- Approval based on results from two Phase 1/2 EPCORE®
clinical trials, which demonstrated strong and durable efficacy in
patients with relapsed or refractory (R/R) follicular lymphoma (FL)
who had received two or more lines of systemic therapy
- EPKINLY is the first and only T-cell engaging bispecific
antibody administered subcutaneously approved in Japan to treat
both R/R FL and R/R large B-cell lymphomas, after two or more prior
lines of therapy
- EPKINLY is the only bispecific antibody approved with a dual
indication for the treatment of certain B-cell malignancies in the
United States, European Union and Japan
Genmab A/S (Nasdaq: GMAB) announced today that the
Japan Ministry of Health, Labour and Welfare has approved EPKINLY®
(epcoritamab) for the treatment of patients with relapsed or
refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have
received two or more prior lines of therapy. With this additional
indication, EPKINLY is now the first and only T-cell engaging
bispecific antibody administered subcutaneously to be approved in
Japan to treat both R/R FL and R/R large B-cell lymphomas,
including diffuse large B-cell lymphoma (DLBCL), high-grade B-cell
lymphoma and primary mediastinal large B-cell lymphoma, after two
or more prior lines of therapy.
FL is typically an indolent (or slow growing) form of
non-Hodgkin’s lymphoma (NHL) that arises from B-lymphocytes and is
the second most common form of NHL, accounting for 20-30 percent of
all cases.i There are approximately 19,000 patients currently
living with FL in Japan.ii FL is considered incurable with current
standard of care therapies.iii Patients often relapse and, with
each relapse, the remission and time to next treatment is
shorter.iv Over time, transformation to DLBCL, an aggressive form
of NHL associated with poor survival outcomes, can occur in more
than 25 percent of FL patients.v
“In the treatment of follicular lymphoma, where options become
limited with each relapse, there remains a high unmet need for
third-line and subsequent therapies in the absence of a clear
standard of care,” said Dr. Koji Izutsu, Head of the Department of
Hematology, National Cancer Center Hospital, who served as the
principal investigator of the Japanese Phase 1/2 clinical trial
(EPCORE NHL-3 trial). “The responses and tolerability demonstrated
in this trial support the potential of epcoritamab to become an
important option in future treatment strategies for
relapsed/refractory follicular lymphoma.”
The approval is based on results from the global Phase 1/2
EPCORE NHL-1 and the Japanese Phase 1/2 EPCORE NHL-3 clinical
trials, which were open-label, multicenter studies to evaluate the
safety and efficacy of EPKINLY as a monotherapy in patients with
R/R mature B-cell non-Hodgkin’s lymphoma, including FL. In the
Japanese trial, a 2-step step-up dosing (SUD) regimen was used. In
the global trial, two different dose escalation methods were used –
2-step and 3-step SUD regimens – to mitigate a common adverse
reaction from T-cell engaging cancer treatments known as cytokine
release syndrome (CRS).
EPCORE® NHL-1 Global Clinical Trial Results
Among the 128 evaluable patients with R/R FL in the EPCORE NHL-1
trial, the overall response rate (ORR) and the complete response
(CR) rate were 82 percent (95 percent CI: 74.3-88.3) and 62.5
percent, respectively (data cut-off: April 21, 2023). Ninety-one
patients were evaluable for a minimal residual disease (MRD)
analysis, with 67 percent of patients achieving 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).
Among the patients who received EPKINLY with the 2-step SUD
regimen (n=128), adverse events were observed in 119 patients (93
percent). The most common treatment-emergent adverse events (TEAEs)
(≥20 percent) included CRS (66.4 percent) and injection site
reactions (36.7 percent).
As part of a separate dose-optimization cohort in the trial, a
3-step SUD regimen was evaluated in 86 patients with FL (Grades 1
to 3A). Adverse events were observed in 78 patients (90.7 percent).
The most common TEAEs included CRS (48.8 percent) and injection
site reactions (26.7 percent).
