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依洛尤单抗:美国首次批准

Ivonescimab: First Approval.

机构信息

Springer Nature, Private Bag 65901, Mairangi Bay, Auckland, 0754, New Zealand.

出版信息

Drugs. 2024 Sep;84(9):1135-1142. doi: 10.1007/s40265-024-02073-w. Epub 2024 Jul 29.

DOI:10.1007/s40265-024-02073-w
PMID:39073550
Abstract

Ivonescimab () is a first-in-class, humanized, tetravalent bispecific monoclonal antibody targeting programmed cell death protein 1 (PD-1) and vascular endothelial growth factor (VEGF)-A being developed by Akeso Biopharma for the treatment of non-small cell lung cancer (NSCLC) and other solid tumours, including breast cancer, liver cancer and gastric cancer. Ivonescimab simultaneously blocks the binding of PD-1 to its ligand (PD-L1), thereby relieving PD-1/PD-L1-mediated immunosuppression, and blocks the binding of VEGF-A to its receptor (VEGFR2), thus blocking tumour angiogenesis in the tumour microenvironment. In May 2024, ivonescimab, in combination with pemetrexed and carboplatin, received its first approval in China for the treatment of patients with EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after tyrosine kinase inhibitor (TKI) therapy. Clinical studies of ivonescimab are underway in multiple countries worldwide. This article summarizes the milestones in the development of ivonescimab leading to this first approval for EGFR-mutated locally advanced or metastatic non-squamous NSCLC who have progressed after TKI therapy.

摘要

依维莫司单抗()是一种首创的、人源化的四价双特异性单克隆抗体,靶向程序性死亡蛋白 1(PD-1)和血管内皮生长因子(VEGF)-A,由和黄医药开发,用于治疗非小细胞肺癌(NSCLC)和其他实体瘤,包括乳腺癌、肝癌和胃癌。依维莫司单抗同时阻断 PD-1 与其配体(PD-L1)的结合,从而缓解 PD-1/PD-L1 介导的免疫抑制,阻断 VEGF-A 与其受体(VEGFR2)的结合,从而阻断肿瘤微环境中的肿瘤血管生成。2024 年 5 月,依维莫司单抗与培美曲塞和卡铂联合治疗,在中国获得首次批准,用于治疗 EGFR 突变局部晚期或转移性非鳞状 NSCLC 患者,这些患者在接受酪氨酸激酶抑制剂(TKI)治疗后进展。依维莫司单抗的临床试验正在全球多个国家进行。本文总结了依维莫司单抗开发的里程碑事件,这些事件导致了对接受 TKI 治疗后进展的 EGFR 突变局部晚期或转移性非鳞状 NSCLC 患者的首次批准。

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J Immunother Cancer. 2024 Apr 19;12(4):e008037. doi: 10.1136/jitc-2023-008037.
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