康方生物-B(09926.HK):卡度尼利聯合化療一線治療晚期胃癌╱胃食管結合部腺癌Ib/II期臨牀研究成果在2022 ASCO GI發佈
格隆匯1月21日丨康方生物-B(09926.HK)發佈公吿,公司自主研發的全球首創新型腫瘤免疫治療新藥卡度尼利(PD-1/CTLA-4雙特異性抗體,研發代號:AK104)聯合卡培他濱、奧沙利鉑(XELOX)一線治療晚期胃癌或胃食管結合部腺癌(GC/GEJ)的Ib/II期臨牀研究數據在2022年美國臨牀腫瘤學會胃腸道腫瘤研討會(ASCOGI)上發佈。
該研究是一項針對未接受過全身治療的不可切除的局晚期或轉移性GC/GEJ患者的多中心、開放性臨牀試驗(臨牀試驗代碼NCT03852251),入組患者不考慮PD-L1表達水平,但已知HER2陽性患者除外。主要研究終點安全性和客觀緩解率(ORR)。截止至2021年8月13日,研究納入共計96例患者,中位隨訪時間為9.95個月。研究數據顯示了卡度尼利聯合化療在一線治療GC/GEJ中優異的抗腫瘤活性和安全性,卡度尼利聯合化療有望為未經治療的不可切除的局晚期或轉移性GC/GEJ患者帶來更高效的一線治療選擇。
安全性方面,卡度尼利聯合XELOX的安全性良好,≥3級治療相關不良事件(TRAE)為62.5%,未發現新的安全信號。目前,卡度尼利聯合XELOX對比安慰劑聯合XELOX一線治療晚期胃或胃食管結合部腺癌的III期關鍵性註冊性試驗已於2021年8月啟動,進展順利(臨牀試驗代碼NCT05008783)。公司有望於2024年遞交該項適應症的NDA申請。
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