EPCORE® NHL-3 Japanese Clinical Trial Results
Among the 21 evaluable patients with R/R FL in the Japanese
trial, with a median follow up of 21.2 months, the ORR and the CR
rate were 95.2 percent (95 percent CI: 76.2-99.9) and 76.2 percent,
respectively. Additionally, 88.9 percent of patients achieved MRD
negativity (n=18).
Among patients who received EPKINLY with the 2-step SUD regimen,
the most common TEAEs included CRS (90.5 percent), injection site
reactions (71.4 percent), rash (28.6 percent), neutropenia (28.6
percent), increased alanine aminotransferase (23.8 percent) and
increased aspartate aminotransferase (23.8 percent).
“Patients living with relapsed or refractory follicular lymphoma
in Japan deserve options, and we are proud that EPKINLY may help
treat patients as their cancer returns or stops responding to other
therapies,” said Dr. Judith Klimovsky, Executive Vice President and
Chief Development Officer of Genmab. “Over the last year, EPKINLY
has been approved in the U.S., the European Union (as TEPKINLY®)
and Japan. With a dual indication in relapsed or refractory
follicular lymphoma and diffuse large B-cell lymphoma after two or
more prior therapies, we are committed to making epcoritamab
available to patients in need and continuing its broad development
as a potential core therapy across B-cell malignancies.”
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 (ORR) as
assessed by an Independent Review Committee. Secondary efficacy
endpoints included duration of response (DoR), complete response
(CR) rate, duration of complete response (DoCR), progression-free
survival (PFS), and time to response as determined by the Lugano
criteria. Overall survival (OS), time to next therapy, and rate of
minimal residual disease (MRD) 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 the EPCORE® NHL-3 Trial
EPCORE® NHL-3 is an open-label, multi-center safety and efficacy
trial of epcoritamab that consists of a Phase 1 first-in-human dose
escalation part and a Phase 2 expansion part. The Phase 2 expansion
part evaluated subcutaneous administration of epcoritamab in
Japanese patients with relapsed, progressive, or refractory mature
B-cell NHL, including FL. The primary endpoint of the expansion
part was ORR as assessed by IRC, and secondary efficacy endpoints
included DOR, CR rate, DoCR, PFS, and time to response based on the
Lugano criteria.
About EPKINLY® (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.vi
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. Both companies
will pursue additional international regulatory approvals for the
investigational R/R FL indication and additional approvals for the
R/R DLBCL indication.
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 five 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 patients with newly
diagnosed DLBCL (NCT05578976), a trial evaluating epcoritamab in
combination with rituximab and lenalidomide (R2) in patients with
R/R FL (NCT05409066), a trial evaluating epcoritamab in combination
with rituximab and lenalidomide (R2) compared to chemoimmunotherapy
in patients with previously untreated FL (NCT06191744), and a trial
evaluating epcoritamab in combination with R2 compared to
chemotherapy infusion in patients with R/R DLBCL (NCT06508658). 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. INDICATIONS & IMPORTANT
SAFETY INFORMATION
What is EPKINLY?
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.
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 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 of guiding its unstoppable team to strive toward improving
the lives of patients with innovative and differentiated antibody
therapeutics. For more than 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 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 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 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®.
Media Release no. 04 CVR no. 2102 3884 LEI Code
529900MTJPDPE4MHJ122
Genmab A/S Carl Jacobsens Vej 30 2500 Valby Denmark
i Lymphoma Research Foundation official website.
https://lymphoma.org/aboutlymphoma/nhl/fl/. Accessed November 2024.
ii Portal Site of Official Statistics of Japan (e-Stat). Patient
Survey for FY2020.
https://www.e-stat.go.jp/stat-search/files?page=1&stat_infid=000032212145
(as of January 14, 2025). iii 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. iv Rivas-Delgado A, Magnano L,
Moreno-Velázquez M, 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. v Al-Tourah AJ, Gill KK, Chhanabhai M, et
al. Population-based analysis of incidence and outcome of
transformed non-Hodgkin's lymphoma. J Clin Oncol. 2008 Nov
10;26(32):5165-9. doi: 10.1200/JCO.2008.16.0283. Epub 2008 Oct 6.
PMID: 18838711. vi Engelberts PJ, 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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