Treatment for breast cancer-related hot flashes sees positive trial results

A treatment for breast cancer-related vasomotor symptoms (VMS) – known as hot flashes – has seen positive Phase 3 trial results in women with breast cancer or at high risk of developing breast cancer.

The Phase 3 study investigated the treatment, called elinzanetant, as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy.

According to Bayer, which developed the treatment, elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe hot flashes compared to placebo.

The study also met secondary endpoints, Bayer said, demonstrating reductions in severity of symptoms and frequency reduction, along with improvements of sleep disturbances and menopause-related quality of life at week 12 compared to placebo.

“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 R&D at Bayer.

“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.”

“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.”

Based on the positive results from the Phase 3 clinical development programme, Bayer has confirmed it has submitted applications for marketing authorisations in the US, EU and other markets around the world.