EPCORE NHL-1 3-year update: Epcoritamab for R/R LBCL

Three-year follow-up results from the multi-cohort, open-label, single-arm, phase I/II EPCORE NHL-1 trial (NCT03625037), evaluating the long-term safety and efficacy of epcoritamab in adults with relapsed/refractory (R/R) large B-cell lymphoma (LBCL), were published in Annals of Hematology by Karimi et al. (N = 157). Patients received epcoritamab until progressive disease or unacceptable toxicity. The primary endpoint was overall response rate (ORR).

Key data: At a median follow-up of 37.1 months, the ORR was 59% (95% confidence interval [CI], 50.5–66.4), including a 41% complete response (CR) rate and 17% partial response (PR) rate; median duration of response (DoR) was 20.8 months (95% CI, 13.0–32.0). The median progression-free survival (PFS) was 4.2 months (95% CI, 2.8–5.5) overall and 37.3 months (95% CI, 26.0–not reached [NR]) in patients with a CR. The median overall survival (OS) was 18.5 months (95% CI, 11.7–27.7). Of 119 patients evaluated for measurable residual disease (MRD), 45% achieved MRD negativity at any timepoint assessed during the study, with a 3-year PFS estimate of 52% vs 18% for MRD-negative vs MRD-positive patients (Cycle 3 Day 1 landmark). The safety profile was consistent with previous reports, with no new cases of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or clinical tumor lysis syndrome (TLS). 

Key learning: Epcoritamab demonstrated durable efficacy and safety at 3-year follow-up, supporting its consideration as a treatment option for adults with heavily pretreated R/R LBCL, and highlighting MRD as a potential tool for future response-adapted approaches.