Genmab A/S, a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer, announced that its partner, Janssen Biotech, Inc. (Janssen) will start a phase III study of daratumumab in relapsed or refractory multiple myeloma. The study will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.
"The daratumumab development programme is progressing very well. We are extremely pleased to be able to announce that this study evaluating daratumumab in combination with a core multiple myeloma treatment regime will initiate patient recruitment in the coming months," said Jan van de Winkel, chief executive officer of Genmab.
This phase III study will include approximately 500 patients who have relapsed or refractory multiple myeloma. Patients will be randomized to receive either daratumumab combined with lenalidomide and dexamethasone, or lenalidomide and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity. Daratumumab is in clinical development for multiple myeloma (MM). Daratumumab targets the CD38 molecule which is highly expressed on the surface of multiple myeloma cells. Daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukaemia, plasma cell leukaemia, acute myeloid leukaemia, follicular lymphoma and mantle cell lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop and commercialize daratumumab.