TIDMGEN
Media Release
COPENHAGEN, Denmark; May 25, 2023
-- Oral presentations will highlight epcoritamab-bysp in combination with
rituximab-lenalidomide (R2) in high-risk follicular lymphoma
-- Poster presentations will highlight epcoritamab in lymphoma across
multiple lines of therapy and histologies where high unmet needs exist
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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 2023 American
Society of Clinical Oncology (ASCO) Annual Meeting, being held in
Chicago, IL and virtually, June 2-6, 2023, and at the 2023 European
Hematology Association (EHA) Congress, being held in Frankfurt,
Germany and virtually, June 8-11, 2023.
Presentations will include data from clinical trials evaluating
the efficacy of epcoritamab in combination with standard-of-care
therapies for the treatment of various types of B-cell non-Hodgkin
lymphoma (NHL), including first-line, high-risk diffuse large
B-cell lymphoma (DLBCL), relapsed or refractory large B-cell
lymphoma (LBCL), and relapsed or refractory follicular lymphoma
(FL). The safety and efficacy of epcoritamab has not been
established for these investigational uses.
All abstracts accepted for presentation have been published and
may be accessed online via the ASCO Meeting Library
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and EHA Open Access Library
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.
"The data being presented this year at ASCO and EHA demonstrate
Genmab's significant progress towards our mission to develop
targeted antibody therapies with the goal of improving the lives of
people impacted by hematologic malignancies," said Dr. Judith
Klimovsky, Executive Vice President and Chief Development Officer
of Genmab. "Together with AbbVie, we are committed to evaluating
epcoritamab as a potential therapy for a variety of B-cell
lymphomas through a robust clinical development program."
Genmab has also submitted abstracts evaluating epcoritamab, for
potential presentation at the International Conference on Malignant
Lymphoma, taking place June 13-17, 2023, in Lugano,
Switzerland.
Abstracts accepted for presentation at ASCO include:
Epcoritamab:
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- ----------------------------------------------------- ------------ ---------------
7506 Epcoritamab + R2 regimen and responses Oral Tuesday, June
in high-risk follicular lymphoma, regardless 6, 2023, 11:45
of POD24 status. R. W. Merryman, et AM CDT
al.
-------- ----------------------------------------------------- ------------ ---------------
7525 Effect of follow-up time on the ability Poster Monday, June
of subcutaneous epcoritamab to induce 5, 2023, 08:00
deep and durable complete remissions AM - 11:00
in patients with relapsed/refractory AM CDT
large B-cell lymphoma: Updated results
from the pivotal EPCORE(TM) NHL-1 trial;
Y. Karimi, et al.
-------- ----------------------------------------------------- ------------ ---------------
7519 Metabolic response rates of epcoritamab Poster Monday, June
+ R-CHOP in patients with previously Discussion 5, 2023, 1:15
untreated (1L) high-risk diffuse large PM CDT
B-cell lymphoma, including double-hit/triple-hit
lymphoma: Updated EPCORE NHL-2 data;
L. Falchi, et al.
-------- ----------------------------------------------------- ------------ ---------------
7592 Phase 3 trial of subcutaneous epcoritamab Poster Monday, June
+ R-CHOP versus R-CHOP in patients 5, 2023, 08:00
(pts) with newly diagnosed diffuse AM - 11:00
large B-cell lymphoma (DLBCL): EPCORE AM CDT
DLBCL-2. L. Sehn, et al.
-------- ----------------------------------------------------- ------------ ---------------
e18919 Practice efficiency of treatment with Publication NA
epcoritamab versus glofitamab in relapsed/refractory
diffuse large B-cell lymphoma. D. Huang,
et al.
-------- ----------------------------------------------------- ------------ ---------------
Real-World Evidence:
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- -------------------------------------------- ------------ ---------------
7552 Real-world outcomes with novel therapies Poster Monday, June
in R/R DLBCL. J. Crombie, et al. 5, 2023, 08:00
AM - 11:00
AM CDT
-------- -------------------------------------------- ------------ ---------------
e19530 Racial and ethnic representation in Publication NA
large B-cell lymphoma trials and real-world
databases. J. Munoz, et al.
