Genmab A/S (Nasdaq: GMAB) today announced that AbbVie
(NYSE: ABBV) will submit a conditional marketing
authorization application (MAA) with the European Medicines Agency
(EMA) for subcutaneous epcoritamab (DuoBody®-CD3xCD20), an
investigational bispecific antibody, for the treatment of patients
with relapsed/refractory diffuse large B-cell lymphoma (DLBCL), in
the second half of 2022. Genmab recently announced that the company
will submit a biologics license application (BLA) for epcoritamab
with the U.S. Food and Drug Administration (FDA) for the treatment
of patients with relapsed/refractory large B-cell lymphoma (LBCL),
also in the second half of 2022.
The MAA submission is supported by results from the large b-cell
lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 open-label,
multi-center trial evaluating the safety and preliminary efficacy
of epcoritamab in patients with relapsed, progressive or refractory
CD20+ mature B-cell non-Hodgkin lymphoma (B-NHL), including DLBCL.
In April 2022, Genmab and AbbVie announced the topline results from
the Phase II expansion part of the EPCORE™ NHL-1 trial. In June
2022, primary results were presented in a late-breaking oral
presentation as part of the Presidential Symposium at the 27th
Annual Meeting of the European Hematology Association (EHA2022) in
Vienna, Austria.
“The MAA submission will mark the next step towards potentially
obtaining marketing approval in Europe and being able to deliver a
new therapeutic option to patients with relapsed or refractory
DLBCL,” said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab. “While there are existing treatments for DLBCL patients
across Europe, we recognize the significant medical need for
alternative therapeutic options for patients unable to tolerate
current treatments or whose treatments have failed.”
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
trial evaluating epcoritamab as a monotherapy in patients with
relapsed/refractory DLBCL (NCT: 04628494).
About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is a fast-growing type of NHL that affects B-cell
lymphocytes, a type of white blood cell. DLBCL, the most common
type of NHL worldwide, accounts for about 25 percent of diagnosed
cases of B-cell NHL worldwide. DLBCL can arise in lymph nodes as
well as in organs outside of the lymphatic system. The disease
occurs more commonly in the elderly and is slightly more prevalent
in men.i,ii
About the EPCORE™ NHL-1 Trial
EPCORE™ 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 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.iii 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.iv,v
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 and follow us
on Twitter.com/Genmab.
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 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 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®; the Y-shaped Genmab logo®; Genmab in combination with the
Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination
with the DuoBody logo®; HexaBody®; HexaBody in combination with the
HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®.
_____________________________ i Diffuse Large B-Cell Lymphoma.”
Lymphoma Research Foundation, https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/.
Accessed 11 February 2022. ii Sandeep A. Padala; Avyakta Kallam.
“Diffuse Large B-Cell Lymphoma.” National Institutes of Health,
National Library of Medicine,
https://www.ncbi.nlm.nih.gov/books/NBK557796/#article-24581.s4.
Accessed 22 June 2022. iii 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 iv 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 v 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
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Communications and Corporate Affairs T: +1 609 524 0065; E:
mmp@genmab.com
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President, Head of Investor Relations T: +45 3377 9558; E:
acn@genmab.com
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