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康方生物(09926.HK):國家藥監局批準開坦尼®(卡度尼利,PD-1/CTLA-4)用於一線治療宮頸癌的新適應症上市申請

格隆匯6月5日丨康方生物(09926.HK)發佈公告,中國國家藥品監督管理局(“NMPA”)已正式批準開坦®(卡度尼利,PD-1/CTLA-4)聯合含鉑化療聯合或不聯合貝伐珠單抗一線治療持續、復發或轉移性宮頸癌的新適應症上市申請(“sNDA”)。該項適應症的獲批填補了國內一線宮頸癌患者中免疫治療的空白,這也是卡度尼利的第三項全人羣獲批的適應症。

本次獲批是基於COMPASSION-16/AK104-303研究,該研究已達到無進展生存期(PFS)和總生存期(OS)雙陽性結果。在意向治療(ITT)人羣中,卡度尼利聯合方案相比標準治療在一線宮頸癌全人羣中顯着延長了PFS和OS,亞組分析顯示,無論PD-L1陽性表達或陰性表達人羣、無論是否聯合貝伐珠單抗,卡度尼利均具有臨牀獲益。

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