Data presented by Janssen this week demonstrated that a Darzalex regimen significantly increased progression-free survival in patients with relapsed/refractory multiple myeloma.
Results from the Phase 3 Candor Study shows the addition of Darzalex (daratumumab) to carfilzomib (Kyprolis) and dexamethasone (DKd) compared to carfilzomib and dexamethasone (Kd) alone resulted in a 37% reduction in the risk of progression or death.
Compared to Kd alone, DKd resulted in significantly longer PFS rates and response rates. The primary endpoint was met after a median follow-up of 16.9 months and 16.3 months for the DKd and Kd arms, respectively.
“These data from the Phase 3 Candor study reinforce the growing body of evidence supporting the use of daratumumab-containing regimens in the treatment of multiple myeloma,” said principal investigator Saad Z. Usmani, Division Chief of Plasma Cell Disorders, Levine Cancer Institute.
“The results provide important evidence for this combination regimen in the relapsed and refractory setting, where there is still significant unmet need, especially among lenalidomide refractory patients.”
Candor is an Amgen-sponsored study and is co-funded by Janssen Research & Development. The study included patients who had received 1–3 prior lines of therapy for multiple myeloma.
Of the patients randomised in the study, 42% and 90% had previous exposure to lenalidomide and bortezomib, respectively; 33% were lenalidomide-refractory and 29% were bortezomib-refractory.