君实生物-Ｂ(01877.HK)：“JUPITER-02”研究完成方案计划280名患者入组
格隆汇11月20日丨君实生物－Ｂ(01877.HK)发布公告，公司自主研发的具有全球知识产权的特瑞普利单抗注射液(产品代号：JS001，商品名：拓益)联合化疗作为复发或转移性鼻咽癌患者一线治疗方案的三期临床研究(以下简称“JUPITER-02”研究)已完成方案计划的280名患者入组。
据悉，JUPITER-02(NCT03581786)是一项在亚太地区开展的评估特瑞普利单抗注射液联合吉西他滨/顺铂作为复发或转移性鼻咽癌患者一线治疗方案的有效性和安全性的随机、安慰剂对照、双盲、多中心的III期临床研究，也是全球首个开设并达成方案计划入组目标的抗PD-1单抗用于鼻咽癌治疗的随机对照关键注册临床。截至公告日，该研究已完成方案计划的280例患者入组。
根据披露，拓益*(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3月，国家药品监督管理局正式受理了特瑞普利单抗注射液的上市注册申请，并将其纳入优先审评审批品种予以加快审评审批。特瑞普利单抗注射液已获批上市适应症的关键注册临床试验结果显示，治疗既往接受全身系统治疗失败的不可切除或转移性黑色素瘤患者的客观缓解率(ORR)达17.3%，疾病控制率(DCR)达57.5%，1年生存率达69.3%。特瑞普利单抗注射液的上市批准对解决中国肿瘤患者临床用药选择具有积极意义。
此外，JUPITER-02是一项随机、安慰剂对照、双盲、多中心的III期临床研究，旨在比较特瑞普利单抗注射液联合吉西他滨/顺铂与安慰剂联合吉西他滨/顺铂作为复发或转移性鼻咽癌患者一线治疗方案的有效性和安全性。JUPITER-02是全球首个开设并达成方案计划入组目标的抗PD-1单抗用于鼻咽癌治疗的随机对照关键注册临床。截至公告日，该研究已完成方案计划的280例患者入组。该实验的主要研究终点为无进展生存期(PFS)，次要研究终点为总生存期(OS)、客观缓解率(ORR)、疗效持续时间(DOR)、疾病控制率(DCR)等。
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