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01-11-2017 14:13:02

Genmab Announces Data to be Presented at 2017 ASH Annual Meeting

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Media Release

  • Over 25 abstracts on Genmab partnered programs scheduled for presentation at ASH

  • Daratumumab: 6 oral presentations; Total of over 20 abstracts accepted including ISS

Copenhagen, Denmark; November 1, 2017 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that over 25 abstracts with Genmab partnered products daratumumab and ofatumumab have been accepted for presentation at the 59th American Society of Hematology (ASH) Annual Meeting taking place December 9-12 in Atlanta, Georgia. The daratumumab abstracts, submitted by our collaboration partner Janssen Biotech, Inc., include updated data for the POLLUX and CASTOR trials, final results from the GEN501 and SIRIUS daratumumab monotherapy trials, data from the subcutaneous Phase Ib PAVO trial, the Phase Ib EQUULEUS trial in combination with backbone regimens and the Phase II CENTAURUS trial in smoldering multiple myeloma. Preliminary data will also be presented for the Phase II GRIFFIN study of daratumumab in combination with lenalidomide, bortezomib and dexamethasone in newly diagnosed multiple myeloma and for the Phase II LYRA study of daratumumab plus cyclophosphamide, bortezomib and dexamethasone in previously untreated and relapsed multiple myeloma.  A number of investigator sponsored studies (ISS) with daratumumab were also accepted for oral and poster presentations. One ofatumumab abstract, submitted by Novartis, is scheduled for poster presentation. All abstracts are available on the ASH website at www.hematology.org. A list of the key daratumumab abstracts is included below.

“We are very pleased with the impressive number of abstracts detailing a wealth of updated and novel data on daratumumab has been accepted for presentation at the world’s leading hematology conference, the 2017 ASH Annual Meeting. We are confident that the presentations of these data provide an exciting  picture of the significant clinical potential of this first-in-class CD38 therapeutic antibody,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Late breaking abstracts are not yet available.

Selected Daratumumab Abstracts

Daratumumab Monotherapy for Patients with Intermediate or High-risk Smoldering Multiple Myeloma (SMM): CENTAURUS, a Randomized, Open-label, Multicenter Phase II Study – Oral presentation, Sunday, December 10

Daratumumab, Lenalidomide and Dexamethasone (DRd) Versus Lenalidomide and Dexamethasone (Rd) in Relapsed or Refractory Multiple Myeloma (RRMM): Updated Efficacy and Safety Analysis of POLLUX - Oral presentation, Monday, December 11

Subcutaneous Delivery of Daraumumab in Patients with Relapsed or Refractory Multiple Myeloma (RRMM): PAVO, an Open-label, Multicenter, Dose Escalation Phase Ib Study – Oral presentation, Monday, December 11

Daratumumab, Lenalidomide and Dexamethasone (DRd) Versus Lenalidomide and Dexamethasone (Rd) in Relapsed or Refractory Multiple Myeloma Based on Prior Treatment History, Renal Function, and Cytogenetic Risk: Subgroup Analyses of POLLUX – Poster presentation, Saturday, December 9

Daratumumab, Bortezomib and Dexamethasone Versus Bortezomib and Dexamethasone for Relapsed / Refractory Multiple Myeloma (RRMM) Patients: An Update of Overall Survival in CASTOR – Poster presentation, Saturday, December 9

Daratumumab in Combination with Lenalidomide and Dexamethasone in Patients with Relapsed or Relapsed / Refractory Multiple Myeloma (GEN503): Final Results of an Open-label, Phase I/II Study – Poster presentation, Saturday, December 9

Daratumumab in Combination with Carfilzomib and Dexamethasone in Patients with Relapsed Multiple Myeloma (MM1001): An Open-label, Phase Ib Study – Poster presentation, Saturday, December 9

Interim Safety Analysis of a Phase II Randomized Study of Daratumumab, Lenalidomide, Bortezomib and Dexamethasone Versus Lenalidomide, Bortezomib and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible for High Dose Therapy (HDT) and Autologous Stem Cell Transplant (ASCT)– Poster presentation, Saturday, December 9

Daratumumab in Combination with Pomalidomide and Dexamethasone for Relapsed and/or Refractory Multiple Myeloma (RRMM) in Patients with ≥2 Prior Lines of Therapy: Updated Analysis of MMY1001 – Poster presentation, Saturday, December 9

Results of an Interim Safety Analysis of a Phase II Study of Daratumumab Plus Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) in Previously Untreated and Relapsed Patients with Multiple Myeloma – Poster presentation, Saturday, December 9

Safety and Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed and Refractory Multiple Myeloma: Final Results from GEN501 and SIRIUS – Poster presentation, Sunday, December 10

Daratumumab in Combination with Carfilzomib, Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma (MMY1001): Updated Results from an Open-label, Phase Ib Study – Poster presentation, Sunday, December 10

Daratumumab in Combination with Lenalidomide Plus Dexamethasone Results in Persistent Natural Killer (NK) Cells with a Distinct Phenotype and Expansion of Effector Memory T-cells in POLLUX, a Phase III Randomized Study – Poster presentation, Sunday, December 10

Daratumumab, Bortezomib and Dexamethasone  (DVd) Versus Bortezomib and Dexamethasone (Vd) in Relapsed or Refractory Multiple Myeloma: Updated Efficacy and Safety Analysis of CASTOR – Poster presentation, Sunday, December 10

Ofatumumab Abstract

Efficacy and Safety of Ofatumumab and Bendamustine Followed by Ofatumumab Maintenance in Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma After Prior Rituximab – Poster presentation, Saturday, December 9

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, other blood cancers, and solid tumors.  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, and the HexaBody® platform which creates effector function enhanced antibodies.  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:          

Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communication

T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

This Media Release 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 Media Release nor to confirm such statements in relation to actual results, unless required by law.

Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.

Media Release no. 06

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

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