Genmab to Showcase Data in Various Patient Populations to be
Presented at the American Society of Clinical Oncology (ASCO)
Annual Meeting
Media ReleaseCOPENHAGEN, Denmark; May
23, 2024
- Six oral and poster presentations will highlight
breadth of clinical program and potential utility of
epcoritamab-bysp in patients with difficult-to-treat lymphomas
across multiple lines of therapy and histologies where high unmet
needs exist
- Results from two studies evaluating tisotumab vedotin
in patients with head and neck squamous cell carcinoma and
recurrent or metastatic cervical cancer accepted for oral and
poster presentations, respectively
- First presentation of Phase 2 study of acasunlimab
(also known as GEN1046/BNT311) in patients with previously treated
metastatic non-small cell lung cancer (mNSCLC)
Genmab A/S (Nasdaq:
GMAB) announced today that
multiple abstracts evaluating epcoritamab, a T-cell engaging
bispecific antibody administered subcutaneously, tisotumab vedotin,
an antibody-drug conjugate (ADC), and acasunlimab (also known as
GEN1046/BNT311), an investigational bispecific antibody, will be
presented at the 2024 American Society of Clinical Oncology (ASCO)
Annual Meeting, being held in Chicago, IL and virtually, May
31-June 2, 2024.
“The data being presented this year at ASCO demonstrate Genmab’s
significant progress towards our mission to develop novel antibody
therapies with the goal of improving the lives of people impacted
by cancer,” said Dr. Judith Klimovsky, Executive Vice President and
Chief Development Officer of Genmab.
Presentations will include data from multiple clinical trials
evaluating the efficacy and safety of epcoritamab in a variety of
treatment settings and patient populations, including a rapid oral
presentation evaluating epcoritamab in combination with rituximab
and lenalidomide (R2) in patients with previously untreated
follicular lymphoma (FL) and a second rapid oral presentation
showcasing results from the pivotal and cycle 1 dose optimization
cohorts of EPCORE NHL-1 evaluating epcoritamab in patients with
relapsed/refractory (R/R) FL.
Data from the Phase 2 innovaTV 207 trial, evaluating tisotumab
vedotin in pretreated patients with relapsed/metastatic head and
neck squamous cell carcinoma will be presented during a rapid oral
session. Additionally, results from the Phase 3 innovaTV 301 trial
evaluating tisotumab vedotin in patients with recurrent or
metastatic cervical cancer with disease progression on or after
chemotherapy will be presented.
Finally, data from the Phase 2 clinical trial evaluating
acasunlimab as monotherapy and in combination with pembrolizumab in
patients with previously treated metastatic non-small cell lung
cancer (mNSCLC) will be presented for the first time during a
poster presentation.
The safety and efficacy of these investigational
medicines have not been established for these uses.
Virtual mid- to late-stage pipeline update at ASCO
2024On Monday, June 3, at 9:00 AM CDT (10:00 AM EDT/4:00
PM CEST), Genmab will host a review of data presented at ASCO from
its mid- to late-stage pipeline. The event will be virtual and
webcast live. Details, including the webcast link and registration
will be available on www.genmab.com. This meeting is not an
official program of the ASCO Annual Meeting.
All abstracts accepted for presentation have been published and
may be accessed online via the ASCO Meeting Library.
Abstracts accepted for presentation at ASCO:
Epcoritamab:
Abstract Number |
Abstract Title |
Type of Presentation |
Date/Time of Presentation |
7014 |
Epcoritamab with rituximab + lenalidomide (R2) in previously
untreated (1L) follicular lymphoma (FL) and epcoritamab maintenance
in FL: EPCORE NHL 2 arms 6 and 7 |
Rapid Oral |
June 2, 4:30-6:00 PM CDT |
7015 |
EPCORE NHL 1 follicular lymphoma (FL) cycle (C) 1 optimization
(OPT) cohort: Expanding the clinical utility of epcoritamab in
relapsed or refractory (R/R) FL |
Rapid Oral |
June 2, 4:30-6:00 PM CDT |
7029 |
Subcutaneous Epcoritamab (SC epcor) administered outpatient (outpt)
for relapsed or refractory (R/R) diffuse large B-cell lymphoma
(DLBCL) and follicular lymphoma (FL): Results from Phase 2 EPCORE
NHL-6 |
Poster |
June 3, 9:00 AM-12:00 PM CDT |
7032 |
Epcoritamab + R-DHAX/C in transplant-eligible patients (pts) with
high-risk relapsed or refractory (R/R) diffuse large B-cell
lymphoma (DLBCL) |
Poster |
June 3, 9:00 AM-12:00 PM CDT |
7037 |
Subcutaneous epcoritamab + GemOx in patients with relapsed or
refractory DLBCL: Updated results from EPCORE NHL-2 |
Poster |
June 3, 9:00 AM-12:00 PM CDT |
7039 |
Extended follow-up results beyond 2.5 years from the pivotal NHL-1
EPCORE trial: Subcutaneous epcoritamab monotherapy in patients with
relapsed/refractory large B-cell lymphoma (R/R LBCL) |
Poster |
June 3, 9:00 AM-12:00 PM CDT |
TPS7084 |
EPCORE FL-2: Phase 3 trial of epcoritamab with rituximab and
lenalidomide (R2) vs chemoimmunotherapy or R2 in previously
untreated follicular lymphoma |
Poster |
June 3, 9:00 AM-12:00 PM CDT |
Tisotumab Vedotin:
Abstract Number |
Abstract Title |
Type of Presentation |
Date/Time of Presentation |
6012 |
Tisotumab vedotin in head and neck squamous cell carcinoma: updated
analysis from innovaTV 207 Part C |
Rapid Oral |
June 3, 8:00-9:30 AM CDT |
5531 |
Tisotumab vedotin in 2L/3L recurrent or metastatic cervical cancer:
subsequent therapy data from ENGOT-cx12/GOG-3057/innovaTV 301 |
Poster |
June 3, 9:00 AM-12:00 PM CDT |
Acasunlimab:
Abstract Number |
Abstract Title |
Type of Presentation |
Date/Time of Presentation |
2533 |
Acasunlimab (DuoBody-PD-L1x4-1BB) alone or in combination with
pembrolizumab (pembro) in patients (pts) with previously treated
metastatic non-small cell lung cancer (mNSCLC): initial results of
a randomized, open-label, Phase 2 trial |
Poster |
June 1, 9:00 AM-12:00 PM CDT |
About Epcoritamab Epcoritamab-bysp is an
IgG1-bispecific antibody created using Genmab's proprietary
DuoBody® technology and administered subcutaneously. 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.i Epcoritamab is being co-developed by Genmab and AbbVie as
part of the companies' oncology collaboration.
