TIDMGEN
Media Release
COPENHAGEN, Denmark; November 2, 2023
-- Eighteen total abstracts accepted for presentation and publication,
including results from four clinical trials evaluating epcoritamab in
multiple treatment settings and patient populations
-- Oral presentations highlighting new findings from a clinical trial of
epcoritamab in patients with relapsed/refractory (R/R) diffuse large
B-cell lymphoma (DLBCL) and a real-world analysis of patients with R/R
large B-cell lymphoma (LBCL) will be featured
-- Initial data from trial of investigational cancer immunotherapy GEN3014
(HexaBody(R)-CD38) also accepted
-- Genmab to host virtual R&D Update and ASH Data Review on December 12
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Genmab A/S (Nasdaq: GMAB) announced today that multiple abstracts
evaluating epcoritamab (DuoBody(R) -CD3xCD20), a T-cell engaging
bispecific antibody administered subcutaneously, across a variety
of treatment settings and hematologic malignancies have been
accepted for presentation and publication at the 65(th) Annual
Meeting and Exposition of the American Society of Hematology (ASH),
being held in San Diego, California, and virtually, December 9-12.
The presentations will include two oral and 11 poster presentations
highlighting data from several trials evaluating the safety and
efficacy of epcoritamab as a monotherapy or in combination for the
treatment of patients with various lymphoma subtypes, across lines
of therapy including relapsed/refractory (R/R) and newly diagnosed
patients.
Additionally, results from a phase 1/2 trial evaluating GEN3014
(HexaBody-CD38), an investigational novel human CD38 monoclonal
antibody, in patients with R/R multiple myeloma (MM), will be
presented.
All abstracts accepted for presentation have been published on
the ASH website
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.
"The breadth and depth of data accepted for presentation at this
year's American Society of Hematology meeting underline our
dedication to comprehensive evaluation of our investigational
medicines and reinforce our joint commitment with AbbVie to develop
epcoritamab as a potential core therapy for B-cell malignancies,"
said Dr. Judith Klimovsky, Executive Vice President and Chief
Development Officer of Genmab.
2023 R&D Update and ASH Data Review
On Tuesday, December 12, at 11:00 AM EST (5:00 PM CET/4:00 PM
GMT), Genmab will host its 2023 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:
Epcoritamab (DuoBody-CD3xCD20)
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- -------------------------------------------- ------------ ------------------
438 Subcutaneous Epcoritamab Plus Lenalidomide Oral Sunday, December
in Patients With Relapsed/Refractory 10,
Diffuse Large B-cell Lymphoma from 9:30 - 11:00 AM
EPCORE NHL-5. Avivi, I et al. PT
-------- -------------------------------------------- ------------ ------------------
1655 Epcoritamab SC Monotherapy Drives Poster Saturday, December
Deep and Durable Responses in Patients 9, 5:30 - 7:30 PM
with Relapsed or Refractory Follicular PT
Lymphoma: Results from the EPCORE
NHL-1 Dose Expansion Cohort. Linton
KM et al.
-------- -------------------------------------------- ------------ ------------------
1729 CRS Mitigation Strategies: Preliminary Poster Saturday, December
Results from the DLBCL Optimization 9, 5:30 - 7:30 PM
Arm A Cohort of EPCORE NHL-1. Vose PT
J et al.
-------- -------------------------------------------- ------------ ------------------
3053 EPCORE FL-1: Phase 3 Trial of Subcutaneous Poster Sunday, December
Epcoritamab With Rituximab and Lenalidomide 10, 6:00 - 8:00
(R2) vs R2 Alone in Patients With PM PT
Relapsed or Refractory Follicular
Lymphoma. Falchi L et al.
-------- -------------------------------------------- ------------ ------------------
3092 Epcoritamab SC + GemOx Leads to High Poster Sunday, December
Complete Metabolic Response Rates 10, 6:00 - 8:00
in Patients with Relapsed/Refractory PM PT
Diffuse Large B-Cell Lymphoma Ineligible
for Autologous Stem Cell Transplant:
Updated Results from EPCORE NHL-2.
Brody J, et al.
-------- -------------------------------------------- ------------ ------------------
3135 Identification of Optimal Dosing Poster Sunday, December
Regimen for Subcutaneous Epcoritamab 10, 6:00 - 8:00
in Relapsed or Refractory B-Cell PM PT
Non-Hodgkin Lymphoma. Li, T et al.
-------- -------------------------------------------- ------------ ------------------
4481 Population Pharmacokinetics of Subcutaneous Poster Monday, December
Epcoritamab in Relapsed or Refractory 11, 6:00 - 8:00
B-Cell Non-Hodgkin Lymphoma. Li, PM PT
T et al.
