Evaluation of the effectiveness and safety of disitamab vedotin in HER2-expressing 2L recurrent or metastatic cervical cancer (r/mCC): Interim results of RC48-C018.

作者：Guangwen Yuan, Guiling Li, Qingshui Li, Youzhong Zhang, Ruifang An, Jinwei Miao, Keqiang Zhang, Hongying Yang, Yi Huang, Ruixia Guo, Li Sun, Lin An, Junying Tang, X. Li, Jianming Ying, Yun Ling, Yanan Wang, Haiwen Zhou, Jianmin Fang, Lingying Wu · 发表于：Journal of Clinical Oncology · 年份：2024 · DOI：10.1200/jco.2024.42.16_suppl.5528 · 被引用次数：11 · 研究领域：HER2/EGFR in Cancer Research、Lung Cancer Treatments and Mutations、Cancer Treatment and Pharmacology

5528 Background: Disitamab Vedotin (DV) is a HER2-targeted antibody-drug conjugate (ADC), and is approved in HER2-expressing gastric cancer and locally advanced or metastatic urothelial carcinoma. HER2 also shows certain expression in Gynecological malignant tumors. A phase 2, open-label, multicenter basket design study (NCT04965519) is currently underway to evaluate the efficacy and safety of DV monotherapy in the treatment of HER2-expressing gynecologic malignancies. Methods: The cervical cancer cohort includes patients (pts) with recurrent/metastatic cervical cancer (r/mCC) who failed with at least one-line platinum-containing standard treatment and had HER2 immunohistochemistry ≥1+. Pts received DV monotherapy administered intravenously at a dose of 2 mg/kg every 2 weeks until disease progression or intolerable toxicity. The primary endpoint is the objective response rate (ORR). Secondary endpoints include duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and safety. Results: 25 r/mCC pts were enrolled and received at least one cycle of treatment. At baseline, the median age was 56 years (range: 35-66 years). The number of pts in the 2L, 3L, and 4L+ was 12(48%), 9 (36%), and 4 (16%), respectively. The majority of pts (n=16, 64%) had a baseline ECOG performance score of 1. 16 pts (64%) had squamous cell carcinoma as the baseline histological type, and 9 pts (36%) had adenocarcinoma. 10 pts (40%) had prior anti-P...