ZENITH Trial Breakthrough: Winrevair Shows Significant Impact on Outcomes of Pulmonary Arterial Hypertension
USA: In patients with advanced pulmonary arterial hypertension (PAH), adding the biologic sotatercept-csrk (Winrevair; Merck) to the maximum tolerated background therapy significantly lowers the risk of death compared to background therapy alone, as shown by the top-line results of the ZENITH trial.
Merck announced yesterday that an interim analysis of the ZENITH trial confirmed it had achieved its primary endpoint, which measured the time to the first morbidity or mortality event. Following this finding, the trial's independent data monitoring committee recommended ending the phase III trial early to enable all participants to transition into an open-label extension study and access the drug.
The ZENITH trial enrolled 172 patients with PAH classified as WHO Functional Class III or IV. Participants were randomized to receive either WINREVAIR or a placebo alongside their maximum tolerated PAH therapy. The study's primary endpoint was the time to the first morbidity or mortality event, defined as all-cause death, lung transplantation, or PAH-related hospitalization lasting 24 hours or more. Secondary measures included overall survival and transplant-free survival.
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