Genmab Announces Data to be Presented at 2019 ASH Annual Meeting

November 6, 2019 at 3:19 PM CET
Supporting Materials:

Media Release

Copenhagen, Denmark, November 6, 2019

  • 37 abstracts on Genmab owned and partnered programs scheduled for presentation at ASH
  • Initial dose-escalation data from ongoing Phase I DuoBody®-CD3xCD20 (GEN3013) trial accepted for oral presentation
  • Daratumumab featured in seven oral presentations with a total of 34 accepted abstracts, including ISS


Genmab A/S (Nasdaq: GMAB) announced today that 37 abstracts related to Genmab owned and partnered programs were accepted for presentation at the 61st American Society of Hematology (ASH) Annual Meeting taking place December 7-10 in Orlando, Florida.
Abstracts accepted for presentation include preliminary dose-escalation data from the ongoing Phase I trial of DuoBody-CD3xCD20 (GEN3013) in B-cell non-Hodgkin lymphomas, which will be presented during an oral session of the conference. Accepted abstracts also include pre-clinical data from Genmab’s next generation CD38 antibody, HexaBody-CD38, and updates on multiple daratumumab clinical trials.

All abstracts are available on the ASH website at www.hematology.org. Details regarding the key abstracts to be presented are included below.

“2019 has been a banner year for Genmab as we advance our proprietary pipeline into the clinic, and we look forward to ending the year on a high note with two key firsts; the first presentation of dose-escalation data from DuoBody-CD3xCD20 and the first presentation of pre-clinical data from HexaBody-CD38,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “We are also very pleased to see that, once again, a significant number of daratumumab abstracts were accepted for presentation at the prestigious ASH conference, as this underscores our confidence in the wide potential of daratumumab.”

Late breaking abstracts are not yet available.

On December 9 at 8:00 PM EST (2:00 AM CET / 1:00 AM GMT on 10 December) Genmab will hold its 2019 R&D Update and ASH Data Review in Orlando, Florida. The event will be webcast live and details, including the webcast link, may be found on Genmab’s website in early December. This meeting is not an official program of the ASH Annual Meeting.

Genmab Abstracts

First-in-Human, Phase 1/2 Trial to Assess the Safety and Clinical Activity of Subcutaneous GEN3013 (DuoBody®-CD3×CD20) in B-cell Non-Hodgkin Lymphomas – Oral presentation, Monday, December 9

DuoBody-CD3xCD20 induces potent anti-tumor activity in malignant lymph node B cells from patients with DLBCL, FL and MCL ex vivo, irrespective of prior treatment with CD20 monoclonal antibodies – Poster presentation, Monday, December 9

Hexabody-CD38, a Novel CD38 Antibody with a Hexamerization Enhancing Mutation, Demonstrates Enhanced Complement-Dependent Cytotoxicity and Shows Potent Anti-Tumor Activity in Preclinical Models of Hematological Malignancies – Poster presentation, Sunday, December 8

Daratumumab Abstracts Sponsored by Janssen Biotech, Inc.

Oral Presentations:

Daratumumab Plus Bortezomib, Melphalan and Prednisone Versus Bortezomib, Melphalan and Prednisone in Patients with Transplant-ineligible Newly Diagnosed Multiple Myeloma: Overall Survival in ALCYONE– Oral presentation, Monday, December 9

Daratumumab Maintenance Therapy Improves Depth of Response and Results in Durable Progression-free Survival Following Daratumumab plus Cyclophosphamide, Bortezomib and Dexamethasone Induction Therapy in Multiple Myeloma: Update of the LYRA Study– Oral presentation, Monday, December 9

Depth of Response to Daratumumab, Lenalidomide, Bortezomib, and Dexamethasone Improves Over Time in Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma: GRIFFIN Study Update - Oral presentation, Monday, December 9

Evaluation of the Prognostic Value of Positron Emission Tomography-Computed Tomography at Diagnosis and Follow-up in Transplant-eligible Newly Diagnosed Multiple Myeloma Patients Treated in the Phase 3 CASSIOPEIA Study: Results of the CASSIOPET Companion Study – Oral presentation, Monday, December 9

Poster Presentations:
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) – Poster presentation, Saturday, December 7

Daratumumab Plus Lenalidomide and Dexamethasone Versus Lenalidomide and Dexamethasone in Patients with Newly Diagnosed Multiple Myeloma Ineligible for Transplant: Updated Analysis of MAIA – Poster presentation, Saturday, December 7

Final Analysis of a Phase 1b Study of Daratumumab in Combination with Carfilzomib and Dexamethasone for Relapsed or Refractory Multiple Myeloma – Poster presentation, Saturday, December 7

Daratumumab Monotherapy for Patients with Relapsed or Refractory Natural Killer/T-cell Lymphoma, Nasal Type: Updated Results from an Open-label, Single-arm, Multicenter Phase 2 Study - Poster presentation, Saturday, December 7

Four-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 7

Daratumumab Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Treatment in Patients with Newly Diagnosed Multiple Myeloma after Frontline Autologous Stem Cell Transplant: Use of Minimal Residual Disease as a Novel Primary Endpoint in the Phase 3 AURIGA Study - Poster presentation, Saturday, December 7

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: Body Weight Subgroup Analysis of COLUMBA - Poster presentation, Saturday, December 7

Randomized, Open-Label, Non-inferiority, Phase 3 Study of Subcutaneous Versus Intravenous Daratumumab Administration in Patients with Relapsed or Refractory Multiple Myeloma: COLUMBA Update - Poster presentation, Saturday, December 7

Daratumumab Subcutaneous Delivery in Relapsed or Refractory Multiple Myeloma: Population Pharmacokinetics and Exposure-response Analysis - Poster presentation, Sunday, December 8

Subcutaneous Daratumumab Plus Standard Treatment Regimens in Patients with Multiple Myeloma Across Lines of Therapy: PLEIADES Study Update – Poster presentation, Sunday, December 8

Efficacy and Safety of Daratumumab, Bortezomib, and Dexamethasone Versus Bortezomib and Dexamethasone in First Relapse Patients with Multiple Myeloma: Four-Year Update of CASTOR - Poster presentation, Sunday, December 8

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. 13
CVR no. 2102 3884
LEI Code 529900MTJPDPE4MHJ122

Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V
Denmark

Attachment