Genmab to Showcase Strength and Breadth of Comprehensive
Epcoritamab-bysp Development Program at 2024 American Society of
Hematology (ASH) Annual Meeting
Media Release
COPENHAGEN, Denmark; November 5, 2024
- More than 20 abstracts, including four oral
presentations, with new clinical data across lines of therapy and
subgroups of non-Hodgkin’s lymphoma (NHL) patients
- New and updated data from
EPCORE® clinical trial
program reinforce the potential of epcoritamab as a monotherapy and
in combination to treat multiple B-cell malignancies across lines
of therapy
Genmab A/S (Nasdaq:
GMAB) announced today more than
20 abstracts evaluating epcoritamab-bysp (EPKINLY®), a
T-cell engaging bispecific antibody administered subcutaneously,
across lines of therapy and B-cell non-Hodgkin’s lymphoma (NHL)
subtypes, will be presented at the 66th Annual Meeting and
Exposition of the American Society of Hematology (ASH), being held
at the San Diego Convention Center in San Diego, California, and
online, December 7-10.
The breadth of the epcoritamab development program will be
featured at this year's ASH in four oral presentations. Three of
the oral presentations will highlight data evaluating
fixed-duration subcutaneous epcoritamab in patients with previously
untreated diffuse large B-cell lymphoma (DLBCL), large B-cell
lymphoma (LBCL), and relapsed/refractory (R/R) follicular lymphoma
(FL). The fourth oral presentation will feature the results of a
study evaluating epcoritamab monotherapy in patients with R/R
chronic lymphocytic leukemia (CLL). Additionally, three-year
efficacy and safety data for subcutaneous epcoritamab in patients
with R/R DLBCL from the EPCORE® NHL-1 trial will be
presented.
“The data evaluating epcoritamab being presented at this year’s
ASH highlight the encouraging clinical results we have seen across
epcoritamab clinical trials and demonstrate its potential as a core
therapy for B-cell malignancies,” said Dr. Judith Klimovsky,
Executive Vice President and Chief Development Officer of Genmab.
“This has been a pivotal year for epcoritamab, and alongside our
partner AbbVie, we are committed to progressing the comprehensive
epcoritamab development program with the goal of potentially
providing additional therapeutic options to patients in need of
treatments.”
All abstracts accepted for presentation have been published on
the ASH Website.
2024 R&D Update and ASH Data Review
On Wednesday, December 11, at 11:00 AM EST (5:00 PM CET/4:00 PM
GMT), Genmab will host its 2024 R&D Update and ASH Data Review.
The event will be virtual and webcast live. Details, including the
webcast link and registration will be available on www.genmab.com.
This meeting is not an official program of the ASH Annual
Meeting.
Abstracts accepted for presentation at ASH
include:
Oral Presentations
|
Abstract Number |
Abstract Title |
Type of Presentation |
Date/Time of Presentation |
|
342 |
Fixed-Duration Epcoritamab + R2 Drives Deep and Durable Responses
in Patients with Relapsed or Refractory Follicular Lymphoma: 2-Year
Follow-Up from Arm 2 of the EPCORE NHL-2 Trial |
Oral |
Saturday, December 7, 4:00 - 5:30 PM PT
|
|
581 |
Fixed-Duration Epcoritamab + R-CHOP Induces High Complete Response
Rates in Patients with Previously Untreated Diffuse Large B-Cell
Lymphoma with High-Risk Features: Long-Term Results from the EPCORE
NHL-2 Trial |
Oral |
Sunday, December 8, 12:00 - 1:30 PM PT |
|
867 |
EPCORE DLBCL-3 First Disclosure: Fixed-Duration Epcoritamab
Monotherapy in Older (≥75 y), Anthracycline-Ineligible Patients
with Previously Untreated Large B-Cell Lymphoma |
Oral |
Monday, December 9, 2:45 - 4:15 PM PT |
|
883 |
Epcoritamab Monotherapy in Patients (Pts) with Relapsed or
Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from
CLL Expansion and Optimization Cohorts of EPCORE CLL-1 |
Oral |
Monday, December 9, 2:45 - 4:15 PM PT |
Poster Presentations
|
Abstract Number |
Abstract Title |
Type of Presentation |
Date/Time of Presentation |
|
1414 |
Exposure-Response Analyses Supporting Optimal Epcoritamab 48 mg
Full Dose and Dosing Schedule in Relapsed or Refractory Follicular
Lymphoma |
Poster |
Saturday, December 7, 5:30 - 7:30 PM PT |
