復宏漢霖(02696.HK):HLX22(重組人源化抗HER2單克隆抗體注射液)聯合曲妥珠單抗和化療(XELOX)對比曲妥珠單抗和化療(XELOX)聯合或不聯合帕博利珠單抗一線治療HER2陽性局部晚期或轉移性胃食管交界部和胃癌的國際多中心3期臨牀研究完成日本首例患者給藥
格隆匯3月26日丨復宏漢霖(02696.HK)宣佈,近日,一項HLX22(重組人源化抗HER2單克隆抗體注射液)("HLX22")聯合曲妥珠單抗和化療(XELOX)對比曲妥珠單抗和化療(XELOX)聯合或不聯合帕博利珠單抗一線治療人類表皮生長因子受體2(HER2)陽性局部晚期或轉移性胃食管交界部和胃癌的國際多中心3期臨牀研究已完成日本首例患者給藥。該3期臨牀研究亦正於中國大陸境內開展中。
本次研究是一項雙盲、國際多中心隨機對照3期研究,旨在比較HLX22聯合曲妥珠單抗和化療對比曲妥珠單抗和化療聯合或不聯合帕博利珠單抗,一線治療HER2陽性局部晚期或轉移性胃癌/胃食管交界部癌患者的療效和安全性。符合條件的受試者將以1:1的比例隨機分配至試驗組(接受HLX22(15mg/kg)聯合曲妥珠單抗和化療)或對照組(接受安慰劑聯合曲妥珠單抗和化療,聯合或不聯合帕博利珠單抗)。該研究的主要終點爲獨立影像評估委員會(IRRC)基於RECIST v1.1評估的無進展生存期(PFS)和總生存期(OS);次要終點包括研究者評估的無進展生存期(PFS)、獨立影像評估委員會(IRRC)或研究者評估的客觀緩解率(ORR)、下一線治療的無進展生存期(PFS2)、緩解持續時間(DOR)、生活質量、安全性、免疫原性和藥代動力學特徵。
HLX22爲公司自AbClon, Inc.許可引進,並後續自主研發的新型靶向HER2的單克隆抗體,潛在適應症包括胃癌和乳腺癌等實體瘤。2025 年3 月,HLX22用於治療胃癌(GC)獲美國食品藥品監督管理局(FDA)孤兒藥資格認定(Orphan-drug Designation)。
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