Treatment with carfilzomib and dexamethasone doubled the PFS in relapsed multiple myeloma patients compared with treatment with bortezomib and dexamethasone.
Chemical structure of carfilzomib
Treatment with the drug carfilzomib plus low-dose dexamethasone doubled the progression-free survival (PFS) of patients with relapsed multiple myeloma compared with treatment with bortezomib and low-dose dexamethasone, according to a press release issued by Amgen, carfilzomib’s manufacturer.
The PFS results come out of an interim analysis of the phase III head-to-head ENDEAVOR study.
The trial included 929 patients who were randomly assigned to carfilzomib/dexamethasone or bortezomib/dexamethasone. Results of this interim analysis showed that the median PFS of patients assigned carfilzomib was 18.7 months compared with 9.4 months for patients assigned bortezomib (hazard ratio [HR] = 0.53; 95% CI, 0.44-0.65).
Amgen also said that carfilzomib demonstrated superiority compared with bortezomib for the secondary endpoints of higher overall response rate and lower neuropathy events. Overall survival data are not yet mature.
In December 2014, results of the phase III ASPIRE trial were presented at the 2014 American Society of Hematology (ASH) Annual Meeting. ASPIRE showed that the addition of carfilzomib to lenalidomide and dexamethasone resulted in a prolonged PFS and better quality of life for patients with relapsed multiple myeloma. Patients given carfilzomib/lenalidomide/dexamethasone had a median PFS of 26.3 months compared with 17.6 months in the control arm (P < .0001).
In 2012, carfilzomib was given accelerated approval by the US Food and Drug Administration (FDA) for the treatment of patients with multiple myeloma who have received at least two prior therapies, including bortezomib and an immunomodulatory agent and have demonstrated disease progression on or within 60 days of the completion of the last therapy.
Amgen said that full data on the ENDEAVOR study will be submitted for presentation at the 2015 ASCO Annual Meeting.
Relapsed/Refractory Multiple Myeloma Trial Updates From ASCO 2023
August 7th 2023Experts from Mayo Clinic and The University of Texas MD Anderson Cancer Center discuss results from multiple myeloma trials presented at the 2023 American Society of Clinical Oncology Annual Meeting and how they may apply to clinical practice.
FDA Approves Cilta-Cel for Relapsed/Refractory Myeloma After 1 Therapy
April 6th 2024The FDA has approved ciltacabtagene autoleucel for the treatment of adult patients with relapsed/refractory multiple myeloma who have received at least 1 prior line of treatment, including a proteasome inhibitor and an immunomodulatory agent, and are refractory to lenalidomide.