Company Announcement
- Approval based on results from Phase 1/2 EPCORE® NHL-1
study, which demonstrated durable, clinically meaningful treatment
responses in patients with challenging-to-treat R/R FL
- EPKINLY offers an off-the-shelf, T-cell engaging treatment
option that enables treatment across practice settings to address
high clinical need
- EPKINLY is the first and only bispecific antibody approved
in the U.S. to treat both relapsed or refractory (R/R) follicular
lymphoma (FL) and R/R diffuse large B-cell lymphoma (DLBCL), after
two or more lines of systemic therapy
Genmab A/S (Nasdaq: GMAB) today announced that the
U.S. Food and Drug Administration (FDA) has approved EPKINLY®
(epcoritamab-bysp) for the treatment of adults with relapsed or
refractory (R/R) follicular lymphoma (FL) after two or more lines
of systemic therapy. With this approval, EPKINLY is the first and
only T-cell engaging bispecific antibody administered
subcutaneously approved in the U.S. to treat this patient
population. This indication is approved under accelerated approval
based on response rate. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in a confirmatory clinical trial(s).
FL is the second most common form of non-Hodgkin’s lymphoma
(NHL), accounting for 20-30 percent of all NHL cases.i About 15,000
people develop FL each year in the U.S.ii FL is considered
incurable with current standard of care therapies and patients
often relapse.iii,iv With each subsequent line of therapy, patients
receiving currently available treatments may experience shorter
durability of response.v
“Patients with relapsed or refractory follicular lymphoma face
significant treatment challenges, especially in third-line settings
where there is currently no clear standard of care treatment,” said
Jeff Sharman, MD, Disease Chair, Hematology Research, Sarah Cannon
Research Institute (SCRI) at Willamette Valley Cancer Institute in
Eugene, Oregon. “This approval and the durable responses observed
in the follicular lymphoma cohort of the EPCORE NHL-1 clinical
trial, which reflected a real-world patient population, including
patients with difficult-to-treat follicular lymphoma, demonstrate
the potential of EPKINLY for patients who face limited therapeutic
options post-relapse.”
The approval is based on results from the phase 1/2 EPCORE®
NHL-1 clinical trial, which evaluated the safety and preliminary
efficacy of EPKINLY in 127 adult patients with R/R FL who
previously received a median of three lines of therapy and with 70%
having double refractory disease. The results showed an overall
response rate (ORR) of 82% and a complete response (CR) rate of
60%, including 67% of patients achieving minimal residual disease
(MRD) negativity. Additionally, more than half of patients who
responded to treatment in the study remained responsive to
treatment at the time of data analysis (i.e., at a median follow-up
of 14.8 months, median duration of response (DoR) was not reached).
The study included prespecified subgroups representing patients
with challenging-to-treat FL, including patients who were
refractory to both anti-CD20 therapy and an alkylating agent,
patients who were refractory to last prior treatment, and patients
whose disease progressed within two years of first-line
immunochemotherapy (POD24). These results were recently published
in the Lancet Haematology.
Common treatment-emergent adverse events (TEAEs) (≥20%) from the
FL cohort of the trial were injection site reaction cytokine
release syndrome (CRS), COVID-19, fatigue, upper respiratory tract
infection, musculoskeletal pain, rash, diarrhea, fever, cough, and
headache. For patients who received EPKINLY at the recommended 3
step-up dosage schedule, CRS was primarily low grade (40% Grade 1,
9% Grade 2). There were no grade 3 CRS events observed. The
prescribing information has a Boxed Warning for serious or
life-threatening CRS and immune effector cell-associated
neurotoxicity syndrome (ICANS). Warnings and precautions include
infections, cytopenias, and embryo-fetal toxicity. Please see
additional Important Safety Information below.
“With this approval, patients whose follicular lymphoma has
relapsed or is refractory to at least two or more lines of systemic
therapy, now have the option to be treated with EPKINLY, which has
demonstrated durable responses without mandatory hospitalization
using a 3 step-up dosage regimen in this patient population in
clinical trials,” said Jan van de Winkel, Ph.D., Chief Executive
Officer of Genmab. “In just over a year, EPKINLY has received a
second indication in the U.S., making it the first and only
bispecific antibody approved to treat patients with diffuse large
B-cell lymphoma and follicular lymphoma after two or more lines of
systemic therapy. The approved indications, along with the ongoing
clinical development program, underscore the potential of
epcoritamab to become a core therapy across B-cell
malignancies.”
“People living with follicular lymphoma are in need of
additional options when their cancer returns,” said Lee
Greenberger, Ph.D., Chief Scientific Officer at The Leukemia &
Lymphoma Society. “Today’s approval is welcome news for patients,
as it provides another tool in the physician arsenal for this
difficult-to-treat form of cancer.”
