Company Announcement
- Subcutaneous fixed-dosed formulation of DARZALEX®
(daratumumab) approved in Europe for the treatment of adult
patients with multiple myeloma
- Approval follows positive opinion by European Committee
for Medicinal Products for Human Use (CHMP) in April 2020 and
applies to all current daratumumab indications in frontline and
relapsed/refractory settings
- Approval based on data from Phase III COLUMBA and Phase
II PLEIADES studies
- In the studies, the fixed-dose subcutaneous formulation
reduced treatment time from hours to minutes and demonstrated
similar efficacy and safety with significantly fewer
infusion-related reactions compared with the intravenous
formulation
Copenhagen, Denmark; June 4, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today that the European
Commission (EC) has granted marketing authorization for the
subcutaneous (SC) formulation of DARZALEX® (daratumumab), for the
treatment of adult patients with multiple myeloma in all currently
approved daratumumab intravenous (IV) formulation indications in
frontline and relapsed / refractory settings. The approval
follows a Positive Opinion by the CHMP of the European Medicines
Agency (EMA) in April 2020. The SC formulation is administered as a
fixed-dose over approximately three to five minutes, significantly
less time than IV daratumumab, which is given over several hours.
Patients currently on daratumumab IV will have the choice to switch
to the SC formulation. In August 2012, Genmab granted Janssen
Biotech, Inc. (Janssen) an exclusive worldwide license to develop,
manufacture and commercialize daratumumab.
“We are extremely pleased that patients in Europe with multiple
myeloma will now, like patients in the U.S., have the opportunity
for treatment with the subcutaneous formulation of daratumumab.
With consistent efficacy, and greater convenience for patients and
health care providers with dosing time reduced from hours to just
minutes and fewer infusion-related reactions, this formulation
provides significant benefits for patients,” said Jan van de
Winkel, Ph.D., Chief Executive Officer of Genmab
The approval was based on data from two studies: the Phase III
non-inferiority COLUMBA (MMY3012) study, which compared the SC
formulation of daratumumab to the IV formulation in patients with
relapsed or refractory multiple myeloma, and data from the Phase II
PLEIADES (MMY2040) study, which is evaluating SC daratumumab in
combination with certain standard multiple myeloma regimens. The
topline results from the COLUMBA study were announced in February
2019 and subsequently presented in oral sessions at the 2019
American Society of Clinical Oncology (ASCO) Annual Meeting and the
24th European Hematology Association (EHA) Annual Congress. Updated
data of the COLUMBA and the PLEIADES studies were presented during
poster sessions at the 61st American Society of Hematology (ASH)
Annual Meeting in December 2019.
About the COLUMBA (MMY3012) studyThe Phase III
trial (NCT03277105) is a randomized, open-label, parallel
assignment study that included 522 adults diagnosed with relapsed
and refractory multiple myeloma. Patients were randomized to
receive either: SC daratumumab, as 1800 mg daratumumab with rHuPH20
2000 U/mL once weekly in Cycle 1 and 2, every two weeks in Cycles 3
to 6, every 4 weeks in Cycle 7 and thereafter until disease
progression, unacceptable toxicity or the end of study; or 16 mg/kg
IV daratumumab once weekly in Cycle 1 and 2, every two weeks in
Cycles 3 to 6, every 4 weeks in Cycle 7 and thereafter until
disease progression, unacceptable toxicity or the end of study. The
co-primary endpoints of the study are overall response rate and
Maximum trough concentration of daratumumab (Ctrough; defined as
the serum pre-dose concentration of daratumumab on Cycle 3 Day
1).
About the PLEIADES (MMY2040) studyThe Phase II
trial (NCT03412565) is a non-randomized, open-label, parallel
assignment study that includes 265 adults either newly diagnosed or
with relapsed or refractory multiple myeloma. Patients with newly
diagnosed multiple myeloma are being treated with 1,800 mg SC
daratumumab in combination with either bortezomib, lenalidomide and
dexamethasone (D-VRd) or bortezomib, melphalan and prednisone
(D-VMP). Patients with relapsed or refractory multiple myeloma are
being treated with 1,800 mg SC daratumumab plus lenalidomide and
dexamethasone (D-Rd). An additional cohort of patients with
relapsed and refractory multiple myeloma treated with daratumumab
plus carfilzomib and dexamethasone (D-Kd) was subsequently added to
the study. The primary endpoint for the D-VMP, D-Kd and D-Rd
cohorts is overall response rate. The primary endpoint for the
D-VRd cohort is very good partial response or better rate.
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.1 DARZALEX is the first monoclonal
antibody (mAb) to receive U.S. Food and Drug Administration (U.S.
FDA) approval to treat multiple myeloma.
DARZALEX is indicated for the treatment of adult patients in
Europe via intravenous infusion or subcutaneous administration: 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 therapy2. Daratumumab
is the first subcutaneous CD38-directed antibody approved in Europe
for the treatment of multiple myeloma. 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.3 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).1,4,5,6,7
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 DARZALEX Prescribing information, April 2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s027lbl.pdf
Last accessed April 20202 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed October 20193 DARZALEX FASPRO Prescribing information, May
2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf
Last accessed May 20204 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: 1840-1848.5Overdijk, 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: 311-21.6 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: 384-94.7 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. 24CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 040620_CA24_Dara SC EU Approval
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