信达生物(01801.HK)与礼来制药开发之治疗肺癌药品达预设主要研究终点
信达生物(01801.HK)公布,集团与礼来制药共同开发的创新PD-1抑制剂达伯舒(信迪利单抗注射液)的一项在中国的3期临床研究(ORIENT-11)-达伯舒(信迪利单抗注射液)联合力比泰(注射用培美曲塞二钠)和铂类用於一线治疗无EGFR敏感突变或ALK基因重排的晚期或复发性非鳞状非小细胞肺癌(nsqNSCLC)期中分析达到预设的主要研究终点。
相关研究结果将在近期的学术会议上予以公布。根据独立资料委员会(IDMC)建议,信达将在近期与礼来启动就向国家药品监督管理局递交注册申请的讨论。
ORIENT-11研究是一项评估达伯舒(信迪利单抗注射液)或安慰剂联合力比泰(注射用培美曲塞二钠)和铂类用於一线治疗无EGFR敏感突变或ALK基因重排的晚期或复发性非鳞状非小细胞肺癌(nsqNSCLC)有效性和安全性的随机、双盲、3期临床研究(ClinicalTrials.gov,NCT03607539)。
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