Results blow for Amgen's myeloma drug
Amgen's multiple myeloma drug Kyprolis (carfilzomib) has failed to meet its primary endpoint in a phase 3 trial, casting doubt on its viability in the highly competitive therapy area.
Amgen and its subsidiary Onyx say that while the resulting are disappointing, it won't affect the planned filing of the drug with regulators, as a previous trial showed the drug to be effective.
But analysts are not so sure about the drug - Sanford Bernstein analyst Geoffrey Porges said in a research note that the results "place Kyprolis at a significant regulatory and competitive disadvantage" to Pomalyst, Celgene's rival drug which is already on the market.
Amgen's 315-patient, open-label FOCUS study evaluated single-agent Kyprolis (carfilzomib) compared to an active control regimen of low-dose dexamethasone, or equivalent corticosteroids, plus optional cyclophosphamide in patients with relapsed and advanced refractory multiple myeloma. The drug failed to meet its primary endpoint of extending overall survival in these difficult to treat patients.
The company says the results from its earlier ASPIRE trial are compelling enough to gain approval for the drug.
"While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world," said Pablo J. Cagnoni, M.D., president, Onyx.
However the company will face intense competition not just from Celgene, but a number of companies poised to launch new drugs, including a partnership between Bristol-Myers Squibb and AbbVie. Their elotuzumab received a Breakthrough Therapy Designation by the FDA earlier this year for combination with Celgene's Revlimid (lenalidomide) and dexamethasone in multiple myeloma patients who have received one or more prior therapies.
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