Company Announcement
- Results from phase 2 clinical trial
demonstrated EPKINLY™
(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®
technology platform
COPENHAGEN, Denmark;
May 19,
2023 –
Genmab A/S
(Nasdaq:
GMAB) today announced
that the U.S. Food and Drug Administration (FDA) has
approved EPKINLY™
(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 Phillips, 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
trialIn 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 CareGenmab 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™ 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™
(epcoritamab-bysp)
EPKINLY 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. 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 INFORMATIONImportant
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
100.4°F (38°C) 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 100.4°F
(38°C) 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 and Medication
Guide, including Boxed Warnings.
Continued DevelopmentGenmab 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 and follow us on Twitter.com/Genmab.
Contact: Marisol
Peron, Senior Vice President, Global Communications and Corporate
AffairsT: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45
3377 9558; E: acn@genmab.com 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® and HexElect®. EPKINLY™ 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
- 190523_CA27_EPKINLY FDA Approval
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