Krypolis Regimen Extends Progression Free Survival in Multiple Myeloma
Trial data shows positive results across a range of difficult-to-treat patients with MM.
Treatment regimens based around carfilzomib (Kyprolis) showed promise across a range of patients with relapsed multiple myeloma in a recent trial.
Data presented during the 57th Annual Meeting and Exposition of the American Society of Hematology in Orlando, FL, showed Kyprolis in combination with dexamethasone significantly extended disease progression compared with bortezomib plus dexamethasone in difficult-to-treat patient populations, specifically in high risk and previously treated patients.
Data from the phase 3 ENDEAVOR trial showed patients with relapsed or refractory multiple myeloma treated with Kyprolis plus dexamethasone had superior progression-free survival (PFS) compared with bortezomib plus dexamethasone.
An exploratory sub-analysis of Kyprolis and dexamethasone or bortezomib and dexamethasone in 929 patients was balanced to compare patients who received 1 prior therapy with patients who received 2 or more prior lines of therapy.
Median PFS in patients after 1 prior line of therapy was 22.2 months in the Kyprolis patient group compared with 10.1 months in the bortezomib patient group. The median PFS in patients with 2 or more prior lines of therapy was 14.9 months in the Kyprolis group compared with 8.4 months in the bortezomib patient group.
A sub-analysis of the efficacy and safety showed Kyprolis to be superior to bortezomib with a favorable benefit—risk profile, regardless of baseline cytogenetic risk status, in patients with high-risk relapsed multiple myeloma, according to the study.
Median PFS in the high-risk group was 8.8 months in the Kyprolis arm compared with 6.0 months in the bortezomib arm. Median PFS in the standard-risk group was not estimable in the Kyprolis group, compared with 10.2 months in the bortezomib group.
An exploratory subgroup analysis from the study showed clinically meaningful improvement of PFS in the Kyprolis arm compared with the bortezomib arm across all age subgroups, with greater improvement observed in patients 75 years or older compared with 2 younger subgroups, with age ranges under 65 and between the ages of 65 and 74.
"Our clinical research with Kyprolis aims to improve outcomes for patients in the relapsed setting, which are currently poor due to more aggressive disease biology as multiple myeloma progresses," said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. "This week's presentations show that even in difficult-to-treat populations, Kyprolis significantly extends the time patients can live without their disease progressing and improves the depth and duration of a response, compared to current standard of care therapies."