While this may not sound like a big advancement, such patients with the blood cancer usually respond to therapy only 11% of the time and survive for only six to 10 months, according to a multi-center study from the International Myeloma Foundation Working Group.
Carfilzomib was well-tolerated and there were no new or unexpected toxicities observed, the company said, but didn't release full results of the Phase 2b trial. These will be presented at an upcoming scientific meeting.
Based on these results, Onyx said it is continuing discussions with the U.S. Food and Drug Administration regarding next steps in filing a new drug application for carfilzomib, which the company expects to submit by year-end 2010 for potential accelerated approval in the U.S.
"Despite recent advances in treating multiple myeloma, all patients eventually relapse. The unmet medical need remains great, as the outlook for patients with relapsed and refractory disease is grim," said Chief Medical Officer Michael Kauffman. "The single-agent activity with durable disease control and favorable tolerability observed in this study indicate that carfilzomib has the potential to alter the natural course of this deadly disease."
CEO Anthony Coles added Onyx is "pursuing an accelerated approval pathway in the U.S., while simultaneously moving forward with two Phase 3 studies."