AbbVie has reported updated results from the Phase 2 EPCORE® NHL-6 study (NCT05451810) assessing feasibility of monitoring the first full dose (48 mg) of subcutaneous epcoritamab in the outpatient setting for adults with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL). Findings were presented at the 13th Society of Hematologic Oncology (SOHO) Annual Meeting.
What’s new
- 92% (81/88) of patients received their first full dose in the outpatient setting.
- Cytokine release syndrome (CRS): occurred in 40.2% (all grades were mainly 1–2), median time to resolution 2 days; no events led to discontinuation.
- ICANS: occurred in 7.6% (predominantly Grade 1–2), median time to resolution 3 days; no events led to discontinuation.
Efficacy read-outs
Responses remained consistent with prior epcoritamab experience:
- After one prior line of systemic therapy (n=42): ORR 64.3%; CR 47.6% at 5.8-month median follow-up.
- After ≥2 prior lines (n=50): ORR 60.0%; CR 38.0% at 10.8-month median follow-up.
Study at a glance
- Design: Phase 2, open-label, outpatient monitoring feasibility for the first full dose of epcoritamab monotherapy in adults with R/R DLBCL.
- Population: 92 patients treated; median age 69; 24% prior CAR-T; 51% IPI ≥3; 83% Ann Arbor stage III–IV.
- Primary endpoints: proportion with Grade ≥3 CRS, ICANS and/or neurotoxicity within three months.
- Key secondary endpoints: responses by Lugano 2014 criteria.
Context and next steps
Epcoritamab is a T-cell engaging, CD3xCD20 bispecific antibody co-developed by AbbVie and Genmab and administered subcutaneously. The agent is approved in certain regions (as EPKINLY®/TEPKINLY®) for R/R DLBCL after two or more prior lines; the outpatient first-full-dose approach and use in earlier lines remain investigational. Multiple Phase 3 trials are ongoing across B-cell malignancies.
