OASIS-1 trial reports reduced VMS frequency and severity from elinzanetant

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A recent study showcased at the 2024 ACOG Annual Clinical & Scientific Meeting unveils elinzanetant's efficacy in alleviating vasomotor symptoms, sleep disturbances, and enhancing menopause-related quality of life in postmenopausal women.

OASIS-1 trial reports reduced VMS frequency and severity from elinzanetant | Image Credit: © insta_photos - © insta_photos - stock.adobe.com.

OASIS-1 trial reports reduced VMS frequency and severity from elinzanetant | Image Credit: © insta_photos - © insta_photos - stock.adobe.com.

Elinzanetant has positive tolerance and is effective for managing the frequency and severity of vasomotor symptoms (VMS) in postmenopausal women, as well as sleep disturbances and menopause-related quality of life, according to a recent study highlighted at the 2024 ACOG Annual Clinical & Scientific Meeting.1

Takeaways

  1. Elinzanetant demonstrates effectiveness in managing vasomotor symptoms (VMS), sleep disturbances, and improving menopause-related quality of life in postmenopausal women, as highlighted at the 2024 ACOG Annual Clinical & Scientific Meeting.
  2. Approximately 80% of postmenopausal women experience VMS, necessitating effective therapeutic interventions to mitigate their impact on quality of life.
  3. Elinzanetant, a non-hormonal treatment, targets estrogen-sensitive neurons in the hypothalamus to regulate VMS, offering a promising alternative for women seeking relief from menopausal symptoms.
  4. Results from the OASIS-1 and OASIS-2 trials reveal significant reductions in VMS frequency and severity among participants receiving elinzanetant compared to placebo, with notable improvements in sleep disturbances and menopause-related quality of life.
  5. The favorable safety profile of elinzanetant, coupled with its efficacy in managing menopausal symptoms, positions it as a potential treatment option pending marketing approval from Bayer.

Postmenopausal women often experience adverse impacts on their quality of life because of VMS and sleep disturbances, indicating the need for therapy to manage symptoms in these patients. Approximately 80% of postmenopausal women experience VMS, and the risk of VMS is increased by endocrine therapy used to treat or prevent breast cancer.2

Approximately 1.2 billion women are expected to be experiencing menopause by 2030. During menopause, a hormonal decline occurs, leading to multiple adverse health, quality of life, and work productivity outcomes. This includes the hypothalamus region of the brain becoming hypertrophic, disrupting body heat control mechanisms.

Elinzanetant, a neurokinin-1,3 receptor antagonist, has been proposed as a potential treatment method for individuals with VMS.1 Elinzanetant is a non-hormonal treatment taken orally once per day, managing VMS by regulating estrogen sensitive neurons in the hypothalamus region of the brain.2

The OASIS-1 pivitol phase 3 trial evaluated the safety and efficacy of elinzanetant.1 Participants included postmenopausal women with moderate to severe VMS. These individuals were randomized 1:1 to receive 12-week treatment of Elinzanetant 120 mg or placebo.

The trial was part of the OASIS series of studies. In the OASIS-1 and OASIS-2 trials, the impact of elinzanetant on moderate to severe VMS was assessed over the course of 26 weeks.2 There were 396 and 400 women, respectively, included in the trials, aged 40 to 65 years.

The mean change in the frequency and severity of VMS from baseline to weeks 4 and 12 were reported as the primary outcome of the analysis.1 Secondary outcomes included frequency and severity of symptoms from baseline to week 1, sleep disturbance change from baseline to week 12, and menopause-related quality of life change from baseline to week 12.

Efficacy endpoints were evaluated using mixed models with repeated measures. Adverse events and laboratory and physical assessments were performed to determine the safety profile of elinzanetant.

A reduction in VMS frequency and severity was reported among participants receiving elinzanetant. At week 4 and week 12, the mean frequency reductions were -3.29 and -3.22, respectively. These reductions were above the clinically relevant threshold of 2 VMS per day vs placebo. For severity, these reductions were -0.33 and -0.40, respectively.

VMS symptoms at week 1, sleep disturbances, and menopause-related quality of life were all improved in patients taking elinzanetant vs placebo. A favorable safety profile was also reported, with side effects including headache and fatigue.

Similar results were reported in the OASIS-3 trial, which was a placebo-controlled multicenter study evaluating the safety and efficacy of elinzanetant over a 52 week period in postmenopausal women.2 The long-term safety profile in the OASIS-3 trial remained consistent with previous data.

These results indicated tolerability and improved VMS frequency and severity, sleep disturbances, and menopause-related quality of life from elinzanetant. Bayer plans to submit data from the trials to gain marketing approval of elinzanetant for treating moderate to severe VMS associated with menopause.

References

  1. Simon JA, Nappi RE, Joffe H, Haberland C, Haseli Mashhadi N, Zuurman L. Second Phase 3 trial OASIS 1 confirms efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause. Bayer. May 16, 2024. Accessed May 15, 2024.
  2. Elinzanetant significantly reduces frequency and severity of moderate to severe hot flashes associated with menopause. Bayer. May 16, 2024. Accessed May 15, 2024.
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