Genmab A/S (OMX: GEN) announced that the French Intergroup of Myeloma (IFM) in collaboration with Dutch-Belgian Cooperative Trial Group for Hematology Oncology (HOVON) and Janssen Biotech, Inc. is planning an additional Phase III study of daratumumab in frontline multiple myeloma. The study 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.
The study is planned to start in the second quarter of 2015. The first Phase III study in front line multiple myeloma was announced in July and is expected to start near the end of this year, with the two other Phase III front line studies to start next year. This is the fifth daratumumab Phase III study to be announced.
“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.