TIDMGEN
Media Release
COPENHAGEN, Denmark; November 21, 2022
-- Epcoritamab BLA accepted for FDA Priority review; FDA action date is May
21, 2023
-- Epcoritamab could become the first subcutaneous bispecific antibody
approved for the treatment of LBCL
-- BLA submission supported by positive EPCORE(TM) NHL-1 trial results
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Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and
Drug Administration (FDA) has accepted for Priority Review the
Biologics License Application (BLA) for subcutaneous epcoritamab
(DuoBody(R)-CD3xCD20), an investigational bispecific antibody, for
the treatment of patients with relapsed/refractory large B-cell
lymphoma (LBCL) after two or more lines of systemic therapy. Under
the Prescription Drug User Fee Act (PDUFA), the FDA has set a
target action date of May 21, 2023.
The BLA submission is based on safety and preliminary efficacy
data from the LBCL cohort of the pivotal EPCORE(TM) NHL-1
open-label, multi-center phase 2 clinical trial evaluating
epcoritamab in patients with relapsed, progressive or refractory
CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL). These results
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were presented in a late-breaking oral presentation as a part of
the Presidential Symposium at the 27(th) Annual Meeting of the
European Hematology Association (EHA2022), in Vienna, Austria.
"We are pleased that the BLA for epcoritamab has been accepted
for Priority Review by the FDA, accelerating the pathway for
approval and bringing us one step closer to potentially delivering
a novel treatment option to relapsed and refractory LBCL patients
who are in need of additional treatment options," said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab. "Together with
our partner, AbbVie, we recognize the unmet need for safe,
effective and accessible treatments for patients with B-cell
malignancies and we believe that epcoritamab has the potential to
become a core therapy in this patient population."
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. The companies are
committed to evaluating epcoritamab as a monotherapy, and in
combination, across lines of therapy in a range of hematologic
malignancies, including an ongoing phase 3, open-label, randomized
clinical trial evaluating epcoritamab as a monotherapy in patients
with relapsed/refractory diffuse large B-cell lymphoma (DLBCL)
(NCT: 04628494) and a phase 3, open-label clinical trial evaluating
epcoritamab in combination in patients with relapsed/refractory
follicular lymphoma (FL) (NCT: 05409066).
In October 2022, the European Medicines Agency validated
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for review a Marketing Authorization Application (MAA) for
epcoritamab for the treatment of patients with relapsed/refractory
DLBCL-- a major subtype of LBCL -- after two or more lines of
systemic therapy.
Based on the existing agreement, this milestone triggers a USD
80 million milestone payment from AbbVie. The milestone payment
will not impact Genmab's 2022 financial guidance provided on
November 9, 2022.
About Large B-cell Lymphoma (LBCL) and Diffuse Large B-cell
Lymphoma (DLBCL)
Large B-cell lymphoma (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) Diffuse large B-cell lymphoma (DLBCL) is a
fast-growing type of NHL(3) and the most common type of NHL
worldwide, accounting for approximately 31 percent of all NHL
cases.(2) 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)
About the EPCORE(TM) NHL-1 Trial
EPCORE(TM) NHL-1 is an open-label, multi-center safety and
preliminary efficacy trial of epcoritamab including a phase 1
first-in-human, dose escalation part; a phase 2 expansion part; and
an optimization part. The trial was designed to evaluate
subcutaneous epcoritamab in patients with relapsed, progressive or
refractory CD20+ mature B-NHL, including LBCL and DLBCL. Data from
the dose escalation part of the study, which determined the
recommended phase 2 dose, were published in
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The Lancet in 2021. In the phase 2 expansion part, additional
patients are treated with epcoritamab to further explore the safety
and efficacy of epcoritamab in patients with different types of
relapsed/refractory B-NHLs who had limited therapeutic options.
The primary endpoint of the phase 2 expansion part was overall
response rate (ORR) as assessed by an IRC. Secondary efficacy
endpoints included duration of response, complete response rate,
progression-free survival, overall survival, time to response, time
to next therapy, and rate of minimal residual disease
negativity.
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 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.(4) 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.(5) (,) (6)
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:
Marisol Peron, Senior Vice President, Global Communications
& Corporate Affairs
T: +1 609 955 2392; E: mmp@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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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) .
(1) Sehn, Salles. "Diffuse Large B-Cell Lymphoma." N Engl J Med.
2021;384:842-858. DOI: 10.1056/NEJMra2027612
(2) Martelli, Ferreri, Agostinelli, et al. "Diffuse large B-cell
lymphoma." Crit Rev Oncol Hematol. 2013;87(2):146-71. DOI:
10.1016/j.critrevonc.2012.12.009
(3) "Diffuse Large B-Cell Lymphoma." Lymphoma Research
Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/. Date
accessed: October 26, 2022.
(4) 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
(5) 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
(6) Singh, Gupta, Almasan. "Development of Novel Anti-Cd20
Monoclonal Antibodies and Modulation in Cd20 Levels on Cell
Surface: Looking to Improve Immunotherapy Response." J Cancer Sci
Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373
Media Release no. 17
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- GENMAB_FDA Submission Acceptance Release_FINAL
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