康方生物(09926.HK)：國家藥監局已受理依達方(依沃西，PD-1/VEGF)單藥一線治療PD-L1表達陽性非小細胞肺癌的新適應症上市申請
格隆匯7月30日丨康方生物(09926.HK)公吿，中國國家藥品監督管理局(NMPA)已於近日正式受理由公司自主研發的全球首創雙特異性抗體依達方(依沃西，PD-1/VEGF)單藥一線治療PD-L1表達陽性(PD-L1 TPS≥1%)的局部晚期或轉移性非小細胞肺癌(NSCLC)的新適應症上市申請(sNDA)。
此次sNDA是基於AK112–303/HARMONi-2，該研究的期中分析已經取得了強陽性結果。在意向治療人羣(ITT)中，依沃西單藥相較於帕博利珠單藥顯著延長了患者無進展生存期(PFS)，風險比(HR)顯著優於預期。
依沃西成為全球首個且唯一在單藥頭對頭III期臨牀研究中證明療效顯著優於帕博利珠單抗的藥物。依沃西也將成為肺癌一線去化療治療的新標準方案。
據悉，依達方(依沃西)是公司自主研發的、全球首創PD-1/VEGF雙特異性腫瘤免疫治療藥物。依達方於2024年5月24日獲得NMPA批准上市，用於治療經EGFRTKI治療後進展的EGFR突變的局部晚期或轉移性非鱗狀NSCLC。目前，依沃西在中國已經獲批1項適應症，還有5項III期臨牀研究正在開展，其中包括2項國際多中心III期臨牀及4項為以PD-1單抗為陽性對照藥物的III期註冊臨牀研究。依沃西現有涵蓋消化道腫瘤、肝細胞癌、結直腸癌等16個適應症的臨牀試驗正在進行中。
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