Amgen has reported positive top-line results from Phase III ARROW clinical trial of Kyprolis (carfilzomib) in combination with dexamethasone for patients with relapsed and refractory multiple myeloma.
Kyprolis is designed to block proteasomes, which break down proteins, to cause excessive build-up of proteins within cells, thereby leading to potential cell death.
The trial has met the primary endpoint of statistically significant superior progression-free survival (PFS) with an increase of patient survival by 3.6 months without worsening of disease.
These findings were observed in patients administered with once-weekly 70mg/m2 Kyprolis and 40mg dexamethasone, compared to twice weekly 27mg/m2 dose with 40mg dexamethasone.
The randomised, open-label Phase III trial compared the once-weekly and twice-weekly dosing regimen in 478 subjects who have undergone a minimum of two but not more than three previous therapies.
Amgen Research and Development executive vice-president Sean Harper said: “Kyprolis has been demonstrated to be the most effective proteosome inhibitor available to patients with multiple myeloma.
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“We are encouraged by the efficacy and safety profile of Kyprolis and dexamethasone administered once-weekly in the ARROW study.”
Performed at around 100 centres, the trial evaluated safety, overall response rate, tolerability and overall survival as the secondary endpoints.
According to the reported results, the overall safety profile of the once-weekly regimen of Kyprolis was comparable to that of its twice-weekly dosing.
In the treatment group, the most frequently reported treatment-emergent adverse events were found to be anaemia, diarrhoea, fatigue, hypertension, insomnia and pyrexia.