Evidence map›Paper›PMID 38308771›Full record

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

Bemarituzumab as first-line treatment for locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma: final analysis of the randomized phase 2 FIGHT trial.

Zev A Wainberg, Yoon-Koo Kang, Keun-Wook Lee, Shukui Qin, Kensei Yamaguchi, In-Ho Kim, Anwaar Saeed, Sang Cheul Oh, Jin Li, Haci Mehmet Turk and 8 more

3 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIRandomized Controlled Trial
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 3 registered trials, which are not on this map. Cited by 54 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
54citing papers in PubMed, 2 pooled it
14.5field-weighted citation impact, top 1% of its field
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
NCT05052801 phase3completednot on this map

A Randomized, Multi-center, Double-blind, Placebo-controlled Phase 3 Study of Bemarituzumab Plus Chemotherapy Versus Placebo Plus Chemotherapy in Subjects With Previously Untreated Advanced Gastric or Gastroesophageal Junction Cancer With FGFR2b Overexpression

TypeinterventionalSponsorAmgenRan2022 to 2026Enrolled547ConditionsGastric Cancer, Gastroesophageal Junction AdenocarcinomaArmsBemarituzumab, mFOLFOX6, Placebo
NCT05111626 phase3terminatednot on this map

A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression

TypeinterventionalSponsorAmgenRan2022 to 2025Enrolled515ConditionsGastric Cancer, Gastroesophageal Junction AdenocarcinomaArmsBemarituzumab, Nivolumab, Chemotherapy, Placebo
3 · Its place in the literature

Who cites it

54 citing papers in PubMed, 2 syntheses or guidelines pooled it, 62 citations in OpenAlex.

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  11. FGFR2 amplification and fusion identified by NGS align with FGFR2b overexpression.Virchows Archiv : an international journal of pathology · 2026
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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

18 authors at 16 institutions in 9 countries.

Zev A WainbergDivision of Hematology-Oncology, Department of Medicine, University of California Los Angeles Medical Center, David Geffen School of Medicine, 2825 Santa Monica Blvd., Suite 200, Santa Monica, Los Angeles, CA, 90404-2429, USA. ZWainberg@mednet.ucla.edu.
Yoon-Koo KangAsan Medical Centre, University of Ulsan College of Medicine, Seoul, South Korea.
Keun-Wook LeeSeoul National University College of Medicine, Seoul National University Bundang Hospital, Seongnam, South Korea.
Shukui QinNanjing Tianyinshan Hospital, The 1st Affiliated Hospital of China Pharmaceutical University, Nanjing, China.
Kensei YamaguchiGastroenterological Chemotherapy Department, The Cancer Institute Hospital of JFCR, Tokyo, Japan.
In-Ho KimDepartment of Oncology, The Catholic University of Korea, Seoul St Mary's Hospital, Seoul, South Korea.
Anwaar SaeedUPMC Hillman Cancer Center, University of Pittsburgh, Pittsburgh, PA, USA.
Sang Cheul OhDepartment of Internal Medicine, Korea University Guro Hospital, Seoul, South Korea.
Jin LiDepartment of Oncology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, China.
Haci Mehmet TurkDepartment of Medical Oncology, Bezmialem Vakif University, Istanbul, Turkey.
Alexandra TeixeiraGastroenterology Division, Hospital da Senhora da Oliveira, Guimarães, Portugal.
Erika HitreDepartment of Medical Oncology and Clinical Pharmacology "B", National Institute of Oncology, Budapest, Hungary.
Adrian A UdreaMedical Oncology, Medisprof Cancer Center, Cluj-Napoca, Romania.
Giovanni Gerardo CardellinoDepartment of Oncology, Azienda Sanitaria Universitaria Friuli Centrale, Udine, Italy.
Raquel Guardeño SanchezDepartment of Medical Oncology, Catalan Institute of Oncology, Girona, Spain.
Anita Zahlten-KümeliAmgen Inc, Thousand Oaks, CA, USA.
Kate TaylorAmgen Inc, Uxbridge, UK.
Peter C EnzingerDepartment of Medicine, Dana-Farber Cancer Institute, Boston, MA, USA.
Amgen (United Kingdom) · GBAmgen (United States) · USBezmiâlem Vakıf Üniversitesi · TRCatholic University of Korea · KRChina Pharmaceutical University · CNDana-Farber Cancer Institute · USHospital da Senhora da Oliveira Guimarães · PTInstitut Català d'Oncologia · ESKorea University Medical Center · KRLos Angeles Medical Center · USNational Institute of Oncology · HUSeoul National University Bundang Hospital · KRShanghai East Hospital · CNThe Cancer Institute Hospital · JPUlsan College · KRUPMC Hillman Cancer Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundWe report the final results of the randomized phase 2 FIGHT trial that evaluated bemarituzumab, a humanized monoclonal antibody selective for fibroblast growth factor receptor 2b (FGFR2b), plus mFOLFOX6 in patients with FGFR2b-positive (2 + /3 + membranous staining by immunohistochemistry), HER-2-negative gastric or gastroesophageal junction cancer (GC).

methodsPatients received bemarituzumab (15 mg/kg) or placebo once every 2 weeks with an additional bemarituzumab (7.5 mg/kg) or placebo dose on cycle 1 day 8. All patients received 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.

resultsIn the bemarituzumab-mFOLFOX6 (N = 77) and placebo-mFOLFOX6 (N = 78) arms, respectively, 59.7% and 66.7% of patients were FGFR2b-positive in ≥ 10% of tumor cells. The median PFS (95% confidence interval [CI]) was 9.5 months (7.3-13.7) with bemarituzumab-mFOLFOX6 and 7.4 months (5.7-8.4) with placebo-mFOLFOX6 (hazard ratio [HR], 0.72; 95% CI 0.49-1.08); median OS (95% CI) was 19.2 (13.6-24.2) and 13.5 (9.3-15.9) months, respectively (HR 0.77; 95% CI 0.52-1.14). Observed efficacy in FGFR2b-positive GC in ≥ 10% of tumor cells was: PFS: HR 0.43 (95% CI 0.26-0.73); OS: HR 0.52 (95% CI 0.31-0.85). No new safety findings were reported.

conclusionsIn FGFR2b-positive advanced GC, the combination of bemarituzumab-mFOLFOX6 led to numerically longer median PFS and OS compared with mFOLFOX6 alone. Efficacy was more pronounced with FGFR2b overexpression in ≥ 10% of tumor cells. Confirmatory phase 3 trials are ongoing (NCT05052801, NCT05111626). CLINICAL

trial registrationNCT03694522.

Indexed as

AdenocarcinomaAntibodies, Monoclonal, HumanizedEsophageal NeoplasmsStomach NeoplasmsAntineoplastic Combined Chemotherapy ProtocolsEsophagogastric JunctionFluorouracilHumansReceptor, Fibroblast Growth Factor, Type 2Antibodies, Monoclonal, HumanizedbemarituzumabFluorouracilReceptor, Fibroblast Growth Factor, Type 2BemarituzumabFGFR2bGastric cancermFOLFOX6Targeted therapy

Identifiers

PMID38308771
PMCPMC11016503
OpenAlexW4391514762

What OpenQuestion holds

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LicenceCC BY
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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.