Amgen (AMGN) Drops After Hours On Failed Phase 3 Multiple Myeloma Trial
8/13/2014 4:14:02 PM
Amgen Drops After Hours On Failed Phase 3 Multiple Myeloma Trial
August 14, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Amgen (AMGN) stock dropped slightly after hours Wednesday, but rebounded Thursday at opening after announcing its phase 3 clinical trial FOCUS didn’t meet its primary endpoint. FOCUS, which stands for CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study, had a primary endpoint of improved overall survival for the treatment of multiple myeloma with the drug Kyprolis® (carfilzomib).
FOCUS evaluated 315 patients with relapsed and advanced refractory multiple myeloma treated with single-agent Kyprolis versus an active control treatment of low-dose steroids with optional cyclophosphamide. The primary endpoint was overall survival, and secondary endpoints were progression-free survival, overall response rate, clinical benefit rate, and duration of response and safety. Although there was an increase in adverse renal events in the Kyprolis group, the primary reason for discontinuing the study was no evidence of improved survival or symptoms.
In the U.S., Kyprolis is marked by Onyx Pharmaceuticals, Inc., a subsidiary of Amgen. In a press release, Onyx president Pablo J. Cagnoni, M.D., said, “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.”
Amgen recently announced that the ASPIRE phase 3 clinical trial had met its primary endpoint of progression-free survival. In ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of Patients with Relapsed Multiple MyEloma), patients that were treated with Kyprolis in combination with Revlimid® (lenalidomide) and low-dose dexamethasone (KRd) had longer survival rates without progression of the disease than patients in the control group. The company plans to submit Kyprolis for regulatory purposes worldwide in the first half of 2015.
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