Daratumumab Combination Approved by FDA in Resistant Multiple Myeloma
Posted: Monday, August 24, 2020
On August 20, 2020, the U.S. Food and Drug Administration (FDA) approved daratumumab (Darzalex) in combination with carfilzomib (Kyprolis) and dexamethasone (DKd) in the treatment of adults with relapsed or refractory multiple myeloma who have received one to three previous lines of therapy. Daratumumab has been approved in combination with two carfilzomib dosing regimens, 70 mg/m2 once weekly and 56 mg/m2 twice weekly, based on results from the phase III CANDOR and phase Ib EQUULEUS trials, representing the first approval of an anti-CD38 with carfilzomib.
“The significant increase in progression-free survival seen among patients receiving the DKd regimen supports the use of this new combination for patients with relapsed and refractory multiple myeloma,” said Saad Z. Usmani, MD, Division Chief of Plasma Cell Disorders at Atrium Health's Levine Cancer Institute and principal investigator of the CANDOR study. “The DKd regimen fills an important gap in the treatment landscape, as many patients may relapse following an immunomodulatory drug–based therapy, such as lenalidomide-containing regimens, and therefore new therapeutic options are needed.”
In the CANDOR trial, which administered carfilzomib twice weekly, the median progression-free survival had not been reached in the DKd arm and was 15.8 months in the carfilzomib plus dexamethasone arm (hazard ratio = 0.63; 95% confidence interval = 0.46–0.85; P = .0014). This represented a 37% reduction in the risk of disease progression or death with the daratumumab combination. In addition, the DKd regimen was supported by results from the EQUULEUS trial, which administered carfilzomib once weekly. In this study, daratumumab was evaluated in combination with various treatment regimens.
