Data from Phase III OASIS-4 study to be presented for the first time at 2025 ASCO Annual Meeting:
- In the Phase III OASIS-4 study conducted outside of the U.S., the investigational compound elinzanetant significantly reduced the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to weeks 4 and 12, versus placebo, in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer.
- Elinzanetant has also shown in key secondary endpoints statistically significant improvements in sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo.
- Further secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 versus placebo.
- The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data on elinzanetant in postmenopausal women with VMS.
- Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily.
- This international study represents the fourth Phase III study in the clinical OASIS program and results are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and have been simultaneously published in the New England Journal of Medicine (NEJM).