基石药业(02616.HK)：CS1001联合化疗一线治疗NSCLC适应症达到预设主要研究终点
格隆汇 8 月 6日丨基石药业－Ｂ(02616.HK)发布公告，抗PD-L1单抗CS1001注射液联合化疗用于IV期非小细胞肺癌(“NSCLC”)患者一线治疗的III期临床试验在计划的期中分析中，经独立资料监查委员会评估达到了预设的主要研究终点，结果具有统计学显著性与临床意义。
根据披露，在包含鳞状和非鳞状NSCLC的所有患者中，研究者评估的无进展生存期(“PFS”)风险比HR(95%CI)为0.5(0.39,0.64)，p<0.0001。CS1001联合化疗的中位PFS为7.8月，安慰剂联合化疗中位PFS为4.9月；亚组分析显示，鳞状与非鳞状NSCLC的患者、PD-L1表达>=1%与PD-L1表达<1%的患者均显示出临床获益；盲态独立中心审阅委员会评价的PFS结果与主要研究终点一致。其他次要终点资料也支持主要研究终点结果；及CS1001联合化疗的安全性良好，未发现新的安全性信号。
CS1001-302研究主要研究者，上海市肺科医院肿瘤科主任周彩存教授表示：“我们高兴的看到 CS1001-302研究在期中分析中达到了预设的主要研究终点，CS1001联合化疗在包含了鳞状和非鳞状 NSCLC患者中显著改善PFS，并且安全性良好。它是全球第一个抗PD-L1单抗联合化疗在晚期NSCLC 取得成功的随机双盲的III期研究。”
基石药业董事长，执行董事兼首席执行官江宁军博士表示：“目前，国内尚无抗PD-L1单抗获批用于IV 期NSCLC。CS1001是国内首个证实联合化疗显著改善中国NSCLC患者PFS的抗PD-L1单抗，并有望成为全球首个联合化疗同时获批鳞状和非鳞状NSCLC一线治疗的抗PD-L1单抗。这一振奋人心的进展将进一步推进CS1001的研发，并对基石药业持续推进商业化进程意义重大。”
基石药业首席医学官杨建新博士表示：“CS1001-302研究相比其他已公布结果的抗PD-1/PD-L1单抗联合化疗在一线NSCLC研究，采用了创新性的设计，是中国首个同时涵盖鳞状和非鳞状NSCLC两种亚型的一线III期临床试验。作为一项接近500例患者的大型III期研究，尽管面临激烈的入组竞争和新冠肺炎的影响，我们从首例患者给药到公布主要研究结果仅仅用了20个月。我们将继续全力推进、更广泛地评估该产品在血液肿瘤、Ⅲ期NSCLC、晚期胃癌、肝癌和食管癌患者中的疗效与安全性。”
基石药业计划近期向国家药品监督管理局递交CS1001联合化疗一线治疗NSCLC适应症的新药上市申请。具体研究资料将于近期召开的学术会议中公布。
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