Amgen has reported positive data from a long-term analysis of the Phase III ENDEAVOR trial of Kyprolis (carfilzomib) for the treatment of relapsed or refractory multiple myeloma.
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Requested by the US Food and Drug Administration (FDA), the post-hoc analysis included overall survival (OS) and long-term safety evaluation of twice weekly 56mg/m² Kyprolis and 20mg of dexamethasone combination (Kd), compared to Velcade (bortezomib) and dexamethasone combination (Vd).
Kyprolis is being developed to cause myeloma cell death by blocking proteins and leading to an increased build-up of proteins within the cells.
The analysis showed that Kd decreased the risk of death by 24% and increased the survival period by nine months, while the adverse events were found to be consistent with the prior ENDEAVOR data.
Amgen research and development executive vice-president Sean Harper said: "We are excited about the three-year follow-up of the ENDEAVOR study, as the overall survival benefit reflects both the efficacy and the long-term safety of this Kyprolis regimen in patients with relapsed multiple myeloma.
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By GlobalData"These results confirm that when a patient relapses, Kyprolis should replace Velcade as a standard-of-care."
The randomised, open-label Phase III ENDEAVOR trial evaluated Kd in 929 subjects who had relapsed after a minimum of one but not more than three previous treatments.
ENDEAVOR’s primary endpoint was progression-free survival (PFS), which was measured as the time from initiation of treatment to disease progression or death.
The trial was performed at 235 centres and involved administration of Kyprolis regimen as a 30-minute infusion in 28-day treatment cycles, while bortezomib was given through subcutaneous or intravenous route.
Based on the primary analysis of progression-free survival in the ENDEAVOR trial, the Kd regimen is currently approved in various countries such as the US and the European Union.
Image: Skull X-ray of a patient with multiple myeloma. Photo: courtesy of James Heilman.