NCCN® Clinical Practice Guidelines
The National Comprehensive Cancer Network® (NCCN®) Clinical
Practice Guidelines in Oncology (NCCN Guidelines®) for “B-Cell
Lymphomas” were recently updated (Version 2.2024) to add EPKINLY as
a Category 2A, preferred recommendation for third-line and
subsequent therapy for patients with FL. This recommendation is
based on uniform NCCN consensus that the intervention is
appropriate.vi
About the EPCORE® NHL-1 Trial
EPCORE® NHL-1 is an open-label, multi-center safety and
preliminary efficacy trial of epcoritamab that consists of three
parts: a dose escalation part; an expansion part; and an
optimization part. The trial was designed to evaluate subcutaneous
epcoritamab in patients with relapsed or refractory B-cell
non-Hodgkin’s lymphoma (B-NHL), including FL. In the expansion
part, additional patients were enrolled to further explore the
safety and efficacy of epcoritamab in three cohorts of patients
with different types of relapsed/refractory B-NHLs who have limited
therapeutic options. The expansion part generated pivotal data from
patients with FL and DLBCL. The optimization part evaluated
additional CRS mitigation strategies during cycle 1. The primary
endpoint of the expansion part was overall response rate as
assessed by an Independent Review Committee. Secondary efficacy
endpoints included duration of response, complete response rate,
duration of complete response, progression-free survival, and time
to response as determined by the Lugano criteria. Overall survival,
time to next therapy, and rate of minimal residual disease
negativity were also evaluated as secondary efficacy endpoints. The
primary endpoint of the optimization part was the rate of ≥ Grade 2
CRS events and all grade CRS events from first dose of epcoritamab
through 7 days following administration of the second full dose of
epcoritamab.
About Follicular Lymphoma (FL)
FL is typically an indolent (or slow-growing) form of
non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes.vii
Although FL is an indolent lymphoma, it is considered incurable
with conventional therapy and patients who achieve remission also
often experience relapse.iii,iv,viii Additionally, with each
relapse the remission and time to next treatment is
shorter.ix,x
About EPKINLY® (epcoritamab-bysp)
EPKINLY is a prescription medicine used to treat adults with
certain types of diffuse large B-cell lymphoma (DLBCL), high-grade
B-cell lymphoma, or follicular lymphoma (FL) that has come back or
that did not respond to previous treatment after receiving 2 or
more treatments. EPKINLY is approved based on patient response
data. Studies are ongoing to confirm the clinical benefit of
EPKINLY. It is not known if EPKINLY is safe and effective in
children.
Epcoritamab 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
toward 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.xi
Epcoritamab (approved under the brand name EPKINLY in the U.S.
and Japan, and TEPKINLY in the EU) has received regulatory approval
in certain lymphoma indications in several territories. 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 (NCT04628494), a trial evaluating
epcoritamab in combination with R-CHOP in adult participants with
newly diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab
in combination with rituximab and lenalidomide in patients with R/R
FL (NCT05409066), and a trial evaluating epcoritamab in combination
with rituximab and lenalidomide (R2) compared to chemoimmunotherapy
in patients with previously untreated FL (NCT06191744). The safety
and efficacy of epcoritamab has not been established for these
investigational uses. Please visit www.clinicaltrials.gov for more
information.
EPKINLY® (epcoritamab-bysp) U.S. IMPORTANT SAFETY
INFORMATION
Important Warnings—EPKINLY can cause serious side effects,
including:
- Cytokine release syndrome (CRS), which is common during
treatment with EPKINLY and can be serious or life-threatening. To
help reduce your risk of CRS, you will receive EPKINLY on a step-up
dosing schedule (when you receive 2 or 3 smaller step-up doses of
EPKINLY before your first full dose during your first cycle of
treatment), and you may also receive other medicines before and for
3 days after receiving EPKINLY. If your dose of EPKINLY is delayed
for any reason, you may need to repeat the step-up dosing
schedule.
- Neurologic problems that can be life-threatening and
lead to death. Neurologic problems may happen days or weeks after
you receive EPKINLY.
People with DLBCL or high-grade B-cell lymphoma should be
hospitalized for 24 hours after receiving their first full dose of
EPKINLY on day 15 of cycle 1 due to the risk of CRS and neurologic
problems.
Tell your healthcare provider or get medical help right
away if you develop a fever of 100.4°F (38°C) or higher;
dizziness or lightheadedness; trouble breathing; chills; fast
heartbeat; feeling anxious; headache; confusion; shaking (tremors);
problems with balance and movement, such as trouble walking;
trouble speaking or writing; confusion and disorientation;
drowsiness, tiredness or lack of energy; muscle weakness; seizures;
or memory loss. These may be symptoms of CRS or neurologic
problems. If you have any symptoms that impair consciousness,
do not drive or use heavy machinery or do other dangerous
activities until your symptoms go away.