-------- -------------------------------------------- ------------ ------------------
4457 Subcutaneous Epcoritamab + R-mini-CHOP Poster Monday, December
in Patients with Previously Untreated 11, 6:00 - 8:00
Diffuse Large B-Cell Lymphoma Ineligible PM PT
for Full-Dose Anthracycline: Results
from the EPCORE NHL-2 Phase 1/2 Trial.
Vermaat JS et al.
-------- -------------------------------------------- ------------ ------------------
GEN3014 (HexaBody-CD38)
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- --------------------------------------------- ------------ ----------------
4757 GEN3014 (HexaBody(R) -CD38) in Anti-CD38 Poster Monday, December
mAb--Naive Patients with Relapsed/Refractory 11, 6:00 - 8:00
Multiple Myeloma: Preliminary Results PM PT
from a Dose-Expansion Cohort of
a Phase 1/2 Trial. Grosicki S, et
al.
-------- --------------------------------------------- ------------ ----------------
Outcomes Research
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- -------------------------------------------- ------------ ------------------
309 Effectiveness of Chemo-Immunotherapy Oral Saturday, December
(CIT) and Novel Therapies in Second 9, 4:00 - 5:30
or Later Line of Therapy (2L+) for PM PT
Patients with Relapsed/Refractory
(R/R) Aggressive Large B-cell Lymphoma
(LBCL). Nastoupil L et al.
-------- -------------------------------------------- ------------ ------------------
1683 Real-World Response Rates Across Poster Saturday, December
Lines of Therapy Among Patients 9, 5:30 - 7:30
With Relapsed/Refractory Follicular PM PT
Lymphoma. Philips T et al.
-------- -------------------------------------------- ------------ ------------------
1733 Efficacy of Subcutaneous Epcoritamab Poster Saturday, December
vs Tisa-cel in R/R LBCL CAR T-naive 9, 5:30 - 7:30
and CAR T-eligible Patients: An PM PT
Indirect Comparison. Salles G et
al.
-------- -------------------------------------------- ------------ ------------------
5089 Cost-Effectiveness of Epcoritamab Poster Monday, December
in Relapsed or Refractory Diffuse 11, 6:00 - 8:00
Large B-Cell Lymphoma After At Least PM PT
Two Lines of Therapy in The United
States. Qu et al.
-------- -------------------------------------------- ------------ ------------------
5158 Patterns of Care and Resource Use Poster Monday, December
Among Elderly Relapsed/Refractory 11, 6:00 -- 8:00
Follicular Lymphoma Patients: US PM PT
Medicare Claims Analysis. Chawla
SB, et al.
-------- -------------------------------------------- ------------ ------------------
NA Practice Efficiency Associated with Publication N/A
Epcoritamab for The Treatment of
Patients with Relapsed or Refractory
Diffuse Large B-Cell Lymphoma from
an Institutional Perspective. Lei
M et al.
-------- -------------------------------------------- ------------ ------------------
NA Estimating the Number of Relapsed/Refractory Publication N/A
Follicular Lymphoma Patients on
Therapy in the United States. Johnston
K et al.
-------- -------------------------------------------- ------------ ------------------
Discovery Research
Abstract Abstract Title Type of Date/Time of
Number Presentation Presentation
-------- ---------------------------------------- ------------ ------------
NA Assessment of ultra-deep DIA mass Publication N/A
spectrometry-based proteomics compared
to flow cytometry and RNA-based methods
for the discovery and validation of
therapeutic targets in immune cells;
Wah Au et al.
-------- ---------------------------------------- ------------ ------------
NA Unbiased Subtyping of AML: Unraveling Publication N/A
Genomic and Transcriptomic Features
for Precision Medicine and Targeted
Therapies using Beat-AML and TCGA
Data; Karagoz et al
-------- ---------------------------------------- ------------ ------------
The safety and efficacy of epcoritamab has not been established
for these investigational uses. The safety and efficacy of
HexaBody-CD38 has not been established.
About Large B-cell Lymphoma (LBCL)
LBCL is a fast-growing type of non-Hodgkin's lymphoma (NHL), a
cancer that develops in the lymphatic system and affects B-cell
lymphocytes, a type of white blood cell. There are an estimated
150,000 new LBCL cases each year globally.(1) (,) (2) There are
several subtypes of LBCL, including diffuse large B-cell lymphoma
(DLBCL), high grade B-cell lymphoma (HGBCL), primary mediastinal
large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B
(FL3B).
About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of NHL worldwide, accounting for
approximately 30 percent of all NHL cases and comprising an
estimated 30,400 U.S. cases in 2022. DLBCL can arise in lymph nodes
as well as in organs outside of the lymphatic system, occurs more
commonly in the elderly and is slightly more prevalent in men.(1,)
(3) DLBCL is a fast-growing type of NHL, a cancer that develops in
the lymphatic system and affects B-cell lymphocytes, a type of
white blood cell. For many people living with DLBCL, their cancer
either relapses, which means it may return after treatment, or
becomes refractory, meaning it does not respond to treatment.
