Evolocumab: Additional Phase III data

Additional data from the double-blind, placebo- and active-controlled, international Phase III LAPLACE-2 trial in 1,896 patients with primary hypercholesterolemia and mixed dyslipidemia (LDL-C >=80 mg/dL) showed that subcutaneous evolocumab plus daily statin therapy led to placebo plus statin therapy-adjusted mean percent reductions in LDL-C from baseline to weeks 10 and 12, a co-primary endpoint, of 63-75% at the once-monthly 420 mg dose and of 66-75% at the 140 mg given every 2 weeks dose (p<0.001 for both). Additionally, evolocumab led to ezetimibe plus statin therapy-adjusted mean percent reductions in LDL-C from baseline to weeks 10 and 12 of 44% at the once-monthly dose and of 38-45% at the every 2 weeks dose (p<0.001 for both).

On the co-primary endpoint of percent reduction in LDL-C from baseline to week 12, evolocumab plus daily statin therapy led to placebo plus statin therapy-adjusted mean percent reductions of 55-71% at the once-monthly dose and of 68-76% at the every 2 weeks dose (p<0.001 for both). Additionally, evolocumab led to ezetimibe plus statin therapy-adjusted mean percent reductions in LDL-C from baseline to week 12 of 39-41% at the once-monthly dose and of 40-47% at the every 2 weeks dose (p<0.001 for both). There were no neurocognitive adverse events in patients receiving evolocumab in the trial. Data were presented at the American College of Cardiology meeting in Washington, D.C. In January, Amgen reported top-line data from LAPLACE-2 showing that evolocumab met the co-primary endpoints (see BioCentury, Feb. 3). ...