Janssen has announced results from a two late-stage studies highlighting the potential benefit of Darzalex in a range of patients with multiple myeloma.
The Phase III ALCYONE study showed that the addition of Darzalex (daratumumab) to bortezomib, melphalan and prednisone (D-VMP) improved overall survival (OS) in patients with newly diagnosed, transplant-ineligible multiple myeloma, with a 40% reduction in the risk of death compared to VMP alone.
Results showed – after a median duration of follow-up of more than three years – an estimated 42-month OS rate of 75% for Darzalex-VMP versus 62% for VMP, marking a statistically significant difference.
Meanwhile, the Phase III CANDOR study, which was co-funded by Amgen, showed that adding Darzalex to carfilzomib (Kyprolis) and dexamethasone (DKd), compared to carfilzomib and dexamethasone (Kd) alone, significantly improved progression-free survival (PFS) in patients with relapsed/refractory multiple myeloma, resulting in a 37 percent reduction in the risk of progression or death.
The data “reinforce the growing body of evidence supporting the use of daratumumab-containing regimens in the treatment of multiple myeloma," said Saad Z. Usmani, division Chief of Plasma Cell Disorders, Levine Cancer Institute, and principal investigator.
The data were presented at the 2019 American Society of Hematology (ASH) Annual Meeting.