TIDMGEN
Company Announcement
-- TEPKINLY(R) (epcoritamab) is the first and only subcutaneous bispecific
antibody approved as a monotherapy for adult patients with relapsed or
refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more
lines of systemic therapy
-- Conditional marketing authorization approval from the European Commission
is supported by data from the pivotal phase 1/2 EPCORE(TM) NHL-1 clinical
trial, which demonstrated 62 percent overall response rate, 39 percent
complete response, and 15.5-month median duration of response
in challenging-to-treat R/R DLBCL patients
-- Epcoritamab represents the eighth approved medicine incorporating
Genmab innovation and fourth created via Genmab's DuoBody(R) technology
platform
COPENHAGEN, Denmark; September 25, 2023 --
https://www.globenewswire.com/Tracker?data=rOTeIgEU_idM5C2KWVaCzMY2FPnP9iPV2WOl5HtpzU9DAfF-A0pmAd4c6xf1AxhIW1MwfxOk1NCqdVA9x2ffAQ==
Genmab A/S (Nasdaq: GMAB) announced today that the European
Commission (EC) has granted conditional marketing authorization for
TEPKINLY(R) (epcoritamab) as a monotherapy for the treatment of
adult patients with relapsed or refractory (R/R) diffuse large
B-cell lymphoma (DLBCL) after two or more lines of systemic
therapy. TEPKINLY is the first and only subcutaneous T-cell
engaging bispecific antibody approved for the treatment of this
patient population in the European Union (EU), as well as
Liechtenstein, Norway and Iceland.
DLBCL is the most common type of B-cell non-Hodgkin's lymphoma
worldwide. While patients may have access to chemoimmunotherapy
regimens to treat their disease, they face limited treatment
options, with few readily available, off-the-shelf medicines,
especially for those whose disease has relapsed or become
refractory to prior treatments.(i)
"With TEPKINLY, people in Europe living with relapsed or
refractory diffuse large B-cell lymphoma who are in need of
additional treatment options now have a readily available,
innovative therapeutic option for this aggressive cancer," said Jan
van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Today's
approval underscores our commitment to bringing our bispecific
antibody to more patients worldwide. We're excited to continue
working with our partner AbbVie to further explore epcoritamab as
potential core therapy across B-cell malignancies."
This conditional approval is supported by data from the pivotal
EPCORE(TM) NHL-1 phase 1/2 open-label, multi-cohort, multi-center,
single-arm trial evaluating the preliminary efficacy and safety of
TEPKINLY in patients with R/R large B-cell lymphoma (LBCL),
including its subtype DLBCL. In this study, DLBCL patients treated
with TEPKINLY (n=139) achieved an overall response rate of 62
percent (n=86) and a complete response rate of 39 percent (n=54),
with a median duration of response of 15.5 months (range: 9.7, not
reached).
Results from the trial showed that TEPKINLY demonstrated a
manageable safety profile across the LBCL patient cohort (n=167),
which included the DLBCL patient population. The most common
adverse reactions (>= 20 percent) were cytokine release
syndrome, fatigue, neutropenia, injection site reaction,
musculoskeletal pain, abdominal pain, pyrexia, nausea and
diarrhea.
"Relapsed or refractory DLBCL is an aggressive cancer and
patients can face a difficult and emotional treatment journey. At
this point in the journey, a patient may have had multiple lines of
therapy and will already have experienced relapse," said Anna
Sureda, M.D., Ph.D., head of clinical hematology department,
Institut Català d'Oncologia -- L'Hospitalet, Barcelona, Spain.
"This European Commission approval represents an important moment
for the DLBCL patient community and brings with it a potential
opportunity for effective disease management for a condition with
limited available treatment options."
Conditional marketing authorization is granted to medicines that
address an unmet medical need, where the benefit of its immediate
availability to patients outweighs the risk of limited data
availability, and where confirmatory comprehensive data will need
to be provided subsequently to maintain the marketing
authorization.(ii)
Epcoritamab is being co-developed by AbbVie and Genmab 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. AbbVie will
continue to pursue regulatory submissions for epcoritamab across
international markets throughout the year.
About the EPCORE(TM) NHL-1 Trial
EPCORE(TM) NHL-1 is an open-label, multi-center preliminary
efficacy and safety trial of epcoritamabthat 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 non-Hodgkin's lymphoma (NHL),
including large B-cell lymphoma (LBCL) and diffuse large B-cell
lymphoma (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 efficacy and safety of epcoritamab in three cohorts of
patients with different types of relapsed or refractory (R/R)
B-cell NHLs who had limited therapeutic options.(ii) (i)
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.
