The EPCORE FL-1 trial demonstrated that epcoritamab combined with lenalidomide and rituximab significantly improved response rate and progression-free survival compared to lenalidomide and rituximab alone. Epcoritamab plus R² showed a higher incidence of grade 3 or higher adverse events, with manageable safety profile positioning it as a new standard of care for relapsed or refractory follicular lymphoma.
Study
|
Global, open-label, randomised, phase 3 trial [EPCORE FL-1] |
| Relapsed or refractory follicular lymphoma after at least one previous line of chemoimmunotherapy |
| Epcoritamab+R² (n=243) vs R² (n=245) for 12 cycles
|
Efficacy
|
ORR: 95% (Epcoritamab+R²) vs 79% (R²) |
| mPFS: Not reached (Epcoritamab+R²) vs 11.7 mos (R²) (HR 0.21 [0.14-0.31]) |
| 16-mo PFS: 85.5% (Epcoritamab+R²) vs 40.2% (R²) |
| 16-mo OS: 95.8% (Epcoritamab+R²) vs 88.8% (R²)
|
Safety
|
Grade >=3 AE: neutropenia (69% vs 42%), infections (33% vs 16%) |
| Serious AEs higher in Epcoritamab+R²: 56% vs 29% |
| Treatment discontinuations due to AEs: 19% vs 12%
|
Lancet. Published online December 7, 2025
http://doi.org/10.1016/S0140-6736(25)02360-8
Reviewed by Ulas D. Bayraktar, MD on Dec 12, 2025
