Merck’s VICTOR trial did not reach statistical significance for primary endpoint

Merck (MRK) announced results evaluating VERQUVO in adult patients with stable chronic heart failure and reduced ejection fraction. 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 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 at the European Society of Cardiology Congress 2025 in a Hot Line session and simultaneously published in The Lancet. 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% of patients treated with VERQUVO compared to 19.1% in the placebo group. For the key secondary endpoints, cardiovascular death was numerically lower with VERQUVO compared to placebo and heart failure hospitalization occurred in 11.4% of patients receiving VERQUVO and 11.9% of patients receiving placebo. The overall safety profile of VERQUVO in the VICTOR trial was consistent with previous clinical trials. Dr. Joerg Koglin, senior vice president and head of general medicine, global clinical development, Merck Research Laboratories, said: “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.”