New analyses that provide further evidence of the benefits of intensive lipid-lowering to reduce CV events with evolocumab; new data from the GOULD registry, a real-world study with more than 5,000 adults to better understand cholesterol treatment patterns in patients with established cardiovascular disease (CVD); and new first-in-human data for olpasiran (formerly AMG 890), a novel small interfering RNA (siRNA) being developed for patients with CVD with elevated lipoprotein(a) (Lp(a)), a risk factor for CV events. Primary results from GALACTIC-HF, the Phase 3 outcomes trial of omecamtiv mecarbil, an investigational cardiac myosin activator for the treatment of heart failure with reduced ejection fraction (HFrEF), will also be presented in a late-breaking clinical trial session. Amgen announced in October that GALACTIC-HF met its primary composite endpoint and did not meet its secondary endpoint of reduction in CV death.
GALACTIC-HF Primary Results
Omecamtiv Mecarbil in Chronic Heart Failure with Reduced Ejection Fraction: the Global Approach to Lowering Adverse Cardiac Outcomes through Improving Contractility in Heart Failure (GALACTIC-HF) Trial
Late Breaking Oral Presentation, Friday, Nov. 13, 2020 10:35-10:45 a.m. CT
About GALACTIC-HF: Trial Design
GALACTIC-HF,2 (Global Approach to Lowering Adverse Cardiac Outcomes Through Improving Contractility in Heart Failure), one of the largest Phase 3 global CV outcomes studies in heart failure ever conducted, enrolled 8,256 patients in 35 countries with HFrEF, New York Heart Association (NYHA) class II-IV, left ventricular ejection fraction (LVEF) ≤35%, elevated natriuretic peptides and either current hospitalization for heart failure or history of hospitalization or emergency department visit for heart failure within a year. Patients were randomized to either oral placebo or a starting dose of 25 mg omecamtiv mecarbil twice daily (maintenance dose of 50 mg, 37.5 mg, or 25 mg twice daily) guided by pharmacokinetic-guided dose selection. A blood test, the QMS Omecamtiv Mecarbil Immunoassay (the OM Test) was used to measure plasma levels of omecamtiv mecarbil in each patient in order to guide selection of the appropriate maintenance dose.
The primary composite endpoint of this double-blind, placebo-controlled, event-driven trial was time to CV death or first heart failure event (heart failure hospitalization and other urgent treatment for heart failure). Secondary endpoints were: time to CV death, patient reported outcomes (measured by Kansas City Cardiomyopathy Questionnaire [KCCQ] Total Symptom Score [TSS]), time to first heart failure hospitalization and time to all-cause death.