ASH 2025 | Outpatient administration of epcoritamab monotherapy for R/R DLBCL: Results from EPCORE NHL-6, by race and ethnicity

During the 67th American Society of Hematology (ASH) Annual Meeting and Exposition, December 6–9, 2025, Orlando, US, the Lymphoma Hub was pleased to speak with Adelba Torres, Hospital Auxilio Mutuo, San Juan, PR. We asked, What does the latest analysis of the phase II EPCORE NHL-6 trial (NCT05451810) tell us about the efficacy and safety of bispecific antibodies in an ethnically and racially diverse group of patients?

In this interview, Torres highlights how findings from the EPCORE NHL-6 trial support the safe and efficacious administration of subcutaneous epcoritamab in the outpatient setting in adult patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) and discusses efficacy and safety findings in an ethnically and racially diverse group of patients.

Key points¹

• The primary endpoints for the phase II EPCORE NHL-6 trial are rates of Grade ≥3 cytokine release syndrome (CRS), immune cell-associated neurotoxicity syndrome (ICANS), and neurologic events. Secondary endpoints include responses assessed by investigators, per Lugano criteria, and efficacy and safety outcomes.
• 92 patients with R/R DLBCL were enrolled: 26 were Black/Hispanic, and 66 were White/Asian.
• Analysis by racial/ethnic subgroups demonstrate that CRS was reported in 38.5% of patients in the Black/Hispanic group (Grade 1, 15.4%; Grade 2, 23.1%) and 40.9% of patients in the White/Asian subgroup (Grade 1, 24.2%; Grade 2, 13.6%; Grade 3, 3.0%).
• ICANS occurred in 7.7% of patients in the Black/Hispanic group (all Grade 1) and 7.6% in the White/Asian group (Grade 1, 3.0%; Grade 2, 3.0%; Grade ≥3, 1.5%).
• CRS and ICANS incidence and severity were consistent across racial subgroups and with previous outpatient cohort data, as well as data from the pivotal phase I/II EPCORE NHL-1 trial (NCT03625037).
• The overall response rate was 61.5% (complete response [CR], 53.8%) in the Black/Hispanic group and 62.1% (CR, 37.9%) in the White/Asian group; with median duration of response being not reached (NR) (95% confidence interval [CI], 2.9–NR) and 15.2 months (95% CI, 4.4–NR), respectively.
• The median progression-free survival was NR (95% CI, 1.6 months–NR) in the Black/Hispanic group and 5.7 months (95% CI, 2.9–16.4) in the White/Asian group, with a median duration of study follow-up of 5.6 months (95% CI, 3.2–6.0) and 8.1 months (95% CI, 5.5–8.5), respectively.
• Currently, patients are typically hospitalized for the initial full-dose administration of epcoritamab and for 24 hours afterwards. These findings demonstrate that epcoritamab can be administered safely in the outpatient setting, and efficacy and safety are consistent across ethnic and racial subgroups.

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