Genmab: EC approves TEPKINLY (epcoritamab) + lenalidomide and rituximab for relapsed/refractory follicular lymphoma
- European Commission approved TEPKINLY (epcoritamab) plus lenalidomide and rituximab for adult relapsed/refractory follicular lymphoma as a fixed‑duration, chemotherapy‑free second‑line option.
- EPCORE FL‑1 showed a 79% reduction in risk of progression or death with the combination vs R2 alone (HR 0.21; 95% CI 0.13–0.33; p<0.0001).
- Overall response rate was 96% (95% CI 90.2–98.6) vs 81% for R2; complete response rates were 74% vs 43% (n=181/243 vs n=106/245).
- Serious adverse reactions occurred in 44% of patients on the combination; events ≥5% included cytokine release syndrome, pneumonia, COVID‑19 and febrile neutropenia.
European approval
Genmab announced the European Commission granted marketing authorization for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab for adult patients with relapsed or refractory follicular lymphoma, providing a fixed‑duration, chemotherapy‑free second‑line option.
Pivotal Phase 3 data
The authorization is based on the open‑label EPCORE FL‑1 trial comparing fixed‑duration epcoritamab + R2 (n=243) to R2 alone (n=245). The combination reduced the risk of progression or death by 79% (HR 0.21; 95% CI 0.13–0.33; p<0.0001). Overall response rate for the combination was 96% (95% CI 90.2–98.6) versus 81% for R2 (95% CI 72.7–87.7), and complete response rates were 74% (181/243) versus 43% (106/245). Efficacy endpoints were assessed by an Independent Review Committee per Lugano 2014 criteria and the results were published in The Lancet (January 2026).
Safety and development status
The safety profile was consistent with known profiles for epcoritamab and R2. The most common (≥20%) adverse reactions included neutropenia, rash, upper respiratory tract infections, fatigue, diarrhea, injection‑site reactions and cytokine release syndrome. Serious adverse reactions occurred in 44% of patients receiving the combination; events reported in ≥5% included CRS, pneumonia, COVID‑19 and febrile neutropenia. Epcoritamab is an IgG1 bispecific antibody (DuoBody‑CD3xCD20) administered subcutaneously, co‑developed by Genmab and AbbVie, and has prior regulatory approvals in multiple lymphoma indications across more than 65 territories while additional Phase 3 studies in B‑cell malignancies continue.
Source: Genmab