Announcement • Jul 07

Abbvie Receives European Commission Approval for Tepkinly in Combination with Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma

AbbVie announced that the European Commission (EC) granted marketing authorization for TEPKINLY (epcoritamab) in combination with lenalidomide and rituximab (TEPKINLY + R2) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). The approval is based on results from the pivotal Phase 3 EPCORE FL-1 trial, which evaluated fixed-duration TEPKINLY in combination with R2 compared to standard of care R2. TEPKINLY (epcoritamab) plus lenalidomide and rituximab (R2) is the first and only bispecific-based therapy approved in Europe for the treatment of relapsed or refractory follicular lymphoma in the second-line setting, offering a chemotherapy-free option. In the Phase 3 EPCORE FL-1 trial, fixed-duration TEPKINLY + R2 achieved statistically significant improvement of progression-free survival and overall response rates compared to R2, with approximately three out of four patients achieving a complete response. The study demonstrated TEPKINLY + R2 reduced the risk of disease progression or death by 79% (HR 0.21, 95% CI: 0.13 - 0.33, p<0.0001). Efficacy was established based on the dual primary endpoints of progression free survival (PFS) and overall response rate (ORR) determined by Lugano 2014 criteria as assessed by Independent Review Committee (IRC). Additional efficacy outcome measures include complete response (CR) and duration of response (DOR). The pivotal Phase 3 EPCORE FL-1 trial results were published in The Lancet in January 2026. Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology and administered subcutaneously. Genmab's DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells. Epcoritamab (approved under the brand name EPKINLY in the U.S. and Japan, and TEPKINLY in the European Union) has received regulatory approval in certain lymphoma indications in more than 65 territories. Epcoritamab is being co-developed by AbbVie and Genmab as part of the companies' oncology collaboration. The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Both companies will pursue additional international regulatory approvals for the investigational relapsed or refractory (R/R) follicular lymphoma (FL) indication and additional approvals for the R/R diffuse large B-cell lymphoma (DLBCL) indication. AbbVie and Genmab continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes several Phase 3, open-label, randomized trials, including a trial evaluating epcoritamab in combination with R-CHOP in adult patients with newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in combination with lenalidomide compared to chemotherapy infusion in patients with R/R DLBCL (NCT06508658), and a trial evaluating epcoritamab in combination with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in patients with previously untreated FL (NCT06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Tepkinly (epcoritamab) as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. Tepkinly in combination with lenalidomide and rituximab is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL). Tepkinly as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. The safety of Tepkinly in combination with lenalidomide and rituximab was evaluated in 243 patients with relapsed or refractory follicular lymphoma (FL) after one prior line of therapy (3-step step-up dose schedule N=133). The most common (= 20%) adverse reactions were neutropenia, rash, upper respiratory tract infections, fatigue, diarrhoea, injection site reactions, anaemia, constipation, thrombocytopenia, CRS, hypogammaglobulinaemia, COVID-19, pyrexia, and pneumonia. Serious adverse reactions occurred in 44% of patients. Serious adverse reactions in = 5% of patients included CRS, pneumonia, COVID-19, and febrile neutropenia. Adverse reactions that led to permanent discontinuation of Tepkinly occurred in 6.6% of patients. Discontinuation of Tepkinly in more than 1 patient included pneumonia, COVID-19, upper respiratory tract infections, and neutropenia. Dose delays due to an adverse reaction occurred in 70% of patients. Adverse reactions which resulted in dose delays (= 5%) included neutropenia, upper respiratory tract infections, COVID-19, pneumonia, rash, and thrombocytopenia.

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Abbvie Receives European Commission Approval for Tepkinly in Combination with Lenalidomide and Rituximab for Relapsed or Refractory Follicular Lymphoma

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