Amgen (NASDAQ: AMGN) today announced top-line results of the Phase 3 EVOLVE™ (EValuation Of Cinacalcet HCl Therapy to Lower CardioVascular Events) trial, which evaluated 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 cardiovascular event, including myocardial infarction, hospitalization for unstable angina, heart failure or peripheral vascular event. Although patients in the Sensipar/Mimpara arm experienced numerically fewer composite primary events, the results were not statistically significant, and the trial did not meet its primary endpoint in the intent-to-treat analysis.
"Amgen embarked on the EVOLVE trial to understand whether treating secondary HPT with Sensipar/Mimpara could positively impact the high rates of mortality and cardiovascular events among patients with CKD receiving dialysis," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "We thank the patients, caregivers and investigators for their participation and engagement in this landmark trial. EVOLVE will provide the nephrology community with important information."
The most frequently reported adverse events in the Sensipar/Mimpara arm of the trial were consistent with the known safety profile of this therapy and included nausea, vomiting and hypocalcemia.
Detailed efficacy and safety analyses from this landmark study are ongoing and will be submitted for presentation at a major medical meeting later this year.
Sensipar/Mimpara is an oral calcimimetic agent approved for the treatment of secondary HPT in patients with CKD receiving dialysis.