Benzinga | Sep 9, 2021 07:03AM EDT

Clinical Trial of Investigational Epcoritamab In Patients With Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma 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(tm) NHL-1 first-in-human (FIH) dose escalation and cohort expansion clinical trial evaluating safety and preliminary efficacy of the investigational therapy epcoritamab (DuoBody(r)-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

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."

"These initial trial results are encouraging, and their publication in The Lancet speaks to the strong interest from the clinical community in this important area of study," said Mohamed Zaki, M.D., Ph.D., vice president and head, global oncology development, AbbVie. "We look forward to further study epcoritamab in B-cell lymphomas and other hematologic malignancies, and continued pursuit of potential new treatment options for patients."

Results from this trial were also recently presented during an oral session at the 16th Annual International Conference on Malignant Lymphoma (ICML), held virtually June 18-22. The abstract is available for download via the 16-ICML Virtual Platform. Additionally, these results were presented as a poster at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually, June 4-8, and during the European Hematology Association (EHA) congress, held virtually, June 9-17. The posters are available for download via the ASCO Meeting Library and the EHA Open Access Library.