Reading, UK, 9th January 2025 – Bayer today announced topline 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. 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 data2,3,4 on elinzanetant in postmenopausal women with VMS.
“Elinzanetant has consistently demonstrated positive results across all four Phase III clinical trials that assessed its efficacy and safety profile as the treatment of moderate to severe vasomotor symptoms associated with menopause or caused by adjuvant endocrine therapy,” said Dr. Christian Rommel, Head of Research and Development, Member of the Executive Committee of Bayer’s Pharmaceuticals Division. “The latest topline results from OASIS 4 reaffirm our commitment at Bayer to advancing innovative treatments for the different needs of women and their health.”
Breast cancer is the most frequent cancer in women globally with 2.3 million new cases in 20205, with nearly 70% of tumours being hormone-receptor positive6. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer.7 Treatment with adjuvant endocrine therapy (such as tamoxifen or aromatase inhibitors) for up to 10 years substantially reduces the breast cancer mortality rate throughout the two decades after diagnosis.8 Adjuvant endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. VMS is a common adverse reaction of the adjuvant endocrine therapy, which may affect quality of life and treatment compliance, with potential impact on recurrence and long term outcomes9. The medical need for an effective non-hormonal treatment for VMS caused by adjuvant endocrine therapy is high as there are currently no approved treatment options available.
“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 Dr. Fatima Cardoso, Principal Investigator of OASIS 4, Lisbon, Portugal. “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.”
Elinzanetant is a dual neurokinin-1, 3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer in women, administered orally once daily. OASIS 4 (NCT05587296) is an international Phase III study to assess the safety profile and efficacy of a non-hormonal treatment of moderate to severe VMS caused by adjuvant endocrine therapy. It is the fourth Phase III study in the OASIS clinical development programme, with detailed results planned to be presented at upcoming scientific congresses.
Data from OASIS 1 and 2 were published in the Journal of the American Medical Association (JAMA)4 in August 2024. Detailed results of the Phase III study OASIS 3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the results from the Phase III clinical development programme, submissions for marketing authorisations for elinzanetant are ongoing in the U.S., EU, the UK and other markets around the world.
ENDS
Bayer media contact:
Veronica Yao, +44 (0) 7870 485 926
Email: veronica.yao@bayer.com
Notes to Editors
About the OASIS Clinical Development Programme
The Phase III clinical development programme of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. The OASIS 1, 2 and 3 studies investigate the efficacy and safety profile of elinzanetant 120 mg once daily in women with moderate to severe VMS associated with menopause. The OASIS 4 study is a double-blind, randomised, placebo-controlled multicenter study to investigate efficacy and safety profile of elinzanetant for the treatment of moderate to severe VMS caused by adjuvant endocrine therapy, over 52 weeks and optionally for an additional two years in women with, or at high risk for developing hormone-receptor positive breast cancer. 474 patients at 90 centers in 16 countries (excluding the U.S.) were randomised.10
About Elinzanetant
Elinzanetant is a dual neurokinin-1,3 (NK-1,3) receptor antagonist, in late-stage clinical development as a non-hormonal treatment of moderate to severe VMS associated with menopause in women, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of oestrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of oestrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.
Elinzanetant is also being investigated in women with sleep disturbances associated with menopause.
About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flushes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons.10 This is due to a decrease of oestrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or adjuvant endocrine therapy.11
VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life.11 Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period,12,13 with relevant impact on quality of life.
VMS may also be caused by adjuvant endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence.14 For these women with VMS due to induced menopause, there are currently no licensed treatment options.
About Menopause
By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year.15 Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s.16 The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity.17 The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes.17 Menopausal symptoms can also be the result of surgical or medical treatment. Addressing the symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective.
About Women’s Healthcare at Bayer
Bayer is a recognised global leader in women’s healthcare with a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynaecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programmes for capacity building and by ensuring the supply of affordable modern contraceptives. This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations.
About Bayer
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros. R&D expenses before special items amounted to 5.8 billion euros. For more information, go to www.bayer.co.uk.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer’s public reports which are available on the Bayer website at www.bayer.co.uk. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
References:
1. Bayer data on file.
2. Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246.
3. Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 27 (5): 498-505.
4. Pinkerton JV, Simon JA, Joffe H, et al. Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause. OASIS 1 and 2 Randomized Clinical Trials. https://jamanetwork.com/journals/jama/fullarticle/2822766 JAMA. 2024;332(16):1343-1354. doi:10.1001/jama.2024.14618
5. M Arnold, et al. Current and future burden of breast cancer: Global statistics for 2020 and 2040. The Breast 66 (2022) 15–23. https://doi.org/10.1016/j.breast.2022.08.010.
6. Bae et al. Poor prognosis of single hormone receptorpositive breast cancer: similar outcome as triple-negative breast cancerBMC Cancer (2015) 15:138. DOI 10.1186/s12885-015-1121-4
7. Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update - PubMed
8. Davies et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. Lancet 2013; 381: 805–16. http://dx.doi.org/10.1016/ S0140-6736(12)61963-1
9. Pistilli et al. J Clin Oncol 38:2762-2772
10. A study to learn more about how well elinzanetant works and how safe it is compared to placebo for the treatment of hot flashes caused by anti-cancer therapy in women with, or at high risk for developing hormone-receptor positive breast cancer (OASIS 4). EU Clinical Trials Register. Available at: https://www.clinicaltrialsregister.eu/ctr-search/trial/2022-000095-18/DE. Last accessed: January 2025.
11. Mittelman-Smith et al. Role for kisspeptin/neurokinin B/dynorphin (KNDy) neurons in cutaneous vasodilatation and the estrogen modulation of body temperature. PNAS. November 27, 2012, vol. 109 no. 48|19849PHYSIOLOGY. www.pnas.org/cgi/doi/10.1073/pnas.1211517109.
12. Angelo SD, et al. Impact of Menopausal Symptoms on Work: Findings from Women in the Health and Employment after Fifty (HEAF) Study. Int. J. Environ. Res. Public Health 2023, 20, 295. https://doi.org/10.3390/ijerph20010295.
13. Nancy E. Avis, et al. Vasomotor Symptoms Across the Menopause Transition: Differences Among Women. Obstet Gynecol Clin North Am. 2018 December ; 45(4): 629–640. doi:10.1016/j.ogc.2018.07.005.
14. Gucciniello L, et al. Estrogen deprivation effects of endocrine therapy in breast cancer patients: Incidence, management and outcome. Cancer Treatment Reviews 120 (2023) 102624. https://doi.org/10.1016/j.ctrv.2023.102624.
15. Kenneth Hill. The demography of menopause. Maturitas 23 (1996) 113-127. Journal of the Climacteric & Postmenopause. SSDI 0327-5122(95)00968-R.
16. Menopause. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/menopause. Last accessed: January 2025.
17. Wulf H Utian. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: A comprehensive review. Health and Quality of Life Outcomes 2005, 3:47 doi:10.1186/1477-7525-3-47
RP-ELINZA-GB-0045 / January 2025