On November 6, 2019 Genmab A/S (Nasdaq: GMAB) reported that 37 abstracts related to Genmab owned and partnered programs were accepted for presentation at the 61st American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 7-10 in Orlando, Florida (Press release, Genmab, NOV 6, 2019, View Source [SID1234550464]). 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.
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All abstracts are available on the ASH (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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 (Free ASH Whitepaper) 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