Epkinly (epcoritamab), developed by AbbVie and Genmab, is a subcutaneously administered bispecific antibody targeting CD3 on T cells and CD20 on B cells, designed to engage T cells in killing malignant B cells.25
A Phase III trial for Epkinly in combination with rituximab and lenalidomide (R2) as second-line treatment for relapsed or refractory (r/r) follicular lymphoma (FL) achieved a 95.7% overall response rate and a 79% reduction in disease progression or death compared to R2 alone.15
The combination met both dual primary endpoints for overall response rate and progression-free survival, with the safety profile consistent with previous studies and no new safety signals observed in the trial.5
The FDA has already accepted a priority review application for this Epkinly combination regimen in previously treated FL, with a decision expected by November 30, 2025.1
If approved, this would expand Epkinly’s US label to include second-line use in follicular lymphoma, beyond its existing third-line approval for FL and for relapsed/refractory diffuse large B-cell lymphoma (DLBCL).154
Epkinly is forecasted to see substantial sales growth through label expansions and increased adoption, with projections of $3.94 billion in annual sales by 2031, reflecting its positioning as a standard of care in several B-cell malignancies.3
AbbVie and Genmab's partnership has driven regulatory submissions for Epkinly internationally, following previous accelerated approval for DLBCL.24
Sources:
1. https://www.thepharmaletter.com/biotechnology/genmab-eyes-us-nod-after-epcoritamab-combo-clears-phase-iii-hurdle
2. https://news.abbvie.com/2023-11-27-AbbVie-Announces-U-S-Food-and-Drug-Administration-FDA-and-European-Medicines-Agency-EMA-Updates-for-Epcoritamab-EPKINLY-R-TEPKINLY-R-for-the-Treatment-of-Relapsed-Refractory-Follicular-Lymphoma
3. https://www.clinicaltrialsarena.com/analyst-comment/eha-2025-genmab-abbvie-epkinly-dlbcl/
4. https://www.fiercepharma.com/pharma/abbvie-genmab-lymphoma-drug-epcoritamab-fda-approval-heated-blood-cancer-race
5. https://www.clinicaltrialsarena.com/news/epkinly-breaks-ground-in-phase-iii-fl-trial/