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Genmab A/S Genmab Announces Positive Topline Results In Phase Iii Study Of Daratumumab In Combination With Carfilzomib And De...

13/09/2019 2:40pm

UK Regulatory (RNS & others)


 
TIDMGEN.CO 
 
 
   Company Announcement 
 
 
   -- Phase III CANDOR study of daratumumab in combination with carfilzomib and 
      dexamethasone in relapsed or refractory multiple myeloma met the primary 
      endpoint of improvement in progression free survival 
 
   -- Data to be discussed with health authorities in preparation for 
      regulatory submissions 
 
 
   Copenhagen, Denmark; September 13, 2019 -- Genmab A/S (Nasdaq: GMAB) 
announced today topline results from the Phase III CANDOR study, 
sponsored by Amgen, of daratumumab in combination with carfilzomib and 
dexamethasone (Kd) versus Kd alone in patients with multiple myeloma who 
have relapsed after one to three prior therapies. The study met the 
primary endpoint of improving progression free survival (PFS). The 
regimen resulted in a 37% reduction in the risk of progression or death 
in patients with relapsed or refractory multiple myeloma treated with 
daratumumab in combination with Kd (HR=0.630; 95% CI: 0.464, 0.854; 
p=0.0014). The median PFS for patients treated with daratumumab in 
combination with Kd had not been reached by the cut-off date compared to 
a median PFS of 15.8 months for patients who received Kd alone. 
 
   There was a higher frequency of adverse events reported with daratumumab 
plus Kd, a three-agent regimen, than with Kd, a two-agent regimen. The 
types of observed adverse events were consistent with the known safety 
profiles of the individual agents. The most frequently reported 
treatment-emergent adverse events (greater than or equal to 20%) in the 
daratumumab plus Kd arm were thrombocytopenia, anemia, diarrhea, 
hypertension, upper respiratory tract infection, fatigue and dyspnea. 
 
   The CANDOR data will be submitted to a future medical meeting and Amgen 
will discuss the data with health authorities in preparation for 
regulatory submissions. 
 
   "We are very pleased that daratumumab has shown efficacy in yet another 
combination regimen -- in this case with carfilzomib, a newer member of 
the proteasome inhibitor class. We look forward to the potential for 
this combination to provide an additional regimen for patients diagnosed 
with relapsed multiple myeloma," said Jan van de Winkel, Ph.D., Chief 
Executive Officer of Genmab. 
 
   In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive 
worldwide license to develop, manufacture and commercialize daratumumab. 
 
   About the CANDOR study 
 
   The Phase III trial (NCT03158688) is a randomized, open-label study that 
includes approximately 460 patients with multiple myeloma who have 
relapsed after 1 to 3 prior therapies. Patients were randomized to 
receive either daratumumab in combination with carfilzomib (a proteasome 
inhibitor) and dexamethasone (a corticosteroid) or carfilzomib and 
dexamethasone alone. In the daratumumab treatment arm, patients received 
8 milligrams per kilogram (mg/kg) on days 1 and 2 of cycle 1, then 16 
mg/kg once weekly for the remaining doses of the first 2 cycles, then 
every 2 weeks for 4 cycles (cycles 3 to 6), and then every 4 weeks for 
the remaining cycles or until disease progression. In both treatment 
arms carfilzomib was dosed twice weekly (20 mg/m(2) on cycle 1 days 1 
and 2 and 56 mg/m(2) beginning on cycle 1 day 8 and thereafter) and 
dexamethasone was given weekly (40 mg orally or via IV infusion). The 
primary endpoint of the study is 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 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(R) (daratumumab) 
 
   DARZALEX(R) (daratumumab) intravenous infusion is indicated for the 
treatment of adult patients in the United States:  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 in Europe 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 therapy. 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 is approved in combination with lenalidomide and 
dexamethasone, or bortezomib and dexamethasone, for the treatment of 
adults with relapsed or refractory multiple myeloma and 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. 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. 
 
