Zolbetuximab (anti-CLDN18.2 quimérico IgG1 mAb) + quimioterapia está aprobado por la FDA (oct 2024)...
Vista determinista de la entidad fuente YAML. La autoridad clínica sigue con los ID de fuente citados y estado de firma del revisor.
| ID | BMA-CLDN18-2-GASTRIC |
|---|---|
| Tipo | Relevancia terapéutica |
| Situación | reviewed 2026-05-03 | pending_clinical_signoff | actionability review required |
| Enfermedades | DIS-GASTRIC |
| Fuentes | SRC-ESMO-GASTRIC-2024 SRC-NCCN-GASTRIC-2025 |
Hechos relativos a la posibilidad de adoptar medidas
| Biomarcador | BIO-CLDN18-2 |
|---|---|
| Variante | ≥75% de las células tumorales con tinción membranosa moderada a fuerte (2+/3+) mediante el diagnóstico de acompañante RxDx de VENTANA CLDN18 (43-14A) |
| Enfermedad | DIS-GASTRIC |
| El nivel de ESCAT | IA |
| Combinaciones recomendadas | zolbetuximab + mFOLFOX6 (1L; SPOTLIGHT regimen — preferred if oxaliplatin-based tolerability, no neuropathy contraindication), zolbetuximab + CAPOX (1L; GLOW regimen — alternative when 3-weekly schedule preferred) |
| Monoterapia contraindicada | zolbetuximab en monoterapia (no se requieren datos de registro; espina vertebral de quimioterapia) |
| Resumen de las pruebas | Zolbetuximab (anti-CLDN18.2 chimeric IgG1 mAb) + chemotherapy is FDA-approved (Oct 2024) for CLDN18.2-positive (≥75% 2+/3+ cells), HER2-negative, locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) adenocarcinoma, 1L. Two registrational phase III trials: SPOTLIGHT (Shah et al. Lancet 2023 — zolbetuximab + mFOLFOX6 vs mFOLFOX6; mOS 18.2 vs 15.5 mo, HR 0.75, p=0.0053; mPFS 10.6 vs 8.7 mo, HR 0.75) and GLOW (Lordick et al. Lancet Oncol 2023 — zolbetuximab + CAPOX vs CAPOX; mOS 14.4 vs 12.2 mo, HR 0.77, p=0.0053; mPFS 8.2 vs 6.8 mo, HR 0.68). CLDN18.2 prevalence: ~38% of HER2-negative metastatic gastric/GEJ adenocarcinomas meet the ≥75% 2+/3+ threshold. Companion diagnostic (VENTANA CLDN18 43-14A RxDx) required before initiation. Priority hierarchy when co-positive: HER2+ (TOGA/KEYNOTE-811) > MSI-H (KEYNOTE-859) > CLDN18.2+ (SPOTLIGHT/GLOW). |
Notas
ESCAT IA. Two concordant phase III RCTs (SPOTLIGHT + GLOW) with survival benefit in CLDN18.2+ HER2-negative subgroup. Companion diagnostic (VENTANA RxDx) FDA-cleared — reflex CLDN18.2 IHC testing now NCCN Category 1 for all newly diagnosed metastatic gastric/GEJ adenocarcinoma alongside HER2, MSI, PD-L1. N/V management (nausea/vomiting prominent AE profile for zolbetuximab — intensive antiemetic prophylaxis required including 5-HT3 + NK1 antagonist + dexamethasone on Day 1). EMA approval pending as of 2026-05-03.
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No se encuentran referencias inversas en el corpus YAML.