AbbVie Shares Promising Phase 2 Results for Epcoritamab Treatment in Outpatients with DLBCL

AbbVie Presents Updated Phase 2 Results on Epcoritamab in Outpatients with DLBCL

On September 3, 2025, AbbVie (NYSE: ABBV) announced significant findings from the Phase 2 EPCORE® NHL-6 clinical trial, focusing on the use of Epcoritamab, a T-cell engaging bispecific antibody, for treating patients suffering from relapsed or refractory diffuse large B-cell lymphoma (DLBCL). This groundbreaking study was presented at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting.

Study Overview

The EPCORE® NHL-6 trial (NCT05451810) aimed to assess the safety and feasibility of dosing Epcoritamab in an outpatient setting. Epcoritamab is administered via subcutaneous injection and is designed for adult patients with relapsed or refractory DLBCL who have undergone at least one prior systemic therapy. Out of 88 participants who received the first full dose (48 mg) of Epcoritamab, 81 patients (92%) were observed in outpatient settings, and the remaining seven (8%) were monitored in hospitals.

Results and Efficacy

The trial demonstrated noteworthy results, particularly concerning the incidence of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS). Among the 92 patients, CRS occurred in 37 (40.2%), primarily of low grades (Grade 1-2), with all cases resolving within a median duration of two days. Only seven patients (7.6%) experienced ICANS, also mainly low grade, which resolved within three days on average. Importantly, no instances of CRS or ICANS resulted in treatment discontinuation.

Further analysis of treatment responses indicated an overall response rate (ORR) of 64.3% among patients who received Epcoritamab after just one previous therapy line. Additionally, 47.6% of the patients achieved a complete response (CR) within a median follow-up of 5.8 months. In those who had undergone two or more previous therapies (50 participants), the ORR dropped slightly to 60% with a CR rate of 38% at a median follow-up of 10.8 months.

Expert Commentary

Dr. Jeff Sharman from the Sarah Cannon Research Institute commented on the significance of these findings. Current therapies for relapsed DLBCL patients often necessitate hospitalization for monitoring CRS responses. However, the potential to administer Epcoritamab in outpatient settings could vastly increase access to this treatment across diverse healthcare environments.

Svetlana Kobina, Vice President of Oncology Medical Affairs for AbbVie, stated, "These updated findings suggest that Epcoritamab can be safely utilized in outpatient scenarios, hinting at a promising shift in patient care and accessibility to innovative therapies."

Understanding DLBCL

Diffuse large B-cell lymphoma is the most prevalent type of non-Hodgkin's lymphoma globally, representing roughly 25-30% of all cases. In the United States alone, approximately 25,000 new DLBCL cases are diagnosed yearly. This aggressive cancer impacts the lymphatic system and is characterized by its rapid growth. Unfortunately, many DLBCL cases tend to relapse or become refractory to treatments, posing significant management challenges ...

As AbbVie continues its collaboration with Genmab to advance research surrounding Epcoritamab, the potential to shift to outpatient treatment environments could revolutionize patient care in this field. Continued trials and investigations are underway to explore further approvals for Epcoritamab in DLBCL and other malignancies. This reflects AbbVie's commitment to comprehensive cancer care, aiming at the enhancement of treatment modalities that significantly improve patient outcomes.