Kyprolis interim data from ASPIRE trial positive in Multiple Myeloma - Amgen/Onyx Pharma

Amgen and its subsidiary, Onyx Pharmaceuticals, Inc. announced that a planned interim analysis demonstrated that the Phase III clinical trial ASPIRE (CArfilzomib, Lenalidomide, and DexamethaSone versus Lenalidomide and Dexamethasone for the treatment of PatIents with Relapsed Multiple MyEloma) met its primary endpoint of progression-free survival (PFS). Patients treated with Kyprolis (carfilzomib) for Injection in combination with Revlimid (lenalidomide) and low-dose dexamethasone (KRd) lived significantly longer without their disease worsening (median 26.3 months) compared to patients treated with Revlimid and low-dose dexamethasone (Rd) (median 17.6 months) (HR=0.690, 95 percent CI, 0.570, 0.834, p<0.0001).

While the data for overall survival, a secondary endpoint, are not yet mature, the analysis showed a trend in favour of KRd that did not reach statistical significance. The safety profile observed in this study is consistent with the current U.S. Kyprolis label, including the rate of cardiac events.

Results from the ASPIRE study will form the basis for regulatory submissions throughout the world beginning in the first half of 2015. In the U.S., the data may support the conversion of accelerated approval to full approval and expand the current indication.