Phase III VICTORIA study of BAY 1021189 shows reduced risk of hospitalisation or death in heart failure.- Merck Inc + Bayer Healthcare

Merck Inc announced the presentation of results from the VICTORIA trial, a Phase III study evaluating the efficacy and safety of its investigational drug BAY 1021189 (vericiguat), an orally administered soluble guanylate cyclase (sGC) stimulator being developed to treat patients with heart failure with reduced ejection fraction and following a worsening event. VICTORIA is the first contemporary outcomes study focused exclusively on symptomatic chronic heart failure patients (ejection fraction <45%) following a worsening event. Vericiguat is being jointly developed with Bayer AG.

Over a median of 10.8 months, the incidence of cardiovascular death or heart failure-related hospitalization occurred in 897 (35.5%) patients receiving vericiguat and 972 (38.5%) receiving placebo (HR 0.90; 95% CI 0.82–0.98; P=0.019). This effect was consistent across the majority of pre-specified subgroups, including patients receiving or not receiving sacubitril/valsartan. Levels of NT-proBNP at baseline and age were shown to correlate with the treatment effect. Here, the data suggest that the majority of patients in the study with NT-proBNP in the lower quartile ranges and those under 75 years of age may have achieved a greater benefit. The safety profile of vericiguat was consistent with that reported in previous studies. These results were presented at the virtual American College of Cardiology’s 69th Annual Scientific Session Together With World Congress of Cardiology (ACC.20/WCC) and published in The New England Journal of Medicine.

Patients enrolled in VICTORIA were at high risk of hospitalization and cardiovascular death following a recent heart failure decompensation. Vericiguat, when given in combination with available heart failure therapies, met the primary efficacy endpoint of reducing the risk for the composite endpoint of heart failure hospitalization or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction (HFrEF), compared to placebo. A hazard ratio of 0.90 (95% CI 0.82-0.98) in this high risk population translated into a clinically relevant 4.2/100 patient-years absolute reduction in event rate. Based on this absolute risk reduction, the number needed to treat with vericiguat for one year to prevent a primary outcome event is approximately 24 patients.

See: “Vericiguat in Patients with Heart Failure and Reduced Ejection Fraction.” Paul W. Armstrong et al. New England Journal of Medicine, March 28, 2020 DOI:10.1056/NEJMoa1915928