BioCentury
ARTICLE | Clinical News

Amgen's Kyprolis misses in Phase III FOCUS trial

August 14, 2014 1:34 AM UTC

Amgen Inc. (NASDAQ:AMGN) and its Onyx Pharmaceuticals Inc. subsidiary said Kyprolis carfilzomib as monotherapy missed the primary endpoint of improving overall survival (OS) vs. best supportive care (BSC) in the Phase III FOCUS trial to treat refractory multiple myeloma patients (HR=0.975, 95% CI: 0.76, 1.249). Amgen and Onyx said the incidence of renal adverse events was higher in the Kyprolis arm compared to both the control arm and Kyprolis' U.S. label, but declined to provide details. The open-label, European trial enrolled 315 MM patients who had received three or more prior therapies. BSC comprised low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide. Kyprolis has accelerated approval from FDA to treat MM patients who have received at least two prior lines of therapy.

Investors have said Amgen needs both FOCUS and the Phase III ASPIRE trial to succeed to help justify the $10.4 billion it paid for Onyx last year. ASPIRE is the confirmatory trial for full U.S. approval of Kyprolis for MM, while FOCUS would support an MAA in the EU for relapsed or refractory MM (see BioCentury, July 14). ...