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君實生物-B(01877.HK):“JUPITER-02”研究完成方案計劃280名患者入組
格隆匯 11-20 19:56

格隆匯11月20日丨君實生物-B(01877.HK)發佈公告,公司自主研發的具有全球知識產權的特瑞普利單抗注射液(產品代號:JS001,商品名:拓益)聯合化療作為復發或轉移性鼻咽癌患者一線治療方案的三期臨牀研究(以下簡稱“JUPITER-02”研究)已完成方案計劃的280名患者入組。

據悉,JUPITER-02(NCT03581786)是一項在亞太地區開展的評估特瑞普利單抗注射液聯合吉西他濱/順鉑作為復發或轉移性鼻咽癌患者一線治療方案的有效性和安全性的隨機、安慰劑對照、雙盲、多中心的III期臨牀研究,也是全球首個開設並達成方案計劃入組目標的抗PD-1單抗用於鼻咽癌治療的隨機對照關鍵註冊臨牀。截至公告日,該研究已完成方案計劃的280例患者入組。

根據披露,拓益*(特瑞普利單抗注射液)作為中國首個批准上市的以PD-1為靶點的國產單抗藥物,獲得國家科技重大專項項目支持。特瑞普利單抗注射液自2016年初開始臨牀研發,至今已在中、美等多國開展了覆蓋十餘個瘤種的30多項臨牀研究。2018年3月,國家藥品監督管理局正式受理了特瑞普利單抗注射液的上市註冊申請,並將其納入優先審評審批品種予以加快審評審批。特瑞普利單抗注射液已獲批上市適應症的關鍵註冊臨牀試驗結果顯示,治療既往接受全身系統治療失敗的不可切除或轉移性黑色素瘤患者的客觀緩解率(ORR)達17.3%,疾病控制率(DCR)達57.5%,1年生存率達69.3%。特瑞普利單抗注射液的上市批准對解決中國腫瘤患者臨牀用藥選擇具有積極意義。

此外,JUPITER-02是一項隨機、安慰劑對照、雙盲、多中心的III期臨牀研究,旨在比較特瑞普利單抗注射液聯合吉西他濱/順鉑與安慰劑聯合吉西他濱/順鉑作為復發或轉移性鼻咽癌患者一線治療方案的有效性和安全性。JUPITER-02是全球首個開設並達成方案計劃入組目標的抗PD-1單抗用於鼻咽癌治療的隨機對照關鍵註冊臨牀。截至公告日,該研究已完成方案計劃的280例患者入組。該實驗的主要研究終點為無進展生存期(PFS),次要研究終點為總生存期(OS)、客觀緩解率(ORR)、療效持續時間(DOR)、疾病控制率(DCR)等。

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