Company Announcement
- Phase III ANDROMEDA study of subcutaneous daratumumab
in combination with cyclophosphamide, bortezomib and dexamethasone
for patients with newly diagnosed light-chain (AL) amyloidosis met
the primary endpoint of patients with hematologic complete
response
- Janssen will discuss data with health authorities to
prepare for regulatory filings
Copenhagen, Denmark; May 28, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today positive topline
results from the Phase III ANDROMEDA (AMY3001) study of
subcutaneous (SC) daratumumab in combination with cyclophosphamide,
bortezomib and dexamethasone (CyBorD) for patients with newly
diagnosed light-chain (AL) amyloidosis. The study,
conducted by Janssen Biotech, Inc. (Janssen), met the primary
endpoint of percentage of patients with hematologic complete
response. Patients in the study treated with daratumumab in
combination with CyBorD had a 53.3% hematologic complete response
compared to 18.1% of patients who were treated with CyBorD alone
(odds ratio of 5.1 (95% CI 3.2 – 8.2, p<0.0001)).
Overall, the safety profile of daratumumab SC in combination
with CyBorD is consistent with the known safety profile of the
CyBorD regimen and the known safety profile of daratumumab.
“We are very pleased with the topline results from the Phase III
ANDROMEDA study in AL amyloidosis. We believe the data supports the
potential of daratumumab in the treatment of this devastating,
progressive disease, for which no approved treatments are
available,” said Jan van de Winkel, Ph.D., Chief Executive Officer
of Genmab.
Janssen, which obtained an exclusive worldwide license to
develop, manufacture and commercialize daratumumab from Genmab in
2012, will discuss with health authorities the potential for a
regulatory submission for this indication.
About the ANDROMEDA (AMY3001) studyThe Phase
III study (NCT03201965) included 388 patients newly diagnosed with
AL amyloidosis. Patients were randomized to receive treatment with
either subcutaneous daratumumab in combination with
cyclophosphamide (a chemotherapy), bortezomib (a proteasome
inhibitor) and dexamethasone (a corticosteroid) or treatment with
cyclophosphamide, bortezomib and dexamethasone alone. The primary
endpoint of the study is the percentage of patients who achieve
hematologic complete response.
About Light-chain (AL) AmyloidosisAmyloidosis
is a disease that occurs when amyloid proteins, which are abnormal
proteins, accumulate in tissues and organs. When the amyloid
proteins cluster together, they form deposits that damage the
tissues and organs. AL amyloidosis most frequently affects the
heart, kidneys, liver, nervous system and digestive tract. There is
currently no cure or existing approved therapies for AL amyloidosis
though it can be treated with chemotherapy, dexamethasone, stem
cell transplants and supportive therapies.1 It is estimated that
there are approximately 3,000 to 4,000 new cases of AL amyloidosis
diagnosed annually in the U.S.2
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.3 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 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
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 therapy4. 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 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 relapsed or
refractory multiple myeloma. 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.
DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj), a
subcutaneous formulation of daratumumab, is approved in the United
States for the treatment of adult patients with multiple myeloma:
in combination with bortezomib, melphalan and prednisone in newly
diagnosed patients who are ineligible for ASCT; in combination with
lenalidomide and dexamethasone in newly diagnosed patients who are
ineligible for ASCT and in patients with relapsed or refractory
multiple myeloma who have received at least one prior therapy; in
combination with bortezomib and dexamethasone in patients who have
received at least one prior therapy; and as monotherapy, in
patients 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
FASPRO is the first subcutaneous CD38-directed antibody approved in
the U.S. for the treatment of multiple myeloma.
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).3,5,6,7,8,9
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 and T-cell acute lymphocytic leukemia (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 is the creator of
three approved antibodies: DARZALEX® (daratumumab, under agreement
with Janssen Biotech, Inc.) for the treatment of certain multiple
myeloma indications in territories including the U.S., Europe and
Japan, Arzerra® (ofatumumab, under agreement with Novartis AG), for
the treatment of certain chronic lymphocytic leukemia indications
in the U.S., Japan and certain other territories and TEPEZZA™
(teprotumumab, under agreement with Roche granting sublicense to
Horizon Therapeutics plc) for the treatment of thyroid eye disease
in the U.S. A subcutaneous formulation of daratumumab, DARZALEX
FASPRO™ (daratumumab and hyaluronidase-fihj), has been approved in
the U.S. for the treatment of adult patients with certain multiple
myeloma indications. Daratumumab is in clinical development by
Janssen for the treatment of additional multiple myeloma
indications, other blood cancers and amyloidosis. A subcutaneous
formulation of ofatumumab is in development by Novartis for the
treatment of 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 sites in Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan.
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 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 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® and
DARZALEX FASPRO™ are trademarks of Janssen Pharmaceutica NV.
TEPEZZA™ is a trademark of Horizon Therapeutics plc.
1 Mayo Clinic website:
www.mayoclinic.com/health/amyloidosis/DS004312 Research and
Markets, “Amyloidosis Treatment Market Size, Share & Trends
Analysis Report by Treatment (Stem Cell Transplant, Chemotherapy,
Supportive Care, Surgery, Targeted Therapy), By Country, And
Segment Forecasts, 2018 - 20253 DARZALEX Prescribing information,
April 2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf
Last accessed April 20204 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed October 20195 DARZALEX FASPRO Prescribing information, May
2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf
Last accessed May 20206 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: 1840-1848.7 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: 311-21.8 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: 384-94.9Jansen, 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. 22CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 280520_CA22_ANDROMEDA TLR
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