Denmark-based biotechnology firm Genmab has announced that its partner, Janssen Biotech (Janssen) will initiate a Phase III trial of daratumumab for treatment of patients with relapsed or refractory multiple myeloma (MM).
Around 500 patients who have relapsed or refractory MM will be enrolled in the Phase III trial, which will compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone.
Patient enrolment is scheduled to start in the coming months and the primary endpoint of the trial is progression free survival (PFS).
Genmab chief executive officer Jan van de Winkel said: "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."
In the trial, patients will be randomised to receive either daratumumab combined with lenalidomide and dexamethasone, or lenalidomide and dexamethasone alone.
Daratumumab, which is a human CD38 monoclonal antibody with broad-spectrum killing activity, is currently in clinical development for MM.
It targets the CD38 molecule which is highly expressed on the surface of MM cells.
The company said that daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, plasma cell leukemia, acute myeloid leukemia, follicular lymphoma and mantle cell lymphoma.
The US Food and Drug Administration (FDA) has already granted Breakthrough Therapy Designation for daratumumab.
Janssen Biotech received exclusive worldwide license to develop and commercialise daratumumab from Genmab in August 2012.
Genmab specialises in the creation and development of differentiated human antibody therapeutics for the treatment of cancer.
The company’s validated and next generation antibody technologies are expected to provide a steady stream of future product candidates.
Image: Micrograph of a plasmacytoma, the histologic correlate of multiple myeloma. Photo: courtesy of Nephron.