TIDMGEN
Media Release
-- Subcutaneous EPKINLYTM (epcoritamab) is the first and only bispecific
antibody approved in Japan to treat adult patients with certain types of
relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after two or more
lines of systemic therapy
-- Approval based on results of EPCORETM NHL-3 and EPCORETM NHL-1 clinical
trials, evaluating EPKINLY in patients with certain types of R/R LBCL
-- LBCL is a common form of non-Hodgkin's lymphoma (NHL) and currently has
limited treatment options, particularly in the R/R setting
COPENHAGEN, Denmark; September 25, 2023 --
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Genmab A/S (Nasdaq: GMAB) announced today that the Japan Ministry
of Health, Labour and Welfare has approved EPKINLY(TM)
(epcoritamab) as the first and only T-cell engaging bispecific
antibody treatment in Japan of adult patients with certain types of
relapsed or refractory large B-cell lymphoma (LBCL), including
diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma
(HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and
follicular lymphoma grade 3B (FL3B), after two or more lines of
systemic therapy. Epcoritamab is being co-developed by Genmab and
AbbVie as part of the companies' oncology collaboration.
"Despite recent advances in the treatment of LBCL, the prognosis
for patients with relapsed/refractory LBCL remains generally poor,
and there is a need for additional treatment options for patients
whose condition has worsened after multiple lines of treatment,"
said Koji Izutsu, MD, PhD, principal investigator of the phase 1/2
EPCORE NHL-3 trial in Japan and Head of the Hematology Department,
National Cancer Center Hospital. "In the EPCORE NHL-3 trial,
subcutaneous epcoritamab monotherapy demonstrated responses in a
considerable number of patients with relapsed/refractory DLBCL,
indicating that this approval is of great significance."
The approval of EPKINLY in Japan is based on the results from
two open-label, multi-center studies designed to evaluate the
safety and preliminary efficacy of EPKINLY monotherapy in patients
with R/R LBCL. In the phase 1/2 EPCORE NHL-1 trial, 157 patients
with relapsed or refractory LBCL demonstrated an overall response
rate (ORR) of 63 percent ([95 percent confidence interval (CI):
55.0-70.6]) and a complete response (CR) rate of 39 percent (data
cutoff: January 31, 2022). Of 157 patients treated with EPKINLY,
130 (82.8 percent) experienced treatment related side effects. The
most common side effects (>15 percent) included cytokine release
syndrome (49.7 percent), injection site reactions (19.7 percent),
and neutropenia (17.8 percent).
In the phase 1/2 EPCORE NHL-3 trial, 36 patients with relapsed
or refractory DLBCL after two or more lines of treatment
demonstrated similar results with an ORR of 56 percent ([95 percent
CI: 38.1-72.1]) and a CR rate of 44 percent (data cutoff: January
31, 2022). Of 36 patients treated with EPKINLY, 36 (100 percent)
experienced treatment related side effects. The most common side
effects (>15 percent) included cytokine release syndrome (83.3
percent), injection site reactions (58.3 percent), neutropenia
(30.6 percent), lymphopenia (19.4 percent), decreased appetite
(19.4 percent), thrombocytopenia (19.4 percent), and rash (19.4
percent).
"This approval marks an important milestone for patients in
Japan with relapsed/refractory large B-cell lymphoma who are in
need of alternative therapeutic options and who may now have access
to EPKINLY, the first approved T-cell engaging bispecific
antibody," said Jan van de Winkel, Ph.D., Chief Executive Officer
of Genmab. "We are working closely with AbbVie to deliver EPKINLY
to patients in Japan as quickly as possible and we remain committed
to continue evaluating epcoritamab as a potential core therapy
across B-cell malignancies."
About the EPCORE(TM) NHL-3 Trial
EPCORE(TM) NHL-3 is an open-label, multi-center safety and
preliminary efficacy trial of epcoritamab including a phase 1
first-in-human, dose escalation part; and a phase 2 expansion part.
The trial was designed to evaluate subcutaneous epcoritamab in
Japanese patients with relapsed, progressive or refractory mature
B-NHL, including DLBCL. In the phase 2 expansion part, additional
patients are treated with epcoritamab to further explore the safety
and efficacy of epcoritamab in patients with R/R DLBCL and R/R FL
who had limited therapeutic options.
