君实生物(01877.HK):特瑞普利单抗注射液NCT04394975研究完成首例患者给药
格隆汇 9 月 4日丨君实生物(01877.HK)发布公告,近日,特瑞普利单抗注射液(商品名:拓益®,产品代号:JS001)联合阿昔替尼作为一线晚期肾癌患者治疗方案的III期临床研究(NCT04394975研究)已完成首例患者给药。
特瑞普利单抗注射液作为中国首个批准上市的以PD-1为靶点的国产单抗药物,获得国家科技重大专项项目支持。特瑞普利单抗注射液自2016年初开始临床研发,至今已在中、美等多国开展了覆盖十余个瘤种的30多项临床研究。2018年12月,特瑞普利单抗注射液获得国家药品监督管理局有条件批准上市,用于治疗既往标准治疗失败后的局部进展或转移性黑色素瘤。2020年4月,特瑞普利单抗注射液用于治疗既往接受过二线及以上系统治疗失败的复发╱转移鼻咽癌的新适应症上市申请获得国家药监局受理。2020年5月,特瑞普利单抗注射液用于治疗既往接受过系统治疗的局部进展或转移性尿路上皮癌的新适应症上市申请获得国家药监局受理。2020年7月,上述两项新适应症上市申请已于被国家药监局纳入优先审评程序。
根据披露,NCT04394975研究是一项随机、开放、阳性对照、多中心的III期注册临床研究,旨在评估特瑞普利单抗注射液联合阿昔替尼对比舒尼替尼作为晚期肾癌一线治疗方案的有效性和安全性。该研究的主要研究终点为独立中心影像评估的无进展生存期(PFS),次要研究终点为研究者评价的PFS,客观缓解率(ORR)、疗效持续时间(DOR)、疾病控制率(DCR)、总生存率及总生存期(OS)等。
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