The Danish biotechnology company, Genmab, have announced that the Phase III trial, ALCYONE, has achieved its primary endpoint of improving progression-free survival in newly diagnosed myeloma patients. This study compared daratumumab (Darzalex®) in combination with bortezomib (Velcade®), melphalan and prednisone (VMP) to VMP alone. Treatment including daratumumab was demonstrated to reduce the risk of disease progression and death by 50% when compared to treatment with VMP alone. The data are expected to be submitted to regulatory authorities soon.
Daratumumab is currently being assessed for use on the NHS by UK drug appraisal bodies for relapsed and refractory myeloma patients, both as a monotherapy and in combination with lenalidomide (Revlimid®) and bortezomib.