New Phase III results of Kyprolis in MM-Amgen/Onyx Pharma

Amgen and Onyx Pharmaceuticals announced results of the Phase III ASPIRE trial which evaluated Kyprolis (carfilzomib) for Injection plus Revlimid (lenalidomide) and dexamethasone (KRd) compared with Revlimid and dexamethasone (Rd) in patients with relapsed Multiple Myeloma. As previously reported, the ASPIRE study met its primary endpoint by demonstrating that KRd significantly extended the time patients lived without their disease worsening, or progression-free survival (PFS), by 26.3 months compared to 17.6 months with Rd, an 8.7 month improvement in PFS. Secondary endpoints, which are being presented for the first time, included overall survival (OS), overall response rate (ORR), duration of response (DOR), health-related quality of life (HR-QoL) measures and safety. While the data for median OS are not yet mature, the analysis showed a trend in favor of KRd compared with Rd. Patients will continue to be monitored for OS.

The ORR was 87.1 percent with KRd and 66.7 percent with Rd. In the KRd and Rd groups, 14 percent versus 4.3 percent of patients achieved a stringent complete response, a measurement indicating superior depth of response. Median DOR was 28.6 months (KRd) and 21.2 months (Rd). KRd consistently improved Global HR-QoL compared with Rd over 18 cycles of treatment. Treatment discontinuation due to an adverse event occurred in 15.3 percent (KRd) versus 17.7 percent (Rd) of patients. In the KRd arm, 7.7 percent versus 8.5 percent (Rd) of patients died while still on study treatment or within 30 days of receiving the last dose of study treatment. The results from ASPIRE will be featured during the 56th American Society of Hematology Annual Meeting.