Kyprolis carfilzomib: Interim Phase II data

Researchers at Erasmus Medical Center and colleagues reported interim data from 70 patients with newly diagnosed MM in the first 2 cohorts of a dose-escalation Phase II trial showing that IV Kyprolis plus thalidomide and low-dose dexamethasone led to an ORR of 96%. In cohort 1 (n=50), patients received induction therapy with 4 cycles of Kyprolis given at 20 mg/m 2 on days 1 and 2 followed by 27 mg/m 2 on days 8, 9, 15 and 16 of cycle 1 and on days 1, 2, 8, 9, 15 and 16 of all subsequent 28-day cycles in combination with daily thalidomide and dexamethasone on days 1, 8, 15 and 22 of each cycle. In cohort 2 (n=20), the 27 mg/m 2 dose of Kyprolis was escalated to 36 mg/m 2 for the same schedule. Stem cell harvest was performed with cyclophosphamide and G-CSF. Patients then received high-dose melphalan and autologous stem cell transplantation (ASCT) followed by consolidation therapy with Kyprolis, thalidomide and dexamethasone. After induction therapy, the CR/stringent CR rate was 19%, the >=VGPR rate was 60% and the >=PR rate was 93%. The CR/stringent CR rate increased to 30% after high-dose melphalan and to 49% after consolidation. Data were presented at the American Society of Hematology meeting in New Orleans. Amgen could not be reached for next steps with Kyprolis in newly diagnosed MM. ...