Phase III ASPIRE trial of Kyprolis (carfilzomib) lenalidomide and dexamethasone in multiple myeloma meets secondary endpoint of overall survival- Amgen

Amgen announced positive results from the final analysis of the Phase III ASPIRE trial in multiple myeloma. The study met the key secondary endpoint of overall survival (OS), demonstrating that Kyprolis (carfilzomib), lenalidomide and dexamethasone (KRd) reduced the risk of death by 21 percent over lenalidomide and dexamethasone alone (Rd) (median OS 48.3 months for KRd versus 40.4 months for Rd, HR = 0.79, 95 percent CI, 0.67 � 0.95). Per protocol, patients received 18 cycles of Kyprolis with Rd before continuing treatment with Rd alone to progression.

This KRd regimen of twice-weekly Kyprolis administered at 27 mg/m2 is currently approved in the U.S., European Union and other countries based on the primary analysis of progression-free survival (PFS) in the ASPIRE study. Adverse events observed in this updated analysis were consistent with those previously reported for ASPIRE. The most common adverse events (greater than or equal to 20 percent) in the Kyprolis arm were diarrhea, anemia, neutropenia, fatigue, upper respiratory tract infection, pyrexia, cough, hypokalemia, thrombocytopenia, muscle spasms, pneumonia, nasopharyngitis, nausea, constipation, insomnia and bronchitis.

Comment: Amgen recently announced OS results from the Phase III head-to-head ENDEAVOR trial, which showed Kyprolis at 56 mg/m2 in combination with dexamethasone reduced the risk of death by 21 percent over Velcade (bortezomib) and dexamethasone (Vd). Patients treated with Kyprolis lived 7.6 months longer than those treated with Velcade (median OS 47.6 months for Kd versus 40.0 months for Vd, HR = 0.79, 95 percent CI, 0.65 � 0.96). The ASPIRE OS data will be submitted to a future medical conference, for publication, and to regulatory agencies worldwide to support a potential label update.