TIDMGEN
Media Release
COPENHAGEN, Denmark; December 11, 2022
-- Epcoritamab featured in multiple data disclosures, including four oral
presentations
-- Results presented from the phase 1b/2 EPCORE(TM) NHL-2 trial of
epcoritamab combined with standard salvage therapy in patients with
transplant eligible relapsed/refractory (R/R) diffuse large B-cell
lymphoma (DLBCL)
-- Additional results also presented from the phase 1b/2 EPCORE NHL-2 trial
evaluating epcoritamab combined with existing therapies in patients with
R/R follicular lymphoma (FL) and previously untreated FL
-- Results presented from phase 1b/2 EPCORE CLL-1 trial evaluating
epcoritamab in patients with Richter's Syndrome (RS)
-- Additional results also presented from the phase 1/2 EPCORE NHL-1 trial,
evaluating epcoritamab in patients with R/R large B-cell lymphoma (LBCL)
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Genmab A/S (Nasdaq: GMAB) today announced the results from multiple
clinical trials evaluating epcoritamab (DuoBody(R) -CD3xCD20), an
investigational subcutaneous bispecific antibody, alone or in
combination with other therapies for the treatment of patients with
relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL),
R/R follicular lymphoma (FL), previously untreated FL, and
Richter's Syndrome (RS). These data, along with additional results
from the phase 1/2 EPCORE NHL-1 clinical trial, evaluating the
safety and efficacy of epcoritamab in patients with R/R large
B-cell lymphoma (LBCL), are being presented at the 64(th) Annual
Meeting and Exposition of the American Society of Hematology (ASH),
being held in New Orleans, Louisiana, and virtually, December
10-13, 2022.
"The breadth of clinical data for epcoritamab presented at ASH
demonstrates Genmab's commitment to addressing treatment needs for
people living with a variety of B-cell lymphomas," said Dr. Judith
Klimovsky, Executive Vice President and Chief Development Officer
of Genmab. "Together with AbbVie, we continue to evaluate
epcoritamab in various treatment settings and patient populations
to unlock its potential to become a core therapy for B-cell
malignancies."
Notably, results from the phase 1b/2 EPCORE NHL-2 arm (Abstract
#443) evaluating 27 patients with R/R DLBCL who were eligible for
autologous stem cell transplant, showed an 85 percent (23/27)
overall response rate (ORR) and a 67 percent (18/27) complete
metabolic response (CMR) rate, following treatment with the
combination of subcutaneous epcoritamab plus standard rituximab,
dexamethasone, cytarabine, and oxaliplatin or carboplatin
(R-DHAX/C) salvage therapy. The most common treatment-emergent
adverse events (TEAEs) of any grade were thrombocytopenia (69
percent), anemia (51 percent), neutropenia (44 percent), cytokine
release syndrome (CRS) (41 percent), nausea (31 percent), fatigue
(28 percent), constipation, diarrhea, headache, pyrexia (all at 24
percent), and increased aspartate aminotransferase (AST) (21
percent). These results were highlighted during an oral
presentation on Sunday, December 11, 2022, at 10:30 a.m. CST.
Results from two additional arms of the EPCORE NHL-2 study,
evaluating subcutaneous epcoritamab in combination with rituximab
and lenalidomide, one arm in patients with R/R FL and the other arm
in previously untreated FL, will be presented during an oral
session on Sunday, December 11, 2022, beginning at 4:30 p.m.
CST.
In the R/R FL arm (Abstract #609), 95 percent (63/66) of
efficacy evaluable patients treated with subcutaneous epcoritamab
in combination with rituximab and lenalidomide achieved an overall
response. Among these patients, 80 percent (53/66) achieved a CMR,
and 15 percent (10/66) achieved a partial metabolic response (PMR).
The majority of patients achieved a response at the first tumor
response assessment and most continued to respond through the
latest assessment at the time of data collection. The most common
TEAEs of any grade were neutropenia (47 percent), CRS (43 percent),
injection-site reactions (32 percent), fatigue (31 percent),
constipation, COVID-19, pyrexia (all at 25 percent), and
infusion-related reaction (21 percent).
In the previously untreated FL patient arm (Abstract #611), 94
percent (34/36) of efficacy evaluable patients who received
subcutaneous epcoritamab in combination with rituximab and
lenalidomide achieved an overall response, including 86 percent
(31/36) achieving a CMR as their best overall response. The most
common TEAEs of any grade were CRS (54 percent), neutropenia (47
percent), pyrexia (44 percent), fatigue (37 percent), injection
site reaction (37 percent), headache (34 percent), COVID-19 (33
percent), diarrhea (32 percent), constipation (29 percent), rash
(27 percent), increased alanine aminotransferase (ALT) (22
percent), and vomiting (22 percent).
Preliminary results from the phase 1b/2 open-label, multi-center
safety and efficacy EPCORE CLL-1 trial (Abstract #348) showed that
treatment with investigational subcutaneous epcoritamab monotherapy
had promising antitumor activity in 10 patients with Richter's
Syndrome, with a 60 percent ORR and a 50 percent CMR rate. Most
responses were observed by the first assessment at week six. The
most common related TEAEs of any grade percent were CRS (90
percent), anemia (50 percent), neutropenia (50 percent),
injection-site reaction (40 percent), thrombocytopenia (40
percent), and hypophosphatemia, hypokalemia, hyperglycemia,
COVID-19, diarrhea, fatigue, and nausea (all at 30 percent). These
results were highlighted during an oral session on Saturday,
December 10, 2022, at 5:15 p.m. CST.
