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Kyprolis makes little impression in survival trial [Medical Marketing and Media](Medical Marketing and Media Via Acquire Media NewsEdge) KYPROLIS failed to improve overall survival in a Phase-III trial involving patients with relapsed and advanced refrac- tory multiple myeloma, said Amgen and its subsidiary Onyx. The drug was approved in 2012 as a third-line defense against multiple myeloma, and had $78 million in sales in the most recent quarter. After Amgen's $10.4 billion purchase of Onyx in 2013, the biotech has sought to expand it into earlier lines of therapy. The 315-person FOCUS trial compared those taking Kyprolis to an active control group tak- ing low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide. The study failed to meet its pri- mary endpoint of demonstrat- ing Kyprolis's ability to improve overall survival. "We do not believe expec- tations for this trial were high (questions have been raised about how the design of the trial might handicap its success)," ISI analyst Mark Schoenebaum wrote in an investor note. The companies hope the drug can still advance to a second-line therapy, based on results from the ASPIRE Phase-III clini- cal trial. This showed subjects who took Kyprolis along with the standard therapy, Celgene's Revlimid, tacked on 8.7 months of progression-free survival, meeting the primary endpoint. The regulatory pathway for Kyprolis should be straightfor- ward in the US but, Schoene- baum predicted, less so in Europe. "The odds that the EMA would want such over- all survival data have likely increased modestly-this could delay filing and the possibility also exists that ASPIRE does not show an overall survival benefit." -Kevin McCaffrey Kyprolis performed well below expectations in the FOCUS trial (c) 2014 Haymarket Media, Inc. |