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Daratumumab Abstracts Selected for Presentation at 17th International Myeloma Workshop

Media Release


Copenhagen, Denmark, August 19, 2019

Thirteen Janssen-sponsored abstracts featuring daratumumab selected for presentation at the 17th International Myeloma Workshop (IMF)

Genmab A/S (Nasdaq:GMAB) announced today that 13 Janssen Research & Development, LLC (Janssen)-sponsored abstracts regarding daratumumab were accepted for presentation at the 17th International Myeloma Workshop, taking place in Boston, Massachusetts from September 12 to 15, 2019.
Data from the Phase II GRIFFIN study (MMY2004) and data from the Phase II PLEIADES (MMY2040) study were both accepted for presentation during oral sessions at the conference. The abstracts are available on the conference website and may be accessed via http://imw2019boston.org.

“We look forward to the first presentation of data from the Phase II PLEIADES and GRIFFIN studies and are pleased to see that key updates from the Phase III MAIA, CASSIOPEIA and COLUMBA studies, have all been selected for presentation at a prestigious medical conference,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Abstracts submitted by Janssen include:

Daratumumab, Lenalidomide, Bortezomib and Dexamethasone Improves Depth of Response in Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN - Oral presentation, Sunday, September 15, 8:45 AM EDT

Concordance of Post-consolidation Minimal Residual Disease Rates by Multiparametric Flow Cytometry and Next-generation Sequencing in CASSIOPEIA – Oral presentation, Friday, September 13,10:45 AM EDT

Daratumumab Plus Bortezomib, Thalidomide, and Dexamethasone in Transplant-eligible Newly Diagnosed Multiple Myeloma: Subgroup Analysis of High-risk Patients in CASSIOPEIA -Oral presentation, Friday, September 13, 10:30 AM EDT

Subcutaneous Daratumumab in Combination with Standard Multiple Myeloma (MM) Treatment Regimens: An Open-label, Multicenter Phase 2 Study (PLEIADES) – Oral presentation, Friday September 13, 1:45 PM EDT

Greater Treatment Satisfaction in Patients Receiving Subcutaneous Versus Intravenous Daratumumab for Relapsed or Refractory Multiple Myeloma: COLUMBA – Poster discussion presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

Results of the Daratumumab Monotherapy Early Access Treatment Protocol in Patients from Brazil with Relapsed or Refractory Multiple Myeloma - Poster discussion presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

Daratumumab, Lenalidomide, and Dexamethasone Delivers a Reduction and Delay in Worsening of Pain Symptoms for Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplant - Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Matching-adjusted Indirect Comparison of Bortezomib-Thalidomide-Dexamethasone and Daratumumab Plus Bortezomib-Thalidomide-Dexamethasone Versus Bortezomib-Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma who are Transplant Eligible - Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Matching-adjusted Indirect Comparison of Daratumumab-Bortezomib-Thalidomide-Dexamethasone Versus Bortezomib-Lenalidomide-Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma who are Transplant Eligible - Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Matching-adjusted Indirect Comparison of Bortezomib-Thalidomide-Dexamethasone and Daratumumab Plus Bortezomib-Thalidomide-Dexamethasone Versus Bortezomib-Cyclophosphamide-Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma who are Transplant Eligible - Poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

Subcutaneous Daratumumab Plus Carfilzomib and Dexamethasone in Relapsed/Refractory Multiple Myeloma: An Open-label, Multicenter, Phase 2 Study (PLEIADES) – Trial-in-progress poster presentation, Friday, September 13, 6:30 PM – 8:30 PM EDT

Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma After Frontline Transplant: A Multicenter, Randomized, Phase 3 Study (AURIGA) - Trial-in-progress poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

A Randomized Phase 2 Study of Subcutaneous Daratumumab Plus Carfilzomib/Dexamethasone Versus Carfilzomib/Dexamethasone Alone in Patients with Multiple Myeloma who have been Previously Treated with Intravenous Daratumumab to Evaluate Retreatment (LYNX) - Trial-in-progress poster presentation, Saturday, September 14, 12:30 PM – 2:00 PM EDT

In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

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 amyloidosis. 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, the HexElect® platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody® platform, which enhances the potential potency of bispecific antibodies through hexamerization. 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. Genmab is headquartered in Copenhagen, Denmark with core sites in Utrecht, the Netherlands and Princeton, New Jersey, U.S.


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 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 or technologies 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 and the risk factors included in Genmab’s final prospectus for our U.S. public offering and listing and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. 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
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