TIDMGEN
Company Announcement
-- Results from phase 2 clinical trial demonstrated EPKINLY(TM)
(epcoritamab-bysp) delivered 61 percent overall response rate, 38 percent
complete response, and 15.6-month median duration of response in
challenging-to-treat R/R DLBCL patients
-- EPKINLY represents the seventh approved medicine incorporating Genmab
innovation and third created via Genmab's DuoBody(R) technology platform
COPENHAGEN, Denmark; May 19, 2023 --
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Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and
Drug Administration (FDA) has approved EPKINLY(TM)
(epcoritamab-bysp) as the first and only T-cell engaging bispecific
antibody for the treatment of adult patients with relapsed or
refractory (R/R) diffuse large B-cell lymphoma (DLBCL), not
otherwise specified (NOS), including DLBCL arising from indolent
lymphoma, and high-grade B--cell lymphoma, after two or more lines
of systemic therapy. EPKINLY was approved under accelerated
approval based on response rate and durability of response.
Continued approval for this indication is contingent upon
verification and description of clinical benefit in a confirmatory
trial(s). EPKINLY is being co-developed and co-commercialized by
Genmab and AbbVie (NYSE: ABBV) as part of the companies' oncology
collaboration.
"The approval of EPKINLY in the U.S. is an incredibly important
milestone for patients with relapsed or refractory DLBCL, who are
in need of a new, innovative treatment option administered
subcutaneously," said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. "As the first and only bispecific antibody
approved in the U.S. to treat relapsed or refractory DLBCL, and the
third approved medicine developed using Genmab's DuoBody
technology, EPKINLY is a testament to our dedication to turn novel
science into medicine and develop innovative and differentiated
antibody therapeutics with the goal of improving the lives of
patients. Together with AbbVie, we are committed to further
evaluating and developing epcoritamab as a potential future core
therapy across B-cell malignancies."
EPKINLY features a dual-targeted approach continuously binding
to T-cells and CD20+ lymphoma B-cells. In the pivotal Phase 2
clinical study, subcutaneous EPKINLY monotherapy demonstrated
responses in challenging-to-treat, relapsed or refractory DLBCL
patients who have received at least two prior treatments. An
overall response (complete or partial response) was seen in 61
percent (90/148 [95 percent confidence interval (CI): 52.5-68.7])
of patients and 38 percent (56/148 [95 percent CI: 30.0-46.2])
achieved complete remission. The median duration of response was
15.6 months (95 percent CI: 9.7-Not reached). EPKINLY can cause
serious side effects, including cytokine release syndrome (CRS),
immune effector cell-associated neurotoxicity syndrome (ICANS),
infections, and cytopenias. Please see additional Important Safety
Information, including Important Warnings on CRS and ICANS,
below.
"Patients with DLBCL who relapse or are refractory to currently
available therapies have limited options. Generally, the prognosis
for these patients is poor and management of this aggressive
disease can be challenging," said Tycel
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Phillips
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, M.D., City of Hope Associate Professor, Division of Lymphoma,
Department of Hematology & Hematopoietic Cell Transplantation.
"Epcoritamab is a subcutaneous bispecific antibody that offers an
additional treatment option for this patient population. With this
approval, patients who are in need of additional therapy may have
the opportunity to receive epcoritamab after failure to respond or
relapse after two or more prior systemic therapies."
DLBCL is a fast-growing type of B-cell non-Hodgkin's lymphoma
(B-NHL), a cancer that develops in the lymphatic system and affects
B-cell lymphocytes, a type of white blood cell. For many people
living with DLBCL, their cancer either relapses, which means it may
return after treatment, or becomes refractory, meaning it does not
respond to treatment. Although new therapies have become available,
treatment management can remain a challenge.(i) (,) (ii)
"Despite recent advances in treating advanced DLBCL, due to the
aggressive nature and complexity of the disease, there remains a
need for new options that can provide remission, are tolerable, and
can be administered upon relapse. The approval of EPKINLY brings a
new option -- and with it -- new hope to patients and the greater
lymphoma community," said Meghan Gutierrez, Chief Executive
Officer, Lymphoma Research Foundation.
About the Phase 1/2 EPCORE NHL-1 trial
In the expansion cohort of the trial, 157 patients with large
B-cell lymphoma (LBCL) were enrolled. Among them, 148 patients with
DLBCL or high-grade B-cell lymphoma were enrolled, 89 percent of
which were diagnosed with DLBCL NOS, including 28 percent with
DLBCL transformed from indolent lymphoma, and 14 percent with
high-grade B-cell lymphoma (HGBCL). The median number of prior
therapies was three (range: 2 to 11), with 29 percent receiving two
prior therapies, 32 percent receiving three prior therapies, and 39
percent receiving four or more prior therapies. Eighteen percent
had prior autologous hematopoietic stem cell transplantation
(HSCT), and 39 percent had prior chimeric antigen receptor (CAR)
T-cell therapy. Eighty-two percent of patients had disease
refractory to last therapy and 29 percent of patients were
refractory to CAR T-cell therapy.
