Evidence map›Paper›PMID 38861192›Full record

Trial reportGastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association2024

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, Shukui Qin, Keun-Wook Lee, Sang Cheul Oh, In-Ho Kim, Jong Gwang Kim, Yong Li, Zhuchen Yan, Jin Li, Li-Yuan Bai and 5 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIMulticenter Study
In one paragraph

Trial report in Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03694522 (FIGHT), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03694522 phase2completednot on this map

FIGHT: A Phase 2 Randomized, Double-Blind, Controlled Study Evaluating Bemarituzumab (FPA144) and Modified FOLFOX6 in Patients With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer: Phase 2 Preceded by Dose-Finding in Phase 1

TypeinterventionalSponsorFive Prime Therapeutics, Inc.Ran2018 to 2022Enrolled155ConditionsGastric CancerArmsBemarituzumab, Placebo, Modified FOLFOX6
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Review
  4. Review
  5. Article
  6. Review
  7. Review
  8. Article
  9. Low positivity rate of fibroblast growth factor receptor 2b is associated with heterogeneous expression in gastric cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2025
    Article
  10. Review
  11. Review
  12. Review
  13. Factors associated with the efficacy of first-line nivolumab plus chemotherapy in advanced gastric cancer patients with deficient mismatch repair.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Yoon-Koo KangDepartment 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.ORCID 0000-0003-0783-6583
Shukui QinNanjing Tianyinshan Hospital, The First Affiliated Hospital of China Pharmaceutical University, Nanjing, China.
Keun-Wook LeeSeoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, Gyeonggi-Do, South Korea.
Sang Cheul OhDepartment of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea.
In-Ho KimDepartment of Oncology, Seoul St. Mary's Hospital, The Catholic University of Korea, Seoul, South Korea.
Jong Gwang KimKyungpook National University Chilgok Hospital, Daegu, South Korea.
Yong LiThe Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei, China.
Zhuchen YanTianjin Medical University Cancer Institute and Hospital, Tianjin, China.
Jin LiDepartment of Oncology, Shanghai East Hospital, Shanghai, China.
Li-Yuan BaiDivision of Hematology and Oncology, China Medical University Hospital, and China Medical University, Taichung, Taiwan.
Catherine ChanAmgen Inc., Thousand Oaks, USA.
Akeem YusufAmgen Inc., Thousand Oaks, USA.
Anita Zahlten-KümeliAmgen Inc., Thousand Oaks, USA.
Kate TaylorAmgen Ltd, Uxbridge, UK.
Kensei YamaguchiGastroenterological Chemotherapy Department, The Cancer Institute Hospital of JFCR, Koto-Ku, Tokyo, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundIn 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.

methodsThis 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.

resultsThe 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.

conclusionIn 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.

Indexed as

Antibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsEsophagogastric JunctionFluorouracilLeucovorinOrganoplatinum CompoundsReceptor, Fibroblast Growth Factor, Type 2Stomach NeoplasmsAdultAgedAged, 80 and overDouble-Blind MethodEast Asian PeopleEsophageal NeoplasmsFemaleHumansAntibodies, Monoclonal, HumanizedFGFR2 protein, humanFluorouracilLeucovorinOrganoplatinum CompoundsReceptor, Fibroblast Growth Factor, Type 2BemarituzumabFGFR2bGastric cancermFOLFOX6Targeted therapy

Identifiers

PMID38861192
PMCPMC11335773

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.