Clinical Trial of Investigational Epcoritamab (DuoBody-CD3xCD20) in Patients with Relapsed/Refractory B-cell non-Hodgkin’s Lymphoma (B-NHL) Published in The Lancet
Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) today announced The Lancet published the results 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 full manuscript is available on The Lancet’s website. Epcoritamab is being co-developed by Genmab and AbbVie.
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.1
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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 percent), primarily associated with cytokine release syndrome (CRS) (59 percent, all grade 1-2), and injection site reactions (47 percent, all grade 1). One case of tumor lysis syndrome (TLS) was observed, (1 percent, grade 3). No grade 3 or above CRS events or discontinuations due to treatment-related AEs or death were observed.1
Preliminary efficacy results reported in the trial were 88 percent overall response rate (ORR) and 38 percent 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 percent ORR and 45 percent CR. Additionally, patients with relapsed/refractory FL treated with 0.76-48mg of epcoritamab (n=10) achieved a 90 percent ORR and a 50 percent CR.1
"The publication of these data in The Lancet, coupled with the presentation of the results at multiple medical congresses, demonstrate the importance of these early results and underscore the significant interest in the potential of next-generation antibody therapeutic options for patients diagnosed with hematologic malignancies, whose current treatments may not be providing benefit,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Together with our partner, AbbVie, we are deeply committed to evaluating the safety and efficacy of epcoritamab in patients diagnosed with B-cell Lymphomas and other hematologic malignancies.”