Phase III study confirms Kyprolis regimen extends overall survival In patients with relapsed multiple myeloma
ENDEAVOR study long-term data show Kyprolis and dexamethasone reduced the risk of death by 24% versus Velcade and dexamethasone.
Amgen has announced positive results from a post-hoc analysis requested by the FDA of the Phase III head-to-head ENDEAVOR trial, which followed patients for at least 3 years after enrollment. The analysis evaluated overall survival (OS) and long-term safety of Kyprolis (carfilzomib) administered at 56 mg/m2 twice weekly and dexamethasone (Kd) versus Velcade (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma. Kd reduced the risk of death by 24% over Vd (median OS 47.8 months for Kd versus 38.8 months for Vd). This Kd regimen is currently approved in the US, European Union and other countries based on the primary analysis of progression-free survival in the ENDEAVOR study.
"For physicians making prescribing decisions, long-term follow-up helps to further support the safety and efficacy of a therapy and instills confidence in the treatment," said Robert Orlowski, Florence Maude Thomas Cancer Research professor and chair, ad interim, Department of Lymphoma & Myeloma at The University of Texas MD Anderson Cancer Center. "The current three-year follow-up analysis demonstrates that this proteasome inhibitor continues to demonstrate a prolonged overall survival benefit and consistent safety profile when combined with dexamethasone for relapsed multiple myeloma patients."
"We are excited about the 3-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," said Sean E. Harper, executive vice president of R&D at Amgen. "These results confirm that when a patient relapses, Kyprolis should replace Velcade as a standard-of-care."
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