- 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®-CD38) also accepted
- Genmab to host virtual R&D Update and ASH Data Review on
December 12
Genmab A/S (Nasdaq: GMAB) announced today that
multiple abstracts evaluating epcoritamab (DuoBody®-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 65th 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.
“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 Number
Abstract Title
Type of Presentation
Date/Time of
Presentation
438
Subcutaneous Epcoritamab Plus Lenalidomide
in Patients With Relapsed/Refractory Diffuse Large B-cell Lymphoma
from EPCORE NHL-5. Avivi, I et al.
Oral
Sunday, December 10,
9:30 - 11:00 AM PT
1655
Epcoritamab SC Monotherapy Drives Deep and
Durable Responses in Patients with Relapsed or Refractory
Follicular Lymphoma: Results from the EPCORE NHL-1 Dose Expansion
Cohort. Linton KM et al.
Poster
Saturday, December 9, 5:30 - 7:30 PM
PT
1729
CRS Mitigation Strategies: Preliminary
Results from the DLBCL Optimization Arm A Cohort of EPCORE NHL-1.
Vose J et al.
Poster
Saturday, December 9, 5:30 - 7:30 PM
PT
3053
EPCORE FL-1: Phase 3 Trial of Subcutaneous
Epcoritamab With Rituximab and Lenalidomide (R2) vs R2 Alone in
Patients With Relapsed or Refractory Follicular Lymphoma. Falchi L
et al.
Poster
Sunday, December 10, 6:00 - 8:00 PM PT
3092
Epcoritamab SC + GemOx Leads to High
Complete Metabolic Response Rates in Patients with
Relapsed/Refractory Diffuse Large B‑Cell Lymphoma Ineligible for
Autologous Stem Cell Transplant: Updated Results from EPCORE NHL-2.
Brody J, et al.
Poster
Sunday, December 10, 6:00 - 8:00 PM PT
3135
Identification of Optimal Dosing Regimen
for Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell
Non-Hodgkin Lymphoma. Li, T et al.
Poster
Sunday, December 10, 6:00 - 8:00 PM PT
4481
Population Pharmacokinetics of
Subcutaneous Epcoritamab in Relapsed or Refractory B-Cell
Non-Hodgkin Lymphoma. Li, T et al.
Poster
Monday, December 11, 6:00 - 8:00 PM PT
4457
Subcutaneous Epcoritamab + R-mini-CHOP in
Patients with Previously Untreated Diffuse Large B-Cell Lymphoma
Ineligible for Full-Dose Anthracycline: Results from the EPCORE
NHL-2 Phase 1/2 Trial. Vermaat JS et al.
Poster
Monday, December 11, 6:00 - 8:00 PM PT
GEN3014 (HexaBody-CD38)
Abstract Number
Abstract Title
Type of Presentation
Date/Time of
Presentation
4757
GEN3014 (HexaBody®-CD38) in Anti-CD38
mAb–Naive Patients with Relapsed/Refractory Multiple Myeloma:
Preliminary Results from a Dose-Expansion Cohort of a Phase 1/2
Trial. Grosicki S, et al.
Poster
Monday, December 11, 6:00 - 8:00 PM PT
Outcomes Research
Abstract Number
Abstract Title
Type of Presentation
Date/Time of
Presentation
309
Effectiveness of Chemo-Immunotherapy (CIT)
and Novel Therapies in Second or Later Line of Therapy (2L+) for
Patients with Relapsed/Refractory (R/R) Aggressive Large B-cell
Lymphoma (LBCL). Nastoupil L et al.
Oral
Saturday, December 9, 4:00 - 5:30 PM
PT
1683
Real-World Response Rates Across Lines of
Therapy Among Patients With Relapsed/Refractory Follicular
Lymphoma. Philips T et al.
Poster
Saturday, December 9, 5:30 - 7:30 PM
PT
1733
Efficacy of Subcutaneous Epcoritamab vs
Tisa-cel in R/R LBCL CAR T-naive and CAR T-eligible Patients: An
Indirect Comparison. Salles G et al.
Poster
Saturday, December 9, 5:30 - 7:30 PM
PT
5089
Cost-Effectiveness of Epcoritamab in
Relapsed or Refractory Diffuse Large B-Cell Lymphoma After At Least
Two Lines of Therapy in The United States. Qu et al.
Poster
Monday, December 11, 6:00 - 8:00 PM PT
5158
Patterns of Care and Resource Use Among
Elderly Relapsed/Refractory Follicular Lymphoma Patients: US
Medicare Claims Analysis. Chawla SB, et al.
Poster
Monday, December 11, 6:00 – 8:00 PM PT
NA
Practice Efficiency Associated with
Epcoritamab for The Treatment of Patients with Relapsed or
Refractory Diffuse Large B-Cell Lymphoma from an Institutional
Perspective. Lei M et al.
Publication
N/A
NA
Estimating the Number of
Relapsed/Refractory Follicular Lymphoma Patients on Therapy in the
United States. Johnston K et al.
Publication
N/A
Discovery Research
Abstract Number
Abstract Title
Type of Presentation
Date/Time of
Presentation
NA
Assessment of ultra-deep DIA mass
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.
Publication
N/A
NA
Unbiased Subtyping of AML: Unraveling
Genomic and Transcriptomic Features for Precision Medicine and
Targeted Therapies using Beat-AML and TCGA Data; Karagoz et al
Publication
N/A
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™) 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 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® 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® (NCCN®) Clinical Practice Guidelines
in Oncology (NCCN Guidelines®) 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™ (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 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 and follow us on Twitter.com/Genmab.
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 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 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®; 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.
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 S. Risk factors of follicular lymphoma.
Expert Opin Med Diagn. 2012;6:323-333. DOI:
10.1517/17530059.2012.686996.
7minari 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.
9n 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.
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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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