Epcoritamab has received regulatory approval in certain lymphoma
indications in several territories. Use of epcoritamab in FL is not
approved in the U.S. or in the EU or in any other territory.
Epcoritamab is being co-developed by Genmab and AbbVie 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.
Genmab and AbbVie continue to evaluate the use of epcoritamab as
a monotherapy, and in combination, across lines of therapy in a
range of hematologic malignancies. This includes four ongoing phase
3, open-label, randomized trials including a trial evaluating
epcoritamab as a monotherapy in patients with R/R DLBCL compared to
investigators choice chemotherapy (NCT: 04628494), a trial
evaluating epcoritamab in combination with R-CHOP in adult
participants with newly diagnosed DLBCL (NCT: 05578976), a trial
evaluating epcoritamab in combination with rituximab and
lenalidomide in patients with R/R FL (NCT: 05409066), and a trial
evaluating epcoritamab in combination with rituximab and
lenalidomide (R2) compared to chemotherapy in patients with
previously untreated FL (NCT: 06191744). The safety and efficacy of
epcoritamab has not been established for these investigational
uses.
About Tisotumab VedotinTisotumab vedotin is an
antibody-drug conjugate (ADC) composed of Genmab’s human monoclonal
antibody directed to tissue factor (TF) and Pfizer’s ADC technology
that utilizes a protease-cleavable linker that covalently attaches
the microtubule-disrupting agent monomethyl auristatin E (MMAE) to
the antibody. Nonclinical data suggest that the anticancer activity
of tisotumab vedotin is due to the binding of the ADC to
TF-expressing cancer cells, followed by internalization of the
ADC-TF complex, and release of MMAE via proteolytic cleavage. MMAE
disrupts the microtubule network of actively dividing cells,
leading to cell cycle arrest and apoptotic cell death. In vitro,
tisotumab vedotin also mediates antibody-dependent cellular
phagocytosis and antibody-dependent cellular cytotoxicity.
Tisotumab vedotin is co-owned by Genmab and Pfizer, under an
agreement in which the companies share costs and profits for the
product on a 50:50 basis.
Tisotumab vedotin has received full approval by the U.S. FDA for
the treatment of adult patients with recurrent or metastatic
cervical cancer (r/mCC) with disease progression on or after
chemotherapy. Tisotumab vedotin in HNSCC is not approved in any
country, including the U.S. and the EU.
About Acasunlimab (GEN1046/BNT311)Acasunlimab
(GEN1046/BNT311) is an investigational PD-L1x4-1BB bispecific
antibody fusing Genmab's proprietary DuoBody® technology platform
and BioNTech’s proprietary immunomodulatory antibodies. Acasunlimab
is designed to elicit an antitumor response via conditional
activation of 4-1BB on T cells and natural killer (NK) cells, which
is strictly dependent on simultaneous binding of the PD-L1
arm.Acasunlimab is being developed in collaboration with BioNTech
SE under a license and collaboration agreement and is currently in
Phase 2 of development.
Please visit www.clinicaltrials.gov for more information about
Genmab’s clinical trials.
About Genmab Genmab is an international
biotechnology company with a core purpose of guiding its
unstoppable team to strive toward improving the lives of patients
with innovative and differentiated antibody therapeutics. For 25
years, its passionate, innovative and collaborative team has
invented next-generation antibody technology platforms and
leveraged translational, quantitative and data sciences, resulting
in a proprietary pipeline including bispecific T-cell engagers,
antibody-drug conjugates, next-generation immune checkpoint
modulators and effector function-enhanced antibodies. By 2030,
Genmab’s vision is to transform the lives of people with cancer and
other serious diseases with knock-your-socks-off (KYSO®) antibody
medicines. Established in 1999, Genmab is
headquartered in Copenhagen, Denmark, with international presence
across North America, Europe and Asia Pacific. For more
information, please visit Genmab.com and follow us
on LinkedIn and X.
Contact: David
Freundel, Senior Director, Product CommunicationsT: +1 609 430
2481; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45
3377 9558; E: acn@genmab.comThis Media Release 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
Media Release 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®. EPKINLY® and EPCORE®
are owned by AbbVie Biotechnology Ltd.
i 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
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