百时美施贵宝(BMY.US)癌症双药组合疗法在华获批临床

智通财经
13 Mar

智通财经APP获悉,中国国家药监局药品审评中心(CDE)官网近日最新公示,百时美施贵宝公司(BMY.US)申报的1类新药BMS-986489(BMS-986012 + nivolumab固定剂量复方)注射液获得临床试验默示许可,拟开发治疗小细胞肺癌(SCLC)患者。公开资料显示,这是一款抗Fucosyl-GM1单抗BMS-986012与抗PD-1单抗纳武利尤单抗的固定剂量组合,已经在国际范围内进入3期临床研究阶段。

神经节苷脂Focusyl-GM1 (FucGM1)是一种肿瘤相关抗原,在约50%~90%的SCLC肿瘤中表达,但在正常组织中表达有限,使其成为免疫肿瘤学中有希望的靶点。

根据百时美施贵宝公开资料介绍,BMS-986012是一种新型的、与FucGM1特异性结合的全人源IgG1抗体。在临床前研究中,该产品显示出对表达FucGM1的肿瘤细胞系的抗体依赖性细胞毒性(ADCC)。在补体依赖性细胞毒性(CDC)和抗体依赖性细胞吞噬(ADCP)实验中也观察到该产品介导的肿瘤细胞杀伤。当BMS-986012与抗PD-1抗体联合使用时,治疗效果明显改善。

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