Bayer expands development program for elinzanetant with Phase III study in breast cancer patients 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. Almost 70% of breast cancers are hormone-receptor positive. The majority of these patients are receiving well-established adjuvant endocrine therapy (with the objective of reducing hormonal levels) for at least five years to reduce the recurrence of breast cancer and improving 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) is 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 treatment options are available.

"For women treated with endocrine therapy for breast cancer – potentially for numerous years - vasomotor symptoms can intensively affect their quality of life and treatment continuation, which in turn might impact the effectiveness of their cancer therapy and hence their survival", 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, to increase their quality of life."

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.