On 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) (Free ASCO Whitepaper) Annual Meeting in Chicago, June 1-5 (Press release, Genmab, APR 25, 2018, View Source [SID1234525692]). 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 (Free ASCO Whitepaper) iPlanner website, with the full abstracts scheduled to be published on May 16, 2018.
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"We are pleased with the selection of these abstracts for presentation at this year’s ASCO (Free ASCO Whitepaper) 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