Bayer to present latest research on treatment of vasomotor symptoms in women with breast cancer receiving endocrine adjuvant therapy at ESMO Breast Cancer 2023
Not intended for U.S. and UK Media - Annual Congress of European Society For Medical Oncology Breast Cancer 2023:
Poster presentation from the REALISE study, a real-world evidence analysis evaluating the status of treatment of vasomotor symptoms (VMS) and symptom burden in women taking adjuvant endocrine therapy (AET) after breast cancer, showing a need for new more effective treatment options for this underserved group / Poster featuring study design of OASIS 4, a Phase III trial assessing the efficacy and safety of elinzanetant in the treatment of vasomotor symptoms caused by adjuvant endocrine therapy for breast cancer
Berlin, May 9, 2023 – Bayer will present latest research on menopause symptoms in women with breast cancer on endocrine adjuvant therapy at the upcoming annual Congress by the European Society For Medical Oncology (ESMO) Breast Cancer 2023, which takes place from May 11 – 13, in Berlin, Germany. The research presented showcases the commitment of Bayer as a leader in women’s healthcare to broaden therapeutic choices and to increase awareness and education around menopause. As part of this commitment, the company is investigating new approaches including the late-stage asset elinzanetant to broaden its menopause portfolio and addressing an important unmet medical need in menopause management. Currently a vast majority of women is not receiving treatment for their menopause symptoms including breast cancer patients experiencing vasomotor symptoms, a known adverse reaction of endocrine therapy, which strongly impacts the quality of life and treatment continuation.
Data presented at ESMO Breast Cancer include key findings from the REALISE study evaluating vasomotor symptoms (VMS) treatment status and symptom burden in women taking adjuvant endocrine therapy (AET) after breast cancer. The results demonstrate large proportions of women with VMS remain untreated as well as high concomitant symptom burden in those treated, with a need for more effective treatment options for this underserved group. In addition, the study design of OASIS 4 – a Phase III study which investigates the efficacy and safety of elinzanetant 120 mg once daily in women at high risk for breast cancer and breast cancer patients with vasomotor symptoms caused by endocrine therapy – will be presented. OASIS 4 is part of the broad Phase III clinical development program OASIS for elinzanetant in menopausal women. First results from the OASIS program are expected in the second half of 2023.
Bayer’s presentations at the Annual ESMO Breast Cancer Congress 2023 are:
· Poster #391: Treatment for vasomotor symptoms in women on adjuvant endocrine therapy after breast cancer: real-world findings from the REALISE study
Megan Scott, Mia Harvey, Nils Schoof, Siir Su Saydam, Cecilia Caetano, Cecile Janssenswillen, Carsten Moeller, Victoria Banks
· Poster #293: OASIS 4 study design: a Phase 3 trial assessing the efficacy and safety of elinzanetant in the treatment of vasomotor symptoms caused by adjuvant endocrine therapy for breast cancer
Fatima Cardoso, Lineke Zuurman, Cecilia Caetano, Susanne Parke, Christian Seitz, Kaisa Laapas, Leonor Matos
The poster session will be held on Friday, 12 May,12:15-13:00 CEST.
To view the complete abstracts, please visit the ESMO Breast Cancer congress website.
About Vasomotor Symptoms
Vasomotor symptoms (VMS; also referred to as hot flashes) are a result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons due to withdrawal of estradiol, which can result from progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.
VMS are reported by up to 80% of women at some point during the menopausal transition and the leading cause for seeking medical attention during this particular phase of a woman’s life. Over 1/3 of women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact in quality of life.
Vasomotor symptoms can also be caused by endocrine therapy for treatment or prevention of breast cancer, with an important negative impact on impact quality of life and treatment adherence and cannot currently be addressed as no approved treatment options are available.
About Breast Cancer
Breast cancer is the most frequent cancer in women globally with 2.3 million new cases in 2020. Almost 70% of breast cancers are hormone-receptor positive. The majority of these patients are receiving well-established adjuvant endocrine therapy for at least five years to reduce the recurrence of breast cancer and associated mortality. Endocrine therapy can also be used as primary prevention in women at high risk for developing breast cancer. Vasomotor symptoms (VMS; also referred to as hot flashes) are a known adverse reaction of endocrine therapy, which strongly impacts the quality of life and treatment continuation. The medical need for an effective non-hormonal treatment for VMS caused by endocrine therapy in breast cancer patients and women at high risk for developing breast cancer is high as currently no approved treatment options are available.
By 2030, the world population of women in the menopause phase is projected to increase to 1.2 billion, with 47 million new entrants each year. Menopause is a natural phase in women’s lives, related to progressive decline of ovarian function, which usually occurs in women in their late 40s or early 50s. It can also be the result of surgical or medical treatment, for example for breast cancer. The decline in hormone production by the ovaries can lead to various symptoms, which can dramatically affect a woman’s health, quality of life, consumption of healthcare and work productivity. The most frequently reported and bothersome symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. With increased longevity, menopause management is of growing importance since this is a period where women are at the peak of their life’s activity, personally and professionally. For this reason, maintaining functional ability and good quality of life is extremely relevant from both a healthcare and socio-economic perspective.
Elinzanetant is a first-in-class, non-hormonal, orally administered, selective neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms during menopause. Elinzanetant addresses vasomotor symptoms by modulating a group of estrogen sensitive neurons in the hypothalamus in the brain (the KNDy neurons), that due to the absence of estrogen, become hyperactive and consequently disrupt body heat control mechanisms resulting in vasomotor symptoms of hot flashes.
The clinical Phase III development program with elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1,2,3 and 4. The initial OASIS Phase III clinical development program (OASIS 1,2,3) investigates the efficacy and safety of elinzanetant 120 mg once daily in menopausal women with vasomotor symptoms.
The OASIS 4 study is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant 120 mg once daily in women at high risk for breast cancer and breast cancer patients with vasomotor symptoms caused by endocrine therapy.
The design and dosing of the Phase III clinical development program is based on the positive data from two Phase II studies (RELENT-1 and SWITCH-1). RELENT-1 was a Phase Ib/IIa study investigating the safety, pharmacokinetics and preliminary efficacy of elinzanetant. SWITCH-1 was a Phase IIb study, which investigated the efficacy and safety of four different doses of elinzanetant compared to placebo in patients with vasomotor symptoms.
About Women’s Healthcare at Bayer
Bayer is a leader in the area of 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 gynecological diseases. Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide such as in the area of 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 programs 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.
Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. Its 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 2022, the Group employed around 101,000 people and had sales of 50.7 billion euros. R&D expenses before special items amounted to 6.2 billion euros. For more information, go to www.bayer.com.
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