|
1622 |
Epcoritamab with R-CHOP Overcomes Poor Risk Features of High
Metabolic Tumor Volume in High-Risk Large B-Cell Lymphoma |
Poster |
Saturday, December 7, 5:30 - 7:30 PM PT |
|
1627 |
Fixed-Duration Epcoritamab in Combination with Bendamustine +
Rituximab for First-Line Treatment of Follicular Lymphoma: Initial
Results from EPCORE NHL-2 Arm 3 |
Poster |
Saturday, December 7, 5:30 - 7:30 PM PT |
|
1703 |
Trends in All-Cause Mortality Rates in Patients with Follicular
Lymphoma in the US before and during the COVID-19 Pandemic: A
Retrospective Observational Study |
Poster |
Saturday, December 7, 5:30 - 7:30 PM PT |
|
1734 |
Immune Biomarkers of Mechanism of Action of Epcoritamab (Epcor)
Plus Polatuzumab Vedotin, Rituximab, Cyclophosphamide, Doxorubicin,
and Prednisone (pola-R-CHP) in Frontline DLBCL |
Poster |
Saturday, December 7, 5:30 - 7:30 PM PT |
|
1737 |
Efficacy and Safety of Epcoritamab Monotherapy in Patients with
Relapsed or Refractory LBCL Not Previously Exposed to CAR T:
Subanalysis of the EPCORE NHL-1 Trial |
Poster |
Saturday December 7, 5:30 - 7:30 PM PT |
|
2349 |
Indirect Comparisons of the Efficacy of Epcoritamab Vs Glofitamab
in Patients (Pts) with Relapsed or Refractory (R/R) Large B-Cell
Lymphoma (LBCL) |
Poster |
Saturday, December 7, 5:30 - 7:30 PM PT |
|
2998 |
Epcoritamab Induces in vitro-derived Terminally Differentiated
Exhausted T Cells to Kill B Cells |
Poster |
Saturday, December 7, 5:30 - 7:30 PM PT |
|
3106 |
Fixed-Duration Epcoritamab + R-Mini-CHOP in Patients with
Previously Untreated Diffuse Large B-Cell Lymphoma Ineligible for
Full-Dose R-CHOP: Updated Results from Arm 8 of the EPCORE NHL-2
Trial |
Poster |
Sunday, December 8, 6:00 - 8:00 PM PT |
|
3110 |
Fixed-Duration Epcoritamab Plus Lenalidomide in Patients with
Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL):
Updated Results from Arm 1 of the Epcore NHL-5 Trial |
Poster |
Sunday, December 8, 6:00 - 8:00 PM PT |
|
3115 |
Prior Bendamustine (Benda) Exposure Did Not Impact Clinical
Outcomes and Decreased CD4+ but Not CD8+ T-Cells in Patients with
Diffuse Large B-Cell Lymphoma (DLBCL) Treated with the Bispecific
Antibody Epcoritamab (Epcor) |
Poster |
Sunday, December 8, 6:00 - 8:00 PM PT |
|
3231 |
T cells from CLL patients on venetoclax mount potent cytotoxic
responses in combination with epcoritamab, a CD20/CD3 bispecific
antibody. |
Poster |
Sunday, December 8, 6:00 - 8:00 PM PT |
|
3723 |
Patient Characteristics and Treatment Patterns for
Relapsed/Refractory Diffuse Large B-Cell Lymphoma (DLBCL) By CAR T
Eligibility and Treatment Status in France, Germany, Italy, Spain,
the UK, and Japan |
Poster |
Sunday, December 8, 6:00 - 8:00 PM PT |
|
4480 |
3-Year Update from the EPCORE NHL-1 Trial: Epcoritamab Leads to
Deep and Durable Responses in Relapsed or Refractory Large B-Cell
Lymphoma |
Poster |
Monday, December 9, 6:00 - 8:00 PM PT |
|
4491 |
Three-Factor Prediction Model for Grade 2+Cytokine Release Syndrome
in Large B-Cell Lymphoma Patients Receiving Epcoritamab
Monotherapy |
Poster |
Monday, December 9, 6:00 - 8:00 PM PT |
|
5124 |
Epcoritamab for Relapsed/ Refractory B cell Lymphoma – the Israeli
Real-World Experience |
Poster |
Monday, December 9, 6:00 - 8:00 PM PT |
E-publications
|
Abstract Number |
Abstract Title |
Type of Presentation |
Date/Time of Presentation |
|
7614 |
Cost-Effectiveness of Epcoritamab Versus Glofitamab in Relapsed or
Refractory Large B-Cell Lymphoma after at Least Two Lines of
Therapy in the United States |
E-publication |
N/A |
|
7617 |
A Canadian Cost-Utility Analysis of Epcoritamab Versus Current
Therapies in Third-Line or Later Large B-Cell Lymphoma |
E-publication |
N/A |
|
7757 |
Epcoritamab plus Gemcitabine and Oxaliplatin versus Glofitamab or
Rituximab plus Gemcitabine and Oxaliplatin in Transplant-Ineligible
Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A
Match-Adjusted Comparative Analysis |
E-publication |
N/A |
|
7760 |
Epcoritamab plus Gemcitabine and Oxaliplatin versus Rituximab,
Gemcitabine, and Oxaliplatin in Transplant-Ineligible
Relapsed/Refractory Diffuse Large B-Cell Lymphoma Patients: A
Match-Adjusted Comparative Analysis |
E-publication |
N/A |
