君實生物(01877.HK):特瑞普利單抗注射液NCT04394975研究完成首例患者給藥
格隆匯 9 月 4日丨君實生物(01877.HK)發佈公告,近日,特瑞普利單抗注射液(商品名:拓益®,產品代號:JS001)聯合阿昔替尼作為一線晚期腎癌患者治療方案的III期臨牀研究(NCT04394975研究)已完成首例患者給藥。
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12月,特瑞普利單抗注射液獲得國家藥品監督管理局有條件批准上市,用於治療既往標準治療失敗後的局部進展或轉移性黑色素瘤。2020年4月,特瑞普利單抗注射液用於治療既往接受過二線及以上系統治療失敗的復發╱轉移鼻咽癌的新適應症上市申請獲得國家藥監局受理。2020年5月,特瑞普利單抗注射液用於治療既往接受過系統治療的局部進展或轉移性尿路上皮癌的新適應症上市申請獲得國家藥監局受理。2020年7月,上述兩項新適應症上市申請已於被國家藥監局納入優先審評程序。
根據披露,NCT04394975研究是一項隨機、開放、陽性對照、多中心的III期註冊臨牀研究,旨在評估特瑞普利單抗注射液聯合阿昔替尼對比舒尼替尼作為晚期腎癌一線治療方案的有效性和安全性。該研究的主要研究終點為獨立中心影像評估的無進展生存期(PFS),次要研究終點為研究者評價的PFS,客觀緩解率(ORR)、療效持續時間(DOR)、疾病控制率(DCR)、總生存率及總生存期(OS)等。
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