Core Insights - Genmab A/S announced promising results from the Phase 1b/2 EPCORE NHL-2 trial, demonstrating the efficacy of epcoritamab in combination with R-ICE for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) [2][4][5] Trial Results - The overall response rate (ORR) was reported at 87 percent, with a complete response (CR) rate of 65 percent and a partial response (PR) rate of 23 percent [2][6] - At six months, 81 percent of responses were ongoing, 74 percent of patients were progression-free, and 100 percent of patients were alive [2][6] - Among patients who progressed within 12 months after first-line treatment, the ORR was 85 percent and the CR rate was 55 percent [4] - For patients who progressed after 12 months from first-line therapy, the ORR was 91 percent and the CR rate was 82 percent [4] Safety Profile - The safety profile indicated low-grade cytokine release syndrome (CRS) with no treatment discontinuations due to treatment-emergent adverse events (TEAEs) [3][5] - The most common TEAEs included neutropenia (74 percent), anemia (68 percent), and thrombocytopenia (68 percent) [3] - Serious infections were reported in 16 percent of patients, with no Grade 5 TEAEs observed [3] Industry Context - DLBCL accounts for approximately 25-30 percent of all non-Hodgkin's lymphoma cases globally, with around 25,000 new cases diagnosed annually in the U.S. [6][7] - The investigational treatment with epcoritamab aims to address significant unmet needs in the management of R/R DLBCL and other hematologic malignancies [5][12] Future Development - Genmab is collaborating with AbbVie to further develop epcoritamab as a core therapy for B-cell lymphomas, with ongoing trials evaluating its use in various treatment lines [5][12] - The EPCORE NHL-2 trial is part of a broader clinical program aimed at advancing epcoritamab both as monotherapy and in combination therapies [8][12]

Core Viewpoint - Genmab A/S plans to submit a supplemental Biologics License Application (sBLA) for subcutaneous epcoritamab in combination with rituximab and lenalidomide for treating adult patients with relapsed or refractory follicular lymphoma in the first half of 2025 [1][3] Company Announcement - The sBLA submission is based on positive topline results from the Phase 3 EPCORE FL-1 trial, which showed that epcoritamab plus rituximab (R) met one of its dual primary endpoints of overall response rate (ORR) with a p-value of less than 0.0001 [2][7] - The safety profile of the combination therapy was consistent with known safety profiles of the individual components, and no new safety signals were observed [2][3] About Follicular Lymphoma (FL) - Follicular lymphoma is a slow-growing form of non-Hodgkin's lymphoma, accounting for 20-30% of all cases, with approximately 15,000 new cases diagnosed annually in the U.S. [4] - It is considered incurable with current standard therapies, and patients often experience shorter remission periods with each relapse [4] About the EPCORE FL-1 Trial - The EPCORE FL-1 trial is a Phase 3 open-label interventional study evaluating the safety and efficacy of epcoritamab plus rituximab and lenalidomide versus rituximab alone in patients with relapsed/refractory follicular lymphoma [5] About Epcoritamab - Epcoritamab is an IgG1-bispecific antibody developed using Genmab's DuoBody technology, designed to target CD3 on T cells and CD20 on B cells, inducing T-cell-mediated killing of CD20+ cells [6][7] - It is currently approved by the FDA as a monotherapy for adults with relapsed or refractory follicular lymphoma after two or more lines of systemic therapy [3][7] Collaboration and Future Plans - Genmab is co-developing epcoritamab with AbbVie, sharing commercial responsibilities in the U.S. and Japan, and both companies are pursuing additional international regulatory approvals for the investigational indication [8][9] - Genmab and AbbVie are also evaluating epcoritamab in various hematologic malignancies across multiple ongoing Phase 3 trials [9]