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&selection_cancer=17270&Text-c=Multiple+myeloma&pYear=3&type=0&window=1&submit=%C2%A0Execute.
Accessed June 2016.
5 American Cancer Society. "How is Multiple Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. 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.pdf Last 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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http://www.globenewswire.com/NewsRoom/AttachmentNg/4f4a5efe-7156-4e7e-b028-c4478bdbb706
