Amgen EVOLVE trial fails to meet primary endpoint

11th June 2012 (Last Updated June 11th, 2012 18:30)

Amgen has reported top-line results from the Phase 3 Sensipar / Mimpara EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) trial.

Amgen has reported top-line results from the Phase 3 Sensipar / Mimpara EValuation of Cinacalcet HCl Therapy to Lower CardioVascular Events (EVOLVE) trial.

The randomised, double-blind study of 3,883 patients with secondary hyperparathyroidism (HPT) and chronic kidney disease (CKD) receiving dialysis, evaluated Sensipar / Mimpara (cinacalcet) for the reduction of the risk of mortality and cardiovascular events.

Amgen research and development executive vice president, Sean Harper, said that 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.

"The results were not statistically significant and the trial did not meet its primary endpoint."

"EVOLVE will provide the nephrology community with important information," Harper added.

Time to the composite event comprising all-cause mortality or first non-fatal cardiovascular event, including myocardial infarction, hospitalisation for unstable angina, heart failure or peripheral vascular event was the primary endpoint of the study.

Even though numerically fewer composite primary events were experienced by the patients in the Sensipar / Mimpara arm, the results were not statistically significant and the trial did not meet its primary endpoint in the intent-to-treat analysis.

The most frequently reported adverse events in the Sensipar / Mimpara arm of the trial were consistent with the known safety profile of the therapy and included nausea, vomiting and hypocalcemia, according to the company.

Sensipar / Mimpara is an oral calcimimetic agent approved for the treatment of secondary HPT in patients with CKD receiving dialysis.

The therapy is also approved by the FDA, EMA and Health Canada for hypercalcemia in patients with parathyroid carcinoma and severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy.