- The application is supported by data from EPCORE™ NHL-1
Phase 1/2 trial evaluating the safety and preliminary efficacy of
subcutaneous epcoritamab in patients with relapsed, progressive or
refractory CD20+ mature B-cell non-Hodgkin's lymphoma, including
large B-cell lymphoma
- If approved for relapsed/refractory large B-cell lymphoma
after two or more lines of systemic therapy, epcoritamab could
become the first subcutaneous bispecific antibody available for the
treatment of large B-cell lymphoma
NORTH
CHICAGO, Ill., Nov. 21,
2022 /PRNewswire/ -- AbbVie (NYSE: ABBV) today
announced that the U.S. Food and Drug Administration (FDA) has
accepted for priority review the Biologics License Application for
epcoritamab (DuoBody®-CD3xCD20), an investigational
subcutaneous bispecific antibody, for the treatment of adult
patients with relapsed/refractory large B-cell lymphoma (LBCL)
after two or more lines of systemic therapy.
The application is supported by previously announced
results from the LBCL cohort of the EPCORE™ NHL-1 open-label,
multi-center Phase 1/2 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).
"We are committed to the research and development of innovative
therapies to provide important treatment options for people living
with blood cancer such as large B-cell lymphoma, which has limited
treatment options in the relapsed/refractory setting," said
Mohamed Zaki, M.D., Ph.D., vice
president and head, global oncology development, AbbVie. "This
milestone signals an early step in our hope to develop a core
therapy for people living with B-cell malignancies."
Additionally, the European Medicines Agency recently validated a
Marketing Authorization Application for epcoritamab for the
treatment of adult patients with relapsed/refractory diffuse large
B-cell lymphoma (DLBCL) – a major subtype of LBCL – after two or
more lines of systemic therapy.
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. This includes an
ongoing Phase 3, open-label, randomized clinical trial evaluating
epcoritamab as a monotherapy in patients with relapsed/refractory
DLBCL (NCT: 04628494) and a Phase 3, open-label clinical trial
evaluating epcoritamab in combination in patients with
relapsed/refractory follicular lymphoma (NCT: 05409066).
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, a type of white blood
cell.1 There are an estimated 150,000 new LBCL
cases each year globally.1 LBCL includes DLBCL, which is
the most common type of NHL worldwide and accounts for
approximately 30 percent of all NHL cases.1
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-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 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-cell NHLs who had limited therapeutic options.
The primary endpoint of the Phase 2 expansion part was overall
response rate as assessed by an Independent Review Committee.
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.2 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.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
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 and our Blood Cancer Press Kit
page.
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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