信达生物(01801.HK)：NMPA受理达伯舒® (信迪利单抗注射液)联合达攸同® (贝伐珠单抗注射液)用于治疗一线肝癌患者新适应症申请
格隆汇 1 月 13日丨信达生物(01801.HK)发布公告，国家药品监督管理局(“NMPA”)已经正式受理达伯舒®(信迪利单抗注射液)联合达攸同®(贝伐珠单抗注射液)用于治疗一线肝癌(“HCC”)患者的新适应症上市申请(“sNDA”)。此次为达伯舒®(信迪利单抗注射液)的第5项适应症申请，同时也是关于达攸同®(贝伐珠单抗注射液)的第4项适应症的申请。达伯舒®(信迪利单抗注射液)于2018年12月获NMPA批准用于至少经过二线或以上系统化疗的复发或难治性经典型霍奇金淋巴瘤的治疗。达攸同®(贝伐珠单抗注射液)此前已获NMPA批准包括晚期非小细胞肺癌(“NSCLC”)、转移性结直肠癌和成人复发性胶质母细胞瘤在内的三个适应症。
此次sNDA是基于一项随机、开放式标签、III期对照临床研究(ORIENT-32)－达伯舒®(信迪利单抗注射液)联合达攸同®(贝伐珠单抗注射液)用于不可切除肝癌或转移性HCC的一线治疗。基于独立数据委员会审核的期中分析结果，达伯舒®(信迪利单抗注射液)联合达攸同®(贝伐珠单抗注射液)对比绍拉非尼单药治疗，显著延长了总生存期(“OS”)和无进展生存期(“PFS”)，达到预设的优效性标准。截至期中分析数据截止日，中位随访时间为10.0个月，达伯舒®(信迪利单抗注射液)联合达攸同®(贝伐珠单抗注射液)组中位OS尚未达到，索拉非尼组中位OS为10.4个月；与索拉非尼组相比，达伯舒®(信迪利单抗注射液)联合达攸同®(贝伐珠单抗注射液)组死亡风险下降43.1％(HR0.569,95%CI:0.431-0.751,P<0.0001)。由独立影像委员会(“IRRC”)基于RECIST1.1评估达伯舒®(信迪利单抗注射液)联合达攸同®(贝伐珠单抗注射液)组中位PFS为4.6个月，索拉非尼组中位PFS为2.8个月；与索拉非尼组相比，达伯舒®(信迪利单抗注射液)联合达攸同®组疾病进展风险下降43.5%(HR0.565,95%CI:0.455-0.701,P<0.0001)。达伯舒®(信迪利单抗注射液)联合达攸同®(贝伐珠单抗注射液)具有可接受的安全性，无新的安全性信号。该研究数据已于11月举办的2020年欧洲肿瘤内科学会亚洲年会上以优选口头报告形式公布。
肝癌是全世界范围内常见的消化系统恶性肿瘤，中国的肝癌患者占全球新症及死亡数量的一半左右。尽管治疗技术在进步，但肝癌患者尚有大量未被满足的有效治疗需求。公司相信，此次sNDA获NMPA正式受理，意味着达伯舒® (信迪利单抗注射液)联合达攸同® (贝伐珠单抗注射液)在HCC适应症探索方面取得重要进展，对于改善中国HCC患者的疗效和预后具有重大意义。
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