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康方生物-B(09926.HK):Cadonilimab聯合化療一線治療GC或GEJ Ib/II期研究最新結果在2021 ASCO GI上發佈
格隆匯 01-20 06:43

格隆匯 1 月 20日丨康方生物-B(09926.HK)發佈公吿,公司核心自主研發的、全球首創的新型腫瘤免疫治療雙特異性抗體新藥Cadonilimab (PD-1/CTLA-4雙特異性抗體,研發代號:AK104)聯合化療一線治療晚期胃癌(“GC”)或胃食管結合部腺癌(“GEJ”)的Ib/II期臨牀研究最新結果在2021年國際胃腸道癌症研討會(“2021 ASCO GI”)上發佈。

研究顯示,截至2020年11月,接受Cadonilimab聯合奧沙利鉑及卡培他濱一線治療的可評估的GC或GEJ患者中,客觀緩解率(ORR)為64.1%,疾病控制率(DCR)為87.2%。4毫克╱千克隊列患者的中位隨訪時間為8.0個月,中位緩解持續時間(DoR)未達到,6個月無進展生存期率(PFS)為76.5%。在已入組的10毫克╱千克隊列患者中,3例達到部分緩解(75%),1例靶病灶縮小22%,仍在治療評估中。

研究的安全性結果顯示,與Cadonilimab或化療相關的3級及以上不良反應發生率為38.9%,其中3級及以上與免疫相關的不良反應發生率為7.4%。研究顯示,Cadonilimab10毫克╱千克每兩星期一次(Q2W)聯合化療一線治療GC或GEJ顯示出良好的安全性和耐受性。與化療聯合一線治療GC或GEJ,Cadonilimab在各劑量水平下均表現出令人鼓舞的抗腫瘤活性、持續的腫瘤應答,並可改善晚期GC患者的無進展生存期。目前,Cadonilimab聯合化療一線治療GC或GEJ的III期研究正在計劃中。Cadonilimab佈局的主要適應症還包括肝癌、宮頸癌、肺癌、食管鱗癌及鼻咽癌等。

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