Results from the Phase 3 VICTOR trial and a pooled analysis of the VICTOR and VICTORIA trials were presented today at the ESC Congress 2025 and simultaneously published in The Lancet
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced results evaluating VERQUVO® (vericiguat) in adult patients with stable chronic heart failure and reduced ejection fraction (HFrEF). The Phase 3 VICTOR trial comparing the efficacy of VERQUVO to placebo in patients with HFrEF without a recent worsening heart failure event treated with guideline-directed medical therapy (GDMT) did not reach statistical significance for its primary endpoint of combined time to first event of cardiovascular death or hospitalization for heart failure. In a separate pre-specified pooled analysis of patient-level data from the complementary Phase 3 VICTOR and VICTORIA trials, VERQUVO reduced the risk of the composite primary endpoint of cardiovascular death or heart failure hospitalization across these patients with a broad range of disease severity. Results from both analyses were presented today at the European Society of Cardiology (ESC) Congress 2025 in a Hot Line session and simultaneously published in The Lancet.
VERQUVO was initially studied and approved in patients with worsening chronic heart failure and ejection fraction less than 45% following a worsening heart failure event based on the pivotal Phase 3 VICTORIA trial. Participants in the VICTOR trial represented a well-treated group of ambulatory HFrEF patients on GDMT and 47.5% of participants had no history of hospitalization for heart failure. Results showed that VERQUVO did not significantly reduce the risk of the primary composite outcome of time to cardiovascular death or hospitalization for heart failure, which occurred in 18% (n=549/3,053) of patients treated with VERQUVO compared to 19.1% (n=584/3,052) in the placebo group (hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.83-1.04; p=0.22). For the key secondary endpoints, cardiovascular death was numerically lower with VERQUVO (9.6%) compared to placebo (11.3%) (HR 0.83; 95% CI 0.71-0.97) and heart failure hospitalization occurred in 11.4% of patients receiving VERQUVO and 11.9% of patients receiving placebo (HR 0.95; 95% CI 0.82–1.10).The overall safety profile of VERQUVO in the VICTOR trial was consistent with previous clinical trials.
“By studying patients without recent heart failure hospitalizations, the Phase 3 VICTOR trial expands our understanding of VERQUVO across the full spectrum of chronic heart failure patients with reduced ejection fraction,” said Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories. “Together with the previously communicated results in VICTORIA in patients with worsening chronic heart failure and ejection fraction less than 45% following a worsening heart failure event, the results today provide valuable information and add to our understanding of heart failure and VERQUVO. We are grateful to the patients and investigators for their participation in these studies and remain confident in the role of VERQUVO for its approved indication for patients with HFrEF following a recent heart failure event and with ejection fraction less than 45% based on the pivotal Phase 3 VICTORIA trial.”
The Phase 3 VICTORIA trial focused exclusively on a population with worsening chronic HFrEF at high risk for cardiovascular mortality and repeated heart failure hospitalizations. In a separate pre-specified pooled analysis across VICTOR and VICTORIA, VERQUVO’s benefit was examined in a large and broad cohort. In this pooled analysis of 11,155 HFrEF patients, VERQUVO showed a statistically significant risk reduction across the primary composite endpoint of cardiovascular death or heart failure hospitalization and its components as secondary endpoints, in a broad spectrum of patients with HFrEF. No new safety signals, beyond those reported in the individual trials, emerged in the pooled analysis.
“While the VICTOR trial did not meet its primary endpoint, the separate pooled analysis across both VICTOR and VICTORIA did demonstrate a statistically significant reduction in the primary composite endpoint of heart failure hospitalization and cardiovascular deaths in patients with heart failure and reduced ejection fraction across the disease severity,” said Javed Butler, MD, MPH, MBA, President of the Baylor Scott and White Research Institute and Professor of Medicine at University of Mississippi in Jackson, Mississippi.
The positive benefit-risk profile of VERQUVO in its approved indication in patients with HFrEF following a recent heart failure event based on the pivotal Phase 3 VICTORIA trial remains unchanged. In the U.S., VERQUVO is approved for the reduction of risk of cardiovascular death and heart failure hospitalization following a hospitalization for heart failure or need for outpatient intravenous diuretics in adults with symptomatic chronic heart failure and ejection fraction less than 45%.
