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Clinical Trial
. 2024 Sep;27(5):1046-1057.
doi: 10.1007/s10120-024-01516-3. Epub 2024 Jun 11.

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

Yoon-Koo Kang  1 , Shukui Qin  2 , Keun-Wook Lee  3 , Sang Cheul Oh  4 , In-Ho Kim  5 , Jong Gwang Kim  6 , Yong Li  7 , Zhuchen Yan  8 , Jin Li  9 , Li-Yuan Bai  10 , Catherine Chan  11 , Akeem Yusuf  11 , Anita Zahlten-Kümeli  11 , Kate Taylor  12 , Kensei Yamaguchi  13
Affiliations
Clinical Trial

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

Yoon-Koo Kang et al. Gastric Cancer. 2024 Sep.

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.

Keywords: Bemarituzumab; FGFR2b; Gastric cancer; Targeted therapy; mFOLFOX6.

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Conflict of interest statement

Yoon-Koo Kang: Consulting fees (self): Amgen, Novartis, Roche, Daehwa, Zymeworks, Blueprint, Surface Oncology, ALX Oncology, Macrogenics, BMS, Merck, Liscure. Shukui Qin: None to disclose. Keun-Wook Lee: All support for the present manuscript: Five Prime Therapeutics; Grants or contracts from any entity: All to institution for conducting clinical trials—AstraZeneca, Ono pharmaceutical, Merck Sharp and Dohme, Merck KGaA, Roche, Pfizer, Beigene, Leap therapeutics, ALX Oncology, Zymeworks, Astellas, Macrogenics, Amgen, Seagen, Bolt therapeutics, Trishula therapeutics, Oncologie, Pharmacyclics, MedPacto, Green Cross Corp, ABLBIO, Y-BIOLOGICS, Daiichi Sankyo, Taiho Pharmaceutical, InventisBio, Elevar Therapeutics, Metafines, Idience, Genome & Company, Exelixis; Honoraria for lectures: Ono pharmaceutical, Boryung, Daiichi Sankyo, Astellas, Sanofi-Aventis; Participation on a Data Safety Monitoring Board or Advisory Board: ALX Oncology, Metafines. Sang Cheul Oh: None to disclose. In-Ho Kim: None to disclose. Jong Gwang Kim: None to disclose. Yong Li: None to disclose. Zhuchen Yan: None to disclose. Jin Li: Research Grants: Roche; Speakers Bureau: Eli Lilly, AstraZeneca. Li-Yuan Bai: None to disclose. Catherine Chan: Employee and stockholder, Amgen Inc. Akeem Yusuf: Employee and stockholder, Amgen Inc. Anita Zalten-Kümeli: Employee and stockholder, Amgen Inc. Kate Taylor: Employee and stockholder, Amgen Inc. Kensei Yamaguchi: Research Grants: Taiho Pharm; Speakers Bureau: Daiichi Sankyo Co., Ltd.,Chugai Pharmaceutical Co., Ltd.,Bristol-Myers Squibb K.K., Eli Lilly Japan K.K., Taiho Pharmaceutical Co., Ltd., Ono Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd., Merck Biopharm Co., Ltd.

Figures

Fig. 1
Fig. 1
Progression-free survival (a) and overall survival (b) in the FIGHT East Asian subgroup. Bema bemarituzumab plus mFOLFOX6, CI confidence interval, HR hazard ratio, mFOLFOX6 modified FOLFOX (infusional 5-fluorouracil, leucovorin, and oxaliplatin), mOS median overall survival, mPFS median progression-free survival, OS overall survival, Pbo placebo plus mFOLFOX6, PFS progression-free survival. HRs and 95% CIs were calculated using the unstratified Cox proportional hazards model. Vertical bars indicate censoring
Fig. 2
Fig. 2
Response by patient in the FIGHT East Asian subgroup. Figure displays data from patients with measurable disease at baseline who were evaluable for evaluation of best overall response
See this image and copyright information in PMC

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