Genmab Announces Another Phase 3 Study Of Daratumumab In Multiple Myeloma
By C. Rajan, contributing writer
Genmab announced last week that its collaboration partner, Janssen Biotech, will start a new Phase 3 study of daratumumab in multiple myeloma. This study (MMY3008) will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone as front line treatment for multiple myeloma patients who are not candidates for stem cell transplantation (SCT).
The study is expected to begin the first half of 2015. The company originally announced that the first Phase 3 study for daratumumab in July and is expected to launch the study towards the end of this year. This latest announcement is the fourth daratumumab Phase 3 study to be announced.
"This new study of daratumumab in front line multiple myeloma is part of the extensive development plan created under our collaboration with Janssen Biotech for our CD38 antibody daratumumab," said Jan van de Winkel, Ph.D., CEO of Genmab.
This Phase 3 study will be a randomized, multicenter study which will include about 700 newly diagnosed multiple myeloma patients who have not received chemotherapy and are ineligible for stem cell transplantation (SCT). Randomized patients will receive either daratumumab combined with lenalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone. The primary endpoint of the study is progression free survival (PFS).
Daratumumab has been granted Breakthrough Therapy Designation from the U.S. FDA. Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity, and 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 be a potential treatment for other cancers in which CD38 is expressed, including several types of leukemia and lymphoma.
Multiple myeloma is the second most common form of blood cancer, which develops in the bone marrow due to abnormal plasma cells. There are approximately 70,000 people in the U.S. living with multiple myeloma, with about 24,000 new cases diagnosed annually. Globally, about 230,000 people are living with multiple myeloma, with an additional 114,000 new cases being diagnosed annually.
In August 2012, Genmab signed a $1.1 billion deal with Janssen (one of the Johnson and Johnson companies) which granted Janssen the exclusive worldwide license to develop and commercialize daratumumab, as well as a backup human CD38 antibody. Under the terms of the agreement, Janssen will be fully responsible for all costs associated with developing and commercializing daratumumab, including the costs of the clinical trials.