27 mar: Investeringsselskabet Artha Optimum A/S – kapitaludvidelse
27 mar: Forløb af ordinær generalforsamling
27-03-2019 10:12:46

Genmab Announces European Regulatory Submission for Daratumumab in Combination with Bortezomib, Thalidomide and Dexamethasone in Frontline Multiple Myeloma

Company Announcement

  • Type II variation application submitted to the EMA for daratumumab in combination with bortezomib, thalidomide and dexamethasone as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant

  • Submission based on data from Phase III CASSIOPEIA study

Copenhagen, Denmark; March 27, 2019 –

Genmab A/S (Nasdaq Copenhagen: GEN) announced today that Janssen Pharmaceutica NV (Janssen) has submitted a Type II variation application to the European Medicines Agency (EMA). This application seeks to broaden the existing marketing authorization for daratumumab (DARZALEX®) to include use in combination with bortezomib, thalidomide and dexamethasone (VTD) as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant (ASCT). The submission is based on data from the Phase III CASSIOPEIA study of daratumumab in combination with VTD as frontline treatment for patients with multiple myeloma who are candidates for ASCT. The study is sponsored by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC.

Topline results of the clinical study were announced in October 2018 and Janssen expects to publish detailed data from the study during 2019. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

“With this submission we move another step closer to potentially expanding the DARZALEX label. This gives us hope that a new population of patients with multiple myeloma in first line may be able to gain access to DARZALEX,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the CASSIOPEIA (MMY3006) study

This Phase III study is a randomized, open-label, multicenter study, run by the French Intergroupe Francophone du Myelome (IFM) in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen R&D, LLC, including 1,085 newly diagnosed subjects with previously untreated symptomatic multiple myeloma who are eligible for high dose chemotherapy and stem cell transplant. In the first part of the study, patients were randomized to receive induction and consolidation treatment with daratumumab combined with bortezomib, thalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or bortezomib, thalidomide and dexamethasone alone. The primary endpoint is the proportion of patients that achieve a stringent Complete Response (sCR). In the second part of the study, patients that achieved a response will undergo 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 (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

®

(daratumumab)

DARZALEX® (daratumumab) injection for intravenous infusion is indicated in the United States  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 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).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 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, such as NKT-cell lymphoma, B and T-ALL.  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 and other blood cancers.  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, the HexaBody® platform, which creates effector function enhanced antibodies and the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency. 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:          

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 Relations

T: +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 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/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® is a trademark of Janssen Pharmaceutica NV.

1 American Cancer Society. "Multiple Myeloma Overview." Available at https://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 https://gco.iarc.fr/today/data/factsheets/840-united-states-of-america-fact-sheets.pdf. Accessed March 2019

4  Globocan 2018. World Fact Sheet. Available at https://gco.iarc.fr/today/data/factsheets/populations/900-world-fact-sheets.pdf. Accessed December 2018.

5  American Cancer Society. "How is Multiple Myeloma Diagnosed?" https://www.cancer.org/cancer/multiplemyeloma/detailedguide/multiple-myeloma-diagnosis. Accessed June 2016.

6 DARZALEX Prescribing information, February 2019. Available at: https://www.accessdata.fda.gov/drugsatfda_docs/label/2019/761036s016lbl.pdf Last accessed February 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. 14

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Attachment

logo.jpg

Relateret indhold
12:25 - 
Genmab/Nordnet: Penge fra USA-notering ryger nok i udvi..
22 jul - 
Genmab gennemfører aktiesalg i USA
19 jul - 
Fredagens aktier: Pandora fik stryg på børsen og tynged..
Relateret debat
17:49 - 
De har oplyst, at det er fordi det er den ticker de han..
17:18 - 
  hvor ser du det henne
17:02 - 
Genmab har skiftet shortname i dag til GMAB fra GEN. In..
Del