In the study, 56 percent of the patients had primary refractory
disease and 81 percent of patients were refractory to their last
therapy. The median number of prior therapies was three (range: 2
to 8), with 44 percent of patients receiving two prior therapies,
25 percent receiving three prior therapies, and 31 percent
receiving four or more prior therapies. Nineteen percent had prior
autologous stem cell transplantation (ASCT), no one had prior
chimeric antigen receptor (CAR) T-cell therapy.
About the EPCORE(TM) NHL-1 Trial
EPCORE(TM) NHL-1 is an open-label, multi-center safety and
preliminary efficacy trial of epcoritamab that includes a phase 1
first-in-human, dose escalation part; a phase 2a expansion part;
and a dose optimization part. The trial was designed to evaluate
subcutaneous epcoritamab in patients with relapsed, progressive or
refractory CD20+ mature B-cell NHL, including large B-cell lymphoma
(LBCL) and DLBCL.(iii) Data from the dose escalation part of the
study, which determined the recommended phase 2 dose, were
published in September 2021.(iv) In the phase 2 expansion part,
additional patients were treated with epcoritamab to further
explore the safety and efficacy of epcoritamab in three cohorts of
patients with different types of relapsed/refractory B-cell NHLs
who had limited therapeutic options.(iii)
The primary endpoint of the phase 2 expansion part was overall
response rate as assessed by an independent review committee.
Secondary efficacy endpoints included duration of response,
complete response rate, progression-free survival, overall
survival, time to response, time to next therapy, and rate of
minimal residual disease negativity.
About Large B-cell Lymphoma (LBCL)
LBCL is a type of non-Hodgkin's lymphoma (NHL), a cancer that
develops in the lymphatic system, and includes several disease
types such as DLBCL, HGBCL, and PMBCL, which are classified as
fast-growing, aggressive lymphomas. The total number of patients
with NHL, which accounts for more than 90 percent of malignant
lymphoma in Japan, is estimated to be approximately 124,000, and
DLBCL is reported to account for approximately 30 to 40 percent of
NHL.(i) (,) (ii) (,) (iii)
About Follicular Lymphoma (FL)
FL is the second most frequent B-cell lymphoma after DLBCL, and
accounts for 10 to 20 percent of NHL. Grade 3B disease, which is
reported to account for 5 to 10 percent of FL, is treated according
to aggressive lymphoma.(iv) (,) (v)
About EPKINLY(TM) (epcoritamab)
Epcoritamab is an IgG1-bispecific antibody created using
Genmab's proprietary DuoBody(R) 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.(vi)
Epcoritamab-bysp (EPKINLY(TM) ) was approved in the United
States in May 2023 and is indicated 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 therapy. This indication
is 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).
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 in patients with R/R follicular lymphoma (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(TM) (epcoritamab-bysp) U.S. 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 100.4degF (38degC) 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
100.4degF (38degC) 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
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www.fda.gov/medwatch or to Genmab US, Inc. at 1-855-4GENMAB
(1-855-443-6622).
Please see the
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Full Prescribing Information and
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Medication Guide, including Important Warnings.
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
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Contact:
David Freundel, Senior Director, Global Communications &
Corporate Affairs
T: +1 609 430 2481m; E: dafr@genmab.com
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Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
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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
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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
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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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination
with the Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ;
HexaBody(R) ; DuoHexaBody(R) and HexElect(R) . EPKINLY(TM) is owned
by AbbVie Biotechnology Ltd.
(i) Patient Survey in 2020 (MHLW),
https://www.mhlw.go.jp/toukei/list/10-20.html (as of August 3,
2023)
(ii) Saito et al, Japanese Journal of Clinical Oncology 2020 Jan
24; 50(1), 96-97. DOI: 10.1093/jjco/hyz202
(iii) Ghielmini et al, 2013; Annals of Oncology. 2013
Mar;24(3):561-76. DOI: 10.1093/annonc/mds517
(iv) Practical Guidelines for Hematological Malignancies 2018,
Japanese Society of Hematology
(v) Barraclough et al, British Journal of Haematolgy, 2021 Oct;
195(1):15-24, DOI: 10.1111/bjh.17404
(vi) 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.
Media Release no. 10
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
Attachment
-- 230925_EPKINLY Japan Approval
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September 25, 2023 05:55 ET (09:55 GMT)
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