EPKINLY can cause other serious side effects,
including:
- Infections that may lead to death. Your healthcare
provider will check you for signs and symptoms of infection before
and during treatment and treat you as needed if you develop an
infection. You should receive medicines from your healthcare
provider before you start treatment to help prevent infection. 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, which 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 cells (neutropenia), which can increase your risk for
infection; low red blood cells (anemia), which can cause tiredness
and shortness of breath; and low platelets (thrombocytopenia),
which can cause bruising or bleeding problems.
Your healthcare provider will monitor you for symptoms of CRS,
neurologic problems, infections, and low blood cell counts during
treatment with EPKINLY. 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 your medical conditions, including if you have an
infection, are pregnant or plan to become pregnant, or are
breastfeeding or plan to breastfeed. If you receive EPKINLY while
pregnant, it may harm your unborn baby. If you are a female who
can become pregnant, your healthcare provider should do a
pregnancy test before you start treatment with EPKINLY and 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. Do not breastfeed during
treatment with EPKINLY and for 4 months after your last dose of
EPKINLY.
In DLBCL or high-grade B-cell lymphoma, 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. The most common severe abnormal
laboratory test results include decreased white blood cells,
decreased red blood cells, and decreased platelets.
In follicular lymphoma the most common side effects of
EPKINLY include injection site reactions, CRS, COVID-19,
tiredness, upper respiratory tract infections, muscle and bone
pain, rash, diarrhea, fever, cough, and headache. The most
common severe abnormal laboratory test results include
decreased white blood cells and decreased red blood cells.
These are not all of 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.
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 we offer support throughout the
treatment journey. MyNavCare Patient Support by Genmab™ is
available to patients in the U.S. who have been prescribed EPKINLY.
MyNavCare offers resources and services, from financial
information to ongoing patient 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. 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 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.
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 preclinical 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®; HexaBody®; DuoHexaBody®,
HexElect® and KYSO®. EPCORE®, EPKINLY®, TEPKINLY® and their designs
are trademarks of AbbVie Biotechnology Ltd. NCCN® and The National
Comprehensive Cancer Network® are trademarks of The National
Comprehensive Cancer Network.
i Ma S. Risk factors of follicular lymphoma. Expert Opin Med
Diagn. 2012;6:3232333. doi: 10.1517/17530059.2012.686996.
ii Leukemia & Lymphoma Society.
https://www.lls.org/research/follicular-lymphoma-fl. Accessed March
2024.
iii Link BK, et al. Second-Line and Subsequent Therapy and
Outcomes for Follicular Lymphoma in the United States: Data From
the Observational National LymphoCare Study. Br J Haematol
2019;184(4):660-663.
iv Ren J, et al. Economic Burden and Treatment Patterns for
Patients With Diffuse Large B-Cell Lymphoma and Follicular Lymphoma
in the USA. J Comp Eff Res 2019;8(6):393-402.
v Ghione P, Palomba ML, Ghesquieres H, et al. Treatment patterns
and outcomes in relapsed/refractory follicular lymphoma: results
from the international SCHOLAR-5 study. Haematologica.
2023;108(3):822-832. doi: 10.3324/haematol.2022.281421.
vi National Comprehensive Cancer Network “NCCN Clinical Practice
Guidelines in Oncology (NCCN Guidelines); B-Cell Lymphomas.”
Version 2.2024 published April 30, 2024.
vii Lymphoma Research Foundation official website.
https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed February
2024.
viii Lymphoma Research Foundation official website.
https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/.
Accessed February 2024.
ix Rivas‐Delgado, A., Magnano, L., Moreno‐Velázquez, et al.
Response duration and survival shorten after each relapse in
patients with follicular lymphoma treated in the rituximab era. Br
J Haematol. 2018;184(5):753-759. doi:10.1111/bjh.15708
x Kuruvilla J, Ewara EM, Elia-Pacitti J, et al. Estimating the
Burden of Illness of Relapsed Follicular Lymphoma and Marginal Zone
Lymphoma in Ontario, Canada. Curr Oncol. 2023;30(5):4663-4676.
doi:10.3390/curroncol30050352
xi 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.
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Genmab A/S Marisol Peron, Senior Vice President, Global
Communications & Corporate Affairs T: +1 609 524 0065; E:
mmp@genmab.com Andrew Carlsen, Vice President, Head of Investor
Relations T: +45 3377 9558; E: acn@genmab.com
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