Sotatercept cuts risk of death and hospitalization by 76% in advanced pulmonary arterial hypertension
Published in The New England Journal of Medicine on May 28, the Zenith trial marks the first demonstration of a survival benefit for sotatercept in late-stage pulmonary arterial hypertension
Overview
- The international Zenith Phase 3 trial enrolled 172 patients with advanced pulmonary arterial hypertension and was halted early after sotatercept showed a 76% lower risk of death, lung transplantation or hospitalization compared to placebo
- Hospitalizations occurred in 9% of sotatercept recipients versus 50% in the placebo group and mortality fell from 15% to 8%
- Adverse events such as vascular malformations and bleeding were reported but did not lead patients to discontinue sotatercept
- Sotatercept was originally approved last year for mild pulmonary arterial hypertension and works by modulating vascular remodeling pathways rather than merely easing symptoms
- Experts say the NEJM-published results could transform treatment options for patients with limited therapies in late-stage disease