Amgen: Lancet Oncology publishes survival analysis from KYPROLIS Phase 3 trial
Amgen announced that results from an overall survival analysis of the Phase 3 head-to-head ENDEAVOR trial were published online first in The Lancet Oncology. Data showed that KYPROLIS administered at 56 mg/m2 twice weekly and dexamethasone reduced the risk of death by 21% over Velcade and dexamethasone, resulting in a 7.6 month OS benefit (median OS 47.6 months for Kd56 versus 40.0 for Vd, HR=0.79; 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). This Kd56 regimen is already approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival in the ENDEAVOR study. "These results showed KYPROLIS and dexamethasone significantly reduced the risk of death compared to Velcade and dexamethasone in patients with relapsed or refractory multiple myeloma," said study co-author and investigator Meletios A. Dimopoulos, M.D., professor of Clinical Therapeutics at the National and Kapodistrian University of Athens, School of Medicine. "These results support the use of KYPROLIS and dexamethasone as a standard of care for multiple myeloma patients at first relapse."