Genmab reports 'positive' topline results from Phase 3 CASSIOPEIA study

Genmab (GMAB) announced positive topline results from the second part of the Phase 3 CASSIOPEIA study of daratumumab monotherapy as maintenance treatment versus observation for patients with newly diagnosed multiple myeloma eligible for autologous stem cell transplant. The second part of the study, which is being conducted by the French Intergroupe Francophone du Myelome in collaboration with the Dutch-Belgian Cooperative Trial Group for Hematology Oncology and Janssen Research & Development, LLC (JNJ), met the primary endpoint of improving progression free survival at a pre-planned interim analysis resulting in a 47% reduction in the risk of progression or death in patients treated with daratumumab. The safety profile observed in this study was consistent with the known safety profile of daratumumab and no new safety signals were observed. Based on the results at the pre-planned interim analysis conducted by an Independent Data Monitoring Committee, it was recommended to unblind the study results. Janssen Biotech, Inc., which licensed daratumumab from Genmab in 2012, plans to discuss the potential for a regulatory submission for this indication with health authorities, and plans to submit the data to an upcoming medical conference and for publication in a peer-reviewed journal. "Following the positive data from the first part of the CASSIOPEIA study, we are very pleased to see this benefit. We are appreciative of the efforts of the IFM, of HOVON and of Janssen for their work on this study," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.