Bayer says menopause drug succeeds in breast cancer study

 

• An experimental menopause drug from Bayer succeeded in a late-stage trial in women taking drugs to treat or prevent breast cancer, the company said Thursday.
• Bayer said the drug, elinzanetant, significantly reduced the frequency of hot flashes and improved sleep in women with breast cancer, or who are at high risk of developing it, and whose symptoms are caused by hormone therapy. The study randomized 474 women to receive treatment or a placebo and measured the effects after four and 12 weeks.
• The announcement represents the fourth positive late-stage study result for elinzanetant, but the first that isn’t in menopausal women. Bayer has already submitted the drug for U.S. approval in postmenopausal women, and the Food and Drug Administration accepted its application in October. If cleared by regulators, the drug would compete with Astellas Pharma’s Veozah.

So-called vasomotor symptoms are typically associated with menopause and, in over one third of menopausal women, can be severe, according to Bayer. But they’re also a side effect of endocrine therapies used to treat or prevent the most common form of breast cancer, which can impact adherence to those medicines.

Bayer believes elinzanetant may be helpful in treating both groups of women and, through four Phase 3 trials, has now accumulated enough evidence to suggest it can.

In the latest study, Bayer said elinzanetant met all of its main and secondary objectives. Though it didn’t provide specifics, the company said elinzanetant reduced the frequency and severity of hot flashes versus placebo at four and 12 weeks. Treatment was also associated with reduced symptom severity after one week, maintained its potency throughout the evaluation period and helped improve sleep.

The company also said the drug’s safety profile was “generally consistent” with previous testing.

“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,” said study investigator Fatima Cardoso, in a statement provided by Bayer.

Bayer’s drug works by blocking receptors known as neurokinin 1 and 3, or NK1 and NK3, which are involved in regulating body temperature. The drug’s mechanism is similar to that of its main competitor, Veozah, which targets the NK3 protein. Veozah is approved to treat symptoms of menopause and is also in Phase 3 testing in women receiving endocrine therapy. The study began last August and has a primary completion date in late 2026, according to a federal database.

Astellas has struggled to grow sales of Veozah amid low demand and trouble securing reimbursement. The Food and Drug Administration also recently issued a safety warning for the risk of rare but potentially severe livery injury after a report of signs of possible liver damage in a patient receiving treatment for about 40 days.

Bayer intends to present full details from the latest study, named Oasis 4, at upcoming medical meetings.

https://www.biopharmadive.com/news/bayer-elinzanetant-endocrine-breast-cancer-study-results/736906/