On November 21, 2017 Genmab A/S (Nasdaq Copenhagen: GEN) reported that data from the Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) versus VMP alone treating newly diagnosed multiple myeloma patients who are ineligible for autologous stem cell transplantation (ASCT), which was submitted by our collaboration partner Janssen Biotech, Inc., was accepted as a late-breaking abstract for oral presentation at the 59th Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) (Press release, Genmab, NOV 21, 2017, View Source [SID1234522193]). The abstract is published online on the ASH (Free ASH Whitepaper) website: www.hematology.org.
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This data will be presented as part of the Late-Breaking Abstracts Session on December 12, 2017 at 8:15 AM EST (2:15 PM CET).
"We are very pleased that the exciting ALCYONE data in front line multiple myeloma has been chosen as one of the Late-Breaking abstracts to be presented at this year’s prestigious ASH (Free ASH Whitepaper) annual meeting, which shows that treatment with daratumumab reduced the risk of disease progression or death by 50%, compared to those in the study who did not receive daratumumab" said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
About the study
This Phase III study (NCT02195479) is a randomized, open-label, multicenter study and includes 706 newly diagnosed patients with multiple myeloma who are ineligible for autologous stem cell transplantation (ASCT). Patients were randomized to receive 9 cycles of either daratumumab combined with VMP [bortezomib (a proteasome inhibitor), melphalan (an alkylating chemotherapeutic agent) and prednisone (a corticosteroid)], or VMP alone. In the daratumumab treatment arm, patients received 16 mg/kg of daratumumab once weekly for six weeks (cycle 1; 1 cycle = 42 days), followed by once every three weeks (cycles 2-9). Following the 9 cycles, patients in the daratumumab treatment arm continued to receive 16 mg/kg of daratumumab once every four weeks until disease progression. The primary endpoint of the study is progression free survival (PFS).