Clinical Trial of Investigational Epcoritamab (DuoBody®-CD3xCD20) in Patients with Relapsed/Refractory B-cell Non-Hodgkin’s Lymphoma (B-NHL) Published within the Lancet
AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) today announced The Lancet published the results of the dose escalation a part of the Phase 1/2 EPCORE™ NHL-1 first-in-human (FIH) dose escalation and cohort expansion clinical test 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 complete manuscript is out there on The Lancet’s website. Epcoritamab is being co-developed by Genmab and AbbVie.
The FIH trial was designed to guage subcutaneous epcoritamab in patients with relapsed, progressive, or refractory CD20+ mature B-NHL, including diffuse large B-cell Lymphoma (DLBCL) and follicular lymphoma (FL), to work out the utmost tolerated dose (MTD) and therefore the recommended Phase 2 dose (RP2D). within the dose escalation phase, patients received subcutaneous epcoritamab (doses ranged from 0.0128-60mg) for 28 days. the security , antitumor activity, and immune biomarkers related to epcoritamab treatment were assessed.1
No dose-limiting toxicities were observed during the dose escalation, and 48mg was identified because the RP2D. Common adverse events (AEs) were pyrexia (69 percent), primarily related to 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 thanks to treatment-related AEs or death were observed.1
Preliminary efficacy results reported within the trial were 88 percent overall response rate (ORR) and 38 percent complete response (CR) in patients with relapsed/refractory DLBCL 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 those data within the Lancet, including the presentation of the results at multiple medical congresses, demonstrate the importance of those early results and underscore the many interest within the potential of next generation antibody therapeutic options for patients diagnosed with hematologic malignancies, whose current treatments might not be providing benefit,” said Jan van de Winkel, Ph.D., Chief military officer of Genmab. “Together with our partner, AbbVie, we are committed to evaluating the security and efficacy of epcoritamab in patients diagnosed with B-cell Lymphomas and other hematologic malignancies.”
“These initial trial results are encouraging, and their publication within the Lancet speaks to the strong interest from the clinical community during this important area of study,” said Mohamed Zaki, M.D., Ph.D., vice chairman and head, global oncology development, AbbVie. “We anticipate to further study of epcoritamab in B-cell Lymphomas and other hematologic malignancies, and our 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 out there for download via the 16-ICML Virtual Platform. Additionally, results were presented as a billboard at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting, held virtually, June 4-8, and through the ecu Hematology Association (EHA) congress, held virtually, June 9-17. The posters are available for download via the ASCO Meeting Library and therefore the EHA Open Access Library.
About the EPCORE™ NHL-1 Trial
The dose escalation a part of the EPCORE NHL-1 Phase 1/2 clinical test is evaluating epcoritamab in 68 patients with relapsed, progressive, or refractory B-cell non-Hodgkin’s lymphoma (B-NHL), including DLBCL, FL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, mantle cell lymphoma, small lymphocytic lymphoma and marginal zone lymphoma. The trial is an open-label, multi-center safety and preliminary efficacy trial of epcoritamab that consists of two parts: a Phase 1 first-in-human (FIH), dose escalation part, and a Phase 2 expansion part. Step-up dosing and standard prophylaxis were wont to mitigate severity of cytokine release syndrome (CRS). the aim of the escalation part is to work out the utmost tolerated dose and therefore the recommended Phase 2 dose (RP2D), also as evaluate the security profile of epcoritamab. within the expansion part, additional patients are going to be treated with epcoritamab with the RP2D to further explore the security and efficacy of epcoritamab.
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is meant to direct cytotoxic T cells selectively to tumors to elicit an immune reaction towards malignant cells. Epcoritamab is meant to simultaneously bind to CD3 on T cell s and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.2 CD20 may be a clinically validated therapeutic target, and is expressed on many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic leukemia .3,4 Epcoritamab is being co-developed by Genmab and AbbVie as a part of the companies’ broad oncology collaboration.
About AbbVie
AbbVie’s mission is to get and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. we attempt to possess an interesting impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, additionally to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.
