Elinzanetant significantly reduces frequency of moderate to severe vasomotor symptoms associated with endocrine therapy for breast cancer in Phase III OASIS-4 study

Data from Phase III OASIS-4 study to be presented at 2025 ASCO Annual Meeting

  • In the Phase III OASIS 4 study the investigational compound elinzanetant significantly reduced the frequency of moderate-to-severe vasomotor symptoms (VMS) from baseline to weeks 4 and 12, versus placebo, in women taking endocrine therapy for the treatment or prevention of hormone receptor (HR+) breast cancer1
  • Elinzanetant also showed in key secondary endpoints statistically significant improvement in sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo2
  • Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 versus placebo1
  • The safety profile over 52 weeks observed in the OASIS 4 study is generally consistent with previously published data3,4,5 on elinzanetant in postmenopausal women with VMS
  • Results of OASIS-4, the fourth Phase III study in the OASIS clinical programme and a first-of-its-kind international study, are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and have been simultaneously published in the New England Journal of Medicine (NEJM)

 

Detailed results from the Phase III OASIS-4 study found that the investigational compound elinzanetant showed a statistically significant reduction 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, in women taking endocrine therapy for the treatment or prevention of hormone receptor (HR+) breast cancer.1 Key secondary endpoints were met with statistically significant improvement of sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo.2 Additional secondary endpoints showed a reduction in VMS frequency at week 1 and improvements in VMS severity at weeks 4 and 12 versus placebo.1 These data are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 – June 3, 2025, in Chicago, IL, USA, and have been simultaneously published in the New England Journal of Medicine (NEJM). OASIS-4 (NCT05587296) is the first pivotal international Phase III study to assess the safety profile and efficacy of elinzanetant for the treatment of moderate to severe VMS associated with endocrine therapy for the treatment or prevention of HR+ breast cancer.

 

“Menopausal symptoms are frequent side effects of endocrine therapy for breast cancer, often leading to treatment discontinuation, which is why management of these symptoms can play an important role in breast cancer treatment,” said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon Portugal. “With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options.”

 

In OASIS-4, elinzanetant showed statistically significant mean reductions versus placebo in frequency of VMS from baseline to week 4 with mean difference -3.5 ([95% confidence interval (CI): -4.4, -2.6]; p<0.0001) and at week 12 with mean difference -3.4 ([95% CI: -4.2, -2.5]; p<0.0001). The safety profile of elinzanetant over 52 weeks in OASIS 4 study is generally consistent with previously published data1-4 in postmenopausal women with VMS. Fatigue, somnolence and diarrhea were the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group.1

 

In key secondary endpoints, elinzanetant demonstrated statistically significant improvements of sleep disturbances with mean difference -6.1 ([95% CI: -7.5, -4.8]; p<0.0001) and menopause-related quality of life (MENQOL) with mean difference -0.7 points in the MENQOL total score ([95% CI; -0.9, -0.5]; p<0.0001) from baseline to week 12 compared to placebo. Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at week 4 and at week 12 with elinzanetant versus placebo.2

 

“The results from OASIS-4 represent a potential advancement in addressing a need for women undergoing breast cancer treatment. Vasomotor symptoms associated with endocrine therapy can impact patients’ quality of life and may affect their ability to adhere to other treatments,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “Advancing elinzanetant as an investigational, hormone-free treatment option for these patients reaffirms our commitment at Bayer to bringing forward innovative treatments for the different health needs of women.”

 

Breast cancer is the most commonly diagnosed cancer in women globally with 2.3 million new cases in 20206, and nearly 70% of tumours are hormone-receptor positive7. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer.8 Treatment with adjuvant endocrine therapy (such as tamoxifen) for up to 10 years substantially reduces the breast cancer mortality rate throughout the two decades after diagnosis.9 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 endocrine therapy, which may affect quality of life and treatment compliance, with potential impact on recurrence and long-term outcomes.10 Currently, there are no approved treatment options available. There is an unmet medical need for an effective hormone-free treatment for women with VMS associated with endocrine therapy.

 

Elinzanetant is the first dual neurokinin targeted (NKT) therapy, antagonising NK-1 and NK-3 receptors, in late-stage clinical development globally for the hormone-free treatment of women with moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily.

 

Data from OASIS-1 and -2 were published in the Journal of the American Medical Association (JAMA)5 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 in Elinzanetant

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 administered orally once daily in women with moderate to severe VMS associated with menopause. The OASIS-4 study is a double-blind, randomised, placebo-controlled multicentre study to investigate the efficacy and safety profile of elinzanetant for the treatment of vasomotor symptoms associated with endocrine therapy for the treatment or prevention of HR+ breast cancer, over 52 weeks and optionally for an additional two years. 474 patients at 90 centers in 16 countries (excluding the U.S.) were randomised.11

 

About Elinzanetant

Elinzanetant is the first dual neurokinin targeted (NKT) therapy, antagonising NK-1 and NK- 3 receptors, in late-stage clinical development for the treatment of women with moderate to severe VMS associated with menopause or endocrine therapy, 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.12 

 

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.12 Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period,13,14 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.15 For these women, there are currently no approved 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.16 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.17 It can also be the result of surgical or medical treatment such as breast cancer treatment. The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilisation and work productivity.18 The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes.18 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. RP-LNK-GB-0001/May 2025 - 6/7 -

 

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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros. R&D expenses amounted to 6.2 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. Cardoso F et al. Efficacy and safety of elinzanetant for vasomotor symptoms associated with adjuvant endocrine therapy: Phase 3 OASIS 4 trial. (Oral presentation, ASCO, Chicago, 2 June 2025). Available at: https://meetings.asco.org/abstracts-presentations/243642. Last accessed: May 2025.

  2. Brennan D et al. Impact of elinzanetant on sleep disturbances and quality of life in women undergoing adjuvant endocrine therapy for breast cancer: Phase 3 OASIS 4 trial. (Poster presentation, ASCO, Chicago, 2 June 2025). Available at: https://www.asco.org/abstracts-presentations/ABSTRACT488300. Last accessed: May 2025.

  3. 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.

  4. 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.

  5. 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

  6. 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.

  7. 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

  8. Adjuvant Endocrine Therapy for Women With Hormone Receptor-Positive Breast Cancer: ASCO Clinical Practice Guideline Focused Update - PubMed

  9. 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

  10. Pistilli et al. J Clin Oncol 38:2762-2772

  11. 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.

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  15. 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.

  16. Kenneth Hill. The demography of menopause. Maturitas 23 (1996) 113-127. Journal of the Climacteric & Postmenopause. SSDI 0327-5122(95)00968-R.

  17. Menopause. World Health Organization. Available at: https://www.who.int/news-room/fact-sheets/detail/menopause. Last accessed: January 2025.

  18. 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-LNK-GB-0001/May 2025

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