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.

IF 6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Gastric Cancer Pub Date : 2024-09-01 Epub Date: 2024-06-11 DOI:10.1007/s10120-024-01516-3
Yoon-Koo Kang, Shukui Qin, Keun-Wook Lee, Sang Cheul Oh, In-Ho Kim, Jong Gwang Kim, Yong Li, Zhuchen Yan, Jin Li, Li-Yuan Bai, Catherine Chan, Akeem Yusuf, Anita Zahlten-Kümeli, Kate Taylor, Kensei Yamaguchi
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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.

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FGFR2b表达过高的局部晚期或转移性胃癌/胃食管交界癌东亚患者的贝马单抗加mFOLFOX6一线治疗:FIGHT最终分析亚组。
研究背景在FIGHT研究(NCT03694522)中,针对成纤维细胞生长因子受体2b(FGFR2b)的选择性人源化单克隆抗体贝马利珠单抗联合mFOLFOX6对FGFR2b阳性(免疫组化2+/3+膜染色)的局部晚期不可切除/转移性胃癌/胃食管癌(G/GEJC)患者显示出有临床意义的疗效。FIGHT中相当一部分患者是在东亚入组的,这反映了G/GEJC的全球流行病学:方法:这项全球 2 期双盲 FIGHT 研究的亚组分析包括所有在东亚地区入组的患者。患者按1:1比例随机接受贝马单抗-mFOLFOX6(15毫克/千克,第1周期第8天一次7.5毫克/千克)或匹配安慰剂-mFOLFOX6治疗。主要终点是研究者评估的无进展生存期(PFS)。次要终点包括总生存期(OS)、客观反应率和安全性。疗效至少在随访 24 个月后进行评估:东亚亚组共有89名患者(占总研究人数的57%),其中45人随机接受贝马单抗-mFOLFOX6治疗,44人随机接受安慰剂-mFOLFOX6治疗。贝马单抗-mFOLFOX6的中位PFS(95%置信区间[CI])为12.9个月(8.8-17.9),安慰剂-mFOLFOX6为8.2个月(5.6-10.3)(HR 0.50,95% CI 0.29-0.87);中位OS(95% CI)分别为24.7个月(13.8-33.1)和12.9个月(9.3-21.4)(HR 0.56,95% CI 0.32-0.96)。在肿瘤细胞中FGFR2b阳性G/GEJC≥10%的患者中,治疗获益更为明显。没有新的安全信号报告:结论:在参加全球FIGHT研究的东亚FGFR2b阳性晚期/转移性G/GEJC患者中,贝马单抗-mFOLFOX6比安慰剂-mFOLFOX6显示出有临床意义的疗效。
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来源期刊
Gastric Cancer
Gastric Cancer 医学-胃肠肝病学
CiteScore
14.70
自引率
2.70%
发文量
80
审稿时长
6-12 weeks
期刊介绍: Gastric Cancer is an esteemed global forum that focuses on various aspects of gastric cancer research, treatment, and biology worldwide. The journal promotes a diverse range of content, including original articles, case reports, short communications, and technical notes. It also welcomes Letters to the Editor discussing published articles or sharing viewpoints on gastric cancer topics. Review articles are predominantly sought after by the Editor, ensuring comprehensive coverage of the field. With a dedicated and knowledgeable editorial team, the journal is committed to providing exceptional support and ensuring high levels of author satisfaction. In fact, over 90% of published authors have expressed their intent to publish again in our esteemed journal.
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