Results from an overall survival (OS) analysis of the Phase 3 head-to-head ENDEAVOR trial were published online first in The Lancet Oncology.

Data showed that carfilzomib administered at 56 mg/m2 twice weekly and dexamethasone reduced the risk of death by 21 percent over bortezomib 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 bortezomib therapy (HR=0.75 for no prior bortezomib; HR=0.84 for prior bortezomib).

The carfilzomib dexamethasone regimen is already approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ENDEAVOR study.

“These results showed carfilzomib and dexamethasone significantly reduced the risk of death compared to bortezomib 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 carfilzomib and dexamethasone as a standard of care for multiple myeloma patients at first relapse.”

Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR.

Notably, rates of grade 2 or higher peripheral neuropathy, a frequent dose-limiting toxicity of bortezomib, were five-times lower in patients receiving the carfilzomib combination versus patients receiving bortezomib and dexamethasone (7 percent versus 35 percent, respectively).

The most common adverse events (greater than or equal to 20 percent) in the carfilzomib arm were anaemia, diarrhoea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral oedema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache.

Source: Amgen