Darzalex, which is being developed jointly by Genmab and Janssen Biotech, is a human IgG1k monoclonal antibody that binds to CD38, a protein expressed on the surface of several immune cells.
It is approved for patients whose prior therapy included a proteasome inhibitor (PI) and an immunomodulatory agent and who have shown disease progression on the last therapy.
The approval was based on data from the phase 2 MMY2002 SIRIUS study; the phase 1/2 GEN501 study, and data from three other supportive studies.
A combined analysis from the MMY2002 and GEN501 trials identified that at a mean follow-up of 14.8 months, the estimated median overall survival was 20 months with daratumumab (16 mg/kg) monotherapy in heavily pretreated patients with myeloma.
The overall response rate in this population was 31% and 83% of patients achieved at least stable disease.
In August 2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop, manufacture and commercialize Darzalex.
Five phase III clinical trials with daratumumab in relapsed and frontline settings are being carried out at present.
Further studies are ongoing or planned to evaluate the drug’s potential in other malignant and pre-malignant diseases on which CD38 is expressed, including smoldering myeloma, non-Hodgkin’s lymphoma and a solid tumor.
Darzalex is believed to induce tumor cell death via apoptosis, in which a series of molecular steps in a cell lead to its death.
Image: Genmab Copenhagen office. Photo: courtesy of Lars Møller, Jeroen Bouman, Marieke de Lorijn.