On November 5, 2015 Genmab A/S (OMX: GEN) reported that 14 daratumumab and 5 ofatumumab abstracts have been accepted for presentation at the 57th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition December 5-8 in Orlando, Florida (Press release, Genmab, NOV 5, 2015, View Source [SID:1234508008]). The abstracts are available on the ASH (Free ASH Whitepaper) website at www.hematology.org.
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"We are delighted that daratumumab will be featured in three oral presentations at the 2015 ASH (Free ASH Whitepaper) Annual Meeting. We are particularly looking forward to the presentation of the updated data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or relapsed and refractory multiple myeloma and the poster presentation describing previously unknown immunomodulatory effects of daratumumab," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "Data from the Phase II study of daratumumab in patients with heavily pretreated relapsed or refractory multiple myeloma, the Phase I/II study of daratumumab in combination with lenalidomide and dexamethasone in patients with relapsed and refractory multiple myeloma will also be presented in oral sessions."
Daratumumab
Highlights
Clinical Efficacy of Daratumumab Monotherapy in Patients with Heavily Pretreated Relapsed or Refractory Multiple Myeloma — Oral presentation, Saturday, December 5
Daratumumab in Combination With Lenalidomide and Dexamethasone in Patients With Relapsed or Relapsed and Refractory Multiple Myeloma: Updated Results from a Phase 1/2 Study (GEN503) — Oral presentation, Monday, December 7
Immunomodulatory Effects and Adaptive Immune Response to Daratumumab in Multiple Myeloma — Poster presentation, Sunday, December 6
Open-label, Multicenter Phase 1b Study of Daratumumab in Combination with Pomalidomide and Dexamethasone in Patients with ≥2 Lines of Prior Therapy and Relapsed or Relapsed and Refractory Multiple Myeloma (MM) — Oral presentation, Monday, December 7
Other abstracts
Serum Proteomic Analysis of Multiple Myeloma Subjects Treated with Daratumumab Monotherapy — Poster presentation, Saturday, December 5
Management of Infusion-related Reactions Following Daratumumab Monotherapy in Patients with ≥3 Lines of Prior Therapy or Double Refractory Multiple Myeloma (MM): 54767414MMY2002 (Sirius) — Poster presentation, Saturday, December 5
Outcomes and Management of Red Blood Cell Transfusions in Multiple Myeloma Patients Treated with Daratumumab — Poster presentation, Monday, December 7
Understanding the Dose Regimen for Daratumumab in Patients with Relapsed or Refractory Multiple Myeloma after Prior Proteasome Inhibitors and Immunomodulatory Drugs: A Quantitative Pharmacologic Perspective — Poster presentation, Monday, December 7
Target-mediated Drug Disposition of Daratumumab Following Intravenous Infusion in Relapsed or Refractory Multiple Myeloma after Prior Proteasome Inhibitors and Immunomodulatory Drugs: A Population Pharmacokinetic Analysis — Poster presentation, Monday, December 7
Analyses of Real-World Data on Overall Survival in Multiple Myeloma Patients With ≥3 Prior Lines of Therapy Including a PI and an IMID, or Double Refractory to a PI and an IMID — Poster presentation, Monday, December 7
Treatment of Ex Vivo Expanded NK Cells with Daratumumab F(ab’)2 Fragments Protects Adoptively Transferred NK Cells from Daratumumab-mediated Killing and Augments Daratumumab-induced Antibody Dependent Cellular Toxicity (ADCC) of Myeloma — Poster presentation, Monday, December 7
Generation and characterization of microvesicles after Daratumumab interaction with myeloma cells — Poster presentation, Saturday, December 5
Expression Profile of CD38 And Related Ectoenzymes in Myeloma Bone Niche: A Rational Basis for the Use of Daratumumab to Inhibit Osteoclast Formation and Activity — Poster presentation, Sunday, December 6
International Validation of a Dithiothreitol (DTT)-based Method to Resolve the Daratumumab Interference with Blood Compatibility Testing — Poster presentation, Monday, December 7
Ofatumumab
Risk-adapted Induction and Maintenance with Ofatumumab in Previously Untreated Patients with CLL/SLL — Poster presentation, Saturday, December 5
A Phase II Study of Ofatumumab-High Dose Methyl-prednisolone Followed by Ofatumumab-Alemtuzumab in 17p Deleted or TP53 Mutated CLL — Poster presentation, Monday, December 7
A Phase II Study of Ofatumumab in Combination with a Pan-AKT Inhibitor (Afuresertib) in Previously Treated Patients with CLL —
Poster presentation, Saturday, December 5
A Phase II Study of Alemtuzumab-Ofatumumab (A+O) Combination in Patients with Previously Untreated CLL — An Update —
Poster presentation, Saturday, December 5
Sequential Therapy with Ofatumumab, High Dose Methyl-prednisolone and Lenalidomide Is a Safe and Effective Regimen for the Treatment of Previously Treated and Untreated CLL/SLL: The HiLO Trial — Poster presentation, Sunday, December 6
About daratumumab
Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms1, including complement-dependent cytotoxicity1, antibody-dependent cellular phagocytosis2 and antibody-dependent cellular cytotoxicity1, as well as via induction of apoptosis3 . Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.
About Ofatumumab (Arzerra)
Ofatumumab is a human monoclonal antibody that is designed to target the CD20 molecule found on the surface of chronic lymphocytic leukemia (CLL) cells and normal B lymphocytes.
In the United States, Arzerra is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate. In the European Union, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy. In more than 50 countries worldwide, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab.
Please see full Prescribing Information, including Boxed WARNING for Arzerra (ofatumumab).
Arzerra is marketed under a collaboration agreement between Genmab and Novartis.