Health Rounds: Experimental Bayer drug eases menopause-like symptoms from breast cancer therapy
The hot flashes and night sweats that plague breast cancer survivors during years-long hormone-suppressing therapy are eased by an experimental non-hormonal drug being developed by Bayer (BAYGn.DE), opens new tab, according to results from a late-stage trial.
The participants in the trial – similar to two-thirds of breast cancer patients overall - had tumors that use the hormones estrogen and progesterone to grow.
The goal of so-called endocrine therapy is to block those hormones, which reproduces the uncomfortable menopause symptoms. The most effective way to relieve these symptoms in healthy women is to replace the hormones, which is not feasible when tumors use the hormones to grow.
In a year-long trial involving 474 breast cancer patients experiencing daily hot flashes due to hormone-suppressing therapy, 316 received Bayer's elinzanetant and 158 received a placebo.
Within three months, more than 70% of those on elinzanetant reported at least a 50% reduction in moderate-to-severe hot flashes, compared to about 36% of the placebo group, the researchers reported at a recent meeting of cancer doctors and in The New England Journal of Medicine, opens new tab.
The Bayer drug also significantly improved sleep quality and menopausal quality of life by week 12.
'It is important to treat vasomotor symptoms because they can negatively impact quality of life and lead to women prematurely stopping their breast cancer treatment,' said study leader Dr. Fatima Cardoso of the Champalimaud Clinical Center in Lisbon.
Elinzanetant belongs to a new class of drugs called neurokinin receptor antagonists that target the neurobiological mechanisms in the brain involved in hot flashes and night sweats.
The U.S. Food and Drug Administration recently approved an Astellas Pharma (4503.T), opens new tab drug from the class under the brand name Vezoah for easing symptoms of menopause. It is not approved for treating breast cancer patients, so that use would be off-label, the study authors noted. Doctors can prescribe any approved medicine as they see fit, but companies can only promote them for approved uses.
An editorial, opens new tab published with the study notes that up to 90% of women with early breast cancer treated with endocrine therapy experience hot flashes and other vasomotor symptoms, which may impact their survival if the symptoms lead them to quit taking the medications.
In one large study of breast cancer survivors, half the participants reported non-adherence to endocrine therapy, the editorial says.
Bayer is awaiting approval of elinzanetant from the FDA and the European Medicines Agency.
Cases of type 1 diabetes caused by cancer immunotherapy drugs can be controlled – and even reversed – by treatment with already approved medicines for autoimmune conditions like psoriasis and rheumatoid arthritis, laboratory studies suggest.
Type 1 diabetes, in which the body mistakenly attacks and destroys insulin-producing cells in the pancreas, occurs in 1% to 2% of patients receiving immunotherapies known as checkpoint inhibitors, such as Merck's (MRK.N), opens new tab Keytruda and Bristol Myers Squibb's (BMY.N), opens new tab Opdivo. The condition is often permanent, requiring insulin therapy for life.
With the increased use of the blockbuster cancer drugs, 'preventing long-term autoimmune damage is becoming a critical part of survivorship care,' study leader Dr. Melissa Lechner of the David Geffen School of Medicine at UCLA said in a statement.
'This is one of the first times we've found a way to intervene in these toxicities in a meaningful way,' she added.
Her team identified a new group of immune cells called CD4+ T follicular helper cells, or Tfh cells, which produce signaling molecules called IL-21 and IFN-gamma that fuel the immune attack on the pancreas.
In experiments in mice, the researchers found that a class of drugs known as JAK inhibitors, which block the IL-21 and IFN-gamma pathways, not only blocked the effects of the two signaling molecules but also reduced the number of Tfh cells and, in some cases, restored normal blood sugar levels.
The results were reported in JCI Insight, opens new tab.
Available JAK inhibitors include Pfizer's (PFE.N), opens new tab Xeljanz, Rinvoq from AbbVie (ABBV.N), opens new tab and Eli Lilly's (LLY.N), opens new tab Olumiant.
'This is the first study to identify Tfh cells and the IL-21/IFN-gamma pathway as key drivers of checkpoint inhibitor–induced type 1 diabetes,' said Lechner.
'Importantly, we show that this pathway can be therapeutically targeted with a drug that is already FDA-approved and widely available without weakening the immune system's ability to fight cancer.'
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