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FGFR2b expression de protéines par IHC ( coloration mémbraneuse)

Vue déterministe de l'entité source de la LJAM. L'autorité clinique demeure avec les ID de la source cités et l'état d'approbation de l ́examinateur.

IDBIO-FGFR2B-IHC
TypeBiomarqueur
Alias
Bemarituzumab biomarqueur de compagnieFGFR2 IIIb isoformeFGFR2b membrane IHCFGFR2b surexpressionFGFR2b expression de protéines (IHC)Експресія білка FGFR2b за ІГХ (мембранне забарвлення)
Étatreviewed 2026-05-07 | pending_clinical_signoff
MaladiesDIS-GASTRIC
SourcesSRC-ESMO-GASTRIC-2024 SRC-FORTITUDE-101 SRC-NCCN-GASTRIC-2025

Données biomarqueurs

Type de biomarqueurprotein_expression_ihc
Mesure
MéthodeIHC with FGFR2b-specific monoclonal antibody (FPR2-D, central laboratory assay used in FIGHT phase 2 and FORTITUDE-101 phase 3). Score: percentage of tumor cells with moderate-to-strong (2+/3+) membranous staining. Requires FGFR2b-IIIb-isoform-selective antibody — generic FGFR2 IHC does not distinguish isoforms.
Unitéscategorical: positive (FGFR2b 2+/3+ membranous staining in ≥10% of tumor cells, FORTITUDE-101 threshold) | negative
Biomarqueurs connexesBIO-FGFR2 BIO-HER2-SOLID BIO-MSI-STATUS BIO-CLDN18-2

Notes

Distinct from BIO-FGFR2 (gene-level alterations: fusion / amplification / mutation). FGFR2b-IHC is the protein-level companion biomarker for bemarituzumab — anti-FGFR2b chimeric IgG1 mAb with afucosylated Fc enhancing ADCC. FIGHT phase 2 (Wainberg, Lancet Oncol 2022) used FGFR2b 2+/3+ in ≥10% of tumor cells as eligibility threshold; phase 3 FORTITUDE-101 (cite as-is — source stub pending citation upgrade) uses the same threshold. Companion-diagnostic IVD development ongoing alongside FORTITUDE-101 readout. Note: FGFR2-pan IHC and FGFR2b-IHC are NOT interchangeable — only the IIIb-isoform-selective antibody enables bemarituzumab patient selection.

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Pertinence thérapeutique

Indication