AbbVie and Genmab announce positive topline results from the Phase 3 EPCORE DLBCL-4 trial, where the combination of Epkinly (epcoritamab) and lenalidomide met its primary endpoint. The chemotherapy-free regimen significantly improves progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma, reducing the risk of disease progression or death by up to 60% compared to standard chemoimmunotherapy. The companies plan to engage global regulatory authorities to discuss potential label expansion.
EPCORE DLBCL-4 trial results
- ▪The EPCORE DLBCL-4 trial is a global, open-label, randomized Phase 3 trial comparing subcutaneous epcoritamab plus oral lenalidomide against rituximab plus gemcitabine and oxaliplatin in adult patients
- ▪The Phase 3 EPCORE DLBCL-4 trial evaluating epcoritamab in combination with lenalidomide met its primary endpoint of progression-free survival in patients with relapsed or refractory diffuse large B-cell lymphoma
Epcoritamab-lenalidomide combination efficacy
- ▪The combination of epcoritamab and lenalidomide reduced the risk of disease progression or death by 60% under US censoring rules (HR, 0.40; 95% CI, 0.30-0.55; P < .0001)
- ▪The safety profile of the epcoritamab and lenalidomide combination was consistent with the previously reported safety profiles of the individual agents
Relapsed/refractory DLBCL treatment
- ▪In the United States, approximately 25,000 new cases of diffuse large B-cell lymphoma are diagnosed each year
- ▪Diffuse large B-cell lymphoma is the most common type of non-Hodgkin lymphoma worldwide, accounting for approximately 25% to 30% of all cases
Epcoritamab regulatory approvals
- ▪Epcoritamab is approved under the brand name Epkinly in the United States and Japan, and Tepkinly in the European Union
- ▪Epcoritamab has received regulatory approval in certain lymphoma indications in more than 65 territories
Epcoritamab development pipeline
- ▪AbbVie and Genmab are evaluating epcoritamab in an ongoing Phase 3 trial in combination with R-CHOP in adult patients with newly diagnosed diffuse large B-cell lymphoma
- ▪AbbVie and Genmab are evaluating epcoritamab in an ongoing Phase 3 trial in combination with lenalidomide and rituximab compared to chemoimmunotherapy in patients with previously untreated follicular lymphoma
Genmab-AbbVie collaboration
- ▪AbbVie is responsible for the global commercialization of epcoritamab outside of the United States and Japan
- ▪Epcoritamab is being co-developed by Genmab and AbbVie as part of an oncology collaboration, sharing commercial responsibilities in the United States and Japan
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