Phase III GALACTIC-HF trial of AMG 423 shows impact of treatment in heart failure.- Cytokinetics

Cytokinetics announced additional results from GALACTIC-HF, the Phase III event-driven cardiovascular outcomes clinical trial of AMG 423 (omecamtiv mecarbil) in heart failure patients. As previously reported, after a median duration of follow-up of 21.8 months, the trial demonstrated a statistically significant effect of treatment with omecamtiv mecarbil to reduce risk of the primary composite endpoint of heart failure events (heart failure hospitalization and other urgent treatment for heart failure) or cardiovascular (CV) death compared to placebo in patients treated with standard of care (hazard ratio, 0.92; 95% confidence interval [CI] 0.86, 0.99; p=0.025). No reduction in the secondary endpoint of time to CV death was observed in the overall population. The effect of omecamtiv mecarbil on the primary composite endpoint in GALACTIC-HF was consistent across most prespecified subgroups and with a potentially greater treatment effect suggested in patients with a lower left ventricular ejection fraction (LVEF at most 28%, n=4,456, hazard ratio, 0.84; 95% CI 0.77, 0.92; interaction p=0.003). Supplemental analyses of this lower ejection fraction subgroup in GALACTIC-HF presented at CVCT showed that this potentially greater treatment effect in patients who received omecamtiv mecarbil was consistently observed in patients with characteristics that may indicate advanced heart failure status, such as being hospitalized within the last 3 months (HR 0.83, 95% CI 0.74 – 0.93, p=0.001), having New York Association Class III or IV heart failure (HR 0.80, 95% CI 0.71 – 0.90, p<0.001), higher n-terminal-pro brain natriuretic peptide levels hr 0.77 95 ci 0.69 0.87 p><0.001), and lower blood pressures hr 0.81 95 ci 0.70 0.92 p="0.002)." the absolute risk reductions arr ranged from 5.2 to 8.1 in these subgroups as compared to the arr of 2.1 observed in the overall population. additionally a supplemental analysis of the continuous relationship between ejection fraction and the hazard ratio for the primary composite endpoint in galactic-hf suggested a potentially stronger treatment effect of omecamtiv mecarbil in patients with increasingly lower ejection fractions. data were presented by john teerlink m.d. professor of medicine university of california san francisco director of heart failure san francisco veterans affairs medical center and executive committee chair galactic-hf at the 17th global cardiovascular clinical trialists forum cvct.>