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. More information can be found
on www.clinicaltrials.gov.
About TEPKINLY (epcoritamab)
Epcoritamab is an IgG1-bispecific antibody created using
Genmab's proprietary DuoBody(R) technology. 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.(v) CD20
is expressed on B-cells and is a clinically validated therapeutic
target in many B-cell malignancies, including DLBCL, follicular
lymphoma, mantle cell lymphoma and chronic lymphocytic
leukemia.(vi) (,) (vii)
Epcoritamab-bysp (EPKINLY(TM) ) was approved under accelerated
approval in the United States in May 2023. Continued approval is
contingent upon verification and description of clinical benefit in
a confirmatory trial(s). For more information, please see the Full
Prescribing Information
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and Medication Guide
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, including Important Warnings.
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.
EU Indications and Important Safety Information about
Tepkinly(R) q (epcoritamab)
Indications
Tepkinly (epcoritamab) as monotherapy is indicated for the
treatment of adult patients with relapsed or refractory diffuse
large B-cell lymphoma (DLBCL) after two or more lines of systemic
therapy.
Important Safety Information
Contraindications
Hypersensitivity to the active substance or to any of the
excipients.
Special warnings and precautions for use
Cytokine release syndrome (CRS)
CRS, which may be life-threatening or fatal, occurred in
patients receiving Tepkinly. The most common signs and symptoms of
CRS include pyrexia, hypotension and hypoxia. Other signs and
symptoms of CRS in more than two patients include chills,
tachycardia, headache and dyspnoea.
Most CRS events occurred in Cycle 1 and were associated with the
first full dose of Tepkinly. Administer prophylactic
corticosteroids to mitigate the risk of CRS. Patients should be
monitored for signs and symptoms of CRS following Tepkinly
administration. Patients should be hospitalised for 24 hours after
administration of the Cycle 1 Day 15 dose of 48 mg to monitor for
signs and symptoms of CRS. At the first signs or symptoms of CRS,
institute treatment of supportive care with tocilizumab and/or
corticosteroids as appropriate. Patients should be counselled on
the signs and symptoms associated with CRS and patients should be
instructed to contact their healthcare professional and seek
immediate medical attention should signs or symptoms occur at any
time. Management of CRS may require either temporary delay or
discontinuation of Tepkinly based on the severity of CRS.
Immune effector cell-associated neurotoxicity syndrome
(ICANS)
ICANS, including a fatal event, have occurred in patients
receiving Tepkinly. ICANS may manifest as aphasia, altered level of
consciousness, impairment of cognitive skills, motor weakness,
seizures, and cerebral oedema. The majority of cases of ICANS
occurred within Cycle 1 of Tepkinly treatment, however some
occurred with delayed onset. Patients should be monitored for signs
and symptoms of ICANS following Tepkinly administration. Patients
should be hospitalised for 24 hours after administration of the
Cycle 1 Day 15 dose of 48 mg to monitor for signs and symptoms of
ICANS. At the first signs or symptoms of ICANS treatment with
corticosteroids and non-sedating-anti-seizure medicinal products
should be instituted as appropriate. Patients should be counselled
on the signs and symptoms of ICANS and that the onset of events may
be delayed. Patients should be instructed to contact their
healthcare professional and seek immediate medical attention should
signs or symptoms occur at any time. Tepkinly should be delayed or
discontinued as recommended.
Serious infections
Treatment with Tepkinly may lead to an increased risk of
infections. Serious or fatal infections were observed in patients
treated with Tepkinly in clinical studies. Administration of
Tepkinly should be avoided in patients with clinically significant
active systemic infections. As appropriate, prophylactic
antimicrobials should be administered prior to and during treatment
with Tepkinly. Patients should be monitored for signs and symptoms
of infection, before and after Tepkinly administration, and treated
appropriately. In the event of febrile neutropenia, patients should
be evaluated for infection and managed with antibiotics, fluids and
other supportive care, according to local guidelines.
Tumour Lysis Syndrome (TLS)
TLS has been reported in patients receiving Tepkinly. Patients
at an increased risk for TLS are recommended to receive hydration
and prophylactic treatment with a uric acid lowering agent.
Patients should be monitored for signs or symptoms of TLS,
especially patients with high tumour burden or rapidly
proliferative tumours, and patients with reduced renal function.
Patients should be monitored for blood chemistries and
abnormalities should be managed promptly.
Tumour flare
Tumour flare has been reported in patients treated with
Tepkinly. Manifestations could include localized pain and swelling.
