Company Announcement
- Based on the topline
results from the EPCORE™ NHL-1 clinical
trial, Genmab and AbbVie will
engage global regulatory
authorities to discuss next steps
- Data from the
clinical trial to be presented at
a future medical
meeting
- Large B-cell lymphoma
(LBCL) is
a common form of non-Hodgkin’s lymphoma
(NHL) and currently
has limited treatment options
COPENHAGEN, Denmark and NORTH CHICAGO,
Illinois; APRIL
13, 2022 –
Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) announced today
topline results from the first cohort of the EPCORE™ NHL-1 phase
1/2, clinical trial evaluating epcoritamab (DuoBody®-CD3xCD20), an
investigational subcutaneous bispecific antibody. The study cohort
includes 157 patients with relapsed/refractory large B-cell
lymphoma (LBCL) who received at least two prior lines of systemic
therapy, including 38.9 percent who received prior treatment with
chimeric antigen receptor (CAR) T-cell therapy. Based on the
topline results, the companies will engage global regulatory
authorities to determine next steps.
The topline results from this cohort demonstrated an overall
response rate (ORR) of 63.1 percent as confirmed by an independent
review committee (IRC), which exceeded the protocol prespecified
threshold for efficacy. The observed median duration of response
(DOR) was 12 months. The most common treatment-emergent adverse
event was cytokine release syndrome (CRS) with 49.7 percent,
including 2.5 percent grade 3. The data will be submitted for
presentation at a future medical meeting.
Epcoritamab is being co-developed by Genmab and AbbVie as part
of the companies' broad oncology collaboration. The companies
remain committed to evaluating epcoritamab as a monotherapy, and in
combination, across lines of therapy, for a variety of hematologic
malignancies, including an ongoing phase 3, open-label, randomized
trial evaluating epcoritamab as a monotherapy in patients with
relapsed/refractory diffuse large B-cell lymphoma (DLBCL) (NCT:
04628494).
“Together with our partner, AbbVie, we will work with regulatory
authorities to determine next steps and continue to evaluate
epcoritamab in a variety of clinical trials as a potential
treatment option for patients with various hematological
malignancies,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. “We look forward to sharing the findings at a
future medical meeting.”
LBCL is a fast-growing type of non-Hodgkin’s lymphoma (NHL) – a
cancer that develops in the lymphatic system – that affects B-cell
lymphocytes, a type of white blood cell. There are an estimated
150,000 new LBCL cases each year globally. LBCL includes DLBCL,
which is the most common type of NHL worldwide and accounts for
approximately 31 percent of all NHL cases.1,2,3,4
“We aim to leverage AbbVie’s strong blood cancer expertise to
further develop epcoritamab, alongside Genmab, for certain blood
cancer patients who have limited treatment options,” said Mohamed
Zaki, M.D., Ph.D., Vice President and Head, Global Oncology
Development, AbbVie.
About the EPCORE™
NHL-1 TrialEPCORE™ NHL-1 an open-label,
multi-center safety and preliminary efficacy trial of epcoritamab
that consists of two parts: a phase 1 first-in-human, dose
escalation part; and a phase 2 expansion part. The trial was
designed to evaluate subcutaneous epcoritamab in patients with
relapsed, progressive or refractory CD20+ mature B-NHL, including
LBCL and DLBCL. The dose escalation findings, which determined the
recommended phase 2 dose RP2D, were published in The Lancet in
2021. In the phase 2 expansion part, additional patients are being
treated with epcoritamab to further explore the safety and efficacy
of epcoritamab in three cohorts of patients with different types of
relapsed/refractory B-NHLs who had limited therapeutic options.
The primary endpoint of the expansion part was ORR as assessed
by an IRC. Secondary efficacy endpoints included DOR, complete
response rate, duration of complete response, progression-free
survival, and time to response as determined by the Lugano
criteria. Overall survival, time to next therapy, and rate of
minimal residual disease negativity were evaluated as secondary
efficacy endpoints.
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.5 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.6,7 Epcoritamab is being
co-developed by Genmab and AbbVie as part of the companies' broad
oncology collaboration.
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.
About AbbVie AbbVie's mission is to discover
and deliver innovative medicines that solve serious health issues
today and address the medical challenges of tomorrow. We strive to
have a remarkable impact on people's lives across several key
therapeutic areas: immunology, oncology, neuroscience, eye care,
virology, women's health and gastroenterology, in addition to
products and services across its Allergan Aesthetics portfolio. For
more information about AbbVie, please visit us at www.abbvie.com.
Follow @abbvie on Twitter, Facebook, Instagram, YouTube and
LinkedIn.
Genmab Media Contact:Marisol Peron, Senior Vice
President, Global Investor Relations & Communications T: +1 609
524 0065; E: mmp@genmab.com
Genmab Investor Relations:Andrew Carlsen, Vice
President, Head of Investor Relations T: +45 3377 9558; E:
acn@genmab.com
AbbVie Media Contact:U.S. MediaIlke LimoncuE:
ilke.limoncu@abbvie.com
Global MediaMabel MartinezE: mabel.martinez@abbvie.com
AbbVie Investor Relations:Liz SheaE:
liz.shea@abbvie.com Genmab Forward-Looking
StatementsThis 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® and HexElect®.
AbbVie Forward-Looking StatementsSome
statements in this news release are, or may be considered,
forward-looking statements for purposes of the Private Securities
Litigation Reform Act of 1995. The words "believe," "expect,"
"anticipate," "project" and similar expressions, among others,
generally identify forward-looking statements. AbbVie cautions that
these forward-looking statements are subject to risks and
uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks
and uncertainties include, but are not limited to, failure to
realize the expected benefits from AbbVie's acquisition of Allergan
plc ("Allergan"), failure to promptly and effectively integrate
Allergan's businesses, competition from other products, challenges
to intellectual property, difficulties inherent in the research and
development process, adverse litigation or government action,
changes to laws and regulations applicable to our industry and the
impact of public health outbreaks, epidemics or pandemics, such as
COVID-19. Additional information about the economic, competitive,
governmental, technological and other factors that may affect
AbbVie's operations is set forth in Item 1A, "Risk Factors," of
AbbVie's 2021 Annual Report on Form 10-K, which has been filed with
the Securities and Exchange Commission, as updated by its
subsequent Quarterly Reports on Form 10-Q. AbbVie undertakes no
obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
References
1 “Diffuse Large B-Cell Lymphoma.” Lymphoma Research Foundation,
https://www.lymphoma.org/aboutlymphoma/nhl/dlbcl/; date accessed:
11 February 2022.2 “Non-Hodgkin Lymphoma.” Lymphoma Research
Foundation, https://lymphoma.org/aboutlymphoma/nhl/; date accessed:
7 April 2022.3 Sehn, Salles. “Diffuse Large B-Cell Lymphoma.” New
England Journal of Medicine. 2021;384:842-858. DOI:
10.1056/NEJMra20276124 Martelli, Ferreri, Agostinelli, et al.
“Diffuse large B-cell lymphoma.” Crit Rev Oncol Hematol.
2013;87(2):146-71. DOI: 10.1016/j.critrevonc.2012.12.0095 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: PMC6992935.6 Rafiq, 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/.7 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. 15CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 130422_CA15_Epcoritamab Topline Results
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