Amgen's multiple myeloma drug fails in phase III single-drug study
- A phase III trial, FOCUS, evaluated treatment of 315 patients with advanced multiple myeloma with single-agent Kyprolis.
- Kryprolis is marketed by Onyx Pharmaceuticals, which is a subsidiary of Amgen.
- In a previous phase III trial (ASPIRE), Kyprolis combined with lenalidomide and low-dose dexamethasone achieved its primary goal, which was to prolong progression-free survival.
Although the FOCUS trial failed with single-dose Kyprolis, Kyprolis in combination with other treatment agents met the primary endpoint.
Researchers expressed optimism despite the disappointing results. “While it is unfortunate that the FOCUS study did not meet its primary endpoint of overall survival, we believe the results of the recent positive ASPIRE phase III clinical trial will be sufficient to support regulatory submissions around the world,” said Dr. Pablo G. Cagnoni.
Amgen's stock is still up approximately 12% for the year, and Q2 2014 Kyprolis sales topped $78 million, according to the Wall Street Journal.