Consistent with the mechanism of action of Tepkinly, tumour flare
is likely due to the influx of T-cells into tumour sites following
Tepkinly administration. There are no specific risk factors for
tumour flare that have been identified; however, there is a
heightened risk of compromise and morbidity due to mass effect
secondary to tumour flare in patients with bulky tumours located in
close proximity to airways and/or a vital organ. Patients treated
with Tepkinly should be monitored and evaluated for tumour flare at
critical anatomical sites.
CD20-negative disease
There are limited data available on patients with CD20-negative
DLBCL treated with Tepkinly, and it is possible that patients with
CD20-negative DLBCL may have less benefit compared to patients with
CD20-positive DLBCL. The potential risks and benefits associated
with treatment of patients with CD20-negative DLBCL with Tepkinly
should be considered.
Immunisation
Live and/or live-attenuated vaccines should not be given during
Tepkinly therapy. Studies have not been conducted in patients who
received live vaccines.
Fertility, pregnancy and lactation
Tepkinly is not recommended during pregnancy and in women of
childbearing potential not using contraception.
Effects on ability to drive and use machines
Tepkinly has minor influence on the ability to drive and use
machines. Due to the potential for ICANS, patients should be
advised to exercise caution while (or avoid if symptomatic)
driving, cycling or using heavy or potentially dangerous
machines.
Undesirable effects
Summary of the safety profile
The most common adverse reactions (>= 20%) were CRS, fatigue,
neutropenia, injection site reactions, musculoskeletal pain,
abdominal pain, pyrexia, nausea, and diarrhoea.
Serious adverse reactions occurred in 52% of patients. The most
frequent serious adverse reaction (>= 10%) was cytokine release
syndrome (31%). Seven patients (4.2%) experienced a fatal adverse
reaction (pneumonia in 3 (1.8%) patients, viral infection in 3
(1.8%) patients and ICANS in 1 (0.6%) patient). Adverse reactions
that led to discontinuation occurred in 6.6% of patients.
Discontinuation of Tepkinly due to pneumonia occurred in 6 (3.6%)
patients, viral infection in 3 (1.8%) patients, and CRS, ICANS, or
fatigue in 1 (0.6%) patient each. Dose delays due to adverse
reactions occurred in 32% of patients. Adverse reactions leading to
dose delays (>= 3%) were viral infections (9.6%), CRS (7.2%),
neutropenia (4.8%), pyrexia (3.0%), and thrombocytopenia
(3.0%).
This is not a complete summary of all safety information.
See Tepkinly(R) full Summary of Product Characteristics (SmPC)
at
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www.ema.europa.eu
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(TM)) 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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and follow us on Twitter.com/Genmab
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.
Contact:
Marisol Peron, Senior Vice President, Global Communications
& Corporate Affairs
T: +1 609 524 0065; E: mmp@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 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 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 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(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) ,HexElect(R) and KYSO(TM). EPCORE(TM),
EPKINLY(TM), TEPKINLY(R) and their designs are trademarks of AbbVie
Biotechnology Ltd.
(i) Sehn, Salles. "Diffuse Large B-Cell Lymphoma." N Engl J Med.
2021;384:842-858. DOI: 10.1056/NEJMra2027612.
(ii) European Medicines Agency. Conditional Marketing
Authorisation.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/general/general_content_000925.jsp.
Accessed August 2023.
(iii) First-in-human (FIH) trial in patients with relapsed,
progressive or refractory B-cell lymphoma - clinicaltrials.gov. in.
(n.d.). https://classic.clinicaltrials.gov/ct2/show/NCT03625037.
Accessed July 5, 2023.
(iv) Hutchings M, Mous R, Roost Clausen M, et al. Dose
escalation of subcutaneous epcoritamab in patients with relapsed or
refractory B-cell non-Hodgkin lymphoma: an open-label, phase 1/2
study. The Lancet. Published Online September 8, 2021;volume 398,
Issue 10306, P-1157-1169.
(v) Engelberts 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.
(vi) Rafiq, Butchar, Cheney, 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.
(vii) Singh, Gupta, Almasan. "Development of Novel Anti-Cd20
Monoclonal Antibodies and Modulation in Cd20 Levels on Cell
Surface: Looking to Improve Immunotherapy Response." J Cancer Sci
Ther. 2015;7(11):347-358. DOI: 10.4172/1948-5956.1000373.
Company Announcement no. 41
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Carl Jacobsens Vej 30
2500 Valby
Denmark
Attachment
-- 230925_CA_TEPKINLY EMA Approval
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