Company Announcement
-- U.S. FDA grants Priority Review to daratumumab in combination with
bortezomib, melphalan and prednisone for the treatment of patients with
newly diagnosed multiple myeloma ineligible for autologous stem cell
transplant
-- May 21, 2018 PDUFA date
Copenhagen, Denmark; January 19, 2018 - Genmab A/S (Nasdaq Copenhagen: GEN)
announced today that the U.S. Food and Drug Administration (FDA) has granted
Priority Review to the supplemental Biologics License Application (sBLA) for
the use of daratumumab (DARZALEX) 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 (ASCT). The sBLA
was submitted by Genmab's licensing partner, Janssen Biotech, Inc., in November
2017. Priority Review is an FDA designation for drugs that treat a serious
condition and may provide a significant improvement in safety or efficacy. The
FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of May
21, 2018 to take a decision on daratumumab in this indication. In August 2012,
Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop,
manufacture and commercialize daratumumab.
"The granting of priority review to the submission of daratumumab in front line
multiple myeloma is an important step forward towards potentially bringing this
product to an even larger number of patients in need," said Jan van de Winkel,
Ph.D., Chief Executive Officer of Genmab.
The sBLA submission was based on data from the Phase III ALCYONE study of
daratumumab in combination with bortezomib, melphalan and prednisone in front
line multiple myeloma. This data was presented as a Late-Breaking Abstract at
the 2017 American Society of Hematology (ASH) Annual Meeting and published in
The New England Journal of Medicine in December, 2017.
About the ALCYONE study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter
study and includes 706 newly diagnosed patients with multiple myeloma who are
ineligible for autologous stem cell transplantation (ASCT). Patients were
randomized to receive 9 cycles of either VMP [bortezomib (a proteasome
inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a
corticosteroid)] combined with daratumumab, or VMP alone. In the daratumumab
treatment arm, patients received 16 mg/kg of daratumumab once weekly for six
weeks (cycle 1; 1 cycle = 42 days), followed by once every three weeks (cycles
2-9). Following the 9 cycles, patients in the daratumumab treatment arm
continued to receive 16 mg/kg of daratumumab once every four weeks until
disease progression. The primary endpoint of the study is progression free
survival (PFS).
About multiple myeloma
Multiple myeloma is an incurable blood cancer that starts in the bone marrow
and is characterized by an excess proliferation of plasma cells.1 Multiple
myeloma is the third most common blood cancer in the U.S., after leukemia and
lymphoma.2 Approximately 30,330 new patients were expected to be diagnosed with
multiple myeloma and approximately 12,650 people were expected to die from the
disease in the U.S. in 2016.3 Globally, it was estimated that 124,225 people
would be diagnosed and 87,084 would die from the disease in 2015.4 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.5 Patients who relapse after
treatment with standard therapies, including proteasome inhibitors or
immunomodulatory agents, have poor prognoses and few treatment options.6
About DARZALEX (daratumumab)
DARZALEX (daratumumab) injection for intravenous infusion is indicated in the
United States 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.6 DARZALEX is the first monoclonal antibody
(mAb) to receive U.S. Food and Drug Administration (FDA) approval to treat
multiple myeloma. DARZALEX is indicated in Europe 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 therapy. In Japan, DARZALEX is approved in combination with lenalidomide
and dexamethasone, or bortezomib and dexamethasone, for treatment of adults
with relapsed or refractory multiple myeloma. DARZALEX is the first human CD38
monoclonal antibody to reach the market. 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).7,8,9,10,11
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 relapsed and frontline
multiple myeloma settings and in amyloidosis. Additional studies are ongoing
or planned to assess the potential of daratumumab in other malignant and
pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma,
NKT-cell lymphoma, myelodysplastic syndromes and solid tumors. Daratumumab has
received two Breakthrough Therapy Designations from the U.S. FDA, for multiple
myeloma, as both a monotherapy and in combination with other therapies.
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 solid tumors.
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, and the HexaBody platform which creates effector
function enhanced antibodies. 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. For more information visit www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations &
Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: rcg@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 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. 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 its subsidiaries own the following trademarks: Genmab; the
Y-shaped Genmab logo; Genmab in combination with the Y-shaped Genmab logo;
the DuoBody logo; the HexaBody logo; HuMax; HuMax-CD20; DuoBody; HexaBody
and UniBody. Arzerra is a trademark of Novartis AG or its affiliates.
DARZALEX is a trademark of Janssen Biotech, Inc.
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 National Cancer Institute. "A Snapshot of Myeloma." Available at
www.cancer.gov/research/progress/snapshots/myeloma. Accessed June 2016.
3 American Cancer Society. "What are the key statistics about multiple
myeloma?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-key-
statistics.
Accessed June 2016.
4 GLOBOCAN 2012: Estimated Cancer Incidence, Mortality and Prevalence
Worldwide: Number of New Cancers in 2015. Available at:
http://globocan.iarc.fr/old/burden.asp'selection_pop=224900&Text-p=World&selecti
on_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=0&window=1&submit=%C2%A0Exe
cute.
Accessed June 2016.
5 American Cancer Society. "How is Multiple Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diag
nosis.
Accessed June 2016.
6 Kumar, SK et al. Risk of progression and survival in multiple myeloma
relapsing after last therapy with IMiDs and bortezomib: a multicenter
international myeloma working group study. Leukemia. 2012; 26:149-57.
7 DARZALEX Prescribing information, June 2017. Available
at:https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761036s005lbl.pdfLa
st
accessed June 2017
8 De 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.
9 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.
10 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.
11 Jansen, 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. 02
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark
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