On November 10, 2014 Genmab reported that the French Intergroup of Myeloma (IFM) in collaboration with Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Biotech, Inc. (Janssen) plans to start an additional Phase III study of daratumumab in frontline multiple myeloma (Press release Genmab, NOV 10, 2014, View Source [SID:1234500941]). The study (MMY3006) will compare daratumumab in combination with bortezomib, thalidomide and dexamethasone (VTD) to bortezomib, thalidomide and dexamethasone alone as front line treatment for patients who are candidates for stem cell transplantation (SCT). The study is planned to start in Q2 2015. The first Phase III study in front line multiple myeloma was announced in July and is expected to start towards the end of this year, with the two other Phase III front line studies to start next year. In total today’s news is the fifth daratumumab Phase III study to be announced.
“The daratumumab development plan is progressing at a very fast pace and we are very pleased to announce yet another Phase III study. The expansive development program covers different stages of multiple myeloma, and this will be the third Phase III study to enroll patients newly diagnosed with the disease,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.