- European Medicines Agency (EMA) validates AbbVie's Marketing
Authorization Application; Genmab submits Biologics License
Application to U.S. Food and Drug Administration (FDA)
- The submissions are supported by the EPCORE™ NHL-1
open-label, multi-center Phase 2 trial evaluating the safety and
preliminary efficacy of subcutaneous epcoritamab in adult patients
with relapsed, progressive or refractory CD20+ mature B-cell
non-Hodgkin's lymphoma (NHL)
NORTH
CHICAGO, Ill., Oct. 28,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that the European Medicines Agency (EMA) has validated a
Marketing Authorization Application (MAA) for epcoritamab
(DuoBody®-CD3xCD20), an investigational subcutaneous
bispecific antibody, for the treatment of adult patients with
relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL)
after two or more lines of systemic therapy. Additionally, Genmab
has submitted a Biologics License Application (BLA) to the U.S.
Food and Drug Administration (FDA) for epcoritamab for the
treatment of adult patients with R/R large B-cell lymphoma (LBCL)
after two or more lines of systemic therapy.
The regulatory submissions are supported by previously
announced results from the LBCL cohort of the EPCORE™ NHL-1
open-label, multi-center Phase 2 trial evaluating the safety and
preliminary efficacy of investigational epcoritamab in adult
patients with relapsed, progressive or refractory CD20+ mature
B-cell non-Hodgkin's lymphoma (NHL), including DLBCL.
LBCL and its major subtype, DLBCL, are fast-growing types of
NHL, a cancer that develops in the lymphatic system and affects
B-cell lymphocytes, a type of white blood cell.1 DLBCL
is the most common type of NHL worldwide and accounts for
approximately 30 percent of all NHL cases globally.1
Because NHL affects B-cell lymphocytes, the disease and its
subtypes are classified as B-cell malignancies.
"The regulatory submissions for epcoritamab exemplify our
pursuit to deliver innovative care for people living with large
B-cell lymphoma and diffuse large B-cell lymphoma who have limited
treatment options," said Mohamed
Zaki, M.D., Ph.D., vice president and head, global oncology
development, AbbVie. "This achievement represents an initial step
in our commitment to scientific research and providing an important
treatment option with the potential to become a core therapy for
people living with B-cell malignancies such as LBCL and DLBCL."
Epcoritamab is being co-developed by AbbVie and Genmab 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 R/R DLBCL (NCT:
04628494).
About Diffuse Large B-cell Lymphoma
(DLBCL)
DLBCL is a fast-growing type of non-Hodgkin's
lymphoma (NHL) that affects B-cell lymphocytes, a type of white
blood cell.1 It is the most common type of NHL worldwide
and accounts for approximately 30 percent of all NHL
cases.1 DLBCL can arise in lymph nodes, as well as in
organs outside of the lymphatic system.1 The disease
occurs more commonly in the elderly and is slightly more prevalent
in men.1
About Large B-cell Lymphoma (LBCL)
LBCL is a
fast-growing type of NHL, a cancer that develops in the lymphatic
system and affects B-cell lymphocytes.1 There are an
estimated 150,000 new LBCL cases globally each
year.1
About the EPCORE™ NHL-1 Trial
EPCORE™ NHL-1 is an
open-label, multi-center safety and preliminary efficacy trial of
epcoritamab that includes 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-cell 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 were treated with epcoritamab
to further explore the safety and efficacy of epcoritamab in three
cohorts of patients with different types of relapsed/refractory
B-cell NHLs who had limited therapeutic options.
The primary endpoint of the Phase 2 expansion part was overall
response rate (ORR) as assessed by an independent review committee
(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 toward 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.2 CD20 is expressed on B-cells and is 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.3,4 Epcoritamab is being co-developed by
AbbVie and Genmab as part of the companies' 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
potential 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.
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.
1 Sehn,
Salles. "Diffuse Large B-Cell Lymphoma." N Engl J Med.
2021;384:842-858. DOI: 10.1056/NEJMra2027612.
|
2 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.
|
3 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.
|
4 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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