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信達生物(01801.HK):信迪利單抗聯合化療一線治療胃或胃食管交界處腺癌的III期臨牀研究達到總生存期的主要研究終點
格隆匯 08-16 07:35

格隆匯8月16日丨信達生物(01801.HK)發佈公吿,信迪利單抗聯合化療(奧沙利鉑+卡培他濱)一線治療不可切除的局部晚期、複發性或轉移性胃或胃食管交界處腺癌的隨機、雙盲、多中心III期臨牀研究(研究代號:ORIENT-16)期中分析達到主要研究終點。

基於獨立數據監察委員會(IDMC)進行的期中分析,對於意向治療分析(ITT)人羣和PD-L1陽性人羣,信迪利單抗聯合化療對比安慰劑聯合化療均顯著延長了患者的總生存期(OS),達到預設的優效性標準,安全性特徵與既往報道的信迪利單抗相關臨牀研究結果一致,無新的安全性信號。相關研究結果將在未來的國際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)聯合奧沙利鉑和卡培他濱用於晚期胃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(CDE)進行溝通。

根據披露,ORIENT-16研究是中國首個證實PD-1單抗聯合化療一線治療能夠顯著延長晚期胃癌病人總生存期的隨機對照III期臨牀研究。胃癌是全世界最常見的惡性腫瘤之一,其中接近一半的病例發生在中國,無法手術切除的晚期或轉移性胃癌患者預後較差,目前仍以傳統化療藥物為主要治療手段,靶向藥物的優勢人羣較少,極需更加有效的治療方案。ORIENT-16研究的成功證實了信迪利單抗聯合化療在晚期胃癌一線治療中的臨牀價值,有望給廣大胃癌患者帶來新的更有效的治療選擇。公司期待達伯舒®(信迪利單抗注射液)能夠儘早惠及更多胃癌患者。

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