About Diffuse Large B-cell Lymphoma (DLBCL)
Diffuse large B-cell lymphoma (DLBCL) is a fast-growing type of
non-Hodgkin's lymphoma (NHL) that affects B-cell lymphocytes, a
type of white blood cell.(1) It is the most common type of NHL
worldwide and accounts for approximately 30 percent of all NHL
cases.(1) DLBCL can arise in lymph nodes, as well as in organs
outside of the lymphatic system.(1) The disease occurs more
commonly in the elderly and is slightly more prevalent in
men.(1)
About Follicular Lymphoma (FL)
Approximately 2.7 per 100,000 people in the U.S. are newly
diagnosed with FL every year and the median age of patients at
diagnoses with FL is 63.(2) (,) (3) (,) (4) FL is typically an
indolent (or slow growing) form of non-Hodgkin's lymphoma (NHL)
that arises from B-lymphocytes.(5) Although FL is an indolent
lymphoma, it is considered incurable with conventional therapy.(6)
(,) (7)
About Richter's Syndrome (RS)
RS, also known as Richter's Transformation, is defined as the
transformation of chronic lymphocytic leukemia (CLL) into an
aggressive lymphoma, most commonly diffuse large B-cell lymphoma
(DLBCL).(8) (,) (9) RS occurs in approximately 2 to 10 percent of
CLL patients during the course of their disease.(8)
About Epcoritamab
Epcoritamab is an investigational IgG1-bispecific antibody
created using Genmab's proprietary DuoBody technology. Genmab's
DuoBody-CD3 technology is designed to direct cytotoxic T cells
selectively to elicit an immune response towards target cells.
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.(10) CD20 is expressed on B-cells and a clinically validated
therapeutic target in many B-cell malignancies, including diffuse
large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma
and chronic lymphocytic leukemia.(11) (,) (12)
Genmab recently announced
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that the Biologics License Application (BLA) for epcoritamab for
the treatment or R/R LBCL was accepted for Priority Review by the
U.S. Food and Drug Administration (FDA), with an FDA action date of
May 21, 2023. Additionally, the European Medicines Agency (EMA)
recently validated
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the Marketing Authorization Application (MAA) for epcoritamab for
the treatment of adult patients with R/R DLBCL after two or more
lines of systemic therapy.
Epcoritamab is being co-developed by AbbVie and Genmab 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. The companies are
committed to evaluating 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 relapsed/refractory diffuse large B-cell lymphoma
(NCT: 04628494) and a Phase 3, open-label clinical trial evaluating
epcoritamab in combination in patients with relapsed/refractory
follicular lymphoma (NCT: 05409066).
About Genmab
Genmab is an international biotechnology company with a core
purpose to improve the lives of people with cancer. For more than
20 years, Genmab's vision to transform cancer treatment has driven
its passionate, innovative and collaborative teams to invent
next-generation antibody technology platforms and leverage
translational research and data sciences, fueling multiple
differentiated cancer treatments that make an impact on people's
lives. To develop and deliver novel therapies to patients, Genmab
has formed 20+ strategic partnerships with biotechnology and
pharmaceutical companies. Genmab's proprietary pipeline includes
bispecific T-cell engagers, next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug
conjugates.
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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.
Genmab Media Contact:
David Freundel, Director, Product Communications
T: +1 609 613 0504; E: dafr@genmab.com
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Genmab Investor Relations:
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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Genmab Forward-Looking Statements
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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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) .
(1) Sehn, Salles. Diffuse Large B-Cell Lymphoma. N Engl J Med.
2021;384:842-858. DOI: 10.1056/NEJMra2027612.
(2) National Institutes of Health official website: SEER Cancer
Statistics. https://seer.cancer.gov/csr/1975_2017/. Table 19.29.
Accessed November 2022.
(3) Cancer Stat Facts: Follicular Lymphoma.
https://seer.cancer.gov/statfacts/html/follicular.html. Accessed
November 2022
(4) SEER Cancer Statistics.
https://seer.cancer.gov/csr/1975_2017/. Table 19.26. Accessed
November 2022.
(5) Lymphoma Research Foundation official website.
https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November
2022.
(6) Link BK, 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.
(7) Ren J, et al. 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.
(8) Richter's syndrome. Leukaemia Foundation. (2022, October 5).
Accessed November 2022, from
https://www.leukaemia.org.au/blood-cancer-information/types-of-blood-cancer/leukaemia/chronic-lymphocytic-leukaemia/richters-syndrome/#::text=Richter's
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percent
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.
(9) Parikh SA, Kay NE, Shanafelt TD. How we treat Richter
syndrome. Blood. 2014 Mar 13;123(11):1647-57. doi:
10.1182/blood-2013-11-516229. Epub 2014 Jan 13. PMID: 24421328;
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(10) 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
(11) Rafiq, Butchar, Cheney, et al. "Comparative Assessment of
Clinically Utilized CD20-Directed Antibodies in Chronic Lymphocytic
Leukemia Cells Reveals Divergent NK Cell, Monocyte, and Macrophage
Properties." J. Immunol. 2013;190(6):2702-2711. DOI:
10.4049/jimmunol.1202588
(12) Singh, Gupta, Almasan. "Development of Novel Anti-Cd20
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Media Release no. 18
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- Genmab_Epcor ASH Data Release_FINAL
https://ml-eu.globenewswire.com/Resource/Download/18818f5d-c4ae-4f95-bf25-bbfc2c72267b
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