Topline results: Winrevair lowers risk for mortality in patients with advanced PAH
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Adults with pulmonary arterial hypertension functional class three or four faced a decreased risk for all-cause mortality or morbidity events with Winrevair vs. placebo, according to phase 3 ZENITH trial topline results.
Morbidity events included lung transplantation or hospitalization related to disease worsening of at least 24 hours, according to a Merck press release.
“This is the second positive phase 3 trial for Winrevair and adds to the growing body of evidence for Winrevair in PAH,” a Merck spokesperson told Healio. “These findings are impressive and support the potential of Winrevair to be practice-changing in the management of PAH.”
As Healio previously reported, the FDA approved Winrevair (sotatercept, Merck), an activin signaling inhibitor, for treating adults with PAH in late March based, in part, on phase 3 STELLAR trial data.
Both the Winrevair group and the placebo group in the ZENITH trial (n = 172) received background therapy in addition to their assigned treatment, according to the release.
Due to the “overwhelming efficacy in the primary endpoint result” found during this interim analysis of the ZENITH trial, Merck reported that the trial will end.
“The study will close down, and all patients will have the opportunity to roll over into the ongoing open-label extension study, SOTERIA,” the Merck spokesperson told Healio.
“SOTERIA (NCT04796337) is an ongoing open-label extension study evaluating the long-term safety, tolerability and efficacy of sotatercept when added to background therapy for the treatment of PAH in patients who have completed previous sotatercept studies (SPECTRA, PULSAR, ZENITH, HYPERION, STELLAR) without early discontinuation,” the spokesperson continued.
Clinicians can expect to see full ZENITH findings in 2025, the Merck spokesperson told Healio.
“We look forward to presenting the full data from ZENITH at a medical meeting in 2025 and plan to submit these results to regulatory authorities,” the spokesperson said.