Genmab Announces Data to be Presented at 2018 ASH Annual Meeting

November 1, 2018 at 2:16 PM CET

Media Release

  • Thirty-five total abstracts on Genmab owned and partnered programs scheduled for presentation at ASH
  • Three abstracts related to Genmab owned programs: DuoBody®-CD3xCD20 & DuoHexaBody™-CD37
  • Daratumumab: 5 oral presentations; total of 30 accepted including ISS


Copenhagen, Denmark; November 1, 2018 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that 35 abstracts related to Genmab owned and partnered programs have been accepted for presentation at the 60th American Society of Hematology (ASH) Annual Meeting taking place December 1-4 in San Diego, California.
Abstracts accepted for presentation include updates on multiple daratumumab and ofatumumab trials, as well as pre-clinical data from Genmab’s DuoBody-CD3xCD20 and DuoHexaBody-CD37 programs. All abstracts are available on the ASH website at www.hematology.org. Details regarding the key abstracts to be presented are included below.

“We are elated that out of the over eighty-five ongoing daratumumab clinical studies, a record thirty abstracts containing daratumumab data in multiple myeloma and other indications were accepted for presentation at this year’s ASH Annual Meeting. We are also thrilled that three abstracts related to pre-clinical data from wholly owned Genmab programs were accepted for inclusion at this prestigious event, including the first proprietary DuoBody program, DuoBody-CD3xCD20, and the first ever DuoHexaBody therapeutic program, DuoHexaBody-CD37,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Late breaking abstracts are not yet available.

Genmab Pre-Clinical Abstracts

DuoBody-CD3xCD20 Shows Unique and Potent Preclinical Anti-Tumor Activity In Vitro and In Vivo, and is Being Evaluated Clinically in Patients with B-Cell Malignancies – Poster presentation, Saturday, December 1

DuoHexaBody-CD37 a Novel Bispecific Antibody with a Hexamerization enhancing Mutation Targeting CD37, Demonstrates Superior CDC in Preclinical B-Cell Malignancy Models – Poster presentation, Monday, December 3

Targeting CD37 in B-Cell Malignancies Using the Novel Therapeutic Ab DuoHexaBody-CD37 Results in Efficient Killing of Tumor B-Cells Ex Vivo via CDC, Even in Relapsed and/or Refractory Patient Samples – Poster presentation, Monday, December 3

Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.

Oral Presentations:

Efficacy and Updated Safety Analysis of a Safety Run-in Cohort from GRIFFIN, a Phase 2 Randomized Study of Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone Versus Bortezomib, Lenalidomide, and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Eligible for High-Dose Therapy and Autologous Stem Cell Transplantation – Oral presentation, Saturday, December 1

LYRA – A Phase 2 Study of Daratumumab Plus Cycolphosphamide, Bortezomib, and Dexamethasone in Newly Diagnosed and Relapsed Patients with Multiple Myeloma – Oral presentation, Saturday, December 1

One-Year Update of a Phase 3 Randomized Study of Daratumumab Plus Bortezomib, Melphalan, and Prednisone Versus Bortezomib, Melphalan, and Prednisone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma: ALCYONE – Oral presentation, Saturday, December 1

Poster Presentations:
Three-Year Follow Up of the Phase 3 POLLUX Study of Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone Alone in Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, December 1

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Safety and Efficacy Update of the Open-label, Multicenter, Phase 1b Study (PAVO) – Poster presentation, Saturday, December 1


Pharmacokinetics of Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Primary Clinical Pharmacology Analysis of the Open-label, Multicenter, Phase 1b Study (PAVO) – Poster presentation, Saturday, December 1


Split First Dose Administration of Daratumumab for the Treatment of Patients with Multiple Myeloma: Clinical Pharmacology and Population Pharmacokinetic Analyses – Poster presentation, Saturday, December 1

Updated Results from the Phase 2 CENTAURUS Study of Daratumumab Monotherapy in Patients with Intermediate-risk or High-risk Smoldering Multiple Myeloma – Poster presentation, Saturday, December 1

Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural Killer/T-cell Lymphoma (NKTCL), Nasal Type: An Open-label, Single-arm, Multicenter Phase 2 Study – Poster presentation, Saturday, December 1

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib, and Dexamethasone in First Relapse Patients: Two-Year Update of CASTOR – Poster presentation, Sunday, December 2

Evaluation of Sustained Minimal Residual Disease Negativity in Relapsed / Refractory Multiple Myeloma Patients Treated with Daratumumab in Combination with Lenalidomide Plus Dexamethasone or Bortezomib Plus Dexamethasone: Analysis of POLLUX and CASTOR – Poster presentation, Sunday, December 2

Efficacy of Daratumumab in Combination with Standard of Care Regimens in Lenalidomide-Exposed or Refractory Patients with Relapsed / Refractory Multiple Myeloma: Analysis of CASTOR, POLLUX and MMY1001 Studies – Poster presentation, Sunday, December 2

Ofatumumab Abstracts Sponsored by Novartis

Oral Presentation:
Results of the Primary Analysis of COMPLEMENT A+B: A Phase III Study of Ofatumumab in Combination with Bendamustine Versus Bendamustine Alone in Patients with Indolent Non-Hodgkin’s Lymphoma That is Unresponsive or Relapsed Following Rituximab or Rituximab-containing Regimen – Oral presentation, Sunday, December 2

Poster Presentation:
Long-Term Evaluation of Efficacy and Safety of Ofatumumab Added to Fludarabine & Cyclophosphamide in Subjects with Relapsed Chronic Lymphocytic Leukemia: Final Analysis of COMPLEMENT 2 Trial – Poster presentation, Sunday, December 2

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:          
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communication
T: +45 33 44 77 20; E: rcg@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 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.


Media Release no. 10
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

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