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Genmab Announces Data to be Presented at 2018 ASCO Annual Meeting

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Media Release

  • 11 industry sponsored abstracts regarding Genmab programs scheduled for presentation at ASCO Annual Meeting
  • One oral presentation, three poster discussion sessions and seven poster presentations

Copenhagen, Denmark; April 25, 2018 – Genmab A/S (Nasdaq Copenhagen: GEN) announced today that nine industry sponsored daratumumab abstracts, one industry sponsored ofatumumab abstract and one tisotumab vedotin abstract have been accepted for presentation at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 1-5. The daratumumab abstracts, submitted by Janssen Research & Development, LLC, include an oral presentation of a subgroup analysis of the MMY1001 (EQUULEUS) trial, two poster discussion sessions regarding the PAVO (MMY1004) and ANDROMEDA (AMY3001) studies, as well as trial in progress poster presentations on multiple other Phase III trials. These include SMM3001 (AQUILA) in smoldering multiple myeloma and MMY3012 (COLUMBA), the study comparing subcutaneous with intravenous daratumumab administration. In addition there are two posters on MMY3007 (ALCYONE) in patients with newly diagnosed multiple myeloma.  One abstract on ofatumumab maintenance treatment in relapsed chronic lymphocytic leukemia (CLL), sponsored by Novartis, will be presented in a poster discussion session. One abstract regarding the Phase II study of tisotumab vedotin in cervical cancer was also accepted for a trial in progress poster presentation. The titles of the abstracts are currently available on the ASCO iPlanner website, with the full abstracts scheduled to be published on May 16, 2018.

“We are pleased with the selection of these abstracts for presentation at this year’s ASCO meeting in Chicago. Attendees of this prestigious conference will be able to view for themselves both some of the very exciting data generated by these products, as well as additional information on a variety of currently running key clinical trials,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

List of Industry Sponsored Abstracts:

Daratumumab:

Daratumumab in Combination with Carfilzomib and Dexamethasone in Lenalidomide-refractory Patients with Relapsed Multiple Myeloma: Subgroup Analysis of MMY1001 – Oral presentation, Friday, June 1, 3:09 PM – 3:21 PM CDT

Subcutaneous Daratumumab Plus Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Amyloid Light Chain (AL) Amyloidosis: Safety Run-in Results of ANDROMEDA (AMY3001) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Subcutaneous Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: Part 2 Update of the Open-label, Multicenter, Dose Escalation Phase 1b Study (PAVO) (MMY1004) – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Phase 3 Study of Subcutaneous Daratumumab Versus Active Monitoring in Patients with High-risk Smoldering Multiple Myeloma: AQUILA (SMM3001) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA (MMY3012) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Pomalidomide and Dexamethasone with or without Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma: a Multicenter, Randomized, Phase 3 Study (APOLLO) (MMY3013) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Randomized, Open-label, Phase 2/3 Study of Daratumumab with or without JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, in Relapsed/Refractory Multiple Myeloma (MMY2036) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Daratumumab Plus Bortezomib-Melphalan-Prednisone (VMP) in Elderly (≥75 y) Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplantation (ALCYONE) (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Improved Health-related Quality of Life for Patients with Newly Diagnosed Multiple Myeloma who are Ineligible for Stem Cell Transplantation: Results from the ALCYONE Trial (MMY3007) – Poster presentation, Monday, June 4, 8:00 AM – 11:30 AM CDT

Tisotumab vedotin

A single arm, Phase 2, multicenter, international trial of tisotumab vedotin (HuMax-TF ADC) in previously treated, recurrent or metastatic cervical cancer – Poster presentation, Monday, June 4, 1:15 PM – 4:45 PM CDT

Ofatumumab

Role of ofatumumab maintenance treatment in relapsed CLL: Final analysis of PROLONG study – Poster discussion session, Monday, June 4, 8:00 AM – 11:30 AM

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: 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®; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.

Media Release no. 02

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Attachment

Vedhæftet fil: i02_ASCO 2018_250418.pdf

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