Amgen (NASDAQ:AMGN) today announced additional results from the primary analysis of the Phase 3 CANDOR study evaluating KYPROLIS® (carfilzomib) in combination with dexamethasone and DARZALEX® (daratumumab) (KdD) compared to KYPROLIS and dexamethasone alone (Kd) in patients with relapsed or refractory multiple myeloma. The data will be presented in a late-breaking abstract session at the 61st American Society of Hematology (ASH) Annual Meeting & Exposition.
At a median follow up of 17 months, the study met its primary endpoint of progression-free survival (PFS), resulting in a 37% reduction in the risk of disease progression or death in patients receiving KdD (HR=0.63; 95% CI: 0.464, 0.854; p=0.0014). Median PFS was not reached for the KdD arm versus 15.8 months for the Kd arm.
“This primary analysis of the CANDOR study adds to the body of evidence supporting the combination of KYPROLIS and DARZALEX, two powerful targeted agents for multiple myeloma,” said David M. Reese, M.D., executive vice president of Research and Development at Amgen. “KYPROLIS has demonstrated deep and sustained responses in treating patients with multiple myeloma that have relapsed. The CANDOR study now offers additional insight into the effectiveness of this combination as a potential new treatment option for relapsed myeloma patients.”
In addition to meeting the primary endpoint, the KdD combination demonstrated efficacy in key secondary endpoints, including overall response rate (ORR), minimal residual disease (MRD) negative-complete response at 12 months and overall survival (OS). The ORR was 84.3% versus 74.7% (p=0.0040), and the rate of complete response or better was 28.5% versus 10.4% for the KdD and Kd arms, respectively. The analysis found the MRD-negative complete response rate at 12 months was 12.5% for KdD versus 1.3% for Kd (p<0.0001), a nearly 10-times higher response rate versus Kd-treated patients. The median OS was not reached in either group (HR=0.75; 95% CI: 0.49, 1.13; p=0.08).
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