Onyx Pharmaceuticals has reported positive results from a Phase IIb study of single-agent carfilzomib in patients with relapsed and refractory multiple myeloma.
The drug demonstrated a 24% overall response rate and a 7.4 month median duration of response in 266 heavily pre-treated patients.
In the trial, proteasome inhibitor carfilzomib was well-tolerated with no new or unexpected toxicities observed, and the clinical benefit rate in the study population was 36%.
The single-arm trial was conducted in collaboration with the Multiple Myeloma Research Consortium.
Onyx is planning to submit a new drug application for carfilzomib to the US Food and Drug Administration by year-end 2010.
Multiple myeloma is a haematologic cancer that results from an abnormality of plasma cells, usually in the bone marrow.
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