康方生物-B(09926.HK):派安普利單抗(PD-1)聯合化療一線治療鱗狀非小細胞肺癌III期臨試中期分析達到主要終點
格隆匯2月24日丨康方生物-B(09926.HK)發佈公吿,公司與中國生物製藥(01177.HK)共同開發的抗PD-1單抗藥物派安普利(安尼可)(研發代號:AK105)聯合紫杉醇和卡鉑用於局部晚期或轉移性鱗狀非小細胞肺癌一線治療的III期臨牀試驗中期分析,達到主要研究終點。
該臨牀研究的中期分析結果經獨立數據監查委員會(IDMC)審核,顯示派安普利單抗聯合紫杉醇和卡鉑對比安慰劑聯合紫杉醇和卡鉑,可顯著降低疾病進展或死亡風險,主要研究終點達到方案預設的優效界值,安全性特徵與既往報導的派安普利單抗研究結果一致,無新的安全性問題。詳細的研究結果將在後續的學術會議上予以公佈。
公司和中國生物製藥有限公司計劃就遞交派安普利單抗聯合紫杉醇和卡鉑用於鱗狀非小細胞肺癌一線治療的新適應症上市申請與中國國家藥品監督管理局(“NMPA”)藥品審核中心(CDE)進行溝通。肺癌是中國目前發病率和死亡率均排名第一的惡性腫瘤,在所有肺癌中非小細胞肺癌大約佔總數的80%。
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