The trial compared single-agent Kyprolis versus best supportive care, which typically involved a steroid such as dexamethasone or prednisone, and could also include cyclophosphamide (Cytoxan).
Kyprolis failed in the trial to meet the key endpoint of improving overall survival versus what was observed in the patients who got best supportive care.
The full Amgen press release with more information about the news can be found here:
"Amgen Announces Top-Line Results From Phase 3 Focus Trial Of Kyprolis® In Patients With Relapsed And Advanced Refractory Multiple Myeloma," Amgen press release (at The Beacon), April 13, 2014.
Amgen says in its press release that it believes the results of a separate Phase 3 Kyprolis trial, known as the ASPIRE trial, will be sufficient for it to gain approval for Kyprolis in Europe and elsewhere -- despite the results of the FOCUS trial. The Beacon recently published a news article about the ASPIRE trial results,
"Kyprolis Succeeds In Phase 3 Relapsed Multiple Myeloma Trial – Approval Filings Planned For Europe And Other Countries," Myeloma Beacon, August 4, 2014
Lori Melancon, who handles press relations at Onyx, the Amgen subsidiary that developed and markets Kyprolis, provided the following additional information related to the FOCUS trial results:
- Amgen and Onyx believe that the results from the recent positive ASPIRE Phase 3 clinical trial will be sufficient to support regulatory submissions around the world and filing in the U.S. for the conversion of accelerated approval to full approval.
- In FOCUS, The majority of patients on the control arm received two active anti-myeloma agents (low-dose dexamethasone or equivalent corticosteroids, and cyclophosphamide) compared to single-agent carfilzomib.
- Patients were heavily pretreated and had received a median of five therapeutic regimens prior to study entry.
- Treatment discontinuation due to adverse events and on-study deaths were comparable between the two arms. The rate of cardiac events observed in the carfilzomib arm was consistent with the current U.S. Kyprolis label. There was an increase in the incidence of renal adverse events of all grades observed in the carfilzomib arm compared to the active control arm and the label.
- Detailed results from FOCUS will be submitted for presentation at an upcoming scientific meeting.
The news about the FOCUS trial was released immediately after the close of U.S. financial markets at 4:00 p.m. Eastern Time. In after hours trading, however, Amgen's stock is down 2 percent as of 5:30 p.m. Eastern Time.
