Bayer today announced positive 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 breast cancer or at high risk of developing breast cancer.

Elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo. The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effects over the study period.

Elinzanetant also showed improvements of 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 data1,2,3 on elinzanetant in postmenopausal women with VMS.

“Elinzanetant has consistently demonstrated positive results across all four Phase III clinical trials that assessed the efficacy and safety for the treatment moderate to severe vasomotor symptoms associated with menopause or caused by adjuvant endocrine therapy,” said Dr. Christian Rommel, Head of Research and Development and Member of the Executive Committee of Bayer’s Pharmaceuticals Division.

“Importantly, OASIS 4 is the first pivotal international study to assess the safety and efficacy of a non-hormonal treatment approach for women with or at high risk of breast cancer who are suffering from VMS caused by adjuvant endocrine therapy, reaffirming 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 2020, with nearly 70% of tumors being hormone-receptor positive.

“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, from 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 the first dual neurokinin-1 and 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, administered orally once daily. OASIS 4 (NCT05030584) is the first pivotal international Phase III study to assess the safety 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 program with positive topline results, with details planned to be presented at upcoming scientific congresses.