Company Announcement
- The positive CHMP opinion is supported by results from
the EPCORE™ NHL-1 phase
1/2 trial evaluating the preliminary
efficacy and safety of epcoritamab in patients
with non-Hodgkin’s lymphoma (NHL), including
diffuse large B-cell lymphoma (DLBCL)
- DLBCL is an aggressive subtype of NHL and accounts for
approximately 30 percent of all global cases
- If approved, epcoritamab
(TEPKINLY®)
would become the first
and only subcutaneous bispecific antibody conditionally approved as
a monotherapy in the
European Union for the treatment of adult patients
with relapsed or refractory (R/R) DLBCL
after two or more lines of systemic therapy
COPENHAGEN, Denmark; July 21,
2023 – Genmab A/S
(Nasdaq: GMAB) today announced that the European
Medicines Agency’s (EMA) Committee for Medicinal Products for Human
Use (CHMP) has adopted a positive opinion recommending the granting
of conditional marketing authorization of epcoritamab
(TEPKINLY®) 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. The final European Commission decision on the indication
for epcoritamab is anticipated later this year.
“Today’s CHMP opinion is an important step forward in our
mission to bringing innovative, readily available medicines like
epcoritamab to patients in Europe who are in need of alternative
treatment options for relapsed or refractory diffuse large B-cell
lymphoma,” said Jan van de Winkel, Ph.D., Chief Executive Officer
of Genmab. “We look forward to continuing our work with AbbVie to
develop epcoritamab as a potential core therapy across B-cell
malignancies.”
AbbVie’s application for the approval of epcoritamab is
supported by results from the pivotal EPCORE™ NHL-1 phase 1/2
open-label, multi-center trial evaluating the safety and
preliminary efficacy of epcoritamab in patients with relapsed,
progressive or refractory CD20+ mature B-cell NHL, including DLBCL.
The primary endpoint of the study was overall response rate, as
assessed by an independent review committee (63.1 percent). The
most common treatment-emergent adverse event was cytokine release
syndrome.i Updated results were recently presented at multiple
medical congresses.
“Diffuse large B-cell lymphoma is an aggressive and often
treatment-resistant disease with limited therapeutic options for
patients whose disease is refractory or who have experienced
relapse after multiple lines of therapy,” said Catherine
Thieblemont, M.D., Ph.D., head of the hemato-oncology department,
Paris University, Hôpital Saint-Louis
Assistance-Publique-Hopitaux de Paris (APHP) in Paris.
“Subcutaneous epcoritamab could become a promising treatment option
for the DLBCL community, and I look forward to the European
Commission’s final decision.”
DLBCL is an aggressive type of cancer that develops in the
lymphatic system. It is the most common type of B-cell NHL
worldwide and accounts for approximately 30 percent of all global
cases. Because NHL affects B-cell lymphocytes, the disease and its
subtypes, including DLBCL, are classified as B-cell
malignancies.ii
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 EPCORE™
NHL-1 TrialEPCORE™ 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. The most common
treatment-emergent adverse events were cytokine release syndrome
(49.7 percent; grade 1 or 2: 47.1 percent; grade 3: 2.5 percent),
pyrexia (23.6 percent) and fatigue (22.9 percent). Results from the
phase 2 expansion part of the study were published in December
2022.i More information can be found on www.clinicaltrials.gov.
About Epcoritamab Epcoritamab is an
investigational 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.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
The safety and efficacy of epcoritamab remain under evaluation
in the European Union. Epcoritamab-bysp (EPKINLYTM) was recently
approved in the United States and is indicated for the treatment of
adult patients with relapsed or refractory 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).
Epcoritamab is not approved in the European Union. If approved,
epcoritamab will be marketed under the brand name
TEPKINLY® in all EU member states plus
Liechtenstein, Norway and Iceland. AbbVie will continue to pursue
regulatory submissions for epcoritamab across international markets
throughout the year.
EPKINLY™
(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
100.4°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.
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.
Contact: David
Freundel, Senior Director, Product CommunicationsT: +1 609 613
0504; E: dafr@genmab.com
Andrew Carlsen, Vice President, Head of Investor RelationsT: +45
3377 9558; E: acn@genmab.com
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®; DuoBody in combination
with the DuoBody logo®; HexaBody®; HexaBody in combination with the
HexaBody logo®; DuoHexaBody® and HexElect®. EPKINLY™ is owned by
AbbVie Biotechnology Ltd.
i Thieblemont C, Phillips T, Ghesquieres H, et al. Epcoritamab,
a Novel, Subcutaneous CD3xCD20 Bispecific T-Cell–Engaging Antibody,
in Relapsed or Refractory Large B-Cell Lymphoma: Dose Expansion in
a Phase I/II Trial. JCO. Published online December 22,
2022:JCO.22.01725. doi:10.1200/JCO.22.01725.ii Sehn, Salles.
"Diffuse Large B-Cell Lymphoma." N Engl J Med. 2021;384:842-858.
DOI: 10.1056/NEJMra2027612.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. 35 CVR no. 2102 3884 LEI Code
529900MTJPDPE4MHJ122
Genmab A/S Kalvebod Brygge 43 1560 Copenhagen V Denmark
- 190723-ca35-epcoritamab-DLBCL-CHMP Opinion
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