The results from the Phase III ALCYONE trial have recently been published in The New England Journal of Medicine. The study compared daratumumab (Darzalex®) in combination with bortezomib (Velcade®), melphalan and prednisone (VMP) to VMP alone in newly diagnosed myeloma patients, ineligible for a stem cell transplant.
The results show that the 18-month progression-free survival rate for patients receiving daratumumab was 71.6%, compared to 50.2% for patients receiving VMP alone. Furthermore, the overall response rate for patients receiving daratumumab was 90.9% compared to 73.9% in the control group. Finally, among the patients receiving daratumumab, 23.3% achieved minimum disease residue (MRD) negativity, compared to 6.2% of patients receiving VMP only.
The study found that treatment with daratumumab was associated with a slightly higher incidence of grade 3 or 4 haematologic side-effects and infection, and 27.7% of patients receiving daratumumab experienced infusion-related reactions.