Elinzanetant May Treat Hot Flashes Caused by Breast Cancer Treatment

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Elinzanetant significantly reduced the frequency and severity of hot flashes in women with breast cancer who were undergoing hormone therapy.

Elinzanetant, a drug targeting estrogen-sensitive neurons in the brain, significantly reduced the frequency and severity of hot flashes in women with breast cancer undergoing hormone therapy.

Among patients who experience moderate to severe vasomotor symptoms (hot flashes) that are caused by breast cancer treatments, treatment with elinzanetant met all primary and secondary end goals in the OASIS 4 phase 3 study, according to a news release.

Specifically, elinzanetant demonstrated a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS) caused by adjuvant endocrine therapy compared with a placebo in women with or at high risk of developing hormone receptor positive breast cancer.

In addition, elinzanetant also demonstrated a reduction in severity of VMS at four and 12 weeks, a reduction in VMS frequency at week one and improvements in sleep disturbances and menopause related quality-of-life.

“Elinzanetant has consistently demonstrated positive results across all four Phase 3 clinical trials that assessed the efficacy and safety for the treatment [of] 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 in a news released issued by Bayer.

Glossary:

Bilateral oophorectomy: surgical removal of both ovaries.

Adjuvant endocrine therapy: hormone therapy given after surgery to treat or prevent breast cancer recurrence.

Arrhythmias: irregular heartbeat.

VMS, or hot flashes, arise from the overactivity of the thermoregulatory pathway, triggered by the enlargement of the KNDy neurons. According to the release, this is caused by a decrease in estrogen, which can occur due to the gradual decline in ovarian function caused by natural menopause or medical intervention, such as bilateral oophorectomy or adjuvant endocrine therapy.

VMS can also be caused by adjuvant endocrine therapy, which is used to treat or prevent breast cancer. This therapy can impact a person’s quality of life and their adherence to treatment.

As mentioned in the release, elinzanetant targets a group of estrogen-sensitive neurons in the hypothalamus region of the brain, the KNDy neurons.

The OASIS 4 Phase 3 Trial

OASIS 4, a double-blind, randomized, placebo-controlled multicenter phase 3 study, aims to investigate the efficacy and safety of elinzanetant in treating VMS caused by adjuvant endocrine therapy. The study will be conducted over 52 weeks, with an optional extension of two years for women with hormone-receptor positive breast cancer or at high risk of developing it.

This trial is the fourth phase 3 study in the OASIS clinical development program, which has yielded positive topline results, according to the release.

Furthermore, based on key secondary endpoints of OASIS 1 and 2, elinzanetant may also reduce sleep disturbances that are commonly associated with menopause.

In the OASIS 4 trial, a total of 474 patients from 90 centers in 16 countries (excluding the United States) were randomized. Patients in the treatment group were to receive 120 milligrams of elinzanetant administered orally and once daily.

According to the National Library of Medicine’s website, exclusion criteria included arrhythmias, heart block, QT prolongation, conditions impacting VMS interpretation, most malignancies, endocrine therapy, uncontrolled hypertension, untreated thyroid dysfunction, unexplained uterine bleeding, abnormal mammogram or liver function and endometrial abnormalities.

“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, in the news release. “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.”

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