Amgen has reported that the primary analysis of the Phase III CANDOR study of Kyprolis in combination with dexamethasone and Darzalex met its primary endpoint in patients with relapsed or refractory multiple myeloma.
The study’s primary endpoint was progression-free survival (PFS).
The combination also demonstrated efficacy in key secondary endpoints, including overall response rate (ORR), minimal residual disease (MRD) and overall survival.
A total of 466 relapsed or refractory multiple myeloma patients were evaluated in the randomised, open-label Phase III CANDOR study of Kyprolis, dexamethasone and Darzalex (KdD) compared to Kyprolis and dexamethasone (Kd).
The study met its primary endpoint at a median follow up of 17 months, resulting in a 37% reduction in the risk of disease progression or death in patients receiving KdD.
Furthermore, the analysis found that the MRD-negative complete response rate was 12.5% for KdD at 12 months versus 1.3% for Kd (p<0.0001), a nearly ten times higher response rate versus Kd-treated patients.
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Amgen Research and Development executive vice-president David Reese said: “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.
“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.”
Subjects were given Kyprolis two times in a week at 56mg/m² and dexamethasone in combination with Darzalex in the first arm.
In the control arm, Kyprolis was given twice weekly at 56mg/m² and dexamethasone.
CANDOR was initiated as part of a partnership with Janssen, which co-funded the study.
In October 2017, Amgen reported positive top-line results from Phase III ARROW clinical trial of Kyprolis (carfilzomib) in combination with dexamethasone for patients with relapsed and refractory multiple myeloma.