On May 12, 2022 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating epcoritamab (DuoBody-CD3xCD20), an investigational subcutaneous bispecific antibody, will be presented at the European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress, being held in Vienna, Austria, and virtually, June 9-12 (Press release, Genmab, MAY 12, 2022, View Source [SID1234614319]). The presentations will include data from various clinical trials, including multiple arms of the phase 1b/2 EPCORE NHL-2 trial, evaluating the safety and preliminary efficacy of epcoritamab in combination with standard-of-care therapies for the treatment of B-cell non-Hodgkin lymphoma (NHL), including first-line, high-risk diffuse large B-cell lymphoma (DLBCL), relapsed or refractory DLBCL, and relapsed or refractory follicular lymphoma (FL). Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV).

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Additionally, results from several clinical trials evaluating Janssen Biotech, Inc. (Janssen’s)’s subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform will be presented. Daratumumab is being developed by Janssen under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab, and the companies have a research and license agreement to create and develop bispecific antibodies using Genmab’s DuoBody technology platform.

All abstracts accepted for presentation have been published on the EHA (Free EHA Whitepaper) website.

"We are looking forward to presenting the results from a variety of clinical trials evaluating the safety and efficacy of epcoritamab at this year’s EHA (Free EHA Whitepaper), which shows the significant progress we have made developing epcoritamab," said Dr. Judith Klimovsky, Executive Vice President and Chief Development Officer of Genmab. "Together with AbbVie, we continue to evaluate epcoritamab in a variety of clinical settings and patient populations, with the shared commitment of potentially delivering a new treatment option to patients in need."

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

Epcoritamab (DuoBody-CD3xCD20):

Abstract #: P1214. Subcutaneous epcoritamab + R-CHOP for first-line treatment of patients with high-risk diffuse large B-cell lymphoma: phase 1/2 data update; Clausen et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1135. Subcutaneous epcoritamab in combination with rituximab + lenalidomide in relapsed or refractory follicular lymphoma: phase 1/2 trial update; Belada et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1215 Preliminary phase 1/2 results of subcutaneous epcoritamab + R-DHAX/C in patients with relapsed or refractory diffuse large B-cell lymphoma eligible for autologous stem cell transplant; Cordoba et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Abstract #: P1213. Subcutaneous epcoritamab with GemOx induced high response rates in patients with relapsed/refractory diffuse large B-cell lymphoma ineligible for autologous stem cell transplant; Wahlin et al. June 10, 2022, 16:30-17:45 CEST/10:30-11:45 a.m. EDT
Publication: Assessing safety, tolerability, and efficacy of subcutaneous epcoritamab in novel combinations with anti-neoplastic agents in patients with non-Hodgkin lymphoma in a phase 1b/2, open-label study; Sehn et al

Daratumumab:

Daratumumab, Bortezomib, and Dexamethasone (D-Vd) Versus Bortezomib and Dexamethasone (Vd) Alone in Chinese Patients With Relapsed or Refractory Multiple Myeloma (RRMM): Updated Analysis of LEPUS; Fu et al
Efficacy and safety of daratumumab (DARA) in pediatric and young adult patients (pts) with relapsed/refractory T-cell acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL): results from the phase 2 DELPHINUS study; Hogan et al
Daratumumab (DARA) in combination with bortezomib plus dexamethasone (D-Vd) or lenalidomide plus dexamethasone (D-Rd) in relapsed or refractory multiple myeloma (RRMM): subgroup analysis of the phase 3 CASTOR and POLLUX studies in patients (pts) with early or late relapse after initial therapy; Spencer et al
Time to response, duration of response, and patient-reported outcomes (PROs) with daratumumab (DARA) plus lenalidomide and dexamethasone (D-Rd) vs lenalidomide and dexamethasone (Rd) alone in transplant-ineligible patients with newly diagnosed multiple myeloma (NDMM): subgroup analysis of the phase 3 MAIA study; Facon et al
Daratumumab (DARA) + lenalidomide, bortezomib, and dexamethasone (RVd) in transplant-eligible newly diagnosed multiple myeloma (NDMM): a post hoc analysis of sustained minimal residual disease (MRD) negativity from GRIFFIN; Rodriguez et al

About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody created using Genmab’s proprietary DuoBody technology. Genmab’s DuoBody-CD3 technology is designed to direct cytotoxic T cells selectively to elicit an immune response towards 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 was developed with selective, silencing mutations that may limit systemic, non-specific activity.ii CD20 is expressed on B-cells and a clinically validated therapeutic target in many B-cell malignancies, including diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma and chronic lymphocytic leukemia.iii,iv Epcoritamab is being co-developed by Genmab and AbbVie as part of the companies’ broad oncology collaboration.

About DARZALEX(daratumumab)
DARZALEX (daratumumab) is the first monoclonal antibody (mAb) to receive U.S. Food and Drug Administration approval to treat certain multiple myeloma indications. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab. The subcutaneous formulation of daratumumab (daratumumab and hyaluronidase-fihj) is the first subcutaneous CD38 antibody approved for the treatment of certain multiple myeloma indications and the first and only approved treatment for certain patients with light-chain (AL) amyloidosis.v,vi,vii

Please see local country prescribing information for all labeled indication and safety information.