Bayer Phase III success with elinzanetant

German pharma major Bayer (BAYN: DE) today announced top-line results of the Phase III study OASIS 4 investigating elinzanetant as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in women at high risk of developing breast cancer.

Elinzanetant successfully met the primary endpoints demonstrating statistically-significant mean reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flushes) from baseline to week 4 and 12 compared to placebo. The study also achieved all secondary endpoints demonstrating mean reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effect over the study period.

Bayer noted that elinzanetant also showed mean improvements in sleep disturbances and menopause-related quality of life at week 12 compared to 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.