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Bemarituzumab + mFOLFOX6 (FORTITUDE-101) — 1L FGFR2b-overexpressing HER2-non-positive gastric/GEJ

Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.

Registro de base de conocimiento para la auditoría. Contenido clínico provisional: esto no es una prescripción. Un oncólogo debe verificar fuentes originales, aplicabilidad y estado de revisión.

Fuente YAML: registro completo

ComponentesDRUG-BEMARITUZUMAB DRUG-OXALIPLATIN DRUG-LEUCOVORIN DRUG-5-FLUOROURACIL
IDREG-BEMARITUZUMAB-MFOLFOX6
TipoEsquema terapéutico
Situaciónreviewed 2026-05-07 | pending_clinical_signoff
EnfermedadesNinguna declarada
FuentesSRC-ESMO-GASTRIC-2024 SRC-FIGHT SRC-FORTITUDE-101 SRC-NCCN-GASTRIC-2025

Notas

FORTITUDE-101 (Rha et al. ESMO 2025 LBA10; NCT05052801) phase 3 registrational: bemarituzumab + mFOLFOX6 vs placebo + mFOLFOX6 in FGFR2b-overexpressing (IHC 2+/3+ ≥10% of tumor cells, validated IIIb-selective antibody) HER2-non-positive 1L unresectable / metastatic gastric/GEJ adenocarcinoma. Primary analysis (median follow-up 11.8 mo): mOS 17.9 vs 12.5 mo (HR 0.61, p=0.005); mPFS 8.6 vs 6.7 mo (HR 0.71, 95% CI 0.53–0.95); ORR ~45% in both arms. Updated descriptive analysis (median follow-up 19.4 mo): mOS 14.5 vs 13.2 mo (HR 0.82, 95% CI 0.62–1.08) — early survival gain attenuated with longer follow-up, raising practice-changing controversy at ESMO 2025 (one discussant characterized the data as "biologic activity, not practice-changing" citing absence of PD-1 backbone in control arm and shrinking median OS difference). Predecessor FIGHT phase 2 (Wainberg et al. Lancet Oncol 2022) showed mPFS 9.5 vs 7.4 mo (HR 0.68) in the same FGFR2b ≥10% 2+/3+ subgroup. Ocular toxicity is the dose-defining AE: ~70% any-grade corneal events (punctate keratitis, reduced visual acuity, dry eye, corneal epithelium defect), ~25% grade ≥3, 28% withdrawal due to ocular toxicity (typical onset ~6 months)...

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