智通财经APP讯，中国生物制药(01177)公布，该集团自主研发的1类创新药贝莫苏拜单抗注射液联合或不联合盐酸安罗替尼胶囊作为巩固治疗在同步╱序贯放化疗后未进展的、局部晚期╱不可切除(III期)的非小细胞肺癌(NSCLC)患者中的III期临床研究 (TQB2450-III-05)已完成方案预设的期中分析，独立数据监查委员会(IDMC)判定主要研究终点无进展生存期(PFS)达到方案预设的优效界值。该集团已与中国国家药品监督管理局药品审评中心(CDE) 就该适应症的上市申请进行沟通，并获得CDE书面同意提交上市申请。集团将于近期递交上市申请。
同步╱序贯放化疗后未进展的、局部晚期╱不可切除(III期)的NSCLC的巩固治疗是安罗替尼即将申报上市的第11个适应症、贝莫苏拜单抗即将申报上市的第4个适应症，有望为NSCLC患者带来新的治疗选择。
TQB2450-III-05研究(NCT04325763)是一项随机、双盲双模拟、安慰剂平行对照、多中心的III期临床研究，旨在评估贝莫苏拜单抗联合或不联合安罗替尼作为巩固治疗在同步╱序贯放化疗后未进展的、局部晚期╱不可切除(III期)NSCLC患者中的有效性和安全性。本研究的期中分析结果显示，相较对照组，贝莫苏拜单抗联合或不联合安罗替尼可显著延长患者的PFS，显著降低患者的疾病进展或死亡风险。其安全性数据与已知风险相符，未发现新的安全性信号。该集团计划于近期开展的国际权威学术大会公布详细研究数据。
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