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Late-Breaking Kerendia (finerenone) Investigational Data Show Reduction in Cardiovascular Death and Total Heart Failure Events in Adults with Heart Failure With Mildly Reduced or Preserved Ejection Fraction
- The primary endpoint results were consistent across all prespecified subgroups1
- KERENDIA is the first-and-only non-steroidal mineralocorticoid receptor antagonist (MRA) to meet a primary composite cardiovascular endpoint in a Phase III trial investigating patients with HF with mildly reduced or preserved ejection fraction (LVEF ≥40%)1
- Results from FINEARTS-HF were simultaneously published in the New England Journal of Medicine
- The primary endpoint results were consistent across all prespecified subgroups1
- KERENDIA is the first-and-only non-steroidal mineralocorticoid receptor antagonist (MRA) to meet a primary composite cardiovascular endpoint in a Phase III trial investigating patients with HF with mildly reduced or preserved ejection fraction (LVEF ≥40%)1
- Results from FINEARTS-HF were simultaneously published in the New England Journal of Medicine
Bayer News
WHIPPANY, N.J.--Detailed results from the Phase III FINEARTS-HF trial presented at the European Society of Cardiology (ESC) Congress 2024 and published in the New England Journal of Medicine showed that KERENDIA® (finerenone) achieved a statistically significant reduction of the composite of cardiovascular death and total (first and recurrent) heart failure (HF) events, defined as either an unplanned hospitalization for HF or an urgent HF visit, by 16% (rate ratio, 0.84; 95% confidence interval [CI], 0.74 to 0.95; P = 0.007) in patients with HF and a LVEF ≥40% (left ventricular ejection fraction) compared to placebo in addition to a patients’ prescribed treatment regimen.1
KERENDIA is the first-and-only non-steroidal mineralocorticoid receptor antagonist (MRA) to meet a primary composite cardiovascular endpoint in a Phase III trial investigating patients with HF and LVEF ≥40%.1
KERENDIA is currently approved to reduce the risk of cardiovascular death, hospitalization for HF, non-fatal myocardial infarction (MI), sustained eGFR decline, and end-stage kidney disease in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).2
KERENDIA already has established cardiovascular benefit (reduction in hospitalization for HF, CV death and non-fatal MI) in adults with CKD associated with T2D,2 and this new data provides positive results in a different patient population not limited to CKD in T2D – patients diagnosed with HF (LVEF ≥40).1
FINEARTS-HF is a multicenter, randomized, double-blind, parallel-group, placebo-controlled, event-driven Phase III trial. It is investigating the efficacy and safety of finerenone for the reduction of risk of cardiovascular death and HF events in patients with a diagnosis of symptomatic HF (New York Heart Association class II-IV) with a LVEF of ≥40%, a measurement that indicates how much blood the left ventricle of the heart pumps with each beat.3 In the FINEARTS-HF trial, no new safety signals were identified compared with those seen in previous studies with the compound.1
“Treating heart failure patients with LVEF ≥40% has provided a challenge for many physicians, as these patients have a substantial risk for cardiovascular events. Unlike heart failure with reduced ejection fraction, there are limited guideline-directed options for heart failure with LVEF >40%,” said Scott D. Solomon, MD, The Edward D. Frohlich Distinguished Chair, Professor of Medicine at Harvard Medical School, Director of Non-invasive Cardiology and Senior Physician at Brigham and Women’s Hospital and Chair of the trial’s Executive Committee. “FINEARTS-HF is the first large-scale trial where a non-steroidal mineralocorticoid receptor antagonist met a primary composite cardiovascular endpoint in patients with heart failure with mildly reduced or preserved ejection fraction (LVEF >40%), and these results provide insights for the cardiology community managing these high-risk patients.”
“Bayer has a strong heritage in cardiology, and heart failure is a key focus area for us, with these results underpinning our ongoing commitment to patients with this devastating condition. Based on FINEARTS-HF, KERENDIA has shown to reduce the risk of cardiovascular outcomes in a complex to treat patient population,” said Dr. Christian Rommel, Head of Research and Development at Bayer’s Pharmaceuticals Division.
