Positive results we announced today from a planned overall survival (OS) interim analysis of the Phase 3 head-to-head ENDEAVOR trial, with the study meeting the key secondary endpoint of OS, demonstrating that patients with relapsed or refractory multiple myeloma treated with carfilzomib and dexamethasone (Kd) lived 7.6 months longer than those treated with 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).
Detailed results will be presented on Saturday, March 4 at 7:30 a.m. IST at the 16th International Myeloma Workshop in New Delhi.
These results follow those from ASH 2015, in which the carfilzomib met the primary endpoint of extending PFS, and last Julys EU extension of carfilzomib for this disease setting.
This Kd regimen administered with 56 mg/m2 carfilzomib twice weekly 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.
The randomised ENDEAVOR trial of 929 patients evaluated carfilzomib in combination with low-dose dexamethasone (Kd), versus bortezomib with low-dose dexamethasone (Vd) in patients whose multiple myeloma has relapsed after at least one, but not more than three prior therapeutic regimens.
“For an incurable disease like multiple myeloma, a major treatment goal for oncologists and haematologists is to help patients live as long as possible,” 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. “Based on these data, we now know that carfilzomib not only significantly extended progression-free survival compared to bortezomib, but also overall survival, making it a clinically meaningful advance in the treatment of relapsed or refractory multiple myeloma.”
Source: IMW Delhi
(27 Mar 2017)