Gunagratinib, a highly selective irreversible FGFR inhibitor, in patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR pathway alterations: A phase IIa dose-expansion study.

作者：Ye Guo, Chunwang Yuan, Weimin Ding, Yi Gao, Xu Zhu, Jieer Ying, Meili Sun, Jingdong Zhang, Zhixiang Zhuang, Yangqing Huang, Lichun Deng, Ping Chen, Yuxian Bai, Zuoxing Niu, Wei Li, Xiaoyu Yin, Aibing Xu, Yufeng Cheng, Jin Li · 发表于：Journal of Clinical Oncology · 年份：2023 · DOI：10.1200/jco.2023.41.4_suppl.572 · 被引用次数：11 · 研究领域：Fibroblast Growth Factor Research、Cholangiocarcinoma and Gallbladder Cancer Studies、Metastasis and carcinoma case studies

572 Background: ICP-192 (gunagratinib), developed by InnoCare Pharma, is a novel pan-FGFR (fibroblast growth factor receptors) inhibitor that potently and selectively inhibits FGFR 1, 2, 3 and 4 activities irreversibly by covalent binding. Here we present data from an ongoing phase IIa dose-expansion study (ICP-CL-00301 NCT03758664) of gunagratinib in patients with cholangiocarcinoma (CCA). Methods: Eligible participants were aged 18-75 years, had locally advanced or metastatic CCA with FGFR2 fusions or rearrangements, and had disease progression after ≥1 prior treatment or intolerant of prior treatment. Patients received oral gunagratinib 20 mg QD (21-day cycle) until disease progression, intolerance, withdrawal of consent, or death. Radiological tumor evaluation was done at baseline and every 6 weeks until disease progression. Primary endpoint was objective response rate (ORR). Results: As of September 5, 2022, 18 CCA patients were enrolled and received 20 mg gunagratinib. The median age of the patients was 52.0 with 44.4% male and ECOG between 0-2. Median follow-up was 5.57 months. Among the 17 patients who have completed at least one tumor assessment, 9 patients had confirmed partial response (PR) and 7 patients had stable disease (SD). The ORR was 52.9% (9/17). The disease control rate (DCR) was 94.1% (16/17). The median progression free survival (mPFS) was 6.93 months (95% CI, 5.42–not reached) (not mature at cutoff). Among the 17 patients with safety data, 16 (94.1%) p...