Analysis of phase III study shows efficacy evidence for Kyprolis (carfilzomib) plus lenalidomide and dexamethasone in multiple myeloma - Amgen

Amgen announced results from a post-hoc analysis of the pivotal Phase III ASPIRE study which highlighted the benefit of continued treatment with Kyprolis (carfilzomib) in combination with lenalidomide and dexamethasone (KRd) in patients with relapsed multiple myeloma. Separate sub-analyses of the Phase III ENDEAVOR study further confirmed efficacy and depth of response benefits of Kyprolis plus dexamethasone (Kd). Results from the ASPIRE analysis showed that cumulative rates of complete response or better continued to increase over time in the KRd arm, most quickly in the first 15 months of treatment. In addition, the progression-free survival (PFS) hazard ratio (HR) at 18 months was 0.58, while the overall study HR at 31 months was 0.69, possibly related to patients in the KRd arm receiving Kyprolis for a maximum of 18 months.

Researchers assessed 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), fatigue (22.4 percent) and thrombocytopenia (22.4 percent). A secondary analysis of data from the Phase III ENDEAVOR study found treatment with Kd compared to subcutaneous bortezomib led to prolonged PFS regardless of prior bortezomib treatment. The results suggest Kd has a favorable benefit-risk profile and delivers superior efficacy and improved clinical outcomes. These results were presented at the 21st Congress of the European Hematology Association (EHA).