Amgen’s research: when a patient relapses, KYPROLIS should replace Velcade

Amgen posted positive results from a post-hoc analysis requested by the U.S. Food and Drug Administration (FDA) of the Phase 3 head-to-head ENDEAVOR trial, which followed patients for at least three 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 percent over Vd (median OS 47.8 months for Kd versus 38.8 months for Vd, HR=0.76, 95 percent CI, 0.63-0.92; p=0.0017). This Kd regimen is currently approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival in the ENDEAVOR study, Amgen said.

Robert Orlowski, a cancer research professor said that 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. He said that 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.

Sean E. Harper, executive vice president of Research and Development at Amgen, 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. These results confirm that when a patient relapses, KYPROLIS should replace Velcade as a standard-of-care.”