ACC25: Merck & Co.’s Winrevair reduces mortality in most severe PAH patients

Merck's Winrevair (sotatercept) demonstrated significant benefits for patients with severe pulmonary arterial hypertension (PAH) in the Phase 3 ZENITH trial presented at ACC.251 3:

Key Findings

76% reduction in risk of major morbidity and mortality events compared to placebo
Composite endpoint included all-cause death, lung transplantation, and PAH-related hospitalization
Study stopped early due to overwhelming efficacy

Detailed Results

- Deaths:
8.1% in Winrevair arm vs 15.1% in placebo arm

- Lung transplantation:
1.2% with Winrevair vs 7.0% with placebo

- PAH-related hospitalizations:
9.0% with Winrevair vs 50.0% with placebo2

Study Population

Adults with PAH WHO functional class III or IV at high risk of mortality
Patients on maximum tolerated background PAH therapy
72.1% on triple therapy, 27.9% on double therapy2

Mechanism of Action

Winrevair is the first FDA-approved activin signaling inhibitor for PAH, working to improve the balance between pro- and anti-proliferative signaling in blood vessels4.

Expert Commentary

"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," said Dr. Marc Humbert, lead investigator2.

This landmark trial demonstrates Winrevair's potential to significantly improve outcomes for patients with severe PAH, representing an important advance in treatment options for this rare and progressive disease.

Sources:

1. https://www.managedhealthcareexecutive.com/view/winrevair-shows-its-promise-in-advancing-pah-treatment

2. https://www.biospace.com/press-releases/winrevair-sotatercept-csrk-reduced-the-risk-of-a-composite-of-all-cause-death-lung-transplantation-and-hospitalization-for-pulmonary-arterial-hypertension-pah-by-76-compared-to-placebo-in-the-phase-3-zenith-trial

3. https://www.ajmc.com/view/sotatercept-reduces-risk-of-death-transplant-or-hospitalization-in-advanced-pah

4. https://www.merck.com/news/fda-approves-mercks-winrevair-sotatercept-csrk-a-first-in-class-treatment-for-adults-with-pulmonary-arterial-hypertension-pah-who-group-1/