ESC: MSD/Bayer's Verquvo disappoints in heart failure trial

Bayer and MSD's hopes of expanding the use of their sGC stimulator Verquvo in heart failure have been dashed by a failed phase 3 trial.

The results of the 6,105-patient VICTOR study showed that Verquvo (vericiguat) was unable to meet its objective of reducing the rate of heart failure hospitalisations or cardiovascular death in ambulatory heart failure with reduced ejection fraction (HFrEF) patients compared to placebo.

The results, reported at the European Society of Cardiology (ESC) congress, showed, however, that Verquvo was associated with fewer cardiovascular deaths and all-cause deaths when added to standard background therapy for heart failure.

Verquvo has been approved to treat HFrEF with worsening symptoms – specifically after hospitalisation or the need for intravenous diuretics – since 2021, based on the results of the VICTORIA trial. VICTOR was designed in the hope of extending the use of the drug to patients without worsening symptoms.

Over 18.5 months median follow-up, the primary endpoint occurred in 18% of patients in the vericiguat group and 19.1% of patients in the placebo group, a 7% improvement that was not statistically significant. Most of the difference came from reduced cardiovascular death, 17% lower with Verquvo, and with little difference between the groups in hospitalisations.

Lead investigator Prof Faiez Zannad from the Université de Lorraine in France told delegates that the lack of an impact on hospitalisation "may be due, at least in part, to the high use of contemporary [heart failure] therapies and the low proportion of recent hospitalisations in this population."

It's notable that 83% of patients were on three or more heart failure therapies and nearly half (47.5%) had no cases of hospitalisation for heart failure, setting a high bar for showing a significant benefit over placebo in VICTOR, he said.

"Secondary endpoints indicated fewer events for vericiguat in cardiovascular death and all-cause mortality compared to the placebo group," added Zannad. "Although these results are descriptive, the data on mortality in a well-controlled HFrEF patient population is a positive sign. Overall, these findings support the use of vericiguat in ambulatory patients with HFrEF on top of contemporary therapies."

Bayer and MSD don't give much detail about Verquvo sales in their financial reporting, but said when the drug was first approved that they were targeting peak revenues for the product of around €1 billion a year.