百济神州(06160.HK)一项百泽安联合化疗作为复发或转移性鼻咽癌一线疗法的3期临床试验获得积极主要结果
格隆汇5月24日丨百济神州(06160.HK)于2021年5月21日宣布，经独立数据检测委员会推荐，一项用于评估其抗PD-1抗体百泽安（替雷利珠单抗）联合化疗，对比安慰剂联合化疗，作为用于治疗复发或转移性鼻咽癌患者的一线疗法的3期RATIONALE 309临床试验在中期分析中达到主要终点。根据测试结果，经独立评审委员会(IRC)评估，在意向治疗(ITT)人群中，对比仅用化疗，百泽安联合化疗在无进展生存期(PFS)中取得了具有统计意义的改善。百泽安的安全性结果与其已知风险相符，与化疗联用未出现新的安全性警示。
百济神州肿瘤免疫学首席医学官贲勇医学博士评论道：公司非常兴奋在此项3期临床试验中观察到，百泽安联合化疗能为鼻咽癌患者的无进展生存期带来具有临床意义的改善。这标志着第5项获得积极结果的百泽安3期临床试验，公司同时也正在一项广泛的临床项目中对这款潜在差异化的抗PD-1抗体进行评估。公司十分感激参与该试验的患者和临床医护人员，并期待能为他们提供一项新的治疗选择。
百济神州计划就该试验结果与多个监管部门开展沟通，并于一场即将举行的医学会议上公布数据。
据悉，RATIONALE 309是一项随机、双盲、安慰剂对照的3期临床试验(NCT03924986)，旨在对比百泽安联合吉西他滨和顺铂与安慰剂联合吉西他滨和顺铂作为复发或转移性NPC一线疗法的有效性和安全性。该试验的主要终点是经IRC对ITT人群评估的PFS；关键次要终点包括总生存期(OS)、经IRC评估的客观缓解率(ORR)和缓解持续时间(DoR)，以及经研究者评估的PFS。共有263例亚洲患者入组了该项试验，以1：1的比例随机至百泽安联合化疗试验臂或安慰剂联合化疗试验臂。百泽安（替雷利珠单抗注射液）是一款人源化lgG4抗程式性死亡受体1(PD-1)单克隆抗体，设计目的是为最大限度地减少与巨噬细胞中的Fcγ受体结合。临床前数据表明，巨噬细胞中的Fcγ受体结合之后会启动抗体依赖细胞介导杀伤T细胞，从而降低了PD-1抗体的抗肿瘤活性。
百泽安?是第一款由百济神州的免疫肿瘤生物平台研发的药物，目前正进行单药及联合疗法临床试验，开发一系列针对实体瘤和血液肿瘤的广泛适应症。此外，三项百泽安新适应症上市申请在中国已获受理且正在审评过程中，包括一项联合化疗用于治疗一线晚期非鳞状NSCLC患者，一项用于治疗既往接受铂类化疗后出现疾病进展的二或三线局部晚期或转移性NSCLC患者，以及一项用于治疗既往接受过治疗的不可切除肝细胞癌(HCC)患者。
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