Bayer has shared positive results from a late-stage study of its investigational non-hormonal drug in patients experiencing vasomotor symptoms (VMS) as a result of breast cancer treatment.
The phase 3 OASIS 4 study has been evaluating the candidate, elinzanetant, as a treatment for moderate-to-severe VMS caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in those who are at high risk of developing breast cancer.
VMS, such as hot flashes, are reported by up to 80% of women at some point during the menopausal transition, and over one-third report severe symptoms.
Those receiving adjuvant endocrine therapy, including tamoxifen or aromatase inhibitors, for the treatment or prevention of breast cancer may also experience VMS. There are currently no licensed treatment options for this patient population.
OASIS 4 met its primary endpoint, with elinzanetant resulting in statistically significant mean reductions in the frequency of moderate-to-severe VMS from baseline to weeks four and 12 compared to placebo.
All key secondary endpoints were also achieved, demonstrating a reduction in severity of VMS at weeks four and 12, a reduction in frequency of VMS at week one, as well as improvements in sleep disturbances and menopause-related quality of life at week 12 compared to placebo.
Additionally, the safety profile of elinzanetant observed over 52 weeks was generally consistent with previously conducted studies and published data on the drug in postmenopausal women with VMS.
Administered orally once daily, elinzanetant is a dual neurokinin-1, 3 receptor antagonist in late-stage clinical development to treat moderate-to-severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer.
The latest results for the drug build on positive results from the phase 3 OASIS 1, 2 and 3 trials in women with moderate-to-severe VMS associated with menopause.
Fatima Cardoso, principal investigator of OASIS 4, said: “The positive results from OASIS 4 bring us one step closer to a much-needed non-hormonal option for managing VMS in breast cancer patients and women at risk of breast cancer.”
Submissions for marketing authorisations for elinzanetant are ongoing in the US, EU, UK and other markets globally, Bayer outlined.