百濟神州(06160.HK)：百澤安®第八項新適應症上市申請在中國獲受理
格隆匯7月8日丨百濟神州(06160.HK)發佈公吿，2021年7月7日(美國東部時間)，中國國家藥品監督管理局(NMPA)藥品審評中心(CDE)已受理其抗PD-1抗體藥物百澤安®(替雷利珠單抗注射液)用於治療既往接受過一線標準化療後進展或不可耐受的局部晚期或轉移性食管鱗狀細胞癌(ESCC)患者的新適應症上市申請(sBLA)。
百濟神州腫瘤免疫學首席醫學官賁勇醫學博士表示：“我們很高興地宣佈百澤安®的第八項新適應症上市申請在中國獲受理，其中有五項已在國內獲批。作為首個全球食管鱗狀細胞癌的3期研究，RATIONALE 302研究充分考慮了不同國家和地區的臨牀實踐差異，使其研究成果真正具備全球代表性。臨牀數據顯示，百澤安®單藥治療二線局部晚期或轉移性ESCC患者的療效優於化療，相較於化療患者的總生存期(OS)得到進一步提升。我們期待與藥品審評中心保持溝通與交流，讓這一創新治療藥物能夠儘快造福國內局部晚期或轉移性ESCC患者。”
根據披露，此項新適應症上市申請是基於一項隨機、開放性、多中心的全球3期臨牀試驗RATIONALE 302(NCT03430843)的研究結果。該試驗旨在評估百澤安®對比研究者選擇的化療，作為局部晚期或轉移性ESCC患者二線治療的有效性和安全性。試驗主要終點是意向性治療(ITT)人羣的總生存期(OS)；關鍵次要終點是PD-L1高表達人羣(定義為目測估計綜合陽性評分vCPS≥10%)的OS，其他次要終點包括無進展生存期(PFS)、客觀緩解率(ORR)、緩解持續時間(DoR)和安全性，共有512例來自亞洲、歐洲和北美的11個國家或地區的患者入組試驗，這些患者以1：1的比例隨機分配至百澤安®組或化療組(化療組的治療方案為研究者選擇的紫杉醇、多西他賽或伊立替康)。百濟神州於2021年美國臨牀腫瘤學會年會上公佈了此項臨牀試驗的結果。
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