1. Bemarituzumab plus mFOLFOX6 as first-line treatment in East Asian patients with FGFR2b-overexpressing locally advanced or metastatic gastric/gastroesophageal junction cancer: subgroup of FIGHT final analysis.
- Author
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Kang YK, Qin S, Lee KW, Oh SC, Kim IH, Kim JG, Li Y, Yan Z, Li J, Bai LY, Chan C, Yusuf A, Zahlten-Kümeli A, Taylor K, and Yamaguchi K
- Subjects
- Humans, Male, Female, Middle Aged, Aged, Adult, Double-Blind Method, Esophageal Neoplasms drug therapy, Esophageal Neoplasms pathology, Asia, Eastern, Aged, 80 and over, Survival Rate, East Asian People, Stomach Neoplasms drug therapy, Stomach Neoplasms pathology, Stomach Neoplasms mortality, Receptor, Fibroblast Growth Factor, Type 2, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Fluorouracil administration & dosage, Fluorouracil therapeutic use, Leucovorin therapeutic use, Leucovorin administration & dosage, Antibodies, Monoclonal, Humanized therapeutic use, Esophagogastric Junction pathology, Organoplatinum Compounds therapeutic use, Organoplatinum Compounds administration & dosage
- Abstract
Background: In the FIGHT study (NCT03694522) bemarituzumab, a humanized monoclonal antibody selective for fibroblast growth factor receptor 2b (FGFR2b), plus mFOLFOX6 showed clinically meaningful efficacy in patients with FGFR2b-positive (2+/3+ membranous staining by immunohistochemistry) locally advanced unresectable/metastatic gastric/gastroesophageal cancer (G/GEJC). A meaningful proportion of patients in FIGHT were enrolled in East Asia, reflecting global epidemiology of G/GEJC., Methods: This subgroup analysis of the global, phase 2, double-blind FIGHT study included all patients enrolled in East Asian sites. Patients were randomized 1:1 to bemarituzumab-mFOLFOX6 (15 mg/kg and one 7.5 mg/kg dose on cycle 1, day 8) or matching placebo-mFOLFOX6. The primary endpoint was investigator-assessed progression-free survival (PFS). Secondary endpoints included overall survival (OS), objective response rate, and safety. Efficacy was evaluated after a minimum follow-up of 24 months., Results: The East Asian subgroup comprised 89 patients (57% of overall study population); 45 were randomized to bemarituzumab-mFOLFOX6 and 44 to placebo-mFOLFOX6. Median PFS (95% confidence interval [CI]) was 12.9 months (8.8-17.9) with bemarituzumab-mFOLFOX6 and 8.2 months (5.6-10.3) with placebo-mFOLFOX6 (HR 0.50, 95% CI 0.29-0.87); median OS (95% CI) was 24.7 months (13.8-33.1) vs 12.9 months (9.3-21.4), respectively (HR 0.56, 95% CI 0.32-0.96). Treatment benefit was more pronounced in patients with FGFR2b-positive G/GEJC in ≥ 10% of tumor cells. No new safety signals were reported., Conclusion: In East Asian patients with FGFR2b-positive advanced/metastatic G/GEJC enrolled in the global FIGHT study, bemarituzumab-mFOLFOX6 showed clinically meaningful outcomes over placebo-mFOLFOX6., (© 2024. The Author(s).)
- Published
- 2024
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