NORTH CHICAGO, Ill., and
COPENHAGEN, Denmark, Sept, 9, 2021
/PRNewswire/ -- AbbVie (NYSE: ABBV) and Genmab A/S (Nasdaq:
GMAB) today announced The Lancet published the results of
the dose escalation part of the Phase 1/2 EPCORE™ NHL-1
first-in-human (FIH) dose escalation and cohort expansion clinical
trial evaluating safety and preliminary efficacy of the
investigational therapy epcoritamab (DuoBody®-CD3xCD20) in patients
with relapsed/refractory B-cell non-Hodgkin's lymphoma (B-NHL). The
full manuscript is available on The Lancet's website.
Epcoritamab is being co-developed by Genmab and AbbVie.
The FIH trial was designed to evaluate subcutaneous epcoritamab
in patients with relapsed, progressive, or refractory CD20+ mature
B-NHL, including diffuse large B-cell Lymphoma (DLBCL) and
follicular lymphoma (FL), to determine the maximum tolerated dose
(MTD) and the recommended Phase 2 dose (RP2D). In the dose
escalation phase, patients received subcutaneous epcoritamab (doses
ranged from 0.0128-60mg) for 28 days. The safety, antitumor
activity, and immune biomarkers associated with epcoritamab
treatment were assessed.1
No dose-limiting toxicities were observed during the dose
escalation, and 48mg was identified as the RP2D. Common adverse
events (AEs) were pyrexia (69 percent), primarily associated with
cytokine release syndrome (CRS) (59 percent, all grade 1-2), and
injection site reactions (47 percent, all grade 1). One case of
tumor lysis syndrome (TLS) was observed (1 percent, grade 3). No
grade 3 or above CRS events or discontinuations due to
treatment-related AEs or death were observed.1
Preliminary efficacy results reported in the trial were 88
percent overall response rate (ORR) and 38 percent complete
response (CR) in patients with relapsed/refractory DLBCL who
received the RP2D of 48mg of (n=8) epcoritamab. Patients who were
treated with 12-60mg of epcoritamab (n=22) achieved a 68 percent
ORR and 45 percent CR. Additionally, patients with
relapsed/refractory FL treated with 0.76-48mg of epcoritamab (n=10)
achieved a 90 percent ORR and a 50 percent CR.1
"The publication of these data in The Lancet, coupled
with the presentation of the results at multiple medical
congresses, demonstrate the importance of these early results and
underscore the significant interest in the potential of next
generation antibody therapeutic options for patients diagnosed with
hematologic malignancies, whose current treatments may not be
providing benefit," said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab. "Together
with our partner, AbbVie, we are committed to evaluating the safety
and efficacy of epcoritamab in patients diagnosed with B-cell
Lymphomas and other hematologic malignancies."
"These initial trial results are encouraging, and their
publication in The Lancet speaks to the strong interest from
the clinical community in this important area of study," said
Mohamed Zaki, M.D., Ph.D., vice
president and head, global oncology development, AbbVie. "We look
forward to further study of epcoritamab in B-cell Lymphomas and
other hematologic malignancies, and our continued pursuit of
potential new treatment options for patients."
Results from this trial were also recently presented during an
oral session at the 16th Annual International Conference
on Malignant Lymphoma (ICML), held virtually June 18-22. The abstract is available for
download via the 16-ICML Virtual Platform. Additionally, results
were presented as a poster at the 2021 American Society of Clinical
Oncology (ASCO) Annual Meeting, held virtually, June 4-8, and during the European Hematology
Association (EHA) congress, held virtually, June 9-17. The posters are available for download
via the ASCO Meeting Library and the EHA Open Access
Library.
About the EPCORE™ NHL-1 Trial
The dose escalation part
of the EPCORE NHL-1 Phase 1/2 clinical trial is evaluating
epcoritamab in 68 patients with relapsed, progressive, or
refractory B-cell non-Hodgkin's lymphoma (B-NHL), including DLBCL,
FL, high-grade B-cell lymphoma, primary mediastinal large B-cell
lymphoma, mantle cell lymphoma, small lymphocytic lymphoma and
marginal zone lymphoma. The trial is an open-label, multi-center
safety and preliminary efficacy trial of epcoritamab that consists
of two parts: a Phase 1 first-in-human (FIH), dose escalation part,
and a Phase 2 expansion part. Step-up dosing and standard
prophylaxis were used to mitigate severity of cytokine release
syndrome (CRS). The purpose of the escalation part is to determine
the maximum tolerated dose and the recommended Phase 2 dose (RP2D),
as well as evaluate the safety profile of epcoritamab. In the
expansion part, additional patients will be treated with
epcoritamab with the RP2D to further explore the safety and
efficacy of epcoritamab.
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.2 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.3,4 Epcoritamab is
being co-developed by Genmab and AbbVie as part of the companies'
broad oncology collaboration.
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 patients with
cancer. Founded in 1999, Genmab is the creator of multiple approved
antibody therapeutics that are marketed by its partners. The
company aims to create, develop and commercialize differentiated
therapies by leveraging next-generation antibody technologies,
expertise in antibody biology, translational research and data
sciences and strategic partnerships. To create novel therapies,
Genmab utilizes its next-generation antibody technologies, which
are the result of its collaborative company culture and a deep
passion for innovation. Genmab's proprietary pipeline consists of
modified antibody candidates, including bispecific T-cell engagers
and next-generation immune checkpoint modulators, effector function
enhanced antibodies and antibody-drug conjugates. The company 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.
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, competition from
other products, challenges to intellectual property, difficulties
inherent in the research and development process, adverse
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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 2020 Annual Report on Form
10-K, which has been filed with the Securities and Exchange
Commission. 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®; HexElect®; and
UniBody®.
1 Hutchings M, Mous R, Clausen MR, et al. Dose
escalation of subcutaneous epcoritamab in patients with relapsed or
refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2
study. Lancet 2021; published online Sept 8.
https://doi.org/10.1016/S0140-6736(21)00889-8.
2 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.
3 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/.
4 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/.
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