- Based
on topline results from the EPCORE™ NHL-1 clinical trial, AbbVie
and Genmab will engage global regulatory authorities
- 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
NORTH
CHICAGO, Ill. and COPENHAGEN,
Denmark, April 13, 2022 /PRNewswire/ -- AbbVie
(NYSE: ABBV) and Genmab A/S (Nasdaq: GMAB) today announced 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.
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 diffuse
large B-cell lymphoma (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.
The topline results from this cohort demonstrated a
confirmed overall response rate (ORR) of 63.1 percent by an
independent review committee (IRC). The observed median duration of
response (DOR) was 12 months. The mean lines of prior therapy in
this cohort were 3.5 (2 to 11 lines of therapy). The most common
treatment-emergent adverse events of any grade (greater than or
equal to 20 percent) included cytokine release syndrome
(CRS) (49.7 percent), pyrexia (23.6
percent), fatigue (22.9 percent), neutropenia (21.7
percent), and diarrhea (20.4 percent). The most common Grade 3 or 4
treatment-emergent adverse events (greater than or equal to 5
percent) included neutropenia (14.6 percent), anemia (10.2
percent), neutrophil count decreased (6.4 percent), and
thrombocytopenia (5.7 percent). Additionally, the observed Grade 3
CRS was 2.5 percent. The data will be submitted for presentation at
a future medical meeting.
Epcoritamab is being co-developed by AbbVie and Genmab 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 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, Genmab. "We look
forward to sharing the findings at a future medical meeting."
About the EPCORE™ NHL-1 Trial
EPCORE™ 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, 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 three cohorts of patients with different types of
relapsed/refractory B-NHLs who had limited therapeutic options.
The primary endpoint of the phase 2 expansion part was ORR as
assessed by an IRC. Secondary efficacy endpoints included duration
of response, 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 AbbVie and Genmab as part of the
companies' broad oncology collaboration.
About AbbVie in Oncology
At AbbVie, we are committed
to transforming standards of care for multiple blood cancers while
advancing a dynamic pipeline of investigational therapies across a
range of cancer types. Our dedicated and experienced team joins
forces with innovative partners to accelerate the delivery of
potentially breakthrough medicines. We are evaluating more than 20
investigational medicines in over 300 clinical trials across some
of the world's most widespread and debilitating cancers. As we work
to have a remarkable impact on people's lives, we are committed to
exploring solutions to help patients obtain access to our cancer
medicines. For more information, please visit
http://www.abbvie.com/oncology.
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.
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.
AbbVie Forward-Looking Statements
Some 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.
Genmab Forward-Looking Statements
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® and HexElect®.
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." N
Engl J Med. 2021;384:842-858. DOI: 10.1056/NEJMra2027612
4 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
5 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." J. Immunol. (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." J Cancer
Sci Ther., U.S. National Library of Medicine, Nov. 2015,
www.ncbi.nlm.nih.gov/pmc/articles/PMC4939752/.
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