Company Announcement
- DARZALEX® approved in Europe in combination with
lenalidomide and dexamethasone as treatment for adult patients with
newly diagnosed multiple myeloma who are ineligible for autologous
stem cell transplant
- Approval follows positive opinion by European Committee
for Medicinal Products for Human Use (CHMP) in
October
- Approval based on data from Phase III MAIA
study
Copenhagen, Denmark; November 19, 2019 –
Genmab A/S (Nasdaq: GMAB) announced today that the European
Commission (EC) has granted marketing authorization for DARZALEX®
(daratumumab) in combination with lenalidomide and dexamethasone
(Rd) as treatment for adult patients with newly diagnosed multiple
myeloma who are ineligible for autologous stem cell transplant
(ASCT). The EC approval follows a positive opinion issued
for DARZALEX by the CHMP of the European Medicines Agency (EMA) in
October 2019. In August 2012, Genmab granted Janssen Biotech, Inc.
(Janssen) an exclusive worldwide license to develop, manufacture
and commercialize daratumumab.
“We are pleased that with this approval, patients in the
European Union newly diagnosed with multiple myeloma who are not
candidates for transplant will now have two potential options for
treatment with DARZALEX containing regimens. We look forward to
seeing the combination therapy of DARZALEX with lenalidomide and
dexamethasone launched in Europe,” said Jan van de Winkel, Ph.D.,
Chief Executive Officer of Genmab.
The approval was based on data from the Phase III MAIA (MMY3008)
study of daratumumab in combination with Rd as treatment for
patients with newly diagnosed multiple myeloma, who are not
candidates for high dose chemotherapy and ASCT. Data from this
study was published in The New England Journal of Medicine and was
presented as a Late-Breaking Abstract at the 2018 American Society
of Hematology (ASH) Annual Meeting in December 2018.
About the MAIA (MMY3008) studyThe Phase III
study (NCT02252172) is a randomized, open-label, multicenter study
that includes 737 newly diagnosed patients with multiple myeloma
who are not candidates for high dose chemotherapy and ASCT.
Patients were randomized to receive either treatment with
daratumumab in combination with lenalidomide (an immunomodulatory
drug) and dexamethasone (a corticosteroid) or treatment with
lenalidomide and dexamethasone alone. In the daratumumab treatment
arm, patients received 16 milligrams per kilogram (mg/kg) weekly
for the first 8 weeks (Cycles 1 and 2), every other week for 16
weeks (Cycles 3 to 6) and then every 4 weeks (Cycle 7 and beyond)
until progression of disease or unacceptable toxicity. Lenalidomide
is administered at 25 mg orally on days 1 through 21 of each 28-day
cycle, and dexamethasone is administered at 40 mg once a week for
both treatment arms. Participants in both treatment arms will
continue Rd until disease progression or unacceptable toxicity. The
primary endpoint of the study is progression free survival.
About multiple myelomaMultiple myeloma is an
incurable blood cancer that starts in the bone marrow and is
characterized by an excess proliferation of plasma cells.1
Approximately 16,830 new patients were expected to be diagnosed
with multiple myeloma and approximately 10,480 people were expected
to die from the disease in the Western Europe in 2018.2 Globally,
it was estimated that 160,000 people were diagnosed and 106,000
died from the disease in 2018.3 While some patients with
multiple myeloma have no symptoms at all, most patients are
diagnosed due to symptoms which can include bone problems, low
blood counts, calcium elevation, kidney problems or
infections.4
About DARZALEX®
(daratumumab)DARZALEX® (daratumumab) intravenous
infusion is indicated for the treatment of adult patients in the
United States: in combination with bortezomib, thalidomide and
dexamethasone as treatment for patients newly diagnosed with
multiple myeloma who are eligible for autologous stem cell
transplant; in combination with lenalidomide and dexamethasone for
the treatment of patients with newly diagnosed multiple myeloma who
are ineligible for autologous stem cell transplant; in combination
with bortezomib, melphalan and prednisone for the treatment of
patients with newly diagnosed multiple myeloma who are ineligible
for autologous stem cell transplant; in combination with
lenalidomide and dexamethasone, or bortezomib and dexamethasone,
for the treatment of patients with multiple myeloma who have
received at least one prior therapy; in combination with
pomalidomide and dexamethasone for the treatment of patients with
multiple myeloma who have received at least two prior therapies,
including lenalidomide and a proteasome inhibitor (PI); and as a
monotherapy for the treatment of patients with multiple myeloma who
have received at least three prior lines of therapy, including a PI
and an immunomodulatory agent, or who are double-refractory to a PI
and an immunomodulatory agent.5 DARZALEX is the first monoclonal
antibody (mAb) to receive U.S. Food and Drug Administration (U.S.
FDA) approval to treat multiple myeloma. DARZALEX intravenous
infusion is indicated for the treatment of adult patients in
Europe: in combination with lenalidomide and dexamethasone for the
treatment of patients with newly diagnosed multiple myeloma who are
ineligible for autologous stem cell transplant; in combination with
bortezomib, melphalan and prednisone for the treatment of adult
patients with newly diagnosed multiple myeloma who are ineligible
for autologous stem cell transplant; for use in combination with
lenalidomide and dexamethasone, or bortezomib and dexamethasone,
for the treatment of adult patients with multiple myeloma who have
received at least one prior therapy; and as monotherapy for the
treatment of adult patients with relapsed and refractory multiple
myeloma, whose prior therapy included a PI and an immunomodulatory
agent and who have demonstrated disease progression on the last
therapy6. The option to split the first infusion of DARZALEX over
two consecutive days has been approved in both Europe and the U.S.
