Trial Met Primary Composite Endpoint of Reduction in Cardiovascular Death or Heart Failure Events
Trial Did Not Meet Secondary Endpoint of Reduction in Cardiovascular Death
Results Will Be Presented in Late Breaking Clinical Trial Session at AHA Scientific Sessions 2020
THOUSAND OAKS, Calif. and SOUTH SAN FRANCISCO, Calif. and SURESNES, France, Oct. 8, 2020 /PRNewswire/ -- Amgen (NASDAQ:AMGN), Cytokinetics, Incorporated (NASDAQ:CYTK) and Servier today announced topline results from GALACTIC-HF, a Phase 3 pivotal clinical trial of omecamtiv mecarbil in patients with heart failure with reduced ejection fraction (HFrEF).
The results of GALACTIC-HF show that treatment with omecamtiv mecarbil achieved the primary composite efficacy endpoint and demonstrated a statistically significant effect to reduce cardiovascular (CV) death or heart failure events (heart failure hospitalization and other urgent treatment for heart failure) compared to placebo in patients treated with standard of care (HR: 0.92; 95% CI: 0.86, 0.99, p=0.0252).
No reduction in the secondary endpoint of CV death was observed. Adverse events, including major ischemic cardiac events, were balanced between treatment arms. Additional analyses of data are underway and results from GALACTIC-HF will be presented at the American Heart Association (AHA) Scientific Sessions 2020, in a virtual Late Breaking Clinical Trial session on Friday, November 13, 2020 from 10:35-10.45 a.m. CDT.
Omecamtiv mecarbil is an investigational cardiac myosin activator, the first of a novel class of myotropes1 designed to directly target the contractile mechanisms of the heart.
"The outcomes observed in GALACTIC-HF further the understanding of treating heart failure, a devastating disease in which half of heart failure patients will die within five years of initial hospitalization," said David M. Reese, M.D. executive vice president of Research and Development at Amgen. "At Amgen, we remain committed to developing and delivering transformative medicines that improve the lives of patients with cardiovascular disease."
"GALACTIC-HF provides insights into effects associated with targeting cardiac muscle contractility with omecamtiv mecarbil to treat heart failure patients with reduced ejection fraction," said Fady I. Malik, M.D., Ph.D., Cytokinetics' executive vice president of Research & Development. "We are grateful to the trial investigators, site personnel, patients and caregivers who participated in the trial, and we look forward to further data analyses and the presentation of the results of this Phase 3 trial at the American Heart Association Scientific Sessions."
"Heart failure is a devastating condition jeopardizing patients' lives every day. We are pleased to have collaborated with Amgen and Cytokinetics on one of the largest heart failure trials ever conducted to investigate this novel therapy in patients with heart failure. It is important to now turn our attention to fully analyzing the data from this important study in this clinical setting," said Claude Bertrand, PharmD, PhD, Executive Vice President R&D at Servier.
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 cardiovascular 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.