Date: 2016-09-27
Type of information: Results
phase: 3
Announcement: results
Company: Amgen (USA - CA)
Product: Kyprolis® (carfilzomib)
Action
mechanism: proteasome inhibitor. Carfilzomib is a selective proteasome inhibitor.
Disease: multiple myeloma
Therapeutic area: Cancer - Oncology
Country: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, China, Czech Republic, France, Germany, Greece, Hungary, Israel, Italy, Japan, Republic of Korea, Mexico, The Netherlands, New Zealand, Poland, Romania, Russian Federation, Singapore, Spain, Switzerland, Taiwan, Turkey, Ukraine, UK, USA
Trial
details: The CLARION study is a Phase 3 head-to-head multicenter, open-label, randomized study in transplant-ineligible patients with newly diagnosed multiple myeloma. A total of 955 patients were randomized 1:1 to receive KYPROLIS, melphalan and prednisone or Velcade, melphalan and prednisone for 54 weeks. The median patient age was 72.
The KMP regimen consisted of Kyprolis® as a 30 minute intravenous (IV) infusion on days 1, 2, 8, 9, 22, 23, 29 and 30 during each 42-day cycle (20 mg/m2 on days 1 and 2 of cycle 1; 36 mg/m2 thereafter), melphalan 9 mg/m2 on days 1-4, and prednisone 60 mg/m2 on days 1-4. (NCT01818752)
Latest
news: * On September 27, 2016, Amgen announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of Kyprolis® (carfilzomib), melphalan and prednisone (KMP) versus Velcade® (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95 percent CI, 0.75 - 1.10). While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95 percent CI, 0.90 - 1.64). Neither result was statistically significant.
Overall, the adverse events in the KMP arm were consistent with the known safety profile of KYPROLIS. The incidence of Grade 3 or higher adverse events was 74.7 percent in the KMP arm and 76.2 percent in the VMP arm. Fatal treatment-emergent adverse events occurred in 6.5 percent of KMP patients and 4.3 percent of VMP patients. The incidence of Grade 2 or higher peripheral neuropathy, a secondary endpoint, was 2.5 percent in the KMP arm and 35.1 percent in the VMP arm.
