AbbVie reports Phase 3 EPCORE DLBCL-1 results showing epcoritamab improved progression-free survival in relapsed or refractory diffuse large B-cell lymphoma, marking the first bispecific antibody monotherapy to demonstrate this benefit.
Written By: Pharmacally Medical News Desk
AbbVie and Genmab. announced topline results from the Phase 3 EPCORE DLBCL-1 trial of epcoritamab, a subcutaneous CD3xCD20 bispecific antibody, in adults with relapsed or refractory diffuse large B-cell lymphoma. The study compared epcoritamab monotherapy with investigator’s choice of standard chemoimmunotherapy and showed a meaningful improvement in progression-free survival, the first Phase 3 evidence that a bispecific antibody alone can extend disease control in this setting.
Genmab CEO Jan van de Winkel highlighted that EPCORE DLBCL-1 is the first Phase 3 trial to show that a bispecific antibody used alone can improve progression-free survival in relapsed or refractory DLBCL. He noted that the findings add to the expanding clinical evidence for epcoritamab, which has already been used in thousands of patients, and reaffirmed Genmab and AbbVie’s commitment to developing the therapy as a key treatment option across multiple B-cell cancers.
EPCORE DLBCL-1 Trial
EPCORE DLBCL-1 Trial (NCT04628494) is the global, open-label Phase 3 trial enrolled 483 patients with relapsed or refractory DLBCL who had received at least one prior therapy, with 73 percent exposed to two or more lines. All participants were ineligible for high-dose chemotherapy and autologous stem cell transplant. Patients were randomized to epcoritamab or investigator’s choice of rituximab plus gemcitabine and oxaliplatin, or bendamustine plus rituximab. Enrolments began in January 2021 and follow-up continues.
The study met its primary endpoint with a PFS hazard ratio of 0.74, representing a 26 percent reduction in the risk of progression or death versus standard therapy. Patients treated with epcoritamab also showed higher complete response rates, longer duration of response, and delayed need for next treatment. Overall survival did not reach statistical significance with a hazard ratio of 0.96. Researchers are reviewing potential influences on outcomes, including the COVID-19 Omicron period and the rapid introduction of new lymphoma therapies during the trial.
Safety Profile
Adverse events were consistent with the established safety experience for epcoritamab. Most reactions were manageable with standard monitoring and supportive care. Full safety analyses will be presented at upcoming medical meetings, and the companies plan regulatory discussions based on the complete dataset.
The epcoritamab therapy can cause cytokine release syndrome and serious neurologic events, which in rare cases may be life-threatening. Full prescribing information is available at the official product website and through the FDA label EPKINLY.
About Epcoritamab
Epcoritamab is an IgG1 bispecific antibody developed with Genmab’s DuoBody technology. It binds CD3 on T cells and CD20 on B cells, directing immune cells to destroy malignant lymphocytes. The therapy is administered subcutaneously, providing an off-the-shelf immunotherapy without individualized cell manufacturing.
Regulatory Status
Marketed as EPKINLY in the U.S. and Japan and TEPKINLY in the EU, epcoritamab is approved for certain lymphoma indications in more than 65 countries. AbbVie and Genmab co-develop the medicine, sharing commercial responsibilities in the U.S. and Japan, with AbbVie leading global commercialization. Programs continue to study the agent across earlier treatment lines and in combination regimens.
Disease Background
Diffuse large B-cell lymphoma represents about 25 to 30 percent of non-Hodgkin lymphoma cases, with roughly 25,000 new U.S. diagnoses each year. The disease is aggressive, and many patients relapse or become refractory after initial therapy. New immune-based options such as bispecific antibodies are increasingly important to address this unmet need.
Reference
Genmab Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL), 16 January 2026, https://ir.genmab.com/news-releases/news-release-details/genmab-announces-topline-results-epcoritamab-duobodyr-cd3xcd20
AbbVie Announces Topline Results for Epcoritamab (DuoBody® CD3xCD20) from Phase 3 EPCORE® DLBCL-1 Trial in Patients with Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL), 16 January 2026, https://news.abbvie.com/2026-01-16-AbbVie-Announces-Topline-Results-for-Epcoritamab-DuoBody-R-CD3xCD20-from-Phase-3-EPCORE-R-DLBCL-1-Trial-in-Patients-with-Relapsed-Refractory-Diffuse-Large-B-cell-Lymphoma-DLBCL
A Phase 3 Trial of Epcoritamab vs Investigator’s Choice Chemotherapy in Relapsed/Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL) (EPCORE DLBCL-1), ClinicalTrials.gov ID NCT04628494, https://clinicaltrials.gov/study/NCT04628494