Phase 3 Sensipar®/Mimpara® EVOLVE™ Trial Did Not Meet Primary Endpoint
Amgen (NASDAQ: AMGN) today announced results of the Phase 3 EVOLVE™ (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated treatment with Sensipar®/Mimpara® (cinacalcet) for the reduction of the risk of mortality and cardiovascular (CV) events among 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis. The primary endpoint of the study was time to the composite event comprising all-cause mortality or first non-fatal CV event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Although patients in the Sensipar/Mimpara arm experienced a seven percent reduction in the primary endpoint (Hazard Ratio 0.93, 95 percent CI 0.85 to 1.02, p=0.112), the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis. These data were published today in the New England Journal of Medicine and simultaneously presented at the American Society of Nephrology's Kidney Week (Abstract # 6450).
Baseline characteristics between the Sensipar/Mimpara and placebo groups were generally well-balanced with the notable exception of age – an important predictor of death and CV events. Patients in