-------- -------------------------------------------- ------------ ---------------
Abstracts accepted for presentation at EHA include:
Epcoritamab:
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- -------------------------------------------------- ------------ ---------------
S222 Epcoritamab with rituximab + lenalidomide Oral Friday, June
(R2) provides durable responses in 9, 2023, 15:15
patients with high-risk follicular PM -- 15:30
lymphoma, regardless of POD24 status. PM CEST
A. Sureda, et al.
-------- -------------------------------------------------- ------------ ---------------
P1116 High complete metabolic response rates Poster Friday, June
with epcoritamab + R-CHOP in previously 9, 2023, 6:00
untreated (1L) patients with high-risk PM - 7:00 PM
diffuse large b-cell lymphoma, including CEST
double/triple-hit: EPCORE NHL-2 update.
M. Clausen, et al.
-------- -------------------------------------------------- ------------ ---------------
P1118 Longer follow-up from the pivotal EPCORE Poster Friday, June
NHL-1 trial reaffirms subcutaneous 9, 2023, 6:00
epcoritamab induces deep, durable complete PM - 7:00 PM
remissions in patients with relapsed/refractory CEST
large B-cell lymphoma. W. Jurczak,
et al.
-------- -------------------------------------------------- ------------ ---------------
P1149 Comparison of the efficacy of epcoritamab Poster Friday, June
versus chimeric antigen receptor therapies, 9, 2023, 6:00
polatuzumab-based regimens, and tafasitamab-based PM - 7:00 PM
regimens. A. Rosenthal, et al. CEST
-------- -------------------------------------------------- ------------ ---------------
P1154 Efficacy of subcutaneous epcoritamab Poster Friday, June
vs axi-cel in R/R DLBCL CAR T-naive 9, 2023, 6:00
and CAR T-eligible patients: an indirect PM - 7:00 PM
comparison. G. Salles, et al. CEST
-------- -------------------------------------------------- ------------ ---------------
P1169 Comparison of real-world clinical outcomes Poster Friday, June
in patients with relapsed/refractory 9, 2023, 6:00
large B-cell lymphoma treated with PM - 7:00 PM
epcoritamab vs chemoimmunotherapy. CEST
A. Mutebi, et al.
-------- -------------------------------------------------- ------------ ---------------
P1176 Clinical outcomes of novel therapies Poster Friday, June
in relapsed/refractory diffuse large 9, 2023, 6:00
B-cell lymphoma. T. Wang, et al. PM - 7:00 PM
CEST
-------- -------------------------------------------------- ------------ ---------------
GEN3014 (HexaBody(R) -CD38):
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- ------------------------------------------- ------------ --------------
P816 Pharmacodynamic activity of GEN3014 Poster Friday, June
(Hexabody-CD38) in patients with multiple 9, 2023, 6:00
myeloma supports enhanced complement PM - 7:00 PM
dependent cytotoxicity of GEN3014 compared CEST
to daratumumab. I. Hiemstra, et al.
-------- ------------------------------------------- ------------ --------------
About Epcoritamab
Epcoritamab-bysp is an IgG1-bispecific antibody created using
Genmab's proprietary DuoBody(R) technology and administered
subcutaneously. 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 is
being co-developed by Genmab and AbbVie as part of the companies'
oncology collaboration.
Epcoritamab was recently approved in the U.S. under the brand
name EPKINLY(TM) and is indicated for the treatment of adult
patients with relapsed or refractory diffuse large B-cell lymphoma
(DLBCL), not otherwise specified (NOS), including DLBCL arising
from indolent lymphoma, and high-grade B-cell lymphoma (HGBL) after
2 or more lines of systemic therapy.
This indication is approved under accelerated approval based on
response rate and durability of response. Continued approval for
this indication is contingent upon verification and description of
clinical benefit in a confirmatory trial(s).
