Merck to stop trial evaluating Winrevair early in pulmonary arterial hypertension
Rahway: Merck, known as MSD outside of the United States and Canada, has announced the Phase 3 HYPERION study evaluating WINREVAIR (sotatercept-csrk) versus placebo (both in combination with background therapy) in recently diagnosed adults with pulmonary arterial hypertension (PAH, WHO* Group 1) functional class (FC) II or III at intermediate or high risk of disease progression will be stopped early.
The decision to stop the HYPERION study prior to its scheduled completion was based on the positive results from the interim analysis of the ZENITH trial and a review of the totality of data from the WINREVAIR clinical program to date. The program’s external steering committee and Merck made this decision in light of these data, which will enable all study participants to have the opportunity to access WINREVAIR. Merck discussed this decision to stop the HYPERION study early with the U.S. Food and Drug Administration (FDA) and has informed HYPERION study investigators.
"After closely reviewing the robust efficacy data across a broad spectrum of patients evaluated in the WINREVAIR clinical development program, the steering committee has unanimously concluded that the HYPERION study, evaluating WINREVAIR versus placebo on top of background therapy, has lost clinical equipoise and should be stopped early,” said Dr. Vallerie McLaughlin**, Kim A Eagle MD Endowed Professor of Cardiovascular Medicine and Director, Pulmonary Hypertension Program, University of Michigan in Ann Arbor. “PAH is a progressive and debilitating disease with a high incidence of morbidity and mortality, and we look forward to continuing to evaluate these patients and any potential impact to the treatment landscape as a result of these data.”
“Based on the strong, positive interim efficacy data from the ZENITH trial, as well as the totality of available WINREVAIR data, we concluded that it would not be ethical to continue the HYPERION study,” said Dr. Eliav Barr, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We are grateful to the dedicated community of patients who participated in these studies and are pleased to offer the option of receiving WINREVAIR through the Phase 3 SOTERIA open-label extension study.”
Findings from the HYPERION study will be available later this year and presented at a future medical congress.
WINREVAIR is currently approved in the U.S. and 38 countries based on the results from the Phase 3 STELLAR trial.
