Danish biotechnology firm Genmab is set to investigate the combination of daratumumab with pomalidomide and dexamethasone in its Phase III clinical trial to treat patients with relapsed and refractory multiple myeloma.
The trial will be conducted by Janssen Research and Development in partnership with the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON).
Daratumumab is a human IgG1k monoclonal antibody (mAb) with a high affinity for binding to the CD38 molecule expressed on the surface of multiple myeloma cells.
The product induces the body's immune system to cause tumour cell death by destroying the cancer cells.
Expected to begin in the coming months, the randomised, open-label, multi-centre Phase III trial will evaluate the combination therapy in 354 patients who received prior treatment with an immunomodulatory drug and a proteasome inhibitor (PI).
Designed to support the results obtained from the Phase I MMY1001 (EQUULEUS) trial, the Phase III trial's primary endpoint is progression-free survival (PFS).
Genmab chief executive officer Jan van de Winkel said: "The combination of daratumumab with pomalidomide and dexamethasone may represent a new approach for patients who have been previously treated with an immunomodulatory drug and a PI.
"We look forward to the readout of this study."
Under an exclusive worldwide licence with Genmab, Janssen Biotech holds the rights to develop, manufacture and commercialise daratumumab.
Daratumumab is currently being studied in five Phase III clinical trials for various multiple myeloma settings, with plans to initiate trials for the treatment of other conditions such as smoldering myeloma, NK/T-cell lymphoma, amyloidosis, myelodysplastic syndromes and solid tumours.