The phase 3 trial evaluating long-term safety and efficacy of elinzanetant (NT-814; Bayer) for reducing the frequency of moderate to severe vasomotor symptoms (VMS) has displayed positive results compared to placebo, according to Bayer.
Takeaways
- Elinzanetant, a neurokinin-1,3 receptor antagonist, has shown positive results in reducing moderate to severe vasomotor symptoms (VMS) associated with menopause.
- The OASIS 3 trial, part of a clinical development program, confirms the efficacy and safety of elinzanetant over a 52-week period, building upon previous positive findings from OASIS 1 and 2.
- These results signify a significant step forward in providing a non-hormonal treatment option for menopause-related symptoms, addressing a critical need for women experiencing VMS.
- The study included 628 postmenopausal women aged 50 to 65 years, indicating a robust sample size for evaluating elinzanetant's effectiveness in this demographic.
- Bayer plans to share the comprehensive data from these trials at upcoming medical conferences.
VMS occur because of hyperactivation of the thermoregulatory pathway caused by decreasing estrogen levels. VMS are commonly seen in patients with bilateral oophorectomy or endocrine therapy or naturally during menopause. Endocrine therapy for the treatment of breast cancer may also cause VMS.
Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist designed for nonhormonal treatment of moderate to severe VMS in postmenopausal women. Patients take the drug orally once per day, which modulates estrogen-sensitive neurons associated with thermoregulatory pathway hyperactivation.
The OASIS 3 study is part of the OASIS clinical development program evaluating elinzanetant for treatin VMS. The study is a double-blind, randomized, placebo-controlled multicenter stud evaluating the 52-week safety and efficacy of elinzanetant in postmenopausal women with VMS. The study included 628 postmenopausal women aged 50 to 65 years.
According to Christian Rommel, PhD, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development, the OASIS 3 displayed positive topline results, supporting existing data from the OASIS 1 and 2 profiles.
Positive data for treating moderate to severe VMS associated with menopause were observed in all phase 3 clinical trials. Bayer plans on sharing the full data at future medical conference.
"Women experiencing symptoms associated with menopause have limited licensed therapeutic non-hormonal options to effectively meet their needs and it is a critical time to bring forth novel treatments that address this unmet need," said Nick Panay, MD, BSC, MRCOG, MFSRH, principal investigator for OASIS 3.
"The OASIS 3 results further underscore those seen in the topline data from OASIS 1 and OASIS 2 and strengthens our confidence in the proposed efficacy and safety of elinzanetant as a potential novel non-hormonal solution for women experiencing menopause-related symptoms," Panay added.
Reference
Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant. Business Wire. March 19, 2024. Accessed March 19, 2024. https://www.businesswire.com/news/home/20240319303649/en/
