- EPKINLY + R² reduced disease progression risk by 79% in Phase 3 trial.
- Median progression-free survival was not reached for EPKINLY + R².
- 89% of patients responded to EPKINLY + R², with 74% achieving complete response.
- Common adverse reactions included rash, infections, and fatigue.
FDA Approval
The U.S. FDA has approved EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R²) for adult patients with relapsed or refractory follicular lymphoma. This marks the first bispecific-based therapy approved for this condition in the second-line setting.
Phase 3 Trial Results
The approval is based on the Phase 3 EPCORE FL-1 study, where EPKINLY + R² demonstrated a 79% reduction in the risk of disease progression or death compared to the standard R² treatment. The median progression-free survival was not reached for EPKINLY + R², while it was 11.2 months for R².
Response Rates
In the trial, 89% of patients responded to EPKINLY + R², with 74% achieving a complete response. This is compared to a 74% overall response rate and 43% complete response rate for those treated with R².
Safety Profile
The safety profile of EPKINLY + R² was consistent with known profiles of the individual regimens. Common adverse reactions included rash, upper respiratory tract infections, fatigue, and injection site reactions. Cytokine release syndrome occurred in 24% of patients, primarily low grade, and one case of immune effector cell-associated neurotoxicity syndrome was reported.
