On May 14, 2024 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, will be presented at the 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress, being held in Madrid, Spain and virtually, June 13-16, 2024 (Press release, Genmab, MAY 14, 2024, View Source [SID1234643221]).

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Presentations will include data from clinical trials evaluating the safety and efficacy of epcoritamab as a monotherapy and in combination with standard-of-care or other novel therapies across multiple patient populations. Three oral presentations will highlight data from the pivotal and cycle 1 dose optimization cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with relapsed/refractory follicular lymphoma (FL), from EPCORE NHL-5 evaluating epcoritamab in combination with polatuzumab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola-R-CHP) as a potential first-line treatment regimen for patients with diffuse large B-cell lymphoma (and DLBCL), and from EPCORE CLL-1 evaluating epcoritamab in patients with Richter’s transformation (RT). All abstracts accepted for presentation have been published and may be accessed online via the EHA (Free EHA Whitepaper) Open Access Library.

"Building on the recent global regulatory approvals and pending regulatory decisions for epcoritamab, we look forward to presenting new data at EHA (Free EHA Whitepaper) 2024 that highlight the key progress that has been made developing epcoritamab as a potential core therapy across a variety of B-cell malignances," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we are committed to advancing and evolving the robust development program evaluating epcoritamab, as a monotherapy and in combination, across B-cell malignancies and settings."

The safety and efficacy of these investigational uses have not been established.

Abstracts accepted for presentation at EHA (Free EHA Whitepaper):

Clinical Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
S163 Single-Agent Epcoritamab Leads to Deep Responses in Patients (pts) with Richter’s Transformation (RT): Primary Results from the EPCORE CLL-1 Trial Oral Friday, June 14, 14:45-16:00 CEST
S239 First Data from Subcutaneous Epcoritamab + Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin, and Prednisone (Pola-R-CHP) for First-line Diffuse Large B-Cell Lymphoma (DLBCL): EPCORE NHL-5 Oral Friday, June 14, 14:45-16:00 CEST
S234 Epcoritamab Induces Deep Responses in Relapsed or Refractory (R/R) Follicular Lymphoma (FL): Safety and Pooled Efficacy Data from EPCORE NHL 1 Pivotal and Cycle (C) 1 Optimization (Opt) FL Cohorts Oral Saturday, June 15, 16:30-17:45 CEST
P1146 Epcoritamab with Rituximab + Lenalidomide (R2) in Previously Untreated (1L) Follicular Lymphoma (FL) and Epcoritamab Maintenance Therapy in FL: EPCORE NHL 2 Arms 6 and 7 Poster Friday, June 14, 18:00-19:00 CEST
P1151 Extended Follow-Up Beyond 2.5 Years Shows Long-Term Efficacy in Complete Responders Following Epcoritamab Monotherapy in Relapsed or Refractory Large B-Cell Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P1152 Epcoritamab + GemOx Induces Deep, Durable Responses in Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma: Updated Results From the EPCORE NHL-2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P1161 Epcoritamab + R-DHAX/C Elicits Deep, Durable Responses in Transplant-Eligible Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma, Including High-Risk Disease Poster Friday, June 14, 18:00-19:00 CEST
PB2955 EPCORE FL-2: Phase 3 Trial of Epcoritamab with Rituximab and Lenalidomide (R2) vs Chemoimmunotherapy or R2 in Previously Untreated Follicular Lymphoma Electronic Publication Friday, June 14, 9:00 CEST
Outcomes Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1114 Patient-Reported Outcomes in Patients with Relapsed or Refractory Follicular Lymphoma Treated With Epcoritamab Poster Friday, June 14, 18:00-19:00 CEST
P1121 Matching-Adjusted Indirect Comparisons of Epcoritamab vs Mosunetuzumab or Odronextamab in Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies Poster Friday, June 14, 18:00-19:00 CEST
P1140 The Efficacy of Subcutaneous Epcoritamab vs Standard-of-Care (SCHOLAR-5) in Patients With Relapsed/Refractory Follicular Lymphoma After ≥2 Systemic Therapies: An Indirect Treatment Comparison Poster Friday, June 14, 18:00-19:00 CEST
P1133 Comparative Effectiveness of Epcoritamab versus Real-World Usual Care in Relapsed/Refractory Follicular Lymphoma Poster Friday, June 14, 18:00-19:00 CEST
P2081 Logistical Challenges Associated with Chimeric Antigen Receptor T-Cell Therapy (CAR T) in Non-Hodgkin Lymphoma (NHL): A Survey of Healthcare Professionals Electronic Poster Friday, June 14, 9:00 CEST
Pharmacokinetic/Translational Research

Abstract Number Abstract Title Type of Presentation Date/Time of Presentation
P1244 Immune Correlates of Response to Epcoritamab in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: Dose Expansion in a Phase 1/2 Trial Poster Friday, June 14, 18:00-19:00 CEST
P2059 Minimal Residual Disease (MRD), Pharmacokinetic (PK), and Pharmacodynamic (PD) Assessment of Epcoritamab 2-vs 3-step Step-up Dosing in Patients with Relapsed/Refractory Follicular Lymphoma (R/R FL) Electronic Poster Friday, June 14, 9:00 CEST
P2060 Model-Based Cycle (C) 1 Optimization of Step-Up Dose Regimen For Epcoritamab in Patients With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) Electronic Poster Friday, June 14, 9:00 CEST
About Epcoritamab
Epcoritamab is an IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology and administered subcutaneously. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response toward target cell types. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T-cell-mediated killing of CD20+ cells.i

Epcoritamab has received regulatory approval in certain lymphoma indications in several territories. Use of epcoritamab in FL is not approved in the U.S. or in the EU or in any other territory. Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ oncology collaboration. The companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization.

Genmab and AbbVie continue to evaluate the use of epcoritamab as a monotherapy, and in combination, across lines of therapy in a range of hematologic malignancies. This includes four ongoing phase 3, open-label, randomized trials including a trial evaluating epcoritamab as a monotherapy in patients with R/R DLBCL compared to investigators choice chemotherapy (NCT: 04628494), a trial evaluating epcoritamab in combination with R-CHOP in adult participants with newly diagnosed DLBCL (NCT: 05578976), a trial evaluating epcoritamab in combination with rituximab and lenalidomide in patients with R/R FL (NCT: 05409066), and a trial evaluating epcoritamab in combination with rituximab and lenalidomide (R2) compared to chemotherapy in patients with previously untreated FL (NCT: 06191744). The safety and efficacy of epcoritamab has not been established for these investigational uses. Please visit clinicaltrials.gov for more information.