Elinzanetant reduces severity and frequency of hot flushes and night sweats, regardless of type of hormone treatment breast cancer patients receive
Barcelona, Spain: Results from the OASIS 4 clinical trial last year showed that a new drug, elinzanetant, relieved hot flushes and night sweats that can occur because of the menopause or because of hormone treatment for breast cancer. Now, a new analysis of data from the trial shows that it also gives sustained relief regardless of the type of hormone treatment cancer patients receive.
Professor Fatima Cardoso, who is Head of Clinical Trials, Scientific Affairs and International Development in Breast Oncology at the Centre Antoine Lacassagne in Nice, France [1], and President of the Advanced Breast Cancer (ABC) Global Alliance, presented the findings for the first time at the 15th European Breast Cancer Conference (EBCC15) in Barcelona on Thursday.
“Women who have hormone receptor positive breast cancer are usually treated with drugs that block the effects of oestrogen, such as tamoxifen or aromatase inhibitors, or, in pre-menopausal women, goserelin and leuprorelin, which stop the ovaries from producing oestrogen,” she said. “However, these often cause vasomotor symptoms, such as hot flushes and night sweats, that can be more severe than those that women experience during natural menopause. Breast cancer patients usually should not take hormone replacement therapy to alleviate these symptoms as this could negate the effect of the cancer treatment.”
Elinzanetant is a non-hormonal drug that works by blocking a protein called neurokinin. Neurokinin plays a role in triggering hot flushes and other menopausal symptoms, so by inhibiting it, elinzanetant reduces the frequency and severity of these symptoms. It is important to treat vasomotor symptoms (VMS) because they can have a negative impact on patients’ quality of life and lead to them stopping their breast cancer treatment prematurely.
This new analysis by Prof. Cardoso and colleagues looked at the effect of elinzanetant on VMS frequency and severity according to the type of hormone therapy women received in the OASIS 4 trial.
Women aged between 18-70 years who were experiencing 35 or more moderate-to-severe VMS a week caused by hormone therapy for oestrogen receptor positive (ER+) breast cancer were randomised to receive elinzanetant for 52 weeks or placebo for 12 weeks followed by elinzanetant for 40 weeks.
The researchers analysed the average change in daily moderate-to-severe VMS frequency and severity after one week (frequency only), four and 12 weeks according to whether patients had received tamoxifen, an aromatase inhibitor, an ovarian function suppressor or no ovarian function suppression.
“We found elinzanetant was effective and well tolerated by women experiencing moderate to severe vasomotor symptoms associated with endocrine therapy, independently of the type, such as tamoxifen or aromatase inhibitors, with or without ovarian function suppression,” said Prof. Cardoso.
For example, women taking tamoxifen and elinzanetant had, on average, four fewer VMS after week one, compared to 1.6 in the tamoxifen and placebo group, seven fewer after week four (2.5 fewer in the placebo group), and eight fewer after week 12 (three fewer in the placebo group). A similar pattern was seen across the other groups.
The average daily severity of VMS was also reduced in the groups taking elinzanetant compared to those taking placebo. At the beginning of the trial, women were experiencing moderate to severe VMS, with an average severity score of 2.5 (0 = none, 1 = mild, 2= moderate, 3 = severe) [2]. After 12 weeks, those who were taking elinzanetant were experiencing mild-to-moderate VMS with an average severity score between 1.5-1.6 in each of the hormone treatment groups, compared to moderate VMS with an average severity score between 1.9-2 in each of the groups receiving the placebo.
The reductions in frequency and severity were maintained for 52 weeks, and most side effects of elinzanetant were mild; the most common were diarrhoea, fatigue and sleepiness. There were very low rates of serious side effects.
Prof. Cardoso said: “Elinzanetant is the first approved targeted agent for this very frequent symptom that deeply affects the quality of life of breast cancer patients. By helping patients to tolerate better their breast cancer treatment, elinzanetant may contribute to improved compliance and, therefore, better cancer outcomes.”
Now the researchers hope to evaluate potential interactions between elinzanetant and several other targeted agents used in combination with endocrine therapy in order to widen the patient population who could receive elinzanetant. They would also like to run trials in populations not included in the OASIS 4 trial, such as metastatic breast cancer patients and male patients with breast cancer.
At this stage, Bayer, the company manufacturing and supporting trials of elinzanetant, has no plans to conduct clinical trials with elinzanetant in patients suffering from other types of cancer who experience VMS due to endocrine therapy, such as prostate cancer. However, it plans to support research in this area through investigator-initiated research studies.
Dr Javier Cortés is chair of the EBCC15 national organising committee, and co-director of the International Breast Cancer Center (IBCC) in Barcelona and of IOB in Madrid. He was not involved with the research. He commented: “This new analysis of the effect of elinzanetant according to type of hormonal treatments for ER+ breast cancer provides important information for clinicians and their patients. It is good news that it reduces the frequency and severity of vasomotor symptoms for women regardless of the hormone treatment they receive. Elinzanetant is the first approved targeted treatment so far that helps alleviate VMS with very few adverse side effects. It will enable women with ER+ breast cancer to tolerate their treatments better and improve adherence.”
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Abstract no: 3, “Efficacy of elinzanetant for the treatment of vasomotor symptoms in women with breast cancer: subgroup analysis of the OASIS-4 trial by type of endocrine therapy”, Thursday 26 March, Oral abstract session, 09.30-11:00 hrs, room 113-116, https://cm.eortc.org/cmPortal/Searchable/ebcc15/config/Normal#!abstractdetails/0000984690
[1] Professor Fatima Cardoso was formerly Director of the Breast Unit at the Champalimaud Clinical Centre in Lisbon, Portugal.
[2] At the start of the trial women reported whether they had VMS on any given day. If they did, they rated each VMS episode as mild (sensation of heat without sweating), moderate (sensation of heat with sweating), or severe (sensation of heat with sweating and causing stopping of activity). The severity is calculated as an average of the number of mild, moderate and severe symptoms per day to give a score between 0 and 3. Based on this, each episode was given a score of 1, 2, or 3, respectively, which were averaged to produce a final VMS severity score between 0 and 3.
Funding: The OASIS 4 trial is funded by Bayer AG. ClinialTrials.gov: NCT05587296