近日，阿斯利康与第一三共联合开发的抗体偶联药物优赫得（Enhertu，通用名：德曲妥珠单抗）在中国获批一项新适应证，用于治疗既往接受过至少一种系统治疗的HER2低表达不可切除或转移性乳腺癌成人患者。这是继HER2阳性乳腺癌之后，优赫得在中国获批的又一重要适应证，标志着HER2低表达这一新亚型正式进入精准治疗时代。HER2低表达约占所有乳腺癌患者的50%，长期以来被归类为HER2阴性，缺乏针对性治疗手段。优赫得凭借其独特的药物机制——将靶向HER2的抗体与强效化疗药物通过可裂解连接子结合，在精准递送细胞毒药物的同时显著提升疗效。关键III期临床试验DESTINY-Breast04数据显示，与标准治疗相比，优赫得显著延长了无进展生存期和总生存期，且安全性可控。此次获批不仅为HER2低表达乳腺癌患者带来全新治疗选择，也重新定义了乳腺癌的分型标准，推动个体化精准医疗向前迈进。未来，优赫得在胃癌、肺癌等其他HER2表达肿瘤中的探索也将持续拓展其临床应用边界。
Recently, Enhertu (generic name: trastuzumab deruxtecan), an antibody-drug conjugate jointly developed by AstraZeneca and Daiichi Sankyo, has received approval in China for a new indication: the treatment of adult patients with unresectable or metastatic HER2-low breast cancer who have previously received at least one line of systemic therapy. This marks a significant expansion beyond its prior approval for HER2-positive breast cancer in China and heralds the arrival of precision therapy for the newly defined HER2-low subtype.HER2-low breast cancer accounts for approximately 50% of all breast cancer cases. Historically classified as HER2-negative, these tumors lacked targeted therapeutic options. Enhertu’s unique mechanism—combining a HER2-targeting antibody with a potent cytotoxic agent via a cleavable linker—enables precise delivery of chemotherapy directly to tumor cells, significantly improving efficacy. Results from the pivotal Phase III DESTINY-Breast04 trial demonstrated that Enhertu significantly prolonged both progression-free survival and overall survival compared to standard chemotherapy, with a manageable safety profile.This approval not only offers a new treatment option for patients with HER2-low breast cancer but also redefines breast cancer classification standards, advancing personalized precision medicine. Ongoing clinical trials are further exploring Enhertu’s potential in other HER2-expressing cancers, such as gastric and lung cancers, broadening its therapeutic horizon.
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