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.

Autor: Kang YK; Department of Oncology Asan Medical Centre, University of Ulsan College of Medicine, 88, Olympic-Ro 43-Gil, Songpa-Gu, Seoul, 05505, South Korea. ykkang@amc.seoul.kr., Qin S; Nanjing Tianyinshan Hospital, The First Affiliated Hospital of China Pharmaceutical University, Nanjing, China., Lee KW; Seoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-Do, South Korea., Oh SC; Department of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea., Kim IH; Department of Oncology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea., Kim JG; Kyungpook National University Chilgok Hospital, Daegu, South Korea., Li Y; The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China., Yan Z; Tianjin Medical University Cancer Institute and Hospital, Tianjin, China., Li J; Department of Oncology, Shanghai East Hospital, Shanghai, China., Bai LY; Division of Hematology and Oncology, China Medical University Hospital, and China Medical University, Taichung, Taiwan., Chan C; Amgen Inc., Thousand Oaks, USA., Yusuf A; Amgen Inc., Thousand Oaks, USA., Zahlten-Kümeli A; Amgen Inc., Thousand Oaks, USA., Taylor K; Amgen Ltd, Uxbridge, UK., Yamaguchi K; Gastroenterological Chemotherapy Department, The Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan.
Jazyk: angličtina
Zdroj: Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association [Gastric Cancer] 2024 Sep; Vol. 27 (5), pp. 1046-1057. Date of Electronic Publication: 2024 Jun 11.
DOI: 10.1007/s10120-024-01516-3
Abstrakt: 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).)
Databáze: MEDLINE
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