Randomized double-blind placebo-controlled phase 2 study of bemarituzumab combined with modified FOLFOX6 (mFOLFOX6) in first-line (1L) treatment of advanced gastric/gastroesophageal junction adenocarcinoma (FIGHT).

作者：Zev A. Wainberg, Peter C. Enzinger, Yoon‐Koo Kang, Kensei Yamaguchi, Shukui Qin, Keun‐Wook Lee, Sang Cheul Oh, Jin Li, Hacı Mehmet Türk, Alexandra Carolina Teixeira, Giovanni Gerardo Cardellino, Raquel Guardeño, Siddhartha S. Mitra, Yingsi Yang, Helen Collins, Daniel V.T. Catenacci · 发表于：Journal of Clinical Oncology · 年份：2021 · DOI：10.1200/jco.2021.39.3_suppl.160 · 被引用次数：76 · 研究领域：Gastrointestinal Tumor Research and Treatment、Fibroblast Growth Factor Research、Gastric Cancer Management and Outcomes

160 Background: Bemarituzumab (bema), a first-in-class humanized IgG1 monoclonal antibody, selectively binds to FGFR2b, inhibits ligand binding and mediates antibody-dependent cell-mediated cytotoxicity. A phase 1 study of bema monotherapy in solid tumors had no dose-limiting toxicities and a confirmed objective response rate (ORR) of 18% in patients (pts) with refractory FGFR2b+ gastric cancer (GC). Methods: The FIGHT study (NCT03343301) is a global, randomized, double-blind, placebo-controlled phase 2 trial. Pts with unresectable locally advanced or metastatic GC that was not HER2+ were eligible if their tumor was positive for FGFR2b overexpression by centrally performed immunohistochemistry (IHC) or for FGFR2 amplification by circulating tumor DNA (ctDNA). Pts were treated with mFOLFOX6 and randomized 1:1 to bema 15mg/kg or placebo (pbo) every 2 weeks with 1 additional 7.5mg/kg bema/pbo dose on day 8. Treatment was continued until disease progression, intolerable toxicity, or death. The primary endpoint was investigator-assessed progression-free survival (PFS) and key secondary endpoints include overall survival (OS), overall response rate (ORR), and frequency of adverse events. Statistical significance (2-sided a of 0.2) was tested sequentially for PFS, OS and ORR. Results: Of 910 1L GC pts whose tumors were evaluated 275 (30%) were FGFR2b+. Of 155 pts randomized, 77 to bema+mFOLFOX6 and 78 to pbo+mFOLFOX6, 149 were FGFR2b+ by IHC and 26 by ctDNA. The primary endpoint was...