- Sixteen abstracts accepted for presentation and publication
demonstrate depth and breadth of comprehensive epcoritamab
development program
- Three oral presentations highlight novel data evaluating
epcoritamab in patients with relapsed/refractory (R/R) follicular
lymphoma (FL), in combination for first-line treatment of diffuse
large B-cell lymphoma (DLBCL), and in Richter’s transformation
(RT)
Genmab A/S (Nasdaq: GMAB) announced today that
multiple abstracts evaluating epcoritamab, a T-cell engaging
bispecific antibody administered subcutaneously, will be presented
at the 2024 European Hematology Association (EHA) Congress, being
held in Madrid, Spain and virtually, June 13-16, 2024.
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 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 2024 that highlight the key progress that has been
made developing epcoritamab as a potential core therapy across a
variety of B-cell malignancies,” 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:
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.
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 may receive other medicines
before receiving EPKINLY and you will also be given smaller doses
of EPKINLY for the first 2 doses (called “step-up” dosing). Your
first full dose of EPKINLY will be given on day 15 of your first
cycle of treatment and you should be hospitalized for 24 hours
after due to risk of CRS and neurologic problems. 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.
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. Do not drive or use heavy machinery or do other
dangerous activities if you have any symptoms that impair
consciousness until your symptoms go away.
EPKINLY can cause other serious side effects,
including:
- Infections that may lead to death. 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 are common during treatment with
EPKINLY and 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.
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. These are not
all 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 guiding its unstoppable team to strive towards improving
the lives of patients through 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, next-generation immune checkpoint modulators,
effector function enhanced antibodies, and antibody-drug
conjugates. To help develop and deliver novel antibody therapies to
patients, Genmab has formed 20+ strategic partnerships with
biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New
Jersey, U.S., and Tokyo, Japan. 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™. EPCORE™, EPKINLY®, TEPKINLY® and their designs
are trademarks of AbbVie Biotechnology Ltd.
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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version on businesswire.com: https://www.businesswire.com/news/home/20240514430927/en/
David Freundel, Senior Director, Product Communications T: +1
609 430 2481; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations T:
+45 3377 9558; E: acn@genmab.com
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