信達生物(01801.HK):國藥監局受理達伯舒®((信迪利單抗注射液)聯合健擇®((注射用吉西他濱)和鉑類化療用於治療一線鱗狀非小細胞肺癌患者的新適應症申請
格隆匯 8 月 12日丨信達生物(01801.HK)宣佈,集團和禮來製藥("禮來")共同開發的創新PD-1抑制劑達伯舒®(信迪利單抗注射液)聯合健擇®(注射用吉西他濱)和鉑類化療用於鱗狀非小細胞肺癌("NSCLC")一線治療的新適應症申請(該"sNDA")獲國家藥品監督管理局("NMPA")正式受理。最近,NMPA已於2020年4月23日正式受理達伯舒?(信迪利單抗注射液)聯合力比泰®(注射用培美曲塞二鈉)和鉑類用於非鱗狀NSCLC一線治療的sDNA。
該sNDA基於一項隨機、雙盲、III期對照臨牀研究(ORIENT-12)-達伯舒®(信迪利單抗注射液)或安慰劑聯合健擇?(注射用吉西他濱)和鉑類用於晚期或轉移性鱗狀NSCLC一線治療。基於獨立數據監察委員會進行的分析,達伯舒®(信迪利單抗注射液)聯合健擇?(注射用吉西他濱)和鉑類對比安慰劑聯合健擇?(注射用吉西他濱)和鉑類,顯着延長了無進展生存期("PFS"),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研究結果一致,無新的安全性信號。詳細的研究數據將在今後的國際學術大會和學術期刊中公佈。
據悉,肺癌是中國目前發病率和死亡率均排名第一的惡性腫瘤。在所有肺癌診斷中NSCLC大約佔80%至85%,中國NSCLC患者中約35%為缺乏驅動基因的鱗狀NSCLC。對於該羣患者,治療手段仍然有限。ORIENT-12研究是全球首個證實PD-1抗體聯合吉西他濱和鉑類這一方案能夠顯着改善一線鱗狀NSCLC患者無進展生存獲益的研究,該研究結果具有重要的臨牀意義。達伯舒?(信迪利單抗注射液)是本集團和禮來在中國共同合作研發的具有國際品質的創新生物藥。
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