Amgen's Kyprolis fails in newly-diagnosed myeloma patients vs Velcade

US biotech major Amgen (Nasdaq: AMGN) saw its share dip 1.2% to $171.41 in mid-morning trading today after reported disappointing top-line results with for its Kyprolis (carfilzomib).

Amgen said that the Phase III CLARION trial, which evaluated an investigational regimen of Kyprolis, melphalan and prednisone (KMP) versus Takeda’s Velcade (bortezomib), melphalan and prednisone (VMP) for 54 weeks in patients with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant, failed to meet its primary endpoint of superiority in progression-free survival (PFS) (median PFS 22.3 months for KMP versus 22.1 months for VMP, HR = 0.91, 95% CI, 0.75 - 1.10).

While the data for overall survival, a secondary endpoint, are not yet mature, the observed hazard ratio (KMP versus VMP) was 1.21 (95% CI, 0.90 - 1.64). Neither result was statistically significant.