Outside the US Bayer Extends Development Program for Investigational Product Elinzanetant With Phase III Study in Breast Cancer Patients With Vasomotor Symptoms Caused by Endocrine Therapy

• OASIS- 4 plans to investigate elinzanetant as a non-hormonal treatment for vasomotor symptoms caused by endocrine therapy in breast cancer patients
• Elinzanetant is a non-hormonal compound in development for the treatment of vasomotor symptoms during menopause
• The OASIS- 4 study is not part of the US development program

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer, a global leader in women’s healthcare, announced that it will extend the Phase III clinical development program OASIS by initiating OASIS 4 – a Phase III non-US study in breast cancer patients and women at risk for breast cancer with vasomotor symptoms caused by endocrine therapy.

Breast cancer is the most frequent cancer in women globally with 2.3 million new cases in 2020.¹ Almost 70% of breast cancers are hormone-receptor positive ². The majority of these patients receive well-established adjuvant endocrine therapy (with the goal of reducing estrogen levels) for at least five years in order to decrease the recurrence of their cancer and improve associated mortality.² 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.²

“For women treated with endocrine therapy for breast cancer – potentially for numerous years – vasomotor symptoms can intensively affect patients,” said Dr. Christian Rommel, member of the Executive Committee of Bayer AG’s Pharmaceutical Division and Global Head of Research and Development. “By adding OASIS 4 to our Phase III program with elinzanetant, we aim to help patients experiencing vasomotor symptoms caused by their endocrine therapy.”

The OASIS-4 Phase III study intends to randomize approximately 400 patients at about 95 centers in 15 countries (excluding the US) and is planned to investigate 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.

In August 2021, the OASIS Phase III clinical development program started investigating the efficacy and safety of elinzanetant 120 mg once daily in menopausal women with moderate to severe vasomotor symptoms.

About Elinzanetant

Elinzanetant is a non-hormonal, orally administered, dual neurokinin-1,3 receptor antagonist currently in clinical development for the treatment of vasomotor symptoms during menopause. It’s believed that 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 in menopausal women and consequently disrupt body heat control mechanisms resulting in vasomotor symptoms.

The clinical Phase III development program with elinzantant, OASIS, currently comprises four Phase III studies: OASIS 1,2,3 and 4. OASIS 1, 2 and 3 are part of the US development program. The design and dosing of the Phase III clinical development program is based on the 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 Vasomotor Symptoms

Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons due to withdrawal of estrogen, which can result from progressive reduction of ovarian function. Progressive reduction of ovarian function is due to natural menopause or medical intervention by bilateral oophorectomy or endocrine therapy.

We are looking to expand treatment options for vasomotor symptoms caused by endocrine therapy.

About Women’s Healthcare at Bayer

Bayer is a recognized 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 treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause symptom management. Through it’s We’re For Her mission Bayer is focused on options to address the unmet medical needs of women worldwide. Today, Bayer’s research and development efforts focus on finding new treatment options for menopause and includes several compounds in various stages of pre-clinical and clinical development. Together, these projects reflect the company’s approach to research, which prioritizes targets and pathways with the potential to alter the way that gynecological diseases are treated. Additionally, Bayer intends to provide 100 million women 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.

About Bayer

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 planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to drive sustainable development and generate 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 2021, the Group employed around 100,000 people and had sales of 44.1 billion euros. R&D expenses before special items amounted to 5.3 billion euros. For more information, go to www.bayer.com.

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¹ Sung et al. CA Cancer J Clin 2021; 2. Davies et al. Lancet 2013; 381: 805–16

² Hickey et al, Annals of Oncology 19: 1669–1680, 2008+

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