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
21 jul
GEN
Hmm. Det er med blandede følelser jeg for tid til anden følger med i Genmab trådende. Da Genmab s b..
20
22 jul
GEN
Ja der er så +10 år til og hvis Genmab mener de kunne få brug for +500 mil vil jeg mene det er bedre..
5
16 jul
GEN
Evt godkendelse forventes ultimo 2019 og på markedet  Q1 20 SC-behandlingen bliver sandsynligvis væs..
5
19 jul
GEN
Mon vi skal igennem de 1234 idag    https://www.euroinvestor.dk/nyheder/2019/07/19/genmab-barclays-s..
4
21 jul
GEN
Enhver kap udv er altid en udvanding. Alle nøgletal vil blive ramt af at der er flere aktier uden de..
3
19 jul
GEN
Genmab Announces Submission of Extension of Marketing Authorization to European Medicines Agency for..
3
20 jul
GEN
BlackRock er tilbage  med over 5%, så må de formentlig være enig i at det er fornuft bag beslutninge..
2
20 jul
GEN
Ja men det er så over en 10 årige periode lige fra første forsknings ide til et færdigt lægemiddel. ..
2
20 jul
GEN
Det er blevet diskuteret herinde før, hvorfor Genmab fabdt det nødvendigt at rejse mere kapital, med..
2
18 jul
GEN
De var supergode var de. Der var dog nogle reguleringer der ikke kommer igen. Men indtægt og salg va..
2

Genmab/Nordnet: Penge fra USA-notering ryger nok i udviklingsreserver

23-07-2019 12:25:21
Mandag gennemførte Genmab salget af flere millioner aktier i forbindelse med sin børsnotering i USA, og det indbragte selskabet frisk kapital, som formentlig vil blive lagt til side til fremtidige udviklingsprojekter.Sådan lyder vurderingen fra Per Hansen, investeringsøkonom hos børsmægleren Nordnet, om de godt 3,4 mia. kr., som Genmab har rejst i bruttoprovenu ved salget af 2,85 mio. nye aktier p..

Aktier/tendens: Udenlandsk udvikling bliver afgørende for DSV og andre

23-07-2019 08:22:55
Der er ikke meget fra det hjemlige at tage bestik af på det danske aktiemarked tirsdag morgen.Dermed bliver det den udenlandske udvikling, heriblandt et hæderligt regnskab fra DSV-kollegaen Kuehne+Nagel, der kommer til være bestemmende for retningen fra handlens start tirsdag.De ledende amerikanske aktieindeks sluttede mandag med plusser, og de asiatiske markeder har fulgt op på udviklingen med st..

Italienske Unicredit vil skære op mod 10.000 job i ny strategiplan

Relaterede nyheder
22-07-2019 12:41:42
Den italienske bank Unicredit overvejer ifølge kilder med indblik i sagen at skære tusindvis af job og trimme driftsomkostningerne som en del af bankens nye strategiplan.Det skriver Bloomberg News.Den italienske bank overvejer ifølge nyhedsbureauets kilder, som har bedt om ikke at blive identificeret med navn, at skære op mod 10.000 job, men de eksakte tal er endnu under overvejelse og kan ende me..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Danmark/økonomer: Forbrugerne aner uråd
2
Veloxis/Kempen: Kursmålet løftes med 20 pct.
3
Aktier/tendens: Udenlandsk udvikling bliver afgørende for DSV og andre
4
NKT får ordre på højspændingskabler til Viking Link - NY
5
Professor om Johnsons brexitplan: Han er kravlet op i et træ - NY

Relaterede aktiekurser

Genmab A/S 1.221,00 0,1% Stigning i aktiekurs

Copyright Berlingske Media 2019  Handelsbetingelser  |  Cookiedeklaration  |  Cookie- og Privatlivspolitik  |  Ophavsret og vilkår
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
23. juli 2019 18:05:17
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20190703.1 - EUROWEB6 - 2019-07-23 18:05:17 - 2019-07-23 18:05:17 - 1 - Website: OKAY