The prescribing information has a Boxed Warning for serious or
life-threatening cytokine release syndrome (CRS) and
life-threatening or fatal immune effector cell-associated
neurotoxicity syndrome (ICANS). Warnings and precautions include
infections and cytopenias. The majority of treatment-emergent
adverse events (TEAEs) occurred during the first 12 weeks of
treatment and resolved. The most common (>= 20 percent) adverse
reactions were CRS, injection site reactions, fatigue,
musculoskeletal pain, pyrexia, abdominal pain, nausea, and
diarrhea. The most common Grade 3 to 4 laboratory abnormalities
(>=10 percent) were decreased lymphocyte count, decreased
neutrophil count, decreased white blood cell count, decreased
hemoglobin, and decreased platelets.
Helping Patients Access Care
Genmab strives to positively impact the lives of patients when
our medicines reach the people who need them. We understand the
impact that cancer can have, and so we empower patients and their
care partners to take ownership of their treatment journey,
offering support every step of the way. MyNavCare(TM) Patient
Support by Genmab offers resources and services, from financial
information to ongoing support, to help eligible patients access
their Genmab medication. MyNavCare provides helpful information for
patients, care partners and the healthcare providers who serve
those patients throughout their treatment journey. MyNavCare is
available now to patients who have been prescribed EPKINLY.
Patients, care partners and healthcare providers interested in
learning more about MyNavCare can visit www.MyNavCare.com or call
1-866-NAV-CAR1 (1-866-628-2271).
About Diffuse Large B-cell Lymphoma (DLBCL)
DLBCL is the most common type of NHL worldwide, accounting for
approximately 30 percent of all NHL cases and comprising an
estimated 30,400 U.S. cases in 2022. DLBCL can arise in lymph nodes
as well as in organs outside of the lymphatic system, occurs more
commonly in the elderly and is slightly more prevalent in men. (i)
(,) (iii)
About EPKINLY(TM) (epcoritamab-bysp)
EPKINLY is an IgG1-bispecific antibody created using Genmab's
proprietary DuoBody(R) 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. EPKINLY is designed to simultaneously bind to CD3 on
T-cells and CD20 on B-cells and induces T-cell mediated killing of
CD20+ cells.(iv) EPKINLY is being co-developed by Genmab and AbbVie
as part of the companies' oncology collaboration.
What is EPKINLY?
EPKINLY is a prescription medicine used to treat adults with
certain types of diffuse large B-cell lymphoma (DLBCL) and
high-grade B-cell lymphoma that has come back (relapsed) or that
did not respond to previous treatment (refractory), and who have
received two or more treatments for their cancer. EPKINLY is
approved in the U.S. based on patient response data. A study is
ongoing to confirm the clinical benefit of EPKINLY. It is not known
if EPKINLY is safe and effective in children.
IMPORTANT SAFETY INFORMATION
Important Warnings--EPKINLY can cause serious side effects,
including:
-- Cytokine release syndrome (CRS). CRS is common during treatment with
EPKINLY and can be serious or life-threatening. Tell your healthcare
provider or get medical help right away if you develop symptoms of CRS,
including fever of 100.4degF (38degC) or higher, dizziness or
lightheadedness, trouble breathing, chills, fast heartbeat, feeling
anxious, headache, confusion, shaking (tremors), or problems with balance
and movement, such as trouble walking.
Due to the risk of CRS, you will receive EPKINLY on a "step-up"
dosing schedule. The step-up dosing schedule is when you receive
smaller "step-up" doses of EPKINLY on day 1 and day 8 of your first
cycle of treatment (cycle 1). You will receive your first full dose
of EPKINLY on day 15 of cycle 1. If your dose of EPKINLY is delayed
for any reason, you may need to repeat the step-up dosing schedule.
Before each dose in cycle 1, you will receive medicines to help
reduce your risk of CRS. Your healthcare provider will decide if
you need to receive medicine to help reduce your risk of CRS with
future cycles.
-- Neurologic problems. EPKINLY can cause serious neurologic problems that
can be life-threatening and lead to death. Neurologic problems may happen
days or weeks after you receive EPKINLY. Your healthcare provider may
refer you to a healthcare provider who specializes in neurologic
problems. Tell your healthcare provider right away if you develop any
symptoms of neurologic problems, including trouble speaking or writing,
confusion and disorientation, drowsiness, tiredness or lack of energy,
muscle weakness, shaking (tremors), seizures, or memory loss.
Due to the risk of CRS and neurologic problems, you should be
hospitalized for 24 hours after receiving your first full dose of
EPKINLY on day 15 of cycle 1. Your healthcare provider will monitor
you for symptoms of CRS and neurologic problems during treatment
with EPKINLY, as well as other side effects, and treat you if
needed. Your healthcare provider may temporarily stop or completely
stop your treatment with EPKINLY if you develop CRS, neurologic
problems, or any other side effects that are severe.
Do not drive or use heavy or potentially dangerous machinery if
you develop dizziness, confusion, tremors, drowsiness, or any other
symptoms that impair consciousness until your symptoms go away.
