Genmab partner Janssen Biotech is planning to initiate a new Phase III trial of daratumumab to treat patients with multiple myeloma in the fourth quarter of 2014.
The trial will compare daratumumab in combination with bortezomib, melphalan and prednisone to bortezomib, melphalan and prednisone alone as frontline treatment for patients who are not considered candidates for stem cell transplantation (SCT).
Genmab chief executive officer Jan van de Winkel said: "We are very pleased to announce the plans for the third Phase III study of daratumumab.
"The robust development programme we designed jointly with Janssen continues moving forward rapidly."
The Phase III trial will include appoximately 700 newly diagnosed, chemotherapy naive multiple myeloma patients ineligible for stem cell transplantation (SCT).
During the trial, patients will receive either daratumumab combined with bortezomib, melphalan and prednisone, or bortezomib, melphalan and prednisone alone.
The primary endpoint of the randomised, open-label, multicenter Phase III trial is progression free survival (PFS).
Bortezomib is a unique type of chemotherapy, called a proteasome inhibitor (PI), while melphalan is an alkylating chemotherapeutic agent.
Daratumumab is a human CD38 monoclonal antibody with broad-spectrum killing activity and is currently in clinical development for multiple myeloma (MM).
It targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.
The product 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 granted breakthrough therapy designation for daratumumab.
In August 2012, Genmab granted Janssen Biotech an exclusive worldwide license to develop and commercialise daratumumab.
Image: Micrograph of a plasmacytoma, the histologic correlate of plasma cell myeloma. Photo: courtesy of Nephron.