Genmab A/S (Nasdaq: GMAB):
- 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.
EPKINLY® (epcoritamab-bysp) U.S. IMPORTANT SAFETY
INFORMATION
Important Warnings—EPKINLY can cause serious side effects,
including:
- Cytokine release syndrome (CRS), which is common during
treatment with EPKINLY and can be serious or life-threatening. To
help reduce your risk of CRS, you will receive EPKINLY on a step-up
dosing schedule (when you receive 2 or 3 smaller step-up doses of
EPKINLY before your first full dose during your first cycle of
treatment), and you may also receive other medicines before and for
3 days after receiving EPKINLY. If your dose of EPKINLY is delayed
for any reason, you may need to repeat the step-up dosing
schedule.
- Neurologic problems that can be life-threatening and
lead to death. Neurologic problems may happen days or weeks after
you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma should be
hospitalized for 24 hours after receiving their first full dose of
EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic
problems.
Tell your healthcare provider or get medical help right
away if you develop a fever of 100.4°F (38°C) or higher;
dizziness or lightheadedness; trouble breathing; chills; fast
heartbeat; feeling anxious; headache; confusion; shaking (tremors);
problems with balance and movement, such as trouble walking;
trouble speaking or writing; confusion and disorientation;
drowsiness, tiredness or lack of energy; muscle weakness; seizures;
or memory loss. These may be symptoms of CRS or neurologic
problems. If you have any symptoms that impair consciousness,
do not drive or use heavy machinery or do other dangerous
activities until your symptoms go away.
EPKINLY can cause other serious side effects,
including:
- Infections that may lead to death. Your healthcare
provider will check you for signs and symptoms of infection before
and during treatment and treat you as needed if you develop an
infection. You should receive medicines from your healthcare
provider before you start treatment to help prevent infection. Tell
your healthcare provider right away if you develop any symptoms of
infection during treatment, including fever of 100.4°F (38°C) or
higher, cough, chest pain, tiredness, shortness of breath, painful
rash, sore throat, pain during urination, or feeling weak or
generally unwell.
- Low blood cell counts, which can be serious or severe.
Your healthcare provider will check your blood cell counts during
treatment. EPKINLY may cause low blood cell counts, including low
white blood cells (neutropenia), which can increase your risk for
infection; low red blood cells (anemia), which can cause tiredness
and shortness of breath; and low platelets (thrombocytopenia),
which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS,
neurologic problems, infections, and low blood cell counts during
treatment with EPKINLY. Your healthcare provider may temporarily
stop or completely stop treatment with EPKINLY if you develop
certain side effects.
Before you receive EPKINLY, tell your healthcare provider
about all your medical conditions, including if you have an
infection, are pregnant or plan to become pregnant, or are
breastfeeding or plan to breastfeed. If you receive EPKINLY while
pregnant, it may harm your unborn baby. If you are a female who
can become pregnant, your healthcare provider should do a
pregnancy test before you start treatment with EPKINLY and you
should use effective birth control (contraception) during treatment
and for 4 months after your last dose of EPKINLY. Tell your
healthcare provider if you become pregnant or think that you may be
pregnant during treatment with EPKINLY. Do not breastfeed during
treatment with EPKINLY and for 4 months after your last dose of
EPKINLY.
In DLBCL or high-grade B-cell lymphoma, the most common side
effects of EPKINLY include CRS, tiredness, muscle and bone
pain, injection site reactions, fever, stomach-area (abdominal)
pain, nausea, and diarrhea. The most common severe abnormal
laboratory test results include decreased white blood cells,
decreased red blood cells, and decreased platelets.
In follicular lymphoma the most common side effects of
EPKINLY include injection site reactions, CRS, COVID-19,
tiredness, upper respiratory tract infections, muscle and bone
pain, rash, diarrhea, fever, cough, and headache. The most
common severe abnormal laboratory test results include
decreased white blood cells and decreased red blood cells.
These are not all of the possible side effects of EPKINLY. Call
your doctor for medical advice about side effects. You are
encouraged to report side effects to the FDA at (800) FDA-1088 or
www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB
(1-855-443-6622).
Please see Medication Guide, including Important Warnings.
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.
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
product manufacturing, the lack of market acceptance of our
products, our inability to manage growth, the competitive
environment in relation to our business area and markets, our
inability to attract and retain suitably qualified personnel, the
unenforceability or lack of protection of our patents and
proprietary rights, our relationships with affiliated entities,
changes and developments in technology which may render our
products or technologies obsolete, and other factors. For a further
discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are
available on www.genmab.com and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange 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
Release nor to confirm such statements to reflect subsequent events
or circumstances after the date made or in relation to actual
results, unless required by law.
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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Corporate Affairs T: +1 609 613 0504; E: dafr@genmab.com
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