US-based Amgen and its subsidiary, Onyx Pharmaceuticals, have reported data from the Phase III ASPIRE trial of carfilzomib, lenalidomide, and dexamethasone versus lenalidomide and dexamethasone to treat patients with relapsed multiple myeloma.
The trial met its primary endpoint of progression-free survival (PFS), and patients treated with Kyprolis (carfilzomib) by injection in combination with Revlimid (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening compared with those treated with Revlimid and low-dose dexamethasone (Rd).
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The company said that the data for overall survival, a secondary endpoint, is not yet mature and the analysis showed a trend in favour of KRd that did not reach statistical significance.
In the trial, about 792 patients were enrolled at sites in North America, Europe and Israel, and they were randomised to receive Kyprolis (20mg/m² on days one and two of cycle one only, then 27mg/ m² subsequently), in addition to a standard dosing schedule of lenalidomide (25mg per day for 21 days on, seven days off) and low-dose dexamethasone (40mg per week in four week cycles), versus lenalidomide and low-dose dexamethasone alone.
The safety profile observed in the trial is consistent with the current US Kyprolis label, including the rate of cardiac events.
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Discontinuation of treatment due to adverse events and on-study deaths were comparable between the two arms, and no new safety signals were identified.
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By GlobalDataAmgen chairman and chief executive officer Robert Bradway said: "We are excited about these clinical results and the positive prospects they suggest for patients with multiple myeloma.
"Our mission at Amgen is to serve patients by advancing medicines that address serious disease. Kyprolis is an important building block in our robust, differentiated pipeline."
"Coupled with our recent US regulatory submissions for ivabradine and talimogene laherparepvec and our upcoming regulatory submissions for evolocumab and blinatumomab, our pipeline continues to show notable progress."
The company said that results from the ASPIRE trial will form the basis for regulatory submissions worldwide beginning in the first half of 2015.
In the US, the results may support the conversion of accelerated approval to full approval and expand the current indication.
Onyx Pharmaceuticals president Pablo Cagnoni said: "In the treatment of patients with multiple myeloma, periods of remission become shorter following each treatment regimen, underscoring the need for new options.
"The results of the ASPIRE study demonstrate that Kyprolis can significantly extend the time patients live without their disease progressing.
"The ability of novel therapies to produce deep and durable responses may one day transform this uniformly fatal disease to one that is chronic and manageable."
The ASPIRE trial was conducted by Onyx Pharmaceuticals under a special protocol assessment from the US Food and Drug Administration and has received scientific advice from the European Medicines Agency on the design and planned analysis of the trial.
Image: Micrograph of a plasmacytoma, the histologic correlate of plasma cell myeloma. Photo: courtesy of Nephron.