In Japan, DARZALEX intravenous infusion is approved for the
treatment of adult patients: in combination with lenalidomide and
dexamethasone, or bortezomib and dexamethasone for the treatment of
relapsed or refractory multiple myeloma; in combination with
bortezomib, melphalan and prednisone for the treatment of patients
with newly diagnosed multiple myeloma who are ineligible for
autologous stem cell transplant. DARZALEX is the first human CD38
monoclonal antibody to reach the market in the United States,
Europe and Japan. For more information, visit www.DARZALEX.com.
Daratumumab is a human IgG1k monoclonal antibody (mAb) that
binds with high affinity to the CD38 molecule, which is highly
expressed on the surface of multiple myeloma cells.
Daratumumab triggers a person’s own immune system to attack the
cancer cells, resulting in rapid tumor cell death through multiple
immune-mediated mechanisms of action and through immunomodulatory
effects, in addition to direct tumor cell death, via apoptosis
(programmed cell death).5,6,7,8,9,10
Daratumumab is being developed by Janssen Biotech, Inc. under an
exclusive worldwide license to develop, manufacture and
commercialize daratumumab from Genmab. A comprehensive clinical
development program for daratumumab is ongoing, including multiple
Phase III studies in smoldering, relapsed and refractory and
frontline multiple myeloma settings. Additional studies are ongoing
or planned to assess the potential of daratumumab in other
malignant and pre-malignant diseases in which CD38 is expressed,
such as amyloidosis, NKT-cell lymphoma and B-cell and T-cell ALL.
Daratumumab has received two Breakthrough Therapy Designations from
the U.S. FDA for certain indications of multiple myeloma, including
as a monotherapy for heavily pretreated multiple myeloma and in
combination with certain other therapies for second-line treatment
of multiple myeloma.
About Genmab Genmab is a publicly traded,
international biotechnology company specializing in the creation
and development of differentiated antibody therapeutics for the
treatment of cancer. Founded in 1999, the company has two approved
antibodies, DARZALEX® (daratumumab) for the treatment of certain
multiple myeloma indications, and Arzerra® (ofatumumab) for the
treatment of certain chronic lymphocytic leukemia indications.
Daratumumab is in clinical development for additional multiple
myeloma indications, other blood cancers and amyloidosis. A
subcutaneous formulation of ofatumumab is in development for
relapsing multiple sclerosis. Genmab also has a broad clinical and
pre-clinical product pipeline. Genmab's technology base consists of
validated and proprietary next generation antibody technologies -
the DuoBody® platform for generation of bispecific antibodies, the
HexaBody® platform, which creates effector function enhanced
antibodies, the HexElect® platform, which combines two
co-dependently acting HexaBody molecules to introduce selectivity
while maximizing therapeutic potency and the DuoHexaBody® platform,
which enhances the potential potency of bispecific antibodies
through hexamerization. The company intends to leverage these
technologies to create opportunities for full or co-ownership of
future products. Genmab has alliances with top tier pharmaceutical
and biotechnology companies. Genmab is headquartered in Copenhagen,
Denmark with core sites in Utrecht, the Netherlands and Princeton,
New Jersey, U.S.
Contact:
Marisol Peron, Corporate Vice President, Communications &
Investor Relations T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations: Andrew Carlsen, Senior
Director, Investor RelationsT: +45 3377 9558; E: acn@genmab.com
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 www.genmab.com and the risk factors included in
Genmab’s final prospectus for our U.S. public offering and listing
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 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®; 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®; HexElect®; and UniBody®. Arzerra® is
a trademark of Novartis AG or its affiliates. DARZALEX® is a
trademark of Janssen Pharmaceutica NV.
1 American Cancer Society. "Multiple Myeloma Overview."
Available at
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-what-is-multiple-myeloma.Accessed
June 2016.2 Globocan 2018. Western Europe Fact Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/populations/926-western-europe-fact-sheets.pdf
Accessed March 20183 Globocan 2018. World Fact Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed December 2018.4 American Cancer Society. "How is Multiple
Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis.
Accessed June 20165 DARZALEX Prescribing information, September
2019. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s024lbl.pdf
Last accessed September 20196 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed October 20197De Weers, M et al. Daratumumab, a Novel
Therapeutic Human CD38 Monoclonal Antibody, Induces Killing of
Multiple Myeloma and Other Hematological Tumors. The Journal of
Immunology. 2011; 186: 1840-1848.8 Overdijk, MB, et al.
Antibody-mediated phagocytosis contributes to the anti-tumor
activity of the therapeutic antibody daratumumab in lymphoma and
multiple myeloma. MAbs. 2015; 7: 311-21.9 Krejcik MD et al.
Daratumumab Depletes CD38+ Immune-regulatory Cells, Promotes T-cell
Expansion, and Skews T-cell Repertoire in Multiple Myeloma. Blood.
2016; 128: 384-94.10Jansen, JH et al. Daratumumab, a human
CD38 antibody induces apoptosis of myeloma tumor cells via Fc
receptor-mediated crosslinking. Blood. 2012; 120(21): abstract
2974.
Company Announcement no. 56CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 191119_CA56_MAIA EU Approval
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