Janssen Biotech to start second Phase III myeloma trial of daratumumab in H1 2015

12th August 2014 (Last Updated August 12th, 2014 18:30)

Danish biotechnology firm Genmab's collaboration partner Janssen Biotech is planning to initiate a second Phase III trial (MMY3008) of daratumumab for the treatment of patients with multiple myeloma.

Danish biotechnology firm Genmab's collaboration partner Janssen Biotech is planning to initiate a second Phase III trial (MMY3008) of daratumumab for the treatment of patients with multiple myeloma.

Scheduled to start in the first half of 2015, the trial is designed to compare daratumumab in combination with lenalidomide and dexamethasone to lenalidomide and dexamethasone alone for patients who are not considered candidates for stem cell transplantation (SCT).

Daratumumab, a human CD38 monoclonal antibody with broad-spectrum killing activity, targets the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells.

The company said that the first Phase III trial in front-line multiple myeloma was announced in July and is expected to start towards the end of this year.

The trial will enrol about 700 newly diagnosed, chemotherapy naïve multiple myeloma patients ineligible for SCT.

"The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for daratumumab."

During the trial, patients will be randomised to receive either daratumumab combined with lenalidomide (an immunomodulatory agent) and dexamethasone (a corticosteroid) or lenalidomide and dexamethasone alone.

The primary endpoint of the randomised, open-label, multicentre Phase III trial is progression free survival (PFS).

Genmab CEO Jan van de Winkel said: "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."

According to the company, daratumumab may also have potential in other cancers on which CD38 is expressed, including diffuse large B-cell lymphoma, chronic lymphocytic leukaemia, acute lymphoblastic leukaemia, plasma cell leukaemia, acute myeloid leukaemia, follicular lymphoma and mantle cell lymphoma.

The US Food and Drug Administration (FDA) has granted breakthrough therapy designation for daratumumab.

In August 2012, Janssen Biotech secured an exclusive worldwide license to develop and commercialise daratumumab for Genmab.