Genmab Announces Multiple Abstracts to be Presented at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH)

On November 4, 2021 Genmab A/S (Nasdaq: GMAB) reported that multiple abstracts evaluating several investigational medicines in the company’s pipeline, or created using Genmab’s innovative drug development platforms, will be presented at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH) (Free ASH Whitepaper), being held at the Georgia World Congress Center, in Atlanta, GA, and virtually, December 11-14. The presentations will include data from the phase 1b/2 EPCORE NHL-2 clinical trial evaluating the safety and preliminary efficacy of epcoritamab (DuoBody-CD3xCD20) in various combinations for the treatment of patients with B-cell non-Hodgkin lymphoma (NHL). In addition, preliminary data from the phase 1b/2 EPCORE CLL-1 clinical trial, evaluating epcoritamab in patients with relapsed, refractory chronic lymphocytic leukemia (CLL), will be presented. Results from more than 20 clinical trials evaluating Janssen Biotech, Inc. (Janssen)’s daratumumab, the subcutaneous formulation of daratumumab, and Janssen’s bispecific programs leveraging Genmab’s DuoBody technology platform, will be presented.

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

Epcoritamab is being co-developed by Genmab and AbbVie (NYSE: ABBV). 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.

"The data being presented at this year’s ASH (Free ASH Whitepaper) represent our focus on harnessing the power of antibodies to develop differentiated cancer treatments and our commitment to delivering new therapeutic options to patients through our own research and development and through industry partnerships," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We are especially encouraged by the data from the early-stage epcoritamab clinical trials and look forward to seeing results from additional studies."

On Tuesday, December 14, at 2:00 PM EST (8:00 PM CET / 7:00 PM GMT), Genmab will host its 2021 Virtual R&D Update and ASH (Free ASH Whitepaper) Data Review. The event will be webcast live. Details, including the webcast link, will be available on Genmab’s website, www.genmab.com. This meeting is not an official program of the ASH (Free ASH Whitepaper) Annual Meeting.

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

Epcoritamab (DuoBody-CD3xCD20):

Subcutaneous Epcoritamab in Combination with R-CHOP in Patients with Previously Untreated High-Risk Diffuse Large B-cell Lymphoma: Preliminary Results from a Phase 1/2 Trial

Subcutaneous Epcoritamab in Combination with R2 (Rituximab and Lenalidomide) in Patients with Relapsed or Refractory Follicular Lymphoma: Preliminary Results from a Phase 1/2 Trial

Subcutaneous Epcoritamab in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia: Preliminary Results from the EPCORE CLL-1 Trial
Phase 3 Trial (EPCORE DLBCL-1) of Epcoritamab versus Standard of Care in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Daratumumab:

Daratumumab (DARA) with Bortezomib, Thalidomide, and Dexamethasone (VTd) in Transplant-Eligible Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM): Analysis of Minimal Residual Disease (MRD) Negativity in CASSIOPEIA Part 1 and Part 2
Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Based on Lenalidomide Starting Dose in Transplant-ineligible Patients With Newly Diagnosed Multiple Myeloma and Impaired Renal Function From the Phase 3 MAIA Study
Subcutaneous Daratumumab With Bortezomib, Cyclophosphamide, and Dexamethasone (VCd) in Patients With Newly Diagnosed Light Chain (AL) Amyloidosis: 18-month Landmark Analysis of the Phase 3 ANDROMEDA Study
Pomalidomide and Dexamethasone With or Without Subcutaneous Daratumumab in Patients With Relapsed or Refractory Multiple Myeloma: Updated Analysis of the Phase 3 APOLLO Study
Subcutaneous Daratumumab with Rapid Corticosteroid Tapering in Relapsed or Refractory Multiple Myeloma Patients: Part 3 Update of the Open-label, Multicenter, Phase 1b PAVO Study
Progression-free Survival Outcomes by Response Status for Bortezomib, Melphalan, and Prednisone With or Without Daratumumab in Newly Diagnosed Multiple Myeloma: Pooled Subgroup Analysis of OCTANS and ALCYONE
Daratumumab, Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma: Pooled Analysis of OCTANS and ALCYONE

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 tumors to elicit an immune response towards malignant cells. Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induces T cell mediated killing of lymphoma B cells.i CD20 is 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 lymphocytic leukemia.ii,iii 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.iv,v,vi

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

(Press release, Genmab, NOV 4, 2021, View Source [SID1234594373])