Although new therapies have become available, treatment management
can remain a challenge.(1,) (4)
About Follicular Lymphoma (FL)
FL is typically an indolent (or slow growing) form of NHL that
arises from B-lymphocytes.(5) FL is the second most common form of
NHL overall, accounting for 20-30 percent of all NHL cases, and
represents 10-20 percent of all lymphomas in the western world.(6)
(,) (7) Although FL is an indolent lymphoma, it is considered
incurable with conventional therapy.(8) (,) (9)
About Epcoritamab
Epcoritamab (approved as EPKINLY(TM)) 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. EPKINLY is designed to
simultaneously bind to CD3 on T cells and CD20 on B cells and
induces T-cell mediated killing of CD20+ cells.(10)
EPKINLY (also known as TEPKINLY(R) in certain countries) has
received regulatory approval in various indications and conditions
in the U.S., Japan, the European Union, the United Kingdom and
Canada. In the U.S., epcoritamab was added to the National
Comprehensive Cancer Network(R) (NCCN(R) ) Clinical Practice
Guidelines in Oncology (NCCN Guidelines(R) ) as a treatment option
for diffuse large B-cell lymphoma (DLBCL).
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 three ongoing
phase 3, open-label, randomized trials including a trial evaluating
epcoritamab as a monotherapy in patients with R/R DLBCL (NCT:
04628494) compared to investigators choice chemotherapy, a phase 3
trial evaluating epcoritamab in combination with R-CHOP in adult
participants with newly diagnosed DLBCL (NCT: 05578976), and a
phase 3, open-label clinical trial evaluating epcoritamab in
combination with rituximab and lenalidomide in patients with R/R FL
(NCT: 05409066). Epcoritamab is not approved to treat newly
diagnosed patients with DLBCL or FL. The safety and efficacy of
epcoritamab has not been established for these investigational
uses. Please visit clinicaltrials.gov for more information.
EPKINLY(TM) (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 100.4degF (38degC) 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 100.4degF (38degC) 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
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, 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 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(TM)) 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, 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
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This Company Announcement 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 Company Announcement 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); HexaBody(R);
DuoHexaBody(R),HexElect(R) and KYSO(TM). EPCORE(TM), EPKINLY(TM),
TEPKINLY(R) and their designs are trademarks of AbbVie
Biotechnology Ltd.
(1) Sehn LH, Salles G. Diffuse Large B-Cell Lymphoma. N Engl J
Med. 2021;384:842-858. DOI: 10.1056/NEJMra2027612.
(2) Martelli M, Ferreri AJM, Agostinelli C, Di Rocco A,
Pfreundschuh M, Pileri SA. Diffuse large B-cell lymphoma. Crit Rev
Oncol Hematol. 2013;87(2):146-171. DOI:
10.1016/j.critrevonc.2012.12.009.
(3) Kanas G, Ge W, Quek RGW, Keeven K, Nersesyan K, Arnason JE.
Epidemiology of diffuse large B-cell lymphoma (DLBCL) and
follicular lymphoma (FL) in the United States and Western Europe:
population-level projections for 2020-2025. Leuk Lymphoma.
2022;63(1):54-63. DOI: 10.1080/10428194.2021.1975188.
(4) Crump M, Neelapu SS, Farooq U, et al. Outcomes in refractory
diffuse large B-cell lymphoma: results from the international
SCHOLAR-1 study. Blood. 2017;130(16):1800-1808. DOI:
10.1182/blood-2017-03-769620.
(5) What is Lymphoma. Lymphoma Research Foundation.
https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed October
2023.
(6) Ma S. Risk factors of follicular lymphoma. Expert Opin Med
Diagn. 2012;6:323-333. DOI: 10.1517/17530059.2012.686996.
(7) Luminari S, Bellei M, Biasoli I, Federico M. Follicular
lymphoma--treatment and prognostic factors. Rev Bras Hematol
Hemoter. 2012;34:54-59. DOI: 10.5581/1516-8484.20120015.
(8) Link BK, Day BM, Zhou X, et al. Second-Line and Subsequent
Therapy and Outcomes for Follicular Lymphoma in the United States:
Data From the Observational National LymphoCare Study. Br J
Haematol. 2019;184(4):660-663. DOI: 10.1111/bjh.15149.
(9) Ren J, Asche CV, Shou Y, Galaznik. Economic Burden and
Treatment Patterns for Patients With Diffuse Large B-Cell Lymphoma
and Follicular Lymphoma in the USA. J Comp Eff Res.
2019;8(6):393-402. DOI: 10.2217/cer-2018-0094.
(10) 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.
Media Release no. 12
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
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