Bayer AG has announced encouraging results from a late-stage clinical trial of its experimental, non-hormonal drug, elinzanetant, which may reduce hot flashes and other menopausal symptoms in women undergoing common breast cancer treatments. These findings were presented Monday at the annual meeting of the American Society of Clinical Oncology (ASCO).
Menopausal Symptoms Common and Severe in Breast Cancer Therapy
Vasomotor symptoms, such as hot flashes and disturbed sleep, often affect women during menopause. However, nearly 90% of women receiving endocrine therapy for hormone receptor-positive breast cancer experience these side effects as well. These symptoms are often so severe that some patients stop their cancer treatment, which can negatively impact disease control and survival.
For typical menopause cases, hormone replacement therapy (HRT) can ease these symptoms. But for breast cancer patients, HRT may increase the risk of cancer progression or recurrence. Currently, no approved treatments specifically address these symptoms in breast cancer patients.
“There is an unmet medical need for treatment options as there are currently no approved treatments for this indication,” said Fatima Cardoso, lead investigator of the study and head of the breast cancer department at Lisbon’s Champalimaud Cancer Center.
How Elinzanetant Works
Elinzanetant targets two receptors in the brain, NK1 and NK3, which help regulate body temperature. This non-hormonal approach may avoid risks linked to hormone-based therapies.
The Oasis-4 trial involved 316 women randomly assigned to take elinzanetant daily, while 157 received a placebo. Researchers evaluated vasomotor symptoms after one month and again after three months. After 12 weeks, placebo participants switched to elinzanetant for the rest of the one-year assessment.
Promising Clinical Trial Results
The drug provided fast and significant relief from symptoms. After four weeks, 61% of women on elinzanetant reported their daily moderate to severe vasomotor symptoms had reduced by at least half. After three months, these women also experienced better sleep quality and overall quality of life compared to the placebo group.
Participants who switched from placebo to elinzanetant after 12 weeks showed similar improvements.
Expert Comments on Innovation and Impact
“It’s time for new innovation to enter this space,” said Yesmean Wahdan, vice president of U.S. medical affairs at Bayer Women’s Health. She added that elinzanetant “really targets the root cause of the symptoms that women experience as they go through the menopausal transition and into menopause.”
The results of Oasis-4 were also published Monday in the New England Journal of Medicine.
Potential First-of-its-Kind Treatment for Breast Cancer Patients
If approved, elinzanetant would be the first drug specifically indicated for vasomotor symptoms caused by breast cancer endocrine therapy.
“This therapy is for all women who experience these symptoms,” said Vardan, emphasizing that women undergoing endocrine therapy have long lacked treatment options for menopausal symptoms.
Comparison to Existing Non-Hormonal Drugs
Japanese company Astellas Pharma markets a non-hormonal drug called Veozah for vasomotor symptoms, but it is not approved for breast cancer patients. Veozah has faced commercial challenges due to low demand, reimbursement issues, and a recent FDA safety warning about possible liver damage.
Safety and Side Effects
In the Oasis-4 trial, nearly 70% of women taking elinzanetant reported at least one side effect, compared to 62% on placebo. Common side effects included fatigue, headache, and sleepiness. Eight women on the drug experienced serious adverse events.
Ann Partridge, interim chief of medical oncology at Dana-Farber Cancer Institute, commented in a New England Journal of Medicine editorial that understanding elinzanetant’s side effects is critical. She noted it is reassuring that the drug has not shown increased liver toxicity, a concern with other drugs in its class such as Veozah.
Bayer’s elinzanetant offers hope for many women who suffer severe menopausal symptoms during breast cancer treatment. Further studies and regulatory reviews will determine if it becomes a new standard of care for this underserved patient group.
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