|
7802 |
Matching-Adjusted Indirect Treatment Comparison of Epcoritamab
versus Zanubrutinib Plus Obinutuzumab in Relapsed or Refractory
Follicular Lymphoma |
E-publication |
N/A |
The safety and efficacy of epcoritamab has not been
established for these investigational uses.
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 (approved under the brand name EPKINLY®
in the U.S. and Japan, and TEPKINLY® in the EU) has
received regulatory approval in certain lymphoma indications in
several territories. 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. Both companies will pursue additional
international regulatory approvals for the investigational R/R FL
indication and additional approvals for the R/R DLBCL
indication.
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 (NCT04628494), a trial evaluating
epcoritamab in combination with R-CHOP in adult participants with
newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab
in combination with rituximab and lenalidomide (R2) in patients
with R/R FL (NCT05409066), and a trial evaluating epcoritamab in
combination with rituximab and lenalidomide (R2) compared to
chemoimmunotherapy in patients with previously untreated FL
(NCT06191744). The safety and efficacy of epcoritamab has not been
established for these investigational uses. Please
visit www.clinicaltrials.gov for more information.
About Genmab
Genmab is an international biotechnology company with a core
purpose of guiding its unstoppable team to strive toward improving
the lives of patients with innovative and differentiated antibody
therapeutics. For 25 years, its passionate, innovative and
collaborative team has invented next-generation antibody technology
platforms and leveraged translational, quantitative and data
sciences, resulting in a proprietary pipeline including bispecific
T-cell engagers, antibody-drug conjugates, next-generation immune
checkpoint modulators and effector function-enhanced antibodies. By
2030, Genmab’s vision is to transform the lives of people with
cancer and other serious diseases with knock-your-socks-off
(KYSO®) antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen,
Denmark, with international presence across North America, Europe
and Asia Pacific. For more information, please visit Genmab.com and
follow us on LinkedIn and X.
Contact:
David Freundel, Senior Director, Global Communications &
Corporate Affairs
T: +1 609 613 0504; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
This Media Release contains forward looking statements. The
words “believe,” “expect,” “anticipate,” “intend” and “plan” and
similar expressions identify forward looking statements. Actual
results or performance may differ materially from any future
results or performance expressed or implied by such statements. The
important factors that could cause our actual results or
performance to differ materially include, among others, risks
associated with pre-clinical and clinical development of products,
uncertainties related to the outcome and conduct of clinical trials
including unforeseen safety issues, uncertainties related to
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available on www.genmab.com and the risk factors
included in Genmab’s most recent Annual Report on Form 20-F and
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Commission (SEC), which are available at
www.sec.gov. Genmab does not undertake any obligation
to update or revise forward looking statements in this Media
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or circumstances after the date made or in relation to actual
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Genmab A/S and/or its subsidiaries own the following
trademarks: Genmab®; the Y-shaped
Genmab logo®; Genmab in combination
with the Y-shaped Genmab logo®;
HuMax®;
DuoBody®;
HexaBody®;
DuoHexaBody®,
HexElect® and KYSO™.
i Engelberts PJ, Hiemstra IH, de Jong B, et al.
DuoBody-CD3xCD20 induces potent T-cell-mediated killing of
malignant B cells in preclinical models and provides opportunities
for subcutaneous dosing. EBioMedicine. 2020;52:102625.
DOI: 10.1016/j.ebiom.2019.102625.
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