信達生物(01801.HK):信迪利單抗聯合化療一線治療食管鱗癌國際多中心III期臨牀研究(ORIENT-15)達到主要研究終點
格隆匯6月23日丨信達生物(01801.HK)發佈公吿,PD-1抑制劑信迪利單抗聯合化療(順鉑+紫杉醇╱順鉑+5-氟尿嘧啶)一線治療晚期或轉移性食管鱗癌的隨機、雙盲、國際多中心III期臨牀研究(ORIENT-15)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,不論PD-L1表達情況,信迪利單抗聯合化療對比安慰劑聯合化療,顯著延長了總生存期(OS),達到預設的優效性標準,安全性特徵與既往報導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一場主要的國際學術會議上予以公佈。
根據披露,食管癌是來源於食管黏膜上皮的惡性腫瘤,是全球最常見惡性腫瘤之一。根據GLOBOCAN2020數據,全世界食管癌新發病例約60萬,位居所有惡性腫瘤中第7位,死亡病例約54萬,位居所有惡性腫瘤中第6位。全世界食管癌超過50%的新發病例和死亡病例出現在中國,中國食管癌新發病例約32萬,死亡病例約30萬,死亡率位居所有惡性腫瘤中第4位,5年總生存率僅有30%左右。近年來,免疫檢查點抑制劑為食管癌的治療帶來新希望,公司欣喜地看到ORIENT-15的研究結果證實信迪利單抗聯合化療在食管鱗癌一線治療的人羣中顯著延長總生存期,可以惠及更多食管癌患者。
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