   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).(6,7,8,9,10) 
 
   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, NKT-cell lymphoma and 
B-cell and T-cell 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 
has two approved antibodies, DARZALEX(R) (daratumumab) for the treatment 
of certain multiple myeloma indications, and Arzerra(R) (ofatumumab) for 
the treatment of certain chronic lymphocytic leukemia indications. 
Daratumumab is in clinical development for additional multiple myeloma 
indications, other blood cancers and amyloidosis. 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(R) platform for 
generation of bispecific antibodies, the HexaBody(R) platform, which 
creates effector function enhanced antibodies, the HexElect(R) platform, 
which combines two co-dependently acting HexaBody molecules to introduce 
selectivity while maximizing therapeutic potency and the DuoHexaBody(R) 
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 core sites in Utrecht, the Netherlands and Princeton, New Jersey, 
U.S. 
 
 
 
 
 
   Contact: 
 
   Marisol Peron, Corporate Vice President, Communications & Investor 
Relations 
 
   T: +1 609 524 0065; E: 
https://www.globenewswire.com/Tracker?data=ZOAXvT9KNNPtf7MDUZQyaMzybnEJsjpTscq0vSZaI0jPI3keYSTESysHLqUtLldL87UPoE5ZDtr8zhyTDLgaqQ== 
mmp@genmab.com 
 
   For Investor Relations: 
 
   Andrew Carlsen, Senior Director, Investor Relations 
 
   T: +45 3377 9558; E: 
https://www.globenewswire.com/Tracker?data=uPu73c8KWzING6ud7-Jt8SDvmiuwI5bsQ_Z04S83nvDrFgKOV_yTy5mseO73hcuRwNwDBluE-CUCP4CQsRb0kw== 
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 
https://www.globenewswire.com/Tracker?data=W3r4_9P3fb0uS_-nkoyzJnztW86IsPUvet2AM6_rFUfJVp9YlInADzMQH5k4_wkZvkuuE-UzkpW_q76aSXe_dg== 
www.genmab.com and the risk factors included in Genmab's final 
prospectus for our U.S. public offering and listing and other filings 
with the U.S. Securities and Exchange Commission (SEC), which are 
available at 
https://www.globenewswire.com/Tracker?data=W3r4_9P3fb0uS_-nkoyzJsnTNYgbgwB_a6EWW5KRdlljoFjORaeazMJCZsfE9PdMHe1fBHjL9Ej1o1NMU_LEbnoG6qQYs2W96jQZ-fBKM8o= 
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(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination with the 
Y-shaped Genmab logo(R) ; HuMax(R) ; DuoBody(R) ; DuoBody in combination 
with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in combination with 
the HexaBody logo(R) ; DuoHexaBody(R) ; HexElect(R) ; and UniBody(R) . 
Arzerra(R) is a trademark of Novartis AG or its affiliates. DARZALEX(R) 
is a trademark of Janssen Pharmaceutica NV. 
 
   (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 2016. 
 
   (6) DARZALEX Prescribing information, July 2019. Available at: 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s019lbl.pdf 
Last accessed July 2019 
 
   (7) 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. 
 
   (8) 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. 
 
   (9) 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. 
 
   (10) 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. 45 
 
   CVR no. 2102 3884 
 
   LEI Code 529900MTJPDPE4MHJ122 
 
   Genmab A/S 
 
   Kalvebod Brygge 43 
 
   1560 Copenhagen V 
 
   Denmark 
 
   Attachment 
 
 
   -- 190913_CA45_CANDOR 
      https://ml-eu.globenewswire.com/Resource/Download/5a60ab97-4075-46fd-93ee-e8ec7c1663d6 
 
 
 
 
 
 
 

(END) Dow Jones Newswires

September 13, 2019 09:40 ET (13:40 GMT)

Copyright (c) 2019 Dow Jones & Company, Inc.

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