Company Announcement
- First Phase
3 study of epcoritamab as part of broad clinical development plan
with AbbVie
- Diffuse
Large B-cell Lymphoma is the most common form of non-Hodgkin’s
lymphoma worldwide
Copenhagen, Denmark; November 5, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that it will
initiate a Phase 3 study of epcoritamab in diffuse large B-cell
lymphoma (DLBCL). The study will evaluate the
efficacy and safety of subcutaneous epcoritamab, a fully-human
IgG1-bispecific antibody designed to recognize and bind to both CD3
and CD20, versus investigators’ choice of chemotherapy regimen
(either bendamustine and rituximab or gemcitabine, oxaliplatin, and
rituximab) in patients with relapsed or refractory DLBCL.
Epcoritamab is being co-developed by Genmab and AbbVie.
DLBCL is aggressive and the most common form of non-Hodgkin’s
lymphoma worldwide, with 36% of DLBCL patients in the U.S. expected
to die from their disease within five years of diagnosis.1
Prevalence rates are expected to increase, driven by growth in
aging populations. 2
“In collaboration with AbbVie, we have planned a broad,
expansive, accelerated epcoritamab clinical development plan to
maximize the potential of this promising bispecific antibody, with
the ultimate goal of bringing new differentiated treatment options
as soon as possible to patients. We look forward to the data from
this first Phase 3 trial, especially for relapsed or refractory
DLBCL patients as it remains an area of high unmet medical need,”
said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab.
About the StudyThe Phase 3, open-label,
randomized study (GCT3013-05) will include approximately 480
patients with relapsed or refractory DLBCL who failed or are
ineligible for autologous stem cell transplant (ASCT). Patients
will be randomized to receive either subcutaneous epcoritamab or
one of two chemotherapy regimens as per investigator’s choice,
either rituximab, gemcitabine and oxaliplatin (R-GemOx) or
bendamustine and rituximab (BR). The primary endpoint of the study
is overall survival.
About Diffuse Large B-cell LymphomaDLBCL is the
most common type of non-Hodgkin lymphoma (NHL) in the United States
and worldwide, with an average age at diagnosis of mid-60s.2,3 It
is an aggressive form of NHL with relative 10-year survival rates
of approximately 46% and relative 5-year survival rates of
approximately 64%.1,3,4 Prevalence is anticipated to increase,
driven by growth in aging populations.1 DLBCL affects B-lymphocytes
and can develop in the lymph nodes or in other organs, and may be
either localized or generalized.3 The prognosis for relapsed or
refractory DLBCL patients is poor, especially for those with
high-risk factors, and for most patients with refractory DLBCL
there are no curative treatment options.5
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 tumors to
elicit an immune response towards malignant cells. Epcoritamab is
designed to simultaneously bind to CD3 on T cells and CD20 on B
cells and induces T cell mediated killing of lymphoma B cells.6
CD20 is a clinically validated therapeutic target, and is expressed
on many B-cell malignancies, including diffuse large B-cell
lymphoma, follicular lymphoma, mantle cell lymphoma and chronic
lymphocytic leukemia.7,8 Epcoritamab is being co-developed by
Genmab and AbbVie as part of the companies’ broad oncology
collaboration.
About Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company is the creator of
the following approved antibodies: DARZALEX® (daratumumab, under
agreement with Janssen Biotech, Inc.) for the treatment of certain
multiple myeloma indications in territories including the U.S.,
Europe and Japan, Kesimpta® (subcutaneous ofatumumab, under
agreement with Novartis AG), for the treatment of adults with
relapsing forms of multiple sclerosis in the U.S. and TEPEZZA®
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. A subcutaneous formulation of daratumumab, known as
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) in the U.S.,
has been approved in the U.S. and Europe for the treatment of adult
patients with certain multiple myeloma indications. The first
approved Genmab created therapy, Arzerra® (ofatumumab, under
agreement with Novartis AG), approved for the treatment of certain
chronic lymphocytic leukemia indications, is available in Japan and
is also available in other territories via compassionate use or
oncology access programs. Daratumumab is in clinical development by
Janssen for the treatment of additional multiple myeloma
indications, other blood cancers and amyloidosis. Genmab also has a
broad clinical and pre-clinical product pipeline. Genmab's
technology base consists of validated and proprietary next
generation antibody technologies - the DuoBody® platform for
generation of bispecific antibodies, the HexaBody® platform, which
creates effector function enhanced antibodies, the HexElect®
platform, which combines two co-dependently acting HexaBody
molecules to introduce selectivity while maximizing therapeutic
potency and the DuoHexaBody® platform, which enhances the potential
potency of bispecific antibodies through hexamerization. The
company intends to leverage these technologies to create
opportunities for full or co-ownership of future products. Genmab
has alliances with top tier pharmaceutical and biotechnology
companies. Genmab is headquartered in Copenhagen, Denmark with
sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and
Tokyo, Japan.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
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®; DuoBody in combination
with the DuoBody logo®; HexaBody®; HexaBody in combination with the
HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® and
Kesimpta® are trademarks of Novartis AG or its affiliates.
DARZALEX® and DARZALEX FASPRO™ are trademarks of Janssen
Pharmaceutica NV. TEPEZZA® is a trademark of Horizon Therapeutics
plc.
1 SEER https://seer.cancer.gov/statfacts/html/dlbcl.html
accessed October 202042 Ries, L. A. G. et al. (2007) SEER Survival
Monograph: Cancer Survival among Adults: U.S. SEER Program,
1988–2001, Patient and Tumor Characteristics. Available at:
https://seer.cancer.gov/archive/publications/survival/seer_survival_mono_highres.pdf
Accessed October 20203 American Cancer Society. "Types of B-cell
Lymphoma." Available at
https://www.cancer.org/cancer/non-hodgkin-lymphoma/about/b-cell-lymphoma.html
Accessed August 2020.4 Lymphoma Research Foundation, “Diffuse
Large B-Cell Lymphoma.” Available at
https://lymphoma.org/aboutlymphoma/nhl/dlbcl/ Accessed August 20205
Crump, Michael, et al. “Outcomes in Refractory Diffuse Large B-Cell
Lymphoma: Results from the International SCHOLAR-1 Study.” Blood,
American Society of Hematology, 19 Oct. 2017,
www.ncbi.nlm.nih.gov/pmc/articles/PMC5649550/.6 Engelbert 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 Feb;52: 102625. doi:
10.1016/j.ebiom.2019.102625. Epub 2020 Jan 23. PMID: 31981978;
PMCID: PMC6992935.7Rafiq, Sarwish, et al. “Comparative Assessment
of Clinically Utilized CD20-Directed Antibodies in Chronic
Lymphocytic Leukemia Cells Reveals Divergent NK Cell, Monocyte, and
Macrophage Properties.” Journal of Immunology (Baltimore, Md.
1950), U.S. National Library of Medicine, 15 Mar. 2013,
www.ncbi.nlm.nih.gov/pmc/articles/PMC3631574/.8 Singh, Vijay, et
al. “Development of Novel Anti-Cd20 Monoclonal Antibodies and
Modulation in Cd20 Levels on Cell Surface: Looking to Improve
Immunotherapy Response.” Journal of Cancer Science &
Therapy, U.S. National Library of Medicine, Nov. 2015,
www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.
Company Announcement no. 47CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 051120_CA47_Epcoritamab DLBCL Ph 3
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