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Association details:
| Biomarker: | FGFR2 overexpression |
|---|---|
| Cancer: | Gastric Cancer |
| Drug: | bemarituzumab (AMG 552) (FGFR2b inhibitor) |
| Direction: | Sensitive |
Evidence:
Source:
Title:
Bemarituzumab plus Chemotherapy and Nivolumab versus Chemotherapy and Nivolumab Alone Bemarituzumab más quimioterapia y nivolumab frente a solo quimioterapia y nivolumab
Excerpt:
...Prior adjuvant or neo-adjuvant therapy for localized disease is allowed, provided it has been completed more than 6 months prior to the first dose of study treatment.- Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by centrally performed immunohistochemistry (IHC) testing -Adultos con adenocarcinoma gástrico o de la unión gastroesofágica documentado histológicamente, irresecable, localmente avanzada o metastásica (no susceptible de tratamiento curativo).-Estado funcional del Eastern Cooperative Oncology Group (ECOG) de 0 a 1.-Enfermedad medible o no medible, pero evaluable, según los criterios RECIST v. 1.1.-El sujeto debe ser candidato para recibir mFOLFOX6 y nivolumab.-Función orgánica adecuada tal como se define a continuación:•Recuento absoluto de neutrófilos ≥ 1,5 x 109/l.•Recuento plaquetario ≥ 100 x 109/l.•Hemoglobina ≥ 9 g/dl.•Aspartato aminotransferasa (AST) y ALT < 3 x LSN (o < 5 x límite superior de la normalidad [LSN] si hay afectación hepática). ...
Trial ID:
Source:
Title:
Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer
Excerpt:
......
Trial ID:
More C2 evidence
Source:
Title:
A Study of Bemarituzumab (FPA144) Combined With Modified FOLFOX6 (mFOLFOX6) in Gastric/Gastroesophageal Junction Cancer
Excerpt:
...- Fibroblast growth factor receptor 2b (FGFR2b) overexpression as determined by a centrally performed immunohistochemistry tissue test and/or FGFR2 gene amplification as determined by a centrally performed circulating tumor deoxyribonucleic acid (ctDNA) blood based assay...
Trial ID:
Source:
Title:
A Phase 2 Study Evaluating FPA144 and Modified FOLFOX6 in Patients with Previously Untreated Advanced Gastric and Gastroesophageal Cancer: Phase I to be conducted prior to Phase 2
Excerpt:
...Measurable or non-measurable, but evaluable disease using RECIST v1.1 Additional Inclusion Criteria for Phase 3 Only: • Histologically documented gastric or gastroesophageal junction (GEJ) adenocarcinoma (not amenable to curative therapy) • Radiographic imaging of the chest, abdomen and pelvis (computed tomography [CT] preferred, magnetic resonance imaging [MRI] acceptable) performed within 28 days (± 3 days) of treatment (C1D1) • FGFR2b overexpression as determined by a centrally performed IHC tissue test and/or FGFR2 gene amplification as determined by a centrally performed ctDNA blood based assay • Patient must be a candidate for mFOLFOX6 chemotherapy • No prior chemotherapy for metastatic or unresectable disease (except a maximum of 1 dose of mFOLFOX6 administered while waiting for results of FGFR2 testing during the Pre-Screening period) • If prior adjuvant or neo-adjuvant therapy (chemotherapy and/or chemoradiation) has been received, more than 6 months must have elapsed between the end of adjuvant therapy and the confirmation of radiographic disease progression`Phase 1 and Phase 2:1. ...
Trial ID:
Source:
Title:
Bemarituzumab or Placebo Plus Chemotherapy in Gastric Cancers With Fibroblast Growth Factor Receptor 2b (FGFR2b) Overexpression
Excerpt:
...- Fibroblast growth factor receptor 2b (FGFR2b) overexpression positive as determined by centrally performed immunohistochemistry (IHC) testing, based on tumor sample either archival (obtained within 6 months/180 days prior to signing pre-screening informed consent) or a fresh biopsy...
Trial ID:
Less C2 evidence
Source:
Title:
FIGHT: A randomized, double-blind, placebo-controlled, phase II study of bemarituzumab (bema) combined with modified FOLFOX6 in 1L FGFR2b+ advanced gastric/gastroesophageal junction adenocarcinoma (GC).
Published date:
05/19/2021
Excerpt:
Patients with FGFR2b overexpression irrespective of ctDNA gene amplification benefited from bema: IHC+/ctDNA- PFS hazard ratio (HR) 0.63 (95% CI 0.4, 0.99), OS HR 0.66 (95% CI 0.39, 1.12....Pts with overexpression of FGFR2b even without ctDNA amplification demonstrated a benefit from the addition of bema to mFOLFOX6….
Secondary therapy:
mFOLFOX6
DOI:
10.1200/JCO.2021.39.15_suppl.4010
Trial ID:
Source:
Title:
Phase I Escalation and Expansion Study of Bemarituzumab (FPA144) in Patients With Advanced Solid Tumors and FGFR2b-Selected Gastroesophageal Adenocarcinoma
Published date:
03/14/2020
Excerpt:
The ORR was 17.9% (95% CI, 6.1% to 36.9%) in patients with GEA with high FGFR2b overexpression...Stable disease was the best observed response in 13 additional patients, leading to an overall DCR (PR plus stable disease) of 64.3% (95% CI, 44.1% to 81.4%) in the subgroup with high FGFR2b overexpression.
DOI:
10.1200/JCO.19.01834
