What is the role of carfilzomib (Kyprolis) for treatment of refractory or relapsed multiple myeloma (MM)?

Updated: May 11, 2021
  • Author: Dhaval Shah, MD; Chief Editor: Emmanuel C Besa, MD  more...
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In 2012, the FDA approved carfilzomib (Kyprolis) for the treatment of patients with MM 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 therapy completion. The approval was based on a phase 2b, single-arm, multicenter clinical study of 266 patients with relapsed MM with other therapies. The study assessed for overall response rate (ORR), which was 22.9% over a median duration of 7.8 months. [87]

In 2015, the FDA expanded carfilzomib’s indication for MM based on data from the ASPIRE study, conducted in patients with relapsed MM who had received 1-3 prior lines of therapy. In ASPIRE, median PFS for patients treated with carfilzomib combined with lenalidomide and dexamethasone was 26.3 months, compared with 17.6 months in those treated with lenalidomide and low-dose dexamethasone alone. [88]

In 2016, the FDA approved carfilzomib in combination with dexamethasone for relapsed or refractory MM in patients who have received 1-3 prior lines of therapy. Approval was based on the ENDEAVOR study (n=929) where a statistically significant improvement in median PFS was observed with carfilzomib plus dexamethasone compared with bortezomib plus dexamethasone in patients with relapsed MM (26.3 mo vs 17.6 mo; P=0.0001). [89] On interim analysis, median overall survival was 47.6 months in the carfilzomib group versus 40.0 months in the bortezomib group (hazard ratio 0.791, one-sided P=0.010). [90]

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