AMG 416 (etelcalcetide) non-inferior to oral cinacalcet in treatment of secondary hyperparathyroidism- Amgen

Amgen has presented the findings from a head-to-head Phase III study comparing intravenous etelcalcetide (AMG 416) with oral cinacalcet (Mimpara) for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) receiving haemodialysis. The findings were presented at the American Society of Nephrology (ASN) Kidney Week in San Diego. The study met the primary endpoint of non-inferiority of etelcalcetide compared to cinacalcet, measured as the proportion of patients achieving a >30% reduction from baseline in mean pre-dialysis serum intact parathyroid hormone (PTH) levels during the efficacy assessment phase (EAP), defined as the period between weeks 20 and 27. Etelcalcetide is administered intravenously three times per week at the end of each dialysis session. It acts by binding to and activating the calcium-sensing receptor on the parathyroid gland, thereby causing decreases in PTH. Sustained elevations in PTH are known to be associated with significant clinical consequences for patients with CKD. In addition, etelcalcetide was superior to cinacalcet in the secondary endpoints of the proportion of patients achieving >30% reduction (68.2% versus 57.7%, p=0.004) and >50% reduction (52.4% versus 40.2%, p=0.001) in PTH from baseline during the EAP. There was no difference between the treatment arms in the mean number of days of vomiting or nausea per week in the first eight weeks, another secondary endpoint.

Comment: Despite the variety of options available for the treatment of this disease, an unmet need remains for an intravenous therapy that can be administered along with haemodialysis, and AMG 416 seeks to meet this need with its thrice weekly intravenous formulation.