Genmab A/S announced The Lancet published theresults of the dose escalation part of the phase 1/2 EPCORE NHL-1 first-in-human (FIH) dose escalation and cohort expansion clinical trial evaluating safety and preliminary efficacy of the investigational therapy epcoritamab (DuoBody-CD3xCD20) in patients with relapsed/refractory B-cell non-Hodgkin’s lymphoma (B-NHL). The FiH trial was designed to evaluate subcutaneous epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-NHL, including diffuse large B-cell Lymphoma (DLCBL) and follicular lymphoma (FL), to determine the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D). In the dose escalation phase, patients received subcutaneous epcoritamab (doses ranged from 0.0128-60mg) for 28 days. The safety, antitumor activity, and immune biomarkers associated with epcoritamab treatment were assessed. No dose-limiting toxicities were observed during the dose escalation, and 48mg was identified as the RP2D. Common adverse events (AEs) in patients with relapsed/refractory DLCBL were pyrexia (69%), primarily associated with cytokine release syndrome (CRS) (59%, all grade 1-2), and injection site reactions (47%, all grade 1). One case of tumor lysis syndrome (TLS) was observed, (1%, grade 3). No grade 3 or above CRS events or discontinuations due to treatment-related AEs or death were observed. Preliminary efficacy results reported in the trial were 88% overall response rate (ORR) and 38% complete response (CR) in patients with relapsed/refractory DLCBL who received the RP2D of 48mg of (n=8) epcoritamab. Patients who were treated with 12-60mg of epcoritamab (n=22) achieved a 68 % ORR and 45% CR. Additionally, patients with relapsed/refractory FL treated with 0.76-48mg of epcoritamab (n=10) achieved a 90% ORR and a 50% CR.