Company Announcement
- Second part
of the Phase 3 CASSIOPEIA study of daratumumab as maintenance
treatment for patients with newly diagnosed multiple myeloma
eligible for autologous stem cell transplant met the primary
endpoint of progression-free survival at a pre-planned interim
analysis
- Independent
Data Monitoring Committee recommends unblinding the study
results
- Based on the
data, Janssen plans to discuss the potential for a regulatory
submission with health authorities
Copenhagen, Denmark; October 21, 2020 –
Genmab A/S (Nasdaq: GMAB) announced today positive topline
results from the second part of the Phase 3 CASSIOPEIA (MMY3006)
study of daratumumab monotherapy as maintenance treatment versus
observation (no treatment) for patients with newly diagnosed
multiple myeloma eligible for autologous stem cell transplant
(ASCT). The second part of the study, which is being
conducted by the French Intergroupe Francophone du Myelome
(IFM) in collaboration with the Dutch-Belgian Cooperative Trial
Group for Hematology Oncology (HOVON) and Janssen Research &
Development, LLC (Janssen), met the primary endpoint of improving
progression free survival (PFS) at a pre-planned interim analysis
(Hazard Ratio (HR) = 0.53 (95% CI 0.42 – 0.68), p < 0.0001)
resulting in a 47% reduction in the risk of progression or death in
patients treated with daratumumab. The safety profile observed in
this study was consistent with the known safety profile of
daratumumab and no new safety signals were observed.
Based on the results at the pre-planned interim analysis
conducted by an Independent Data Monitoring Committee (IDMC), it
was recommended to unblind the study results. Janssen Biotech,
Inc., which licensed daratumumab from Genmab in 2012, plans to
discuss the potential for a regulatory submission for this
indication with health authorities, and plans to submit the data to
an upcoming medical conference and for publication in a
peer-reviewed journal.
“Following the positive data from the first part of the
CASSIOPEIA study, we are very pleased to see this benefit. We are
appreciative of the efforts of the IFM, of HOVON and of Janssen for
their work on this study,” said Jan van de Winkel, Ph.D., Chief
Executive Officer of Genmab.
About the CASSIOPEIA (MMY3006) StudyThis Phase
3 study is a randomized, open-label, multicenter study, conducted
by the IFM in collaboration with the HOVON and Janssen, which
includes 1,085 newly diagnosed subjects with previously untreated
symptomatic multiple myeloma who were eligible for high dose
chemotherapy and ASCT. In the first part of the study, patients
were randomized to receive induction and consolidation treatment
with daratumumab combined with bortezomib, thalidomide and
dexamethasone (VTd) or VTd alone. The primary endpoint was the
number of patients that achieved a stringent complete response
(sCR). In the second part of the study, patients that achieved a
response underwent a second randomization to either receive
maintenance treatment of daratumumab 16 mg/kg every 8 weeks for up
to 2 years versus no further treatment (observation). The primary
endpoint of this part 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 Multiple
myeloma is the third most common blood cancer in the U.S., after
leukemia and lymphoma.2 Approximately 26,000 new patients were
expected to be diagnosed with multiple myeloma and approximately
13,650 people were expected to die from the disease in the U.S. in
2018.3 Globally, it was estimated that 160,000 people were
diagnosed and 106,000 died from the disease in 2018.4 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
About DARZALEX®
(daratumumab)DARZALEX® (daratumumab) has become a
backbone therapy in the treatment of multiple myeloma. DARZALEX
intravenous infusion is indicated for the treatment of adult
patients in the United States: in combination with carfilzomib and
dexamethasone for the treatment of patients with
relapsed/refractory multiple myeloma who have received one to three
previous lines of therapy; 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.6 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 therapy7. Daratumumab
is the first subcutaneous CD38 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.8 DARZALEX
FASPRO is the first subcutaneous CD38 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).6,9,10,11,12
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 3 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 the following 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, Kesimpta®
(subcutaneous ofatumumab, under agreement with Novartis AG), for
the treatment of adults with relapsing forms of multiple sclerosis
in the U.S. 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, known as DARZALEX FASPRO™ (daratumumab and
hyaluronidase-fihj) in the U.S., has been approved in the U.S. and
Europe for the treatment of adult patients with certain multiple
myeloma indications. The first approved Genmab created therapy,
Arzerra® (ofatumumab, under agreement with Novartis AG), approved
for the treatment of certain chronic lymphocytic leukemia
indications, is available in Japan and is also available in other
territories via compassionate use or oncology access programs.
Daratumumab is in clinical development by Janssen for the treatment
of additional multiple myeloma indications, other blood cancers and
amyloidosis. 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® and Kesimpta® are
trademarks 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 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 Globocan 2018. United States of America Fact
Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf.4
Globocan 2018. World Fact Sheet. Available at
http://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf.
Accessed December 2018.5 American Cancer Society. "How is Multiple
Myeloma Diagnosed?"
http://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis.
Accessed June 20166 DARZALEX Prescribing information, August 2020
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761036s029lbl.pdf
Last accessed August 20207 DARZALEX Summary of Product
Characteristics, available at
https://www.ema.europa.eu/en/medicines/human/EPAR/darzalex Last
accessed June 20208 DARZALEX FASPRO Prescribing information, May
2020. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761145s000lbl.pdf
Last accessed May 20209 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: 1840-1848.10 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: 311-21.11 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: 384-94.12 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. 45CVR no. 2102 3884LEI Code
529900MTJPDPE4MHJ122
Genmab A/SKalvebod Brygge 431560 Copenhagen VDenmark
- 211020_CA45_CASSIOPEIA Pt 2
Genesis Healthcare (NYSE:GEN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Genesis Healthcare (NYSE:GEN)
Historical Stock Chart
From Sep 2023 to Sep 2024