Epcoritamab Monotherapy as Outpatient Treatment for Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma: Interim Results From EPCORE NHL-6
Year: 2026
Type: article
Study design: Clinical Trial
Abstract: Background Epcoritamab, a CD3 × CD20 bispecific antibody approved for relapsed/refractory diffuse large B-cell lymphoma (DLBCL), is administered subcutaneously with recommended 24-hour inpatient monitoring after the first full dose (FFD). EPCORE NHL-6 (NCT05451810) investigated feasibility of outpatient monitoring after FFD of epcoritamab in second-line or later (2L+) DLBCL. Methods Patients received epcoritamab in 28-day (D) cycles (C): (0.16-mg and 0.8-mg C1 step-up doses, 48-mg full dose C1D15 onward [C1-3, QW; C4-9, Q2W; C≥10, Q4W]). Primary endpoints were grade ≥3 cytokine release syndrome (CRS), immune effector cell–associated neurotoxicity syndrome (ICANS), and neurologic events. Patients remained ≤30 minutes from the hospital post-FFD and received mandatory CRS prophylaxis during C1. Results Ninety-two patients enrolled at United States and Puerto Rico academic and community sites received ≥1 epcoritamab dose. With 7.6-month median follow-up, 50.0% remained on treatment. For administration and planned monitoring of FFD, 81/88 patients were outpatient and 7/88 inpatient (admitted for post-dose monitoring [n=5] and other reason [n=2]). Twenty-four of 81 patients monitored outpatient developed CRS within one week post-FFD. CRS hospitalization rate was 13.6% (11/81). Overall, CRS occurred in 40.2% (grade 1-2, 38.0%; grade 3, 2.2%). ICANS occurred in 7.6% (grade 1-2, 6.5%; grade 3, 1.1%). All CRS and ICANS resolved; none led to treatment discontinuation. Overall response rate (Lugano criteria) was 62.0% (complete response rate, 42.4%). Conclusions CRS and ICANS incidence and severity were consistent with the pivotal EPCORE NHL-1 trial findings. The results support feasibility of outpatient administration and monitoring of epcoritamab in 2L+ DLBCL without mandatory hospitalization for monitoring. MicroAbstract The phase 2 EPCORE NHL-6 study evaluated outpatient administration and monitoring of subcutaneous epcoritamab after the first full dose in patients with second-line or later (2L+) diffuse large B-cell lymphoma. Epcoritamab was generally well tolerated and nearly all patients who received the first full dose were successfully monitored in the outpatient setting, highlighting the feasibility of outpatient administration of epcoritamab, and representing an important opportunity to advance patient care across academic and community-based centers. Efficacy was consistent with previous findings in patients with 3L+ DLBCL.
Authors: David Andorsky, Adelba Torres Lopez, Rakhee Vaidya, Fernando Vargas Madueno, Sami Ibrahimi, Seema Naik, Mitul Gandhi, Julie Erika Haydu, Bradley Lash, Mark Fesler, John Hrom, Eric H. Lee, Suchitra Sundaram, Kristin Conte, Kojo Osei-Bonsu, Thomas Doerr, Yang Bai, Neha Dixit, Christian W. Eskelund, Alexander P. Boardman, Ralph Boccia, Christina Y. Lee, Jeff P. Sharman
Institutions: Rocky Mountain Cancer Centers, Auxilio Mutuo Hospital, Atrium Health Wake Forest Baptist, Wake Forest Baptist Comprehensive Cancer Center, Moffitt Cancer Center, Memorial Healthcare System, University of Oklahoma Medical Center, OU Health Stephenson Cancer Center, University of Oklahoma Health Sciences Center, Penn State Cancer Institute, Virginia Cancer Specialists, Massachusetts General Hospital, Hattiesburg Clinic, Forrest General Hospital, Compassionate Cancer Care, Icahn School of Medicine at Mount Sinai, AbbVie (United States), Genmab (Denmark), Memorial Sloan Kettering Cancer Center, Center for Cancers and Blood Disorders, Stony Brook University, Willamette Valley Cancer Institute and Research Center
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $3,890
OpenAlex ID: W7130589709