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Amgen hopes its latest Kyprolis trial hits the mark with regulators

A.R.R.O.W study takes aim at once-weekly dosing regimen in multiple myeloma

Amgen

Amgen has released new trial results for Kyprolis aiming to prove a higher, once-weekly dose of its blood cancer drug produces better results for patients than the currently approved twice-weekly dose.

The phase III A.R.R.O.W trial suggests once-weeky Kyprolis (carfilzomib) could improve overall survival (OS) in relapsed or refractory (R/R) multiple myeloma patients, when given at more than twice the current dose.

The randomised, open-label study evaluated the drug in combination with dexamethasone comparing a once weekly dosing at 70mg/m verses a twice weekly dosing at 27 mg/m in 478 patients.

All patients received two or three lines of prior therapy and those treated with the once-weekly Kyprolis regimen achieved a statistically significant superior PFS compared to those treated with the twice-weekly Kyprolis regimen (11.2 months versus 7.6 months).

Sean Harper, executive vice president of research and development, Amgen, said: “Kyprolis has been demonstrated to be the most effective proteosome inhibitor available to patients with multiple myeloma.

“We are encouraged by the efficacy and safety profile of Kyprolis and dexamethasone administered once-weekly in the A.R.R.O.W study.”

The firm said the most frequently reported treatment-emergent adverse events in either treatment arm of the study were anaemia, diarrhoea, fatigue, hypertension, insomnia and fever.

Kyprolis is already approved in the US in combination with dexamethasone of with lenalidomide plus dexamethasone to treat patients with relapsed or refractory multiple myeloma that have received one to three lines of therapy.

Additionally, it is also approved as a single agent for the treatment of patients with multiple myeloma who have received one or more lines of therapy.

The A.R.R.O.W trial follows the release in July of new analysis of the ASPIRE study of Kyprolis, which produced new overall survival data that Amgen has submitted to European and US regulators for inclusion in the drug’s labelling.

Article by
Gemma Jones

27th October 2017

From: Research

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