The results shown in the primary endpoint results were consistent across all prespecified subgroups. Secondary outcomes tested hierarchically included total number of worsening HF events (rate ratio, 0.82; 95% confidence interval [CI], 0.71 to 0.94, p=0.006) and the Kansas City Cardiomyopathy Questionnaire (KCCQ) Total Symptom Score (TSS) assessed at months six, nine and 12. There was a mean change from baseline in the KCCQ-TSS of 8 points in the finerenone group and 6.4 points in the placebo group (between-group difference of 1.6 points; 95%CI, 0.8 to 2.3, p<0.001).
Serious adverse events were comparable between treatment groups, occurring in 38.7% (1,157/2,993) of the finerenone group and 40.5% (1,213/2,993) of the placebo group. Discontinuation of the trial drug for reasons other than death was similar between groups, with 20.4% (611/2,993) in the finerenone group and 20.6% (616/2,993) in the placebo group. Increases in creatinine and potassium levels were more frequent in patients receiving finerenone compared to placebo, with investigator-reported hyperkalemia in 9.7% (289/2,993) of finerenone-treated patients versus 4.2% (125/2,993) in the placebo group. Serum potassium levels >6 mmol/L were observed in 3% (n=86) of the finerenone group compared to 1.4% (41/2,993) in the placebo group. While hyperkalemia was more common with finerenone, it rarely led to hospitalization (0.5% [16/2,993] versus 0.2% [6/2,993] in the placebo group), and no cases resulted in death.1
HF is a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood.4 Approximately 6.7 million adults in the U.S. live with HF, of whom about 55% have a LVEF ≥40%.5 Despite the high prevalence, guideline-directed medical treatment options for patients with HF with LVEF ≥40% are limited.6 This patient group is often balancing multiple comorbidities, such as obesity, hypertension and CKD.4
Bayer plans to discuss this data and submission for regulatory approval with the U.S. Food and Drug Administration (FDA).
About FINEARTS-HF3
FINEARTS-HF is a randomized, double-blind, placebo-controlled, multicenter, event-driven Phase III trial investigating the efficacy and safety of KERENDIA® (finerenone) for the reduction of risk of cardiovascular death and heart failure (HF) events in patients with a diagnosis of symptomatic heart failure (New York Heart Association class II-IV) with a left ventricular ejection fraction (LVEF) of ≥40%, measured by local imaging measurement within the last 12 months, who received diuretic treatment for at least 30 days prior to randomization. The primary endpoint of FINEARTS-HF was the composite of cardiovascular death and total (first and recurrent) HF events, defined as hospitalizations for HF or urgent HF visits.
Approximately 6,000 patients were randomized to receive KERENDIA or placebo once daily for up to 42 months. Results showed that KERENDIA once daily in addition to a patients’ prescribed treatment regimen reduced the composite of total worsening HF events and cardiovascular death in patients with HF and mildly reduced or preserved ejection fraction. KERENDIA also significantly reduced the secondary endpoints of total HF events (HR 0.82 [95% CI, 0.71-0.94; p=0.0062]) and improved patient-reported health status as measured by the change from baseline in Total Symptom Score of Kansas City Cardiomyopathy Questionnaire (KCCQ-TSS) (between-group difference 1.6 points [95% CI, 0.8-2.3; p<0.0001]).
With overall more than 15,000 patients, the MOONRAKER clinical trial program with KERENDIA, including FINEARTS-HF, is one of the largest HF trial programs to date and aims to establish a comprehensive body of evidence for KERENDIA across a broad spectrum of patients and clinical settings.1
About KERENDIA® (finerenone)2
KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) and was approved by the U.S. Food and Drug Administration (FDA) in July 2021 to reduce the risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for HF in adults with CKD associated with T2D.
In adults with CKD associated with T2D, KERENDIA has been recommended to reduce the risk of hospitalization for HF by the American Diabetes Association (ADA)7 and European Society of Cardiology (ESC).8
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