Elinzanetant found safe and effective for VMS linked to breast cancer treatment
The OASIS 4 clinical trial showed successful reductions in the frequency and severity of hot flashes caused by adjuvant endocrine therapy used in breast cancer management.
Elinzanetant found safe and effective for VMS linked to breast cancer treatment | Image Credit: © AlesiaKan - © AlesiaKan - stock.adobe.com.
Elinzanetant has shown safety and efficacy for the treatment of moderate to severe vasomotor symptoms (VMS) linked to breast cancer treatment, according to a recent phase 3 study published by Bayer.1
VMS are caused by hyperactivation of the thermoregulatory pathway, often linked to a decrease in estrogen from natural menopause or medical interventions such as bilateral oophorectomy and adjuvant endocrine therapy. Up to 80% of women experience VMS during the menopause transition, with some having symptoms for 10 or more years.
Currently, women experiencing VMS from adjuvant endocrine therapy used in breast cancer management do not have an approved treatment option. Elinzanetant, a dual neurokinin-1 and 3 receptor antagonist designed for VMS treatment, may provide a new, non-hormonal option to this population.
Elinzanetant modulates the KNDY neurons in the brain to manage hyperactivation of the thermoregulatory pathway, reducing VMS frequency and severity. Additionally, elinzanetant may be used to reduce sleep disturbances linked to menopause.
The phase 3 OASIS 4 trial is part of the OASIS clinical development program. In the OASIS 1 and 2 trials, the safety and efficacy of elinzanetant was evaluated in postmenopausal women across a 26-week period.
Elinzanetant 120 mg was taken orally once per day by patients in the elinzanetant group for 26 weeks, while those in the control group received placebo for 12 weeks followed by the elinzanetant regimen for 13 weeks. Following these trials, elinzanetant received further investigation across a 52-week period in the OASIS 3 trial.
Supporting the OASIS 1 and OASIS 2 trial data, the OASIS 3 trial displayed safety and efficacy for elinzanetant toward reducing moderate to severe VMS in postmenopausal women.2 According to Nick Panay, MD, BSC, MRCOG, MFSRH, principal investigator for OASIS 3, this strengthened Bayer’s confidence in the use of elinzanetant in women with menopause-related symptoms.
The OASIS 4 trial was designed to evaluate elinzanetant’s safety and efficacy against VMS caused by adjuvant endocrine therapy in women with or at high risk of hormone-receptor positive breast cancer.1 There are 474 participants undergoing 52 weeks and an optional additional 2 years of investigation.
Results indicated success from elinzanetant in reaching the primary endpoints of significantly reduced frequency for moderate to severe VMS between baseline and weeks 4 and 12 when compared to placebo. The severity of VMS was also significantly reduced in patients receiving elinzanetant during this period, and VMS frequency was reduced by week 1.
Participants taking elinzanetant experienced significant improvements in sleep disturbances and menopause-related quality of life by week 12 when compared to placebo. Additionally, the safety of elinzanetant in postmenopausal women with or at high risk of breast cancer was consistent with the populations of the OASIS 1, 2, and 3 trials.
“For women undergoing endocrine therapy against breast cancer, menopausal symptoms like VMS and sleep disturbances are very common and can significantly affect quality of life, potentially impacting treatment adherence,” said Fatima Cardoso, MD, Principal Investigator of OASIS 4.
“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,” added Fatima.
References
- 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. January 9, 2025. Accessed January 9, 2025. https://bayer2019tf.q4web.com/news/news-details/2025/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/default.aspx
- Krewson C. Elinzanetant's efficacy for vasomotor symptoms confirmed in phase 3 trial. March 19, 2024. Accessed January 9, 2024. https://www.contemporaryobgyn.net/view/elinzanetant-s-efficacy-for-vasomotor-symptoms-confirmed-in-phase-3-trial
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