An evaluation of zanidatamab, a novel, anti-HER2 biparatopic antibody, for the treatment of biliary tract cancer.

IF 4 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Expert Opinion on Biological Therapy Pub Date : 2025-09-01 Epub Date: 2025-09-06 DOI:10.1080/14712598.2025.2556903

Jeesun Yoon, Do-Youn Oh

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引用次数: 0

Abstract

Introduction: Zanidatamab is a humanized biparatopic IgG antibody that selectively inhibits HER2 signaling pathway by targeting two distinct epitopes in the extracellular domains II and IV of HER2. Zanidatamab received accelerated approval from the United States Food and Drug Administration for the treatment of HER2-positive (immunohistochemistry [IHC] 3+) biliary tract cancer (BTC) in November 2024. Additionally, zanidatamab received approval for the treatment of HER2 IHC 3+ BTC from the European Medicines Agency in June 2025, and from National Medical Products Administration of China in May 2025.

Areas covered: We review the currently available advanced BTC treatments from the perspective of targeted therapy, discuss the implications of HER2 as a therapeutic target in BTC, and discuss the available clinical trial data for zanidatamab for BTC treatment. We then comment on how zanidatamab can fit into the current standard of care for advanced BTC treatment, and the directions of future development strategies.

Expert opinion: Zanidatamab appears to be effective for controlling disease progression and maintaining a durable response in patients with previously-treated unresectable or metastatic HER2-positive BTC, with acceptable safety profiles. Based on these favorable data, further investigations using zanidatamab as an earlier line of therapy for BTC are ongoing.

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一种新型抗her2双异位抗体zanidatamab用于胆道癌治疗的评估。

Zanidatamab是一种人源双异位IgG抗体，通过靶向HER2细胞外结构域II和IV的两个不同表位，选择性抑制HER2信号通路。Zanidatamab于2024年11月获得美国食品和药物管理局（fda）加速批准，用于治疗her2阳性（免疫组织化学[IHC] 3+）胆道癌（BTC）。此外，zanidatamab于2025年6月和2025年5月分别获得欧洲药品管理局和中国国家药品监督管理局的批准，用于治疗HER2 IHC 3+ BTC。涵盖领域：我们从靶向治疗的角度回顾了目前已有的BTC先进治疗方法，讨论了HER2作为BTC治疗靶点的意义，并讨论了zanidatamab治疗BTC的现有临床试验数据。然后，我们评论了zanidatamab如何适应目前晚期BTC治疗的护理标准，以及未来发展战略的方向。专家意见：Zanidatamab似乎对既往治疗过的不可切除或转移性her2阳性BTC患者控制疾病进展和维持持久反应有效，具有可接受的安全性。基于这些有利的数据，使用zanidatamab作为BTC早期治疗的进一步研究正在进行中。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Biological Therapy 医学-生物工程与应用微生物

CiteScore

8.60

自引率

0.00%

发文量

审稿时长

3-8 weeks

期刊介绍： Expert Opinion on Biological Therapy (1471-2598; 1744-7682) is a MEDLINE-indexed, international journal publishing peer-reviewed research across all aspects of biological therapy. Each article is structured to incorporate the author’s own expert opinion on the impact of the topic on research and clinical practice and the scope for future development. The audience consists of scientists and managers in the healthcare and biopharmaceutical industries and others closely involved in the development and application of biological therapies for the treatment of human disease. The journal welcomes: Reviews covering therapeutic antibodies and vaccines, peptides and proteins, gene therapies and gene transfer technologies, cell-based therapies and regenerative medicine Drug evaluations reviewing the clinical data on a particular biological agent Original research papers reporting the results of clinical investigations on biological agents and biotherapeutic-based studies with a strong link to clinical practice Comprehensive coverage in each review is complemented by the unique Expert Collection format and includes the following sections: Expert Opinion – a personal view of the data presented in the article, a discussion on the developments that are likely to be important in the future, and the avenues of research likely to become exciting as further studies yield more detailed results; Article Highlights – an executive summary of the author’s most critical points.