百濟神州(06160.HK)：百澤安®針對鼻咽癌新適應症上市申請在中國獲受理
格隆匯8月23日丨百濟神州(06160.HK)於2021年8月22日(美國東部時間)宣佈，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)聯合化療用於復發或轉移性鼻咽癌(NPC)患者一線治療的新適應症上市申請(sBLA)。
百濟神州免疫腫瘤學首席醫學官賁勇醫學博士表示：“NPC是中國和亞洲很多地區最常見的頭頸部惡性腫瘤之一，其治療選擇有限，一直以來，化療佔據着一線治療的主導地位。基於RATIONALE 309試驗的積極結果，NMPA受理了百澤安®在中國的第九項新適應症上市申請，這是百澤安®開發歷程中的一項重要里程碑，表明了對這款具有潛在差異化優勢的免疫檢查點抑制劑的認可。我們期待能為國內尚未獲得理想治療的NPC患者帶來一項重要的治療選擇。”
此項新適應症上市申請是基於一項隨機、雙盲的3期臨牀試驗－RATIONALE 309 (NCT03924986)的研究結果。該試驗旨在評估百澤安®聯合吉西他濱和順鉑，對比安慰劑聯合吉西他濱和順鉑，作為復發或轉移性NPC患者一線治療的有效性和安全性。試驗主要終點為經獨立審查委員會(IRC)對意向性治療(ITT)人羣評估的無進展生存期(PFS)；次要終點包括總生存期(OS)、根據IRC評估結果確定的總緩解率(ORR)和緩解持續時間(DoR)，以及根據研究者的評估結果確定的PFS。共有263例亞洲患者入組試驗，這些患者以1：1的比例隨機分配至百澤安®加化療組或安慰劑加化療組。
根據2021年5月公佈的結果，RATIONALE 309在計劃的期中分析中達到了主要終點PFS。百澤安®的安全性特徵與已知風險相符，其與化療聯用時亦未發現新的安全性警示。百濟神州預計將在之後的醫學會議上公佈RATIONALE 309試驗的結果。
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