Elinzanetant Found Safe, Effective for VMS Linked to Breast Cancer Treatment: Daily Dose
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Patient Care brings primary care clinicians a lot of medical news every day—it’s easy to miss an important study. The Daily Dose provides a concise summary of one of the website's leading stories you may not have seen.
On January 9, 2025, we reported on topline results announced by Bayer from the phase 3 OASIS 4 clinical trial examining elinzanetant as non-hormonal treatment for moderate-to-severe vasomotor symptoms (VMS) in women undergoing adjuvant endocrine therapy for hormone receptor-positive breast cancer or those at high risk of developing the disease.
The study
The OASIS 4 study is a double-blind, randomized, placebo-controlled multicenter study conducted among 474 patients in 16 countries outside the US. Participants were randomly assigned to 1 of 2 treatment groups. One group received elinzanetant immediately, and the other received placebo and then switched to elinzanetant.
The findings
The study met all primary and secondary endpoints. Elinzanetant achieved a statistically significant reduction in the frequency of moderate to severe VMS from baseline to weeks 4 and 12 compared to placebo. Notably, the treatment’s effects were observed as early as week 1 and sustained over the 52-week study period.
Additional benefits included reductions in VMS severity and improvements in sleep disturbances and menopause-related quality of life. The safety profile of elinzanetant over 52 weeks was consistent with data from prior studies in postmenopausal women.
Detailed results from OASIS 4 will be presented at upcoming scientific congresses, providing further insights into its potential role in addressing VMS caused by adjuvant endocrine therapy.
Authors' comments
“For women undergoing endocrine therapy, managing menopausal symptoms like VMS is essential for maintaining adherence to life-saving treatments. The promising results of this study bring us closer to a much-needed therapeutic option.”
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