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基石藥業-B(02616.HK):舒格利單抗一線治療胃/胃食管結合部腺癌的註冊性臨牀研究達到總生存期主要終點
格隆匯 08-29 08:06

格隆匯8月29日丨基石藥業-B(02616.HK)發佈公吿,舒格利單抗聯合化療一線治療無法手術切除的PD-L1表達≥5%的局部晚期或轉移性胃/胃食管結合部腺癌的III期研究(GEMSTONE-303)達到了總生存期(OS)主要研究終點。與安慰劑聯合化療對照組相比,舒格利單抗聯合化療能顯著延長患者總生存期,且差異具有統計學顯著性與臨牀意義。安全性與既往報道的舒格利單抗相關臨牀研究結果一致,未發現新的安全性信號。

基石藥業首席執行官兼執行董事楊建新博士表示:“我們很高興看到舒格利單抗在胃癌一線治療格局中證明了其突出的療效和臨牀價值。此前,舒格利單抗已在III期和IV期非小細胞肺癌、食管癌與復發難治性結外NK/T細胞淋巴瘤的治療中取得成功。目前,中國國家藥品監督管理局(NMPA)正在審評舒格利單抗聯合化療一線治療晚期胃癌的新適應症上市申請,舒格利單抗有望成為全球首個在胃/胃食管結合部腺癌適應症獲批的PD-L1單抗。我們還計劃與美國食品藥品監督管理局(FDA)和歐洲藥品管理局(EMA)進行溝通,探索全球註冊路徑,力爭將舒格利單抗這一創新療法帶給全球胃癌患者。”

舒格利單抗GEMSTONE-303研究主要研究者、北京大學腫瘤醫院沈琳教授表示:“臨牀上,大部分胃腺癌患者在被診斷時已經進入晚期階段,無法進行手術切除,而晚期或轉移性胃癌患者的預後通常較差,存在未滿足的醫療需求。今天,我們很高興地看到GEMSTONE-303研究取得了OS陽性結果。舒格利單抗聯合化療可顯着延長胃/胃食管結合部腺癌患者的PFS和OS,並且安全可耐受。我們相信未來舒格利單抗能夠為該患者羣體帶來備受期待的新治療選擇。”

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