Media Release
- Phase 1/2 first-in-human (FIH) dose escalation and cohort
expansion trial evaluating safety and preliminary efficacy of
epcoritamab in patients with relapsed/refractory B-cell
non-Hodgkin’s lymphoma (B-NHL) published in The Lancet
- Results also presented during oral session at the 16th
Annual International Conference on Malignant Lymphoma (ICML) and as
a poster at the 2021 American Society of Clinical Oncology (ASCO)
Annual Meeting and the 2021 European Hematology Association (EHA)
Annual Meeting
Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV) 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 (DLCBL) 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) in patients with relapsed/refractory DLCBL 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 DLCBL 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
deeply 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 epcoritamab
in B-cell lymphomas and other hematologic malignancies, and
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, these 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 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.
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 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
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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®.
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 2020 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.
1Hutchings 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. 2Engelbert 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. 3Rafiq, 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/. 4Singh, 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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Genmab Media Contact: Marisol Peron, Senior Vice
President, Global Investor Relations & Communications T: +1 609
524 0065; E: mmp@genmab.com
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