信达生物(01801.HK):NMPA受理达伯舒®用于治疗中国国内二线鳞状非小细胞肺癌患者的新适应症申请
格隆汇1月12日丨信达生物(01801.HK)宣布,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)用于治疗二线鳞状非小细胞肺癌(“NSCLC”)的新适应症申请(该“sNDA”)获国家药品监督管理局(“NMPA”)受理。此次申请为达伯舒®(信迪利单抗注射液)在NSCLC领域的第3项sNDA。
该sNDA乃基于一项随机、开放式标签、3期临床试验(ORIENT-3)-研究评估达伯舒®(信迪利单抗注射液)用于一线铂类化疗失败的晚期或复发性NSCLC二线治疗。最终分析结果显示,达伯舒®(信迪利单抗注射液)对比多西他赛,显著延长了总生存期(“OS”),达到预设的优效性标准;无进展生存期(“PFS”)和客观缓解率(“ORR”)也均有显著提高。安全性特征与既往报道的信迪利单抗研究结果一致,无新的安全性信号。详细的研究数据将在近期的国际学术会议和学术期刊中公布。
肺癌是中国目前发病率和死亡率均排名第一的恶性肿瘤。在所有肺癌中NSCLC约占80%至85%,约70%的NSCLC患者在初诊时已是不适进行根治性切除手术的局部晚期或转移性肿瘤。同时,该等患者在接受根治性切除手术治疗后仍有相当高的复发率,最终死于疾病进展。中国NSCLC患者中约30%为鳞状NSCLC,该等患者在二线免疫治疗药物的选择非常有限,中国国内目前仍存在庞大的医疗需求。
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