Kyprolis (carfilzomib)+ dexamethasone superior to Velcade (bortezomib) + dexamethasone for relapsed or refractory multiple myeloma according to Phase III head-to-head ENDEAVOR trial.-Amgen

Amgen announced positive results from a planned overall survival (OS) interim analysis of the Phase III head-to-head ENDEAVOR trial. The study met the key secondary endpoint of OS, demonstrating that patients with relapsed or refractory multiple myeloma treated with Kyprolis (carfilzomib) and dexamethasone (Kd) lived 7.6 months longer than those treated with Velcade (bortezomib) and dexamethasone (Vd) (median OS 47.6 months for Kd versus 40.0 for Vd, HR=0.79; 95 percent CI: 0.65 - 0.96; p=0.01). The OS benefit was consistent regardless of prior Velcade therapy (HR 0.75 for no prior Velcade; HR 0.84 for prior Velcade). These data will be presented today during the late-breaking abstract session at the 16th International Myeloma Workshop (IMW) in New Delhi.

"Results from the ENDEAVOR primary analysis proved Kyprolis is the superior proteasome inhibitor, having doubled progression-free survival compared to Velcade," said Meletios A. Dimopoulos , M.D., professor of Clinical Therapeutics at the National and Kapodistrian University of Athens , School of Medicine. "Results presented today showed that progression-free survival advantage translated into significantly improved survival for patients, a clinical endpoint that creates confidence for physicians and patients, especially in a relapsing disease like multiple myeloma."