- FDA grants Priority Review with target action date of June
28, 2024
- Application based on results from Phase 1/2 EPCORE™ NHL-1
trial demonstrating clinically meaningful treatment responses in
difficult-to-treat patients with relapsed or refractory (R/R)
follicular lymphoma (FL)
- sBLA submission demonstrates Genmab’s commitment to
exploring potential utility of epcoritamab across B-cell
malignancies
Genmab A/S (Nasdaq: GMAB) and AbbVie (NYSE: ABBV)
today announced the U.S. Food and Drug Administration (FDA) granted
Priority Review for the supplemental Biologics License Application
(sBLA) for epcoritamab-bysp, a T-cell engaging bispecific antibody
administered subcutaneously, for the treatment of adult patients
with relapsed or refractory (R/R) follicular lymphoma (FL) after
two or more lines of systemic therapy.
The FDA grants Priority Review to investigational therapies
that, if approved, may offer significant improvements in the safety
or effectiveness of the treatment, diagnosis, or prevention of
serious conditions when compared to standard applications. This
designation shortens the review period to six months compared to 10
months for Standard Review.i The FDA has assigned a Prescription
Drug User Fee Act (PDUFA) target action date of June 28, 2024.
“While treatment for patients with relapsed and refractory
follicular lymphoma has progressed, there remains an urgent need
for new treatment options, particularly for patients who are
considered difficult to treat due to relapse following standard
therapies and other poor prognostic factors,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab. “The acceptance
of the epcoritamab application for Priority Review marks an
important milestone toward potentially providing a new treatment
option to patients affected by R/R follicular lymphoma. Together
with AbbVie, we look forward to working with the FDA during the
review and remain committed to developing epcoritamab as a
potential future core therapy for B-cell malignancies.”
The sBLA is based on results from the Phase 1/2 EPCORE™ NHL-1
clinical trial, which demonstrated high overall and complete
responses in patients with R/R FL treated with epcoritamab. Data
from the FL cohort of the trial were presented at the Annual
Meeting and Exposition of the American Society of Hematology (ASH)
in December 2023. The FDA previously granted Breakthrough Therapy
Designation (BTD) to epcoritamab for the treatment of adult
patients with R/R FL after two or more lines of systemic therapy.
The application for BTD included additional data from the dose
optimization part of EPCORE NHL-1.
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.
About the Phase 1/2 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, progressive or refractory CD20+ mature 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 optimization part evaluates the potential
for alternative step-up dosing regimens to help further minimize
Grade 2 cytokine release syndrome (CRS) and mitigate Grade ≥3 CRS.
The primary endpoint of the expansion part was ORR as assessed by
an IRC. 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.ii FL is the second most common form
of NHL overall, accounting for 20-30 percent of all NHL cases, and
represents 10-20 percent of all lymphomas in the western
world.iii,iv Although FL is an indolent lymphoma, it is considered
incurable with conventional therapy and patients who achieve
remission also often experience relapse.v,vi,vii Additionally, with
each relapse the remission and time to next treatment is
shorterviii, adding increased cost to the health system and
negatively impacting the patient's quality of life.ix
About Epcoritamab 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.x
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. 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 three ongoing
phase 3, open-label, randomized trials including a trial evaluating
epcoritamab as a monotherapy in patients with R/R DLBCL (NCT:
04628494) compared to investigators choice chemotherapy, a phase 3
trial evaluating epcoritamab in combination with R-CHOP in adult
participants with newly diagnosed DLBCL (NCT: 05578976), and a
phase 3, open-label clinical trial evaluating epcoritamab in
combination with rituximab and lenalidomide in patients with R/R FL
(NCT: 05409066). Epcoritamab is not approved to treat newly
diagnosed patients with DLBCL or FL. The safety and efficacy of
epcoritamab has not been established for these investigational
uses. Please visit clinicaltrials.gov for more information.
EPKINLY® (epcoritamab-bysp) U.S. IMPORTANT
SAFETY INFORMATION
Use
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 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.
IMPORTANT SAFETY IMPORTANT
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 the Full Prescribing Information and Medication
Guide, including Important Warnings.
Globally, prescribing information varies; refer to the
individual country product label for complete information.
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.
This 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®; HexaBody®; DuoHexaBody®,
HexElect® and KYSO®. EPCORE™, EPKINLY®, TEPKINLY® and their designs
are trademarks of AbbVie Biotechnology Ltd.
________________________ i U.S. Food and Drug Administration
official website.
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review.
Accessed February 2024. ii Lymphoma Research Foundation
official website. https://lymphoma.org/aboutlymphoma/nhl/fl/.
Accessed February 2024. iii Ma S. Risk factors of follicular
lymphoma. Expert Opin Med Diagn. 2012;6:3232333. doi:
10.1517/17530059.2012.686996. iv Luminari S, Bellei M,
Biasoli I, Federico M. Follicular lymphoma—treatment and prognostic
factors. Rev Bras Hematol Hemoter. 2012;34:54-59. doi:
10.5581/1516-8484.20120015. v Link BK, Day BM, Zhou Z, 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. doi:
10.1111/bjh.15149. vi Ren J, Asche CV, Shou Y, Galaznik A.
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. doi: 10.2217/cer-2018-0094. vii
Lymphoma Research Foundation official website.
https://lymphoma.org/understanding-lymphoma/aboutlymphoma/nhl/follicular-lymphoma/relapsedfl/.
Accessed February 2024. viii 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 ix 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 x
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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David Freundel, Senior Director, Global Communications &
Corporate Affairs T: +1 609 430 2481m; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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