智通财经APP获悉，百时美施贵宝(BMY.US)宣布，欧盟委员会(EC)已批准其重磅PD-1抑制剂Opdivo(nivolumab)与CTLA-4靶向抗体Yervoy(ipilimumab)联用，一线治疗不可切除或晚期肝细胞癌(HCC)成人患者。据悉，美国FDA已接受Opdivo联合Yervoy治疗同一患者群体的补充生物制品许可申请，预计在今年4月21日之前完成审评。
公开资料显示，Opdivo是一种PD-1免疫检查点抑制剂，旨在帮助恢复抗肿瘤免疫反应，利用人体自身的免疫系统来对抗癌症。Yervoy则靶向抑制CTLA-4。CTLA-4抗体通过增强T细胞活性来提高肿瘤杀伤能力。
数据显示，Opdivo联合Yervoy治疗显著延长患者的总生存期(OS)，达到试验的主要临床终点。Opdivo加Yervoy联合疗法组患者的中位OS为23.7个月(95% CI：18.8–29.4)，而活性对照药物组患者的中位OS为20.6个月(95% CI：17.5–22.5)，风险比为0.79(0.65–0.96;p=0.018)。总生存期获益在各患者亚组中大致一致。
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