NORTH
CHICAGO, Ill., May 19, 2023
/PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that the U.S.
Food and Drug Administration (FDA) has approved
EPKINLYTM (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
(HGBL), after two or more lines of systemic therapies. EPKINLY
is approved under the FDA's Accelerated Approval program based on
response rate and durability of response. Continued approval for
this indication may be contingent upon verification and description
of clinical benefit in confirmatory trials. EPKINLY is being
co-developed by AbbVie and Genmab as part of the companies'
oncology collaboration.
DLBCL is a type of aggressive, fast-growing non-Hodgkin's
lymphoma (NHL), a cancer that develops in the lymphatic system and
affects B cells, a type of white blood cell. DLBCL is the most
common type of NHL, comprising of an estimated 30,400 U.S. cases in
2022 and 150,000 new cases each year globally. DLBCL patients are
typically treated with chemoimmunotherapy-based regimens. For R/R
patients, several targeted therapies including T-cell mediated
treatments have recently emerged. However, single agent and
ready-available or off-the-shelf treatment options are
limited.1,2,3,4,5
"DLBCL is an aggressive cancer type that can rapidly progress
and resist treatment. The FDA approval of EPKINLY represents a new
treatment mechanism of action for third line DLBCL patients. As a
non-chemotherapy, single-agent treatment for DLBCL patients, we
hope that EPKINLY can effectively treat this aggressive cancer type
and can be used for patient care quickly and in an off the shelf
form for physicians," said Thomas
Hudson, M.D., senior vice president, research and
development, chief scientific officer, AbbVie. "The approval is
just the first step, with our partner Genmab, towards a shared goal
of developing a core therapy for patients with B-cell
malignances."
AbbVie is committed to transforming standards of care across
blood cancers and advancing a dynamic cancer research and treatment
pipeline. EPKINLY marks the third approved blood cancer treatment
available as part of AbbVie's growing oncology portfolio,
as we strive to make a remarkable impact for people living
with cancer.
"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 Philips, 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 systemic therapies."
"The FDA approval of EPKINLY represents a new treatment for
diffuse large B-cell lymphomas among patients who have relapsed or
have refractory disease and are looking for a new medication," said
Meghan Gutierrez, chief executive
officer, Lymphoma Research Foundation.
Highlights of the Phase 1/2 EPCORE™ NHL-1 clinical
trial supporting the approval:
- In the expansion cohort of the EPCORE NHL-1 trial, 148
patients with CD20+ DLBCL were enrolled, 86 percent of which were
diagnosed with DLBCL NOS, including 27 percent with DLBCL
transformed from indolent lymphoma, and 14 percent with HGBL. The
median number of prior therapies was three (range: 2 to 11), with
30 percent receiving two prior therapies, 30 percent receiving
three prior therapies, and 40 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.
- EPKINLY delivered an overall response rate of 61
percent, a complete response rate of 38 percent and
median duration of response of 15.6 months in heavily pretreated
R/R DLBCL patients.
- The prescribing information has a Boxed Warning for serious
or life-threatening cytokine release syndrome (CRS) and immune
effector cell-associated neurotoxicity syndrome (ICANS). Warnings
and precautions include infections, cytopenias, and embryo-fetal
toxicity. The most common (≥ 20 percent) adverse reactions
were CRS, fatigue, musculoskeletal pain, injection site
reactions, pyrexia, abdominal pain, nausea, and diarrhea.
Please see additional Important Safety Information, below.
About EPKINLYTM (epcoritamab-bysp)
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 (HGBL) that has come back (relapsed) or that did not
respond to previous treatment (refractory), and who have received 2
or more treatments for their cancer. EPKINLY is approved 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.
EPKINLY is an IgG1-bispecific antibody created using Genmab's
proprietary DuoBody® technology. Genmab's DuoBody-CD3
technology is designed to direct cytotoxic T cells selectively to
elicit an immune response towards target cell types. It is designed
to simultaneously bind to CD3 on T cells and CD20 on B-cells and
induces T cell mediated killing of CD20+ cells.5,6,7
AbbVie and Genmab are evaluating EPKINLY as a monotherapy, and
in combination, across multiple lines of therapy in a range of
hematologic malignancies. This includes an ongoing Phase 3,
open-label, randomized controlled trial evaluating EPKINLY as a
monotherapy in patients with R/R DLBCL (NCT: 04628494) and two
Phase 3, open-label, randomized controlled trials evaluating
EPKINLY combination regimens in patients with newly diagnosed DLBCL
(NCT: 05660967) and R/R follicular lymphoma (NCT: 05409066). The
companies will share commercial responsibilities in the U.S. and
Japan, with AbbVie responsible for
further global commercialization. AbbVie will continue to
pursue regulatory submissions for epcoritamab across international
markets throughout the year.
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 100.4°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 Medication Guide, including Important Warnings.
About AbbVie in Oncology
At AbbVie, we are committed
to transforming standards of care for multiple blood cancers while
advancing a dynamic pipeline of investigational therapies across a
range of cancer types. Our dedicated and experienced team joins
forces with innovative partners to accelerate the delivery of
potentially breakthrough medicines. We are evaluating more than 20
investigational medicines in over 300 clinical trials across some
of the world's most widespread and debilitating cancers. As we work
to have a remarkable impact on people's lives, we are committed to
exploring solutions to help patients obtain access to our cancer
medicines. For more information, please
visit http://www.abbvie.com/oncology and our Blood
Cancer Press Kit page.
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 and
gastroenterology, in addition to products and services across our
Allergan Aesthetics portfolio. For more information about AbbVie,
please visit us at www.abbvie.com. Follow @abbvie on Twitter,
Facebook, Instagram, YouTube and LinkedIn.
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 and uses of future or conditional verbs,
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 expressed or implied in the forward-looking statements.
Such risks and uncertainties include, but are not limited to,
challenges to intellectual property, competition from other
products, difficulties inherent in the research and development
process, adverse litigation or government action, and changes to
laws and regulations applicable to our industry. 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 2022 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, and specifically
declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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6 Engelberts PJ, Hiemstra IH, de Jong B, 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
7 Rafiq S, Butchar JP, Cheney C, et al. "Comparative
Assessment of Clinically Utilized CD20-Directed Antibodies in
Chronic Lymphocytic Leukemia Cells Reveals Divergent NK Cell,
Monocyte, and Macrophage Properties." J. Immunol.
2013;190(6):2702-2711. DOI: 10.4049/jimmunol.1202588
8 Singh V, Gupta D, Almasan A. "Development of
Novel Anti-Cd20 Monoclonal Antibodies and Modulation in Cd20 Levels
on Cell Surface: Looking to Improve Immunotherapy Response." J
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