Bayer drug could ease side effects of common breast cancer treatment, detailed data show

An experimental, non-hormonal drug from Bayer can reduce the hot flashes and other menopausal side effects many women taking a common breast cancer therapy experience, according to results from a late-stage clinical trial run by the pharmaceutical company.

The study, known as Oasis-4, is the fourth successful trial test of Bayer’s drug, called elinzanetant. Detailed data presented at the American Society of Clinical Oncology’s annual meeting Monday showed treatment reduced vasomotor symptoms in women receiving endocrine therapy to treat or prevent hormone receptor-positive breast cancer.

Vasomotor symptoms include hot flashes and disrupted sleep, and are typically associated with menopause. However, these symptoms can occur in almost 90% of women with early breast cancer who are treated with endocrine drugs. The side effects are disruptive enough to sometimes cause breast cancer patients to stop treatment, which could affect disease progression and, ultimately, survival.

In women experiencing menopause, hormone-replacement therapies can be used to treat vasomotor symptoms. But in women with early-stage breast cancer, those same treatments can increase the risk of their disease worsening or returning.

“With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options,” said Fatima Cardoso, the study’s lead investigator and the director of the breast cancer unit at the Champalimaud Cancer Center in Lisbon, Portugal, in a statement provided by Bayer.

Elinzanent provides a non-hormonal option. The drug targets two receptors, NK1 and NK3, that help regulate body temperature. In Oasis-4, 316 participants were randomly assigned to take elinzanetant once daily, while 157 received placebo. Vasomotor symptoms were assessed at one and three months. After 12 weeks, people who had been given placebo were switched to elinzanetant for the remainder of the main one-year evaluation period.

Results showed that elinzanetant quickly alleviated symptoms at both weeks 4 and 12 compared to placebo, meeting the study’s primary goal. After one month, 61% of women taking the Bayer drug reported the frequency of daily moderate-to-severe vasomotor symptoms had been reduced by at least half. And at three months, women taking the drug experienced greater improvements in sleep and quality of life compared to those on placebo.

Trial participants who switched to elinzanetant after taking a placebo for 12 weeks also experienced similar benefits.

“It’s due time that new innovation comes into this space,” said Yesmean Wahdan, vice president of U.S. medical affairs for Bayer’s women’s health unit, in an interview with BioPharma Dive. “[This therapy] really aims at targeting the source of what’s causing the symptoms that are happening as the woman goes through the menopausal transition and into menopause.”

The Oasis-4 results were also published in The New England Journal of Medicine Monday.

Last year, Bayer unveiled data from a Phase 3 study of women taking elinzanetant for vasomotor symptoms associated with menopause. The drug proved efficacious among this group of women as well, supporting an application by Bayer for approval.

“[Menopause] is a condition many women will enter into and face no matter where you are in life,” Wahdan said. “Some enter it via clinical reasons. They’re put on medications, they have surgery. And some of us enter it as a transition in life.”

If approved in women with vasomotor symptoms as a result of their breast cancer treatment, elinzanetant would be the first therapeutic of its kind.

“It’s a therapy that is targeted at all women who are experiencing these [vasomotor] symptoms,” Wahdan said. “We know that [women taking endocrine therapy] have, for a long time, been excluded from some of the more traditional therapies for symptoms of menopause.”

One approved non-hormonal option for vasomotor symptoms comes from Japanese pharmaceutical company Astellas Pharma, but it is not approved for women being treated for breast cancer. Called Veozah, the drug has struggled commercially due to weaker-than-expected demand and reimbursement issues. The Food and Drug Administration also recently added a safety warning for possible liver damage to the drug’s labeling.

In Oasis-4, almost 70% of women taking elinzanetant reported at least one adverse event, versus 62% of those in the placebo group. There were serious adverse events reported in eight women treated with Bayer’s drug. Most commonly, however, side effects were fatigue, headache and drowsiness.

In an editorial published in NEJM, Ann Partridge, interim chair of the Dana-Farber Cancer Institute’s medical oncology department, noted that a better understanding of elinzanetant’s side effects will be essential to incorporating the drug in patient care.

“Reassuringly, the present trial and previous trials of elinzanetant have shown no increased risk of toxic effects on the liver, which have been reported in rare cases with another agent in this class,” she wrote, referring to Veozah.

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