金吾财讯 | 中国国家药监局药品审评中心(CDE)3月10日公示，辉瑞(PFE)与Seagen联合开发的1类新药PF-08046054(注射用冻干粉针)获得临床试验默示许可，拟开展转移性或不可切除晚期实体瘤适应症研究。该药物是辉瑞研发管线中首款靶向PD-L1的抗体偶联药物(ADC)，具有"first-in-class"潜力。PF-08046054(SGN-PDL1V)采用独特的抗PD-L1抗体-药物偶联设计，由抗PD-L1单抗、可裂解连接子及微管抑制剂MMAE组成。其作用机制包括：通过抗体靶向结合PD-L1阳性肿瘤细胞，释放MMAE诱导直接细胞毒性；通过旁观者效应杀伤邻近肿瘤细胞；以及触发免疫原性细胞死亡增强抗肿瘤免疫应答。临床前研究显示，该ADC在PD-L1低表达(<1%)或异质性表达的动物模型中均表现出显着抗肿瘤活性。相较于传统PD-1/PD-L1抑制剂，该药物通过结合ADC的双重作用机制，可能为PD-L1表达不足或耐药的实体瘤患者提供新治疗选择。
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