Inetetamab是一种新型重组人源化抗HER2单克隆抗体。本研究旨在评估 inetamab 的疗效和安全性以及 HER2 阳性转移性乳腺癌 (MBC) 患者缓解的预测因素。对 2020 年 6 月至 2021 年 8 月期间接受基于 inetamab 治疗的 HER2 阳性 MBC 患者队列进行了评估。主要终点是无进展生存期（PFS），次要终点包括客观缓解率（ORR）和疾病控制率（DCR）。不良事件（AE）根据美国国家癌症研究所通用毒性标准进行分级。最终分析共纳入141名患者。整个队列的中位 PFS 为 7.1 个月。施用的治疗线中位数为三。 ORR 为 36.9%，DCR 为 80.9%。最常用的治疗策略是艾尼泰单抗化疗（49/141，34.8%），其次是艾尼泰单抗 HER2-酪氨酸激酶抑制剂 (HER2-TKI) 化疗、艾尼泰单抗帕妥珠单抗化疗、艾尼泰单抗内分泌治疗和艾尼泰单抗 HER2-TKI。 Cox 多变量分析显示，PFS 与肝转移相关（风险比 [HR] 2.112，95% 置信区间 [CI] 1.334-3.343，p = 0.001）、既往 HER2-TKI 治疗（HR 2.019，95% CI 1.133-3.597） ，p = 0.017）和雌激素受体阳性（HR 0.587，95% CI 0.370-0.934，p = 0.024）。毒性是可以忍受的，其中中性粒细胞减少症是最常见的治疗相关 3/4 级 AE (14.9%)。伊奈他单抗显示出有效性和可控的安全性，为已表现出耐药性的 HER2 阳性乳腺癌患者提供了一种有前景的治疗选择既往抗 HER2 治疗。版权所有 © 2023 作者。由爱思唯尔有限公司出版。保留所有权利。

Inetetamab is a novel recombinant humanized anti-HER2 monoclonal antibody. This study aimed to evaluate the efficacy and safety of inetetamab and predictive factors for response in HER2-positive metastatic breast cancer (MBC) patients.A cohort of HER2-positive MBC patients who received inetetamab-based therapy between June 2020 and August 2021 was evaluated. The primary endpoint was progression-free survival (PFS), and the secondary endpoints included objective response rate (ORR) and disease control rate (DCR). Adverse events (AEs) were graded according to the National Cancer Institute Common Toxicity Criteria.A total of 141 patients were included in the final analysis. The median PFS of the entire cohort was 7.1 months. The median number of treatment lines administered was three. The ORR was 36.9 %, and the DCR was 80.9 %. The most frequently employed treatment strategy was inetetamab + chemotherapy (49/141, 34.8 %), followed by inetetamab + HER2-tyrosine kinase inhibitors (HER2-TKIs) + chemotherapy, inetetamab + pertuzumab + chemotherapy, inetetamab + endocrine treatment and inetetamab + HER2-TKIs. Cox multivariate analysis revealed that PFS was associated with liver metastasis (hazard ratio [HR] 2.112, 95 % confidence interval [CI] 1.334-3.343, p = 0.001), previous HER2-TKI treatment (HR 2.019, 95 % CI 1.133-3.597, p = 0.017) and estrogen receptor positivity (HR 0.587, 95 % CI 0.370-0.934, p = 0.024). The toxicity was tolerable, with neutropenia being the most common treatment-related grade 3/4 AE (14.9 %).Inetetamab demonstrates effectiveness with a manageable safety profile, offering a promising therapeutic option for HER2-positive breast cancer patients who have shown resistance to prior anti-HER2 treatments.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.