Merck’s VERQUVO Misses Primary Endpoint in VICTOR Trial But Pooled Analysis Shows Benefit

Merck (MSD outside the U.S. and Canada) announced results from the Phase 3 VICTOR trial evaluating VERQUVO® (vericiguat) in patients with stable chronic heart failure with reduced ejection fraction (HFrEF). The study compared VERQUVO to placebo in patients without a recent worsening heart failure event who were already on guideline-directed medical therapy (GDMT). The trial did not meet its primary endpoint of reducing the composite outcome of cardiovascular death or heart failure hospitalization.

“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.”

Results showed that the primary outcome occurred in 18% of VERQUVO patients vs. 19.1% on placebo (HR 0.93; p=0.22). While the difference was not statistically significant, VERQUVO showed a numerical reduction in cardiovascular death (9.6% vs. 11.3%), though no clear benefit was seen in heart failure hospitalizations. Safety findings were consistent with prior trials.

“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.

A pooled pre-specified analysis combining data from VICTOR and the pivotal VICTORIA trial (in patients with worsening HFrEF) demonstrated that VERQUVO significantly reduced the composite risk of cardiovascular death or heart failure hospitalization across a broad HFrEF population of 11,155 patients. No new safety concerns were observed. VERQUVO’s approved indication in patients with HFrEF after a recent worsening heart failure event remains unchanged.