君实生物-Ｂ(01877.HK)：POLARIS-03研究完成最后一例患者入组
格隆汇9月16日丨君实生物-Ｂ(01877.HK)宣布，拓益*(通用名：特瑞普利单抗注射液)单药治疗经标准治疗失败后的晚期局部进展或转移性膀胱尿路上皮癌患者的关键注册临床研究(POLARIS-03研究)完成最后一例患者入组。
POLARIS-03研究是在中国开展的评估拓益*(特瑞普利单抗注射液)单药治疗经标准治疗失败後的晚期局部进展或转移性膀胱尿路上皮癌患者的有效性和安全性的一项II期、开放标签、多中心、注册临床研究POLARIS-03(NCT03113266)，计划入组150名受试者，截至公告日，该研究已完成全部患者入组。
今年ASCO年会公布了POLARIS-03研究初步安全性和有效性研究结果，研究显示，截至数据截止日(2019年5月10日)，在76例可评估患者中，特瑞普利单抗的客观缓解率(ORR)达到27.6%，疾病控制率(DCR)为51.3%，在PD-L1阳性的患者中，特瑞普利单抗组ORR为55.0%，是截至目前国内外PD-1/PD-L1单药治疗尿路上皮癌公开数据中最高的。在中国，标准化疗失败的晚期尿路上皮癌患者治疗手段非常有限。既往国外也进行了转移性尿路上皮癌一线化疗失败後接受免疫检查点抑制剂单药治疗的临床研究，这些PD-1/PD-L1抑制剂的ORR绝大多数在20%左右。POLARIS-03(NCT03113266)初步的研究结果符合公司预期，本公司对其未来的研究和应用前景充满信心。
拓益*(特瑞普利单抗注射液)作为中国批准上市的首个国产以PD-1为靶点的单抗药物，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。
POLARIS-03是一项多中心、开放的II期注册研究，评估特瑞普利单抗用于系统性治疗失败的转移性尿路上皮癌的疗效和安全性。研究入组了ECOG0~1分，既往未接受过抗PD-1/L1单抗治疗的患者，接受特瑞普利单抗3mg/kg，Q2W直至疾病进展、不可耐受的毒性或患者自主要求出组。研究采用RECISTv1.1标准，每8周进行1次疗效评价。研究计划入组150例患者，主要终点为客观缓解率(ORR)，次要终点包括疗效持续时间(DOR)、无进展生存期(PFS)和总生存期(OS)。
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