Merck Says Winrevair Reduced Risk Of Death, Lung Transplantation And Hospitalization For PAH

(RTTNews) - Merck (MRK), known as MSD outside of the United States and Canada, Monday announced the first presentation of results from the Phase 3 Zenith trial evaluating Winrevair (sotatercept-csrk) compared to placebo in adults with pulmonary arterial hypertension WHO functional class (FC) III or IV at high risk of mortality who were on maximum tolerated background PAH therapy.

At a median follow-up of 10.6 months, Winrevair reduced the relative risk of major morbidity and mortality events by 76% compared to placebo. For patients treated with Winrevair, 17.4% experienced one or more major morbidity and mortality events, compared with 54.7% of patients in the placebo arm. The safety profile of Winrevair in Zenith was generally consistent with that observed in previous studies.

"The ZENITH study represents the first PAH clinical trial with a primary endpoint comprised entirely of major outcome measures - all-cause death, lung transplantation and hospitalization for PAH," said Dr. Marc Humbert, Department of Respiratory and Intensive Care Medicine Hospital Bicêtre (AP-HP), University Paris-Saclay and Inserm Unit 999. "WINREVAIR had a significant and clinically meaningful impact on the composite of these outcomes, and together with the growing body of evidence from the clinical development program, these data support the practice-changing potential of WINREVAIR for a broad range of patients with PAH."

"The impressive results from ZENITH demonstrated that patients on WINREVAIR had a 76 percent risk reduction in the composite of all-cause death, lung transplantation and hospitalization for PAH compared to placebo, with improvement observed early in treatment and increasing benefit throughout the study," said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. "These results led to the ZENITH study being the first PAH clinical trial stopped early due to overwhelming efficacy, representing an important milestone in clinical research with promise for the PAH community."