These may be symptoms of CRS or neurologic problems.
EPKINLY can also cause other serious side effects,
including:
-- Infections. EPKINLY can cause serious infections that may lead to death.
Your healthcare provider will check you for symptoms of infection before
and during treatment. Tell your healthcare provider right away if you
develop any symptoms of infection during treatment, including fever of
100.4degF (38degC) or higher, cough, chest pain, tiredness, shortness of
breath, painful rash, sore throat, pain during urination, or feeling weak
or generally unwell.
-- Low blood cell counts. Low blood cell counts are common during treatment
with EPKINLY and can be serious or severe. Your healthcare provider will
check your blood cell counts during treatment. EPKINLY may cause low
blood cell counts, including low white blood cell counts (neutropenia),
which can increase your risk for infection; low red blood cell counts
(anemia), which can cause tiredness and shortness of breath; and low
platelet counts (thrombocytopenia), which can cause bruising or bleeding
problems.
Your healthcare provider may temporarily stop or completely stop
treatment with EPKINLY if you develop certain side effects.
Before you receive EPKINLY, tell your healthcare provider about
all of your medical conditions, including if you:
-- have an infection.
-- are pregnant or plan to become pregnant. EPKINLY may harm your unborn
baby. Females who are able to become pregnant: Your healthcare provider
should do a pregnancy test before you start treatment with EPKINLY. You
should use effective birth control (contraception) during treatment and
for 4 months after your last dose of EPKINLY. Tell your healthcare
provider if you become pregnant or think that you may be pregnant during
treatment with EPKINLY.
-- are breastfeeding or plan to breastfeed. It is not known if EPKINLY
passes into your breast milk. Do not breastfeed during treatment with
EPKINLY and for 4 months after your last dose of EPKINLY.
Tell your healthcare provider about all of the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
The most common side effects of EPKINLY include CRS, tiredness,
muscle and bone pain, injection site reactions, fever, stomach-area
(abdominal) pain, nausea, and diarrhea.
These are not all the possible side effects of EPKINLY. Call
your doctor for medical advice about side effects.
You are encouraged to report side effects to the FDA at (800)
FDA-1088 or www.fda.gov/medwatch or to Genmab US, Inc. at
1-855-4GENMAB (1-855-443-6622).
Please see the full Prescribing Information
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and Medication Guide
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, including Boxed Warnings.
Continued Development
Genmab and AbbVie are 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 trial evaluating epcoritamab as a
monotherapy in patients with R/R DLBCL (NCT: 04628494), an ongoing
phase 3, open-label, randomized trial evaluating epcoritamab in
combination with in adult participants with newly diagnosed DLBCL
(NCT: 05578976), and a phase 3, open-label clinical trial
evaluating epcoritamab in combination in patients with R/R
follicular lymphoma (FL) (NCT: 05409066).
In October 2022, Genmab announced that AbbVie submitted a
Marketing Authorization Application for epcoritamab for the
treatment of patients with R/R DLBCL after two or more lines of
systemic therapy, which was validated by the European Medicines
Agency. Additionally, in December 2022, Genmab announced that the
company submitted a Japan new drug application to the Ministry of
Health, Labor and Welfare of Japan for epcoritamab for the
treatment of patients with R/R LBCL after two or more lines of
systemic therapy.
About Genmab
Genmab is an international biotechnology company with a core
purpose guiding its unstoppable team to strive towards improving
the lives of patients through innovative and differentiated
antibody therapeutics. For more than 20 years, its passionate,
innovative and collaborative team has invented next-generation
antibody technology platforms and leveraged translational research
and data sciences, which has resulted in a proprietary pipeline
including bispecific T-cell engagers, next-generation immune
checkpoint modulators, effector function enhanced antibodies and
antibody-drug conjugates. To help develop and deliver novel
antibody therapies to patients, Genmab has formed 20+ strategic
partnerships with biotechnology and pharmaceutical companies. 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 locations in Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan. For more information, please visit
Genmab.com
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and follow us on Twitter.com/Genmab
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.
Contact:
Marisol Peron, Senior Vice President, Global Communications and
Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
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Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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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
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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
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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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody
in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in
combination with the HexaBody logo(R) ; DuoHexaBody(R) and
HexElect(R) . EPKINLY(TM) is owned by AbbVie Biotechnology Ltd.
(i) Sehn LH, Salles G. N Engl J Med. 2021;384:842-858.
(ii) Crump M, Neelapu SS, Farooq U, et al. Blood.
2017;130(16):1800-1808.
(iii) Kanas G, Ge W, Quek RGW, et al. Leukemia & Lymphoma.
2022;63(1):54-63.
(iv) 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
Company Announcement no. 27
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 190523_CA27_EPKINLY FDA Approval
https://ml-eu.globenewswire.com/Resource/Download/9f0ae4b6-37ce-4210-86f3-28f9b350b171
(END) Dow Jones Newswires
May 19, 2023 12:33 ET (16:33 GMT)
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