Winrevair PAH trial stopped due to earlier ‘robust evidence’
The phase 3 HYPERION trial of Winrevair in adults with newly diagnosed pulmonary arterial hypertension functional class two or three is ending early due to robust positive evidence found in previous trials, according to a press release.
In the release, Merck said this was a collaborative decision between the company and the program’s external steering committee.
As Healio previously reported, Merck also ended the phase 3 ZENITH trial of Winrevair (sotatercept, Merck) early after finding “overwhelming efficacy in the primary endpoint result” during interim analysis.
“Based on the strong, positive interim efficacy data from the ZENITH trial, as well as the totality of available Winrevair data, we concluded that it would not be ethical to continue the HYPERION study,” Eliav Barr, MD, senior vice president, head of global clinical development and chief medical officer at Merck Research Laboratories, said in the release.
The FDA approved Winrevair, an activin signaling inhibitor, for treating adults with PAH in March 2024 based, in part, on phase 3 STELLAR trial data.
Both the Winrevair group and the placebo group in the global, double-blind, placebo-controlled phase 3 HYPERION trial (n = ~300) received background therapy in addition to their assigned treatment, according to the release.
Similar to the ZENITH trial, Merck is allowing patients from HYPERION to continue treatment in the SOTERIA study.
“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,” a Merck spokesperson previously told Healio.
According to the release, clinicians can expect to see HYPERION study results in 2025.
Reference:
- Merck announces pivotal phase 3 ZENITH trial evaluating WINREVAIR (sotatercept-csrk) met primary endpoint at interim analysis. https://www.merck.com/news/merck-announces-pivotal-phase-3-zenith-trial-evaluating-winrevair-sotatercept-csrk-met-primary-endpoint-at-interim-analysis/. Published Nov. 25, 2024. Accessed Jan. 30, 2025.
Perspective
Back to Top
The collective results from the sotatercept (Winrevair) clinical trials to date demonstrate unprecedented clinical efficacy in patients with PAH. Through its novel mechanism of action of improving the balance between anti-proliferative and pro-proliferative signaling in the pulmonary arterial circulation, Winrevair has demonstrated marked improvements in hemodynamics, right heart function and clinical improvement when added to standard background PAH medical therapy. These results usher in a new era in the treatment of PAH and cause for optimism for PAH patients and providers.
Read more about