Genmab (GMAB) Reports Positive Phase 3 Results for Epcoritamab in DLBCL Trial
COPENHAGEN, Denmark; January 16, 2026 – Genmab A/S (Nasdaq: GMAB) has announced the topline results from its Phase 3 EPCORE DLBCL-1 trial, which evaluated the efficacy of epcoritamab, a T-cell engaging bispecific antibody, in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). The trial findings indicate a significant improvement in progression-free survival (PFS), marking a pivotal moment in the treatment landscape of this aggressive cancer.
Key Trial Outcomes
The EPCORE DLBCL-1 trial demonstrated a compelling improvement in PFS for patients receiving epcoritamab monotherapy, with a hazard ratio (HR) of 0.74 (95% CI 0.60 to 0.92). Additionally, the results showed enhancements in:
- Complete response rate
- Duration of response
- Time to next treatment
This study is notable as it is the first Phase 3 trial to report improved PFS outcomes for a CD3xCD20 T-cell engaging bispecific antibody in this patient population. However, overall survival (OS) data indicated an HR of 0.96 (95% CI 0.77 to 1.20), which did not reach statistical significance.
Trial Details and Implications
The global study enrolled 483 patients who had received at least one prior therapy, with 73% of the participants having undergone two or more treatment lines. These individuals were ineligible for high-dose chemotherapy and autologous stem cell transplant (HDT-ASCT). The safety and efficacy of epcoritamab were compared to the investigator's choice of either:
- Rituximab plus gemcitabine and oxaliplatin (R-GemOx)
- Bendamustine plus rituximab (BR)
Adverse events reported during the trial aligned with the known safety profile of epcoritamab, and further analysis is underway. Notably, this includes evaluating the potential impact of external factors such as the COVID-19 pandemic and the availability of new anti-lymphoma therapies.
Future Regulatory and Clinical Developments
Genmab, in collaboration with AbbVie, plans to engage with global regulatory authorities to discuss the next steps regarding epcoritamab. Anticipated data from two additional Phase 3 trials evaluating epcoritamab’s fixed duration in DLBCL are expected in 2026. These trials include:
- EPCORE DLBCL-2: Testing epcoritamab in conjunction with the standard R-CHOP regimen
- EPCORE DLBCL-4: Assessing epcoritamab combined with lenalidomide against traditional chemo-immunotherapy
Genmab's CEO, Dr. Jan van de Winkel, emphasized the milestone of the EPCORE DLBCL-1 trial, reinforcing the company’s commitment to advancing epcoritamab as a core therapy across various B-cell malignancies.
Background on Epcoritamab and DLBCL
Epcoritamab is an IgG1-bispecific antibody created using Genmab's proprietary DuoBody technology. This therapy is designed to target CD3 on T cells and CD20 on B cells, inducing T-cell-mediated tumor cell elimination.
Approved under the brand names EPKINLY® in the U.S. and Japan, and TEPKINLY® in the EU, epcoritamab has received regulatory approval for certain lymphoma indications in over 65 countries.
Diffuse large B-cell lymphoma (DLBCL) is the most prevalent type of non-Hodgkin lymphoma, responsible for approximately 25-30% of all cases globally. In the United States alone, about 25,000 new DLBCL cases are diagnosed each year, highlighting the urgent need for effective therapies.
About Genmab
Founded in 1999 and headquartered in Copenhagen, Denmark, Genmab is a leading biotechnology company focused on developing innovative antibody therapies for cancer and other serious diseases. With a robust pipeline and a commitment to scientific advancement, Genmab is dedicated to transforming patient outcomes in oncology.