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Amgen’s Kyprolis regimen improves survival rate phase 3 myeloma trial

PBR Staff Writer Published 14 July 2017

Amgen has reported that Kyprolis (Carfilzomib) in combination with lenalidomide and dexamethasone significantly improved the overall survival in a phase 3 trial in multiple myeloma patients whose disease had relapsed.

The Kyprolis-based regimen yielded positive results by meeting the key secondary endpoint of overall survival (OS) in what was a second phase 3 trial dubbed as ASPIRE conducted in 792 patients.

It was shown to cut down the risk of death in the patients by 21% in comparison to lenalidomide and dexamethasone alone treatment.

As per the trial findings, patients subjected to the Kyprolis-based regimen lived 7.9 months longer than patients treated with the combination of Lenalidomide and Dexamethasone

As per Amgen, adverse events noted in the trial were in line with those recorded in the past with the most common ones being diarrhea, anemia, upper respiratory tract infection, neutropenia among others.

Based on the primary analysis of progression-free survival (PFS) in the ASPIRE trial, the Kyprolis-based regimen containing 27 mg/m2 of Kyprolis administered weekly twice is currently approved in the US, European Union and other countries.

In a recent phase 3 trial named ENDEAVOR, Kyprolis at 56 mg/m2 in combination with dexamethasone was shown to have cut down the risk of death by 21% in comparison to Velcade (bortezomib) and dexamethasone.

Amgen research and development executive vice president Sean E. Harper said: “The ENDEAVOR study has already demonstrated that KYPROLIS is the superior proteasome inhibitor versus Velcade.

“This overall survival benefit from the ASPIRE trial further supports the importance of proteasome inhibition and duration of treatment with KYPROLIS in the treatment of relapsed multiple myeloma.”