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Press Release

Genmab Announces Daratumumab and Ofatumumab Data to Be Included in 18 Presentations at American Society of Hematology Annual Meeting (ASH)


Posted on: 03 Nov 16

Media Release
 

  • 18 abstracts on Genmab programs scheduled for presentation at ASH
  • 6 daratumumab oral presentations and 11 daratumumab poster presentations
  • Key daratumumab abstracts: additional Phase III CASTOR & POLLUX data, Phase I subcutaneous formulation study, immuno-modulatory mechanisms of action, and ‘real life’ clinical practice daratumumab and pomalidomide retreatment data
  • 1 ofatumumab poster presentation


Copenhagen, Denmark; November 3, 2016 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that 17 daratumumab abstracts have been accepted for presentation at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition taking place December 3-6 in San Diego, California. The daratumumab abstracts are sponsored by our collaboration partner Janssen Biotech, Inc., with the exception of one that was based on an investigator-sponsored study, and one that used commercial daratumumab.  One abstract on a study with ofatumumab has also been scheduled for a poster presentation at the meeting.  All abstracts are available on the ASH website at www.hematology.org. A list of the key daratumumab abstracts is included below.

“A number of presentations will highlight additional analyses and details from the daratumumab Phase III POLLUX and CASTOR studies that formed the basis of regulatory filings earlier this year.  Additional presentations include the Phase I study of the subcutaneous formulation of daratumumab, data on the immuno-modulatory properties of daratumumab, and novel ‘real life’ clinical practice data on daratumumab plus pomalidomide retreatment of refractory multiple myeloma patients. We are excited that daratumumab will be featured in so many presentations at this key hematology conference,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Key Daratumumab Abstracts
Efficacy of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in Relapsed or Refractory Myeloma Based on Prior Lines of Therapy: Updated Analysis of CASTOR      - Oral presentation

Efficacy of Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients with 1 to 3 Prior Lines of Therapy: Updated Analysis of POLLUX - Oral presentation

Efficacy of Daratumumab, Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Among Patients with 1 to 3 Prior Lines of Therapy Based on Previous Treatment Exposure: Updated Analysis of POLLUX - Oral presentation

Evaluation of Minimal Residual Disease (MRD) in Relapsed/Refractory Multiple Myeloma (RRMM) Patients Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone - Oral presentation

Open-Label, Multicenter, Dose Escalation Phase 1b Study to Assess the Subcutaneous Delivery of Daratumumab in Patients (pts) with Relapsed or Refractory Multiple Myeloma (PAVO) - Oral presentation

Clinical Efficacy of Daratumumab, Pomalidomide and Dexamethasone in Relapsed, Refractory Myeloma Patients: Utility of Retreatment with Daratumumab Among Refractory Patients – Oral presentation
This is an independent study, not sponsored by Janssen.

Daratumumab, Bortezomib and Dexamethasone Versus Bortezomib and Dexamethasone Alone for Relapsed or Refractory Multiple Myeloma Based on Prior Treatment Exposure: Updated Efficacy Analysis of CASTOR - Poster presentation

Daratumumab in Combination with Lenalidomide Plus Dexamethasone Induces Clonality Increase and T-Cell Expansion: Results from a Phase 3 Randomized Study (POLLUX) - Poster presentation

High-parameter Mass Cytometry (CyTOF) Evaluation of Relapsed/Refractory Multiple Myeloma (MM) Pts (Pts) Treated with Daratumumab Supports Immune Modulation as a Novel Mechanism of Action - Poster presentation

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, Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications and DARZALEX® (daratumumab) for the treatment of heavily pretreated or double refractory multiple myeloma. A subcutaneous formulation of ofatumumab is in development for relapsing multiple sclerosis. Daratumumab is in clinical development for additional multiple myeloma indications and for non-Hodgkin’s lymphoma. 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. 09
CVR no. 2102 3884

Genmab A/S
Bredgade 34E
1260 Copenhagen K
Denmark

GlobeNewswire
globenewswire.com

Last updated on: 03/11/2016

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