基石药业-Ｂ(02616.HK)向ASH2019年年会提交CS1001-201临床研究摘要
格隆汇8月19日丨基石药业-Ｂ(02616.HK)发布公告，公司已于近日向即将召开的美国血液肿瘤协会(“ASH”)2019年年会提交CS1001-201临床研究摘要(“摘要”)，并计划在大会公布试验最新进展。这将是CS1001-201试验启动以来的首次临床试验数据发表。
CS1001是由基石药业开发的在研抗PD-L1单克隆抗体。目前多项评估CS1001的临床试验正于中国开展，其中包括一项多臂Ib期试验，两项注册性II期试验和三项III期试验。此前已公开的数据显示，CS1001整体安全性与耐受性良好，并在多种肿瘤的联合治疗领域展现出广阔的临床应用前景。
在摘要中报告的CS1001-201试验是一项旨在评价CS1001单药治疗复发或难治性结外自然杀伤细胞(“NK”)/T细胞淋巴瘤(“rr-ENKTL”)的有效性、安全性、药代动力学特性和免疫原性的单臂、多中心II期临床研究。该研究以客观缓解率作为主要研究目的。
结外自然杀伤细胞/T细胞淋巴瘤(“ENKTL”)属于成熟T细胞和NK细胞淋巴瘤的一个亚型。ENKTL的分布具有地域特征性，亚洲发病率显着高于欧美。ENKTL在中国每年新发病例约为5300例，约占所有淋巴瘤的6%，其中约50%的病例发展为rr-ENKTL。ENKTL是一种侵袭性恶性肿瘤，预后较差。目前对于经L-门冬醯胺酶联合疗法治疗失败的ENKTL患者还缺乏标准治疗方法。CS1001-201试验是首个针对rr-ENKTL患者的抗PD-L1抗体临床试验，并已在试验中观察到持久的抗肿瘤活性。
向ASH2019年年会提交的摘要如被接受，将公布CS1001-201II期研究在rr-ENKTL患者中获得的安全性及有效性数据。这不仅将是CS1001-201试验的首份报告，也将是继美国临床肿瘤学会年会、欧洲肿瘤学会年会及中国临床肿瘤学会年会之后，CS1001的数据在2019年内第四次亮相重大学术会议。
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