Results from the phase 3 GALACTIC-HF trial evaluating omecamtiv mecarbil (Amgen, Cytokinetics, and Servier) in patients with heart failure with reduced ejection fraction (HFrEF) showed that the investigational treatment was associated with a reduction in cardiovascular death or heart failure events.
Omecamtiv mecarbil is a novel cardiac myosin activator that increases contractility without increasing intracellular calcium in cardiac myocytes or myocardial oxygen consumption. The trial includes 8256 patients who were either hospitalized at the time of enrollment for a primary reason of heart failure or had a hospitalization or admission to an emergency room for heart failure within 1 year prior to screening.
Patients were randomized to receive either oral omecamtiv mecarbil or placebo twice daily plus standard of care. The primary outcome measure was the time to cardiovascular death or first heart failure event through study completion, up to 208 weeks.
Findings showed the study met the primary end point, demonstrating a statistically significant effect with omecamtiv mecarbil in reducing cardiovascular death or heart failure events compared with placebo (hazard ratio 0.92 [95% CI, 0.86-0.99]; P =.0252). However, no reduction in cardiovascular death, a secondary end point, was observed.
Additional data from the study is expected to be presented at the American Heart Association Scientific Sessions 2020 in a virtual Late Breaking Clinical Trial session on November 13, 2020.
In May 2020, the Food and Drug Administration granted Fast Track designation to omecamtiv mecarbil for the treatment of HFrEF. The treatment is also being investigated in the METEORIC-HF phase 3 study to assess the effects of omecamtiv mecarbil on exercise capacity in patients with HFrEF.
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Amgen, Cytokinetics and Servier announce topline results from GALACTIC-HF, a phase 3 trial of omecamtiv mecarbil in patients with heart failure. [press release]. Thousand Oaks, San Francisco, CA: Amgen; October 8, 2020.