Indeed, we are f... ed!
January 09, 2025
Not intended for UK Media
Elinzanetant meets all primary and secondary endpoints in Phase III study OASIS 4 for treatment of moderate to severe vasomotor symptoms caused by breast cancer treatments
In OASIS 4, a Phase III study conducted outside of the US, the investigational compound elinzanetant met all primary endpoints demonstrating a statistically significant reduction in frequency of moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy compared to placebo in women with or at high risk of developing hormone receptor positive breast cancer / The study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life / The safety profile over 52 weeks is generally consistent with previously published data in postmenopausal women with VMS / Positive topline results from OASIS 4, the first pivotal international Phase III study addressing this population of unmet medical need, add to the positive results of OASIS 1,2 and 3 and further support the efficacy and safety of elinzanetant / Elinzanetant is the first dual neurokinin-1 and 3 (NK-1,3) receptor antagonist in development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy, administered orally once daily