Amgen's Kyprolis Does Not Meet Primary Endpoint In Phase III Trial For Multiple Myeloma
By Cyndi Root
Amgen announced in a press release that a Phase III FOCUS trial of Kyprolis (carfilzomib) did not meet its primary endpoint of overall survival in patients with relapsed and advanced refractory multiple myeloma. Earlier in August, the company announced that interim results from a separate Phase III trial did meet its primary endpoint of overall survival in patients with relapsed multiple myeloma.
Pablo J. Cagnoni, M.D., president of Amgen’s subsidiary Onyx Pharmaceuticals, 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.”
Kyprolis FOCUS Study
In the Phase III Kyprolis trial FOCUS (CarFilzOmib for AdvanCed Refractory MUltiple Myeloma European Study), 315 patients participated. One group took Kyprolis as a single agent, and the control group took low-dose dexamethasone (or equivalent corticosteroids) plus optional cyclophosphamide. Patients had received an average of five treatments prior to the study.
Investigators were looking for patients to increase their overall survival in order to meet the primary endpoint. Amgen states that the endpoint was not met. While the company said that secondary endpoints included progression-free survival, it did not share whether the secondary endpoints were met. Amgen intends to detail the results at an upcoming scientific meeting.
FOCUS vs. ASPIRE
The ASPIRE trial, designed with help from the FDA and the European Medicines Agency (EMA), showed that Kyprolis did extend survival. However, those patients took a combination of Kyprolis, Revlimid, and dexamethasone and they lived about 8 months longer than the control group. The FOCUS trial used Kyprolis as a single agent.
Kyprolis
In July 2012, the Food and Drug Administration (FDA) granted Kyprolis for Injection, a proteasome inhibitor, an accelerated approval for multiple myeloma patients whose condition continues to progress and who have received prior therapies such as an immunomodulatory agent (IMiD) or bortezomib. Response rates, symptom diminishment, and survival rates have not yet been proven. The Wall Street Journal reports that Kyprolis sales were $78 million in the second quarter of 2014.