In October 2022, Genmab announced that AbbVie submitted a
Marketing Authorization Application for epcoritamab for the
treatment of patients with R/R DLBCL after two or more lines of
systemic therapy, which was validated by the European Medicines
Agency. Additionally, in December 2022, Genmab announced that the
company submitted a Japan new drug application to the Ministry of
Health, Labor and Welfare of Japan for epcoritamab for the
treatment of patients with R/R LBCL after two or more lines of
systemic therapy.
Genmab and AbbVie are continuing to evaluate the use of
epcoritamab as a monotherapy, and in combination, across lines of
therapy in a range of hematologic malignancies. This includes an
ongoing phase 3, open-label, randomized trial evaluating
epcoritamab as a monotherapy in patients with R/R DLBCL (NCT:
04628494), an ongoing phase 3, open-label, randomized trial
evaluating epcoritamab in combination in adult participants with
newly diagnosed DLBCL (NCT: 05578976), and a phase 3, open-label
clinical trial evaluating epcoritamab in combination in patients
with R/R follicular lymphoma (FL) (NCT: 05409066). Please visit
clinicaltrials.gov for more information.
U.S. IMPORTANT SAFETY INFORMATION
BOXED WARNINGS
-- Cytokine release syndrome (CRS), including serious or life-threatening
reactions, can occur in patients receiving EPKINLY (epcoritamab-bysp).
Initiate treatment with the EPKINLY step-up dosing schedule to reduce the
incidence and severity of CRS. Withhold EPKINLY until CRS resolves or
permanently discontinue based on severity.
-- Immune effector cell--associated neurotoxicity syndrome (ICANS),
including life-threatening and fatal reactions, can occur with EPKINLY.
Monitor patients for neurological signs or symptoms of ICANS during
treatment. Withhold EPKINLY until ICANS resolves or permanently
discontinue based on severity.
Cytokine Release Syndrome (CRS)
-- EPKINLY can cause CRS, including serious or life-threatening reactions.
CRS occurred in 51% of patients at the recommended dose in the clinical
trial (37% grade 1, 17% grade 2, and 2.5% grade 3). Recurrent CRS
occurred in 16% of patients. Of all the CRS events, most (92%) occurred
during cycle 1. In cycle 1, 9% of CRS events occurred after the 0.16 mg
dose (cycle 1, day 1), 16% after the 0.8 mg dose (cycle 1, day 8), 61%
after the 48 mg dose (cycle 1, day 15), and 6% after the 48 mg dose
(cycle 1, day 22). The median time to onset of CRS from the most recently
administered EPKINLY dose across all doses was 24 hours (range, 0-10
days). The median time to onset after the first full 48 mg dose was 21
hours (range, 0-7 days). CRS resolved in 98% of patients; the median
duration of CRS events was 2 days (range, 1-27 days).
-- Signs and symptoms of CRS can include pyrexia, hypotension, hypoxia,
dyspnea, chills, and tachycardia. Concurrent neurological adverse
reactions associated with CRS occurred in 2.5% of patients and included
headache, confusional state, tremors, dizziness, and ataxia.
-- Initiate EPKINLY according to the step-up dosing schedule. Administer
pretreatment medications to reduce the risk of CRS and monitor patients
for potential CRS. Following administration of the first 48 mg dose,
patients should be hospitalized for 24 hours. At the first signs or
symptoms of CRS, immediately evaluate patients for hospitalization,
manage per current practice guidelines, and administer supportive care as
appropriate. Withhold or discontinue EPKINLY based on the severity of
CRS.
-- Patients who experience CRS (or other adverse reactions that impair
consciousness) should be evaluated and advised not to drive and to
refrain from operating heavy or potentially dangerous machinery until
resolution.
