信達生物(01801.HK):NMPA理達伯舒®(信迪利單抗注射液)聯合化療治療一線食管鱗癌新適應症申請
格隆匯9月23日丨信達生物(01801.HK)發佈公吿,國家藥品監督管理局(“NMPA”)已經正式受理達伯舒®(信迪利單抗注射液)聯合化療(順鉑+紫杉醇╱順鉑+5-氟尿嘧啶)一線治療食管鱗癌(“ESCC”)的新適應症上市申請(“sNDA”)。
此次新適應症申請是基於一項隨機、雙盲、國際多中心III期臨牀研究的期中分析(ORIENT-15)-信迪利單抗聯合化療對比安慰劑聯合化療一線治療晚期或轉移性ESCC。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。ORIENT-15的研究結果於2021年於歐洲腫瘤醫學會(“ESMO”)年會上發表。
根據披露,在中國,食管癌是發病率第5位、死亡率第4位的惡性腫瘤,以鱗癌為主。晚期或轉移性ESCC既往一線化療的中位總生存期有限,存在巨大未滿足的臨牀需求。ORIENT-15研究結果證實信迪利單抗聯合化療(順鉑+紫杉醇╱順鉑+5-氟尿嘧啶)在食管鱗癌一線治療的人羣中顯著延長了OS和無進展生存期(“PFS”)。公司希望為中國ESCC患者儘快帶來新的治療方案。
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