Analysis of ASPIRE trial of Kyprolis (carfilzomib) plus lenalidomide and dexamethasone improved PFS and ORR in patients with multiple myeloma- Amgen

Amgen announced data from a secondary analysis of the pivotal Phase III ASPIRE trial that showed Kyprolis (carfilzomib) for Injection in combination with lenalidomide and dexamethasone (KRd) improved progression-free survival (PFS) and overall response rate (ORR) compared to lenalidomide and dexamethasone (Rd) alone in patients with relapsed multiple myeloma with early disease progression after initial therapy or transplant.

The results were presented at the 52nd Annual Meeting of the American Society of Clinical Oncology ( ASCO ). The analysis showed that patients relapsing within one year of initial therapy treated with KRd (n=87) experienced a median PFS of 24.1 months versus 12.5 months in those treated with Rd (n=72) (HR=0.75; 95 percent CI: 0.50-1.13). In addition, ORR in the KRd arm was 79.3 percent versus 61.1 percent in the Rd arm. Patients relapsing early after first prior transplant treated with KRd (n=48) experienced a median PFS of 17.3 months versus 11.1 months in those treated with Rd (n=49) (HR=0.87; 95 percent CI: 0.54-1.41). In addition, the ORR in the KRd arm was 83.3 percent versus 61.2 percent in the Rd arm. Grade 3 adverse events that occurred at least five percent more frequently in the KRd arm compared to the Rd arm in either subgroup were hypokalemia, neutropenia, febrile neutropenia, hypophosphatemia and respiratory tract infection ( ASCO abstract #8045).