AbbVie Highlights Positive Phase 2 Data For Outpatient Epcoritamab Dosing In Relapsed/Refractory DLBCL

AbbVie announced updated results from its Phase 2 EPCORE® NHL-6 trial evaluating the feasibility of outpatient administration of the first full dose of epcoritamab, a subcutaneous T-cell-engaging bispecific antibody, in adult patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). Results showed that the incidence and severity of cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were consistent with earlier studies and manageable. Data were presented at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting.

"The EPCORE® NHL-6 trial results are notable, as current bispecific antibody treatments for relapsed and refractory diffuse large B-cell lymphoma patients may require in-hospital monitoring for cytokine release syndrome after certain initial doses and as needed after subsequent doses. The possibility of treating patients in the outpatient setting is encouraging, and it may enable more people to have access to this treatment option across various sites of care, including community settings," said Jeff Sharman, M.D., disease chair, hematology research, Sarah Cannon Research Institute (SCRI) at Willamette Valley Cancer Institute in Eugene, Oregon. 

The trial enrolled 88 patients who received the first full 48 mg dose of epcoritamab monotherapy, with 92% treated in outpatient settings. CRS occurred in about 40% of patients, was mainly low-grade, and resolved within a median of two days, while ICANS occurred in 7.6% of patients, also low-grade and reversible. Importantly, no CRS or ICANS events led to treatment discontinuation.

"The updated EPCORE® NHL-6 trial findings presented at the Society of Hematologic Oncology Annual Meeting suggest that treatment of relapsed/refractory diffuse large B-cell lymphoma with epcoritamab can be safe in the outpatient setting. This potential shift to outpatient care could help improve access to treatment. AbbVie remains committed to building on our leadership in blood cancer, which includes advancing research with our partner Genmab, that firmly establishes the impact of investigational epcoritamab in successive lines of treatment across B-cell malignancies," said Svetlana Kobina, M.D., Ph.D, vice president, oncology medical affairs, AbbVie. 

Encouraging efficacy signals were observed. In patients treated after one prior line of systemic therapy, epcoritamab achieved an overall response rate (ORR) of 64.3% and a complete response (CR) rate of 47.6%. Among patients treated after two or more prior lines, the ORR was 60% and the CR rate was 38%. These findings highlight epcoritamab’s potential in earlier treatment lines, though its outpatient use for first full dosing and as monotherapy in second-line DLBCL remains investigational.