肝癌患者。
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