June 10, 2016
Amgen has announced results from a post-hoc analysis of the pivotal Phase 3 ASPIRE study which emphasized the advantages of continued treatment with Kyprolis® (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) in patients with relapsed multiple myeloma. Furthermore, separate sub-analyses of the Phase 3 ENDEAVOR study confirmed depth and efficacy of response benefits of Kyprolis plus dexamethasone (Kd). These results were presented at the 21st Congress of the European Hematology Association (EHA).
ASPIRE analysis results showed that cumulative rates of complete response or better (>CR) continued to increase over time in the KRd arm, most quickly in the first 15 months of treatment. Moreover, the progression-free survival (PFS) hazard ratio (HR) at 18 months was 0.58 (95 percent CI: 0.46-0.72), whereas the overall study HR at 31 months was 0.69 (95 percent CI: 0.57-0.83), possibly related to patients in the KRd arm receiving Kyprolis for a maximum of 18 months (EHA abstract #P275). Researchers evaluated PFS HR at 18 months following discontinuation of Kyprolis treatment in the KRd arm per the trial protocol. The most common all grade treatment-related adverse events in the ASPIRE trial included neutropenia (34.2 percent), anemia (25.5 percent), thrombocytopenia (22.4 percent), and fatigue (22.4 percent).