AbbVie and Genmab's Epcoritamab Lymphoma Treatment Shows Promise in Mid-Stage Trial

AbbVie and Genmab's lymphoma drug epcoritamab has shown positive results in a mid-stage trial when administered in an outpatient setting, with its first full dose. The bispecific antibody is already approved for use in certain lymphoma patients, and the new data suggests it can be safely and effectively administered in an outpatient setting. The trial aims to evaluate the drug's efficacy and safety in patients with non-Hodgkin lymphoma.

AbbVie (NYSE: ABBV) and Genmab's investigational bispecific antibody epcoritamab has shown promising results in a Phase 2 trial, indicating that it can be safely and effectively administered in an outpatient setting. The trial, EPCORE® NHL-6, evaluated the feasibility of dosing and monitoring patients in the outpatient setting for the first full dose of epcoritamab monotherapy in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL).

The study, presented at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting, enrolled 92 patients with R/R DLBCL who had received at least one prior line of systemic therapy. The primary objective was to assess adverse events within three months of treatment initiation. Results showed that 81 patients (92%) were monitored in the outpatient setting, with 88 patients receiving the first full dose (48 mg) of epcoritamab monotherapy.

The incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were consistent with previous epcoritamab studies in R/R DLBCL. CRS events occurred in 37 (40.2%) of patients during the entire trial period, primarily low grade (Grade 1-2), and all resolved with a median time of two days. ICANS occurred in seven patients (7.6%), also primarily low grade (Grade 1-2), and all resolved with a median time of three days. No events led to treatment discontinuation.

The overall response rate (ORR) was 64.3% and the complete response (CR) rate was 47.6% at a median follow-up of 5.8 months in patients treated with epcoritamab after only one prior line of systemic therapy. In patients treated with epcoritamab following two or more lines of systemic therapy, the ORR was 60.0% and the CR rate was 38.0% at a median follow-up of 10.8 months.

"The EPCORE® NHL-6 trial results are notable as they suggest that treatment of relapsed/refractory diffuse large B-cell lymphoma with epcoritamab can be safe in the outpatient setting," said Svetlana Kobina, M.D., Ph.D, vice president, oncology medical affairs, AbbVie. "This potential shift to outpatient care could help improve access to treatment."

Epcoritamab is already approved for R/R DLBCL after two or more prior lines of systemic therapy. The trial's findings support the potential use of epcoritamab as a monotherapy in DLBCL in the second-line setting. Further studies are ongoing to confirm the clinical benefit of epcoritamab across various lines of therapy and indications.

References:
[1] https://news.abbvie.com/2025-09-03-AbbVie-Announces-Updated-Results-From-Phase-2-EPCORE-R-NHL-6-Study-Evaluating-the-Potential-for-Outpatient-Monitoring-of-Epcoritamab-in-Patients-With-Relapsed-Refractory-R-R-Diffuse-Large-B-Cell-Lymphoma-DLBCL