金吾财讯 | 辉瑞(PFE)宣布双特异性抗体新药埃纳妥单抗(elranatamab)在中国获批，用于治疗复发或难治性多发性骨髓瘤(RRMM)成人患者。这些患者此前已接受至少三线治疗，包括蛋白酶体抑制剂、免疫调节剂和抗CD38单抗。该药2023年8月获美国FDA加速批准，是同时靶向BCMA(B细胞成熟抗原)和CD3的双特异性抗体。获批依据包括全球关键2期单臂研究MagnetisMM-3及中国1b/2期研究MagnetisMM-8数据。MagnetisMM-3显示，中位随访33.9个月时，药物对三重难治RRMM患者仍保持深度持久疗效：中位缓解持续时间未达到，30个月缓解率61%，中位无进展生存期17.2个月，中位总生存期24.6个月，且未发现新安全性信号。多发性骨髓瘤是无法治愈的血液癌症，多数患者会复发或耐药。随着疾病进展，复发侵袭性增强且缓解期缩短。BCMA作为理想靶点，在骨髓瘤细胞中高表达且随病情加重而增加。
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.