Immune Effector Cell--Associated Neurotoxicity Syndrome
(ICANS)
-- EPKINLY can cause life-threatening and fatal ICANS. ICANS occurred in 6%
(10/157) of patients in the clinical trial (4.5% grade 1, 1.3% grade 2,
0.6% fatal: 1 event). Of the 10 ICANS events, 9 occurred in cycle 1 of
treatment. The median time to onset was 16.5 days (range, 8-141 days)
from the start of treatment. Relative to the most recent administration,
the median time to onset was 3 days (range, 1-13 days). The median
duration of ICANS was 4 days (range, 0-8 days), with ICANS resolving in
90% of patients with supportive care.
-- Signs and symptoms of ICANS can include confusional state, lethargy,
tremors, dysgraphia, aphasia, and nonconvulsive status epilepticus. The
onset of ICANS can be concurrent with CRS, following resolution of CRS,
or in the absence of CRS.
-- Monitor for potential ICANS. At the first signs or symptoms of ICANS,
immediately evaluate patient and provide supportive therapy based on
severity. Withhold or discontinue EPKINLY per recommendations and
consider further management per current practice guidelines.
-- Patients who experience signs or symptoms of ICANS or any other adverse
reactions that impair cognition or consciousness should be evaluated,
including potential neurology evaluation, and patients at increased risk
should be advised not to drive and to refrain from operating heavy or
potentially dangerous machinery until resolution.
Infections
-- EPKINLY can cause serious and fatal infections. In the clinical trial,
serious infections, including opportunistic infections, were reported in
15% of patients treated with EPKINLY at the recommended dose (14% grade 3
or 4, 1.3% fatal). The most common grade 3 or greater infections were
sepsis, COVID-19, urinary tract infection, pneumonia, and upper
respiratory tract infection.
-- Monitor patients for signs and symptoms of infection prior to and during
treatment with EPKINLY and treat appropriately. Avoid administration of
EPKINLY in patients with active infections.
-- Prior to starting EPKINLY, provide Pneumocystis jirovecii pneumonia (PJP)
prophylaxis and consider prophylaxis against herpes virus.
-- Withhold or consider permanent discontinuation of EPKINLY based on
severity.
Cytopenias
-- EPKINLY can cause serious or severe cytopenias, including neutropenia,
anemia, and thrombocytopenia. Among patients who received the recommended
dose in the clinical trial, grade 3 or 4 events occurred in 32%
(decreased neutrophils), 12% (decreased hemoglobin), and 12% (decreased
platelets). Febrile neutropenia occurred in 2.5%.
-- Monitor complete blood counts throughout treatment. Based on severity of
cytopenias, temporarily withhold or permanently discontinue EPKINLY.
Consider prophylactic granulocyte colony-stimulating factor
administration as applicable.
Embryo-Fetal Toxicity
-- EPKINLY may cause fetal harm. Advise pregnant women of the potential risk
to the fetus. Verify pregnancy status in females of reproductive
potential prior to initiating EPKINLY. Advise females of reproductive
potential to use effective contraception during treatment with EPKINLY
and for 4 months after the last dose.
Adverse Reactions
-- The most common (>=20%) adverse reactions were CRS, fatigue,
musculoskeletal pain, injection site reactions, pyrexia, abdominal pain,
nausea, and diarrhea. The most common grade 3 to 4 laboratory
abnormalities (>=10%) were decreased lymphocyte count, decreased
neutrophil count, decreased white blood cell count, decreased hemoglobin,
and decreased platelets.
Lactation
-- Advise women not to breastfeed during treatment and for 4 months after
the last dose of EPKINLY.
Please see the full
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Prescribing Information and
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Medication Guide, including Boxed 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 more than 20 years, its passionate,
innovative and collaborative team has invented next-generation
antibody technology platforms and leveraged translational research
and data sciences, which has resulted 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
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and follow us on Twitter.com/Genmab
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.
Contact:
David Freundel, Senior Director, Product Communications
T: +1 609 430 2481; E: dafr@genmab.com
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Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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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
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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
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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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody
in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in
combination with the HexaBody logo(R) ; DuoHexaBody(R) and
HexElect(R) . EPKINLY(TM) and EPCORE(TM) are owned by AbbVie
Biotechnology Ltd.
i Engelberts 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
Media Release no. 05
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
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