OASIS: Fewer, less severe hot flashes observed with nonhormonal elinzanetant
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Key takeaways:
- Elinzanetant was associated with fewer and less severe menopausal vasomotor symptoms over 12 weeks.
- The neurokinin-1,3 receptor antagonist was associated with improved sleep and quality of life vs. placebo.
SAN FRANCISCO — In two phase 3 trials, the nonhormonal investigational agent elinzanetant was associated with decreased frequency and severity of menopausal vasomotor symptoms over 12 weeks with a favorable safety profile.
Elinzanetant (Bayer) was also associated with a significant reduction of hot flash frequency in the first week of use and with improved sleep and menopause-related quality of life, according to two poster presentations at the ACOG Annual Clinical & Scientific Meeting.
Elinzanetant is a neurokinin-1,3 receptor antagonist under development to treat symptoms associated with menopause. In May 2023, the FDA approved the first agent in this class — fezolinetant (Veozah, Astellas Pharma) — for treatment of moderate to severe vasomotor symptoms.
“Menopausal women who cannot take hormone therapy due to health issues, or choose not to take it, need more therapeutic options to improve their burdensome vasomotor symptoms — hot flashes and sweats — which have been shown to affect workplace productivity and relationships at work and home,” JoAnn V. Pinkerton, MD, professor of obstetrics and gynecology and director of midlife health at the University of Virginia Health System in Charlottesville and executive director emeritus of The Menopause Society, told Healio. “The positive study results shown from OASIS 1 and 2 reinforce the potential of elinzanetant and the hope that it may become a safe and effective option for menopausal women suffering from the triad of moderate to severe vasomotor symptoms, sleep disruption and decreased menopause related quality of life.”
The OASIS 1 and 2 trials each randomly assigned postmenopausal women with moderate to severe vasomotor symptoms to daily 120 mg elinzanetant or placebo for 12 weeks, with a following 14-week active treatment extension. Researchers assessed change in frequency and severity of vasomotor symptoms with elinzanetant. Effects on sleep disturbance were assessed by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance – Short Form 8b (PROMIS SD-SF-8b) total T-score and menopause-related quality of life by Menopause-Specific Quality of Life Questionnaire (MENQOL) total score. Endpoints were analyzed using a mixed model with repeated measures.
In the OASIS 2 trial, Pinkerton and colleagues analyzed data from 200 women in each of the treatment and placebo groups. At weeks 4 and 12, elinzanetant was associated with reductions in vasomotor symptom frequency (week 4: –3.04; week 12: –3.24; P < .0001 for both) vs. placebo. Researchers said the reduction in frequency was clinically relevant at two events per day and apparent at week 1 (P = .0013). Elinzanetant was associated with decreased severity of vasomotor symptoms (week 4: –0.22; P = .0003; week 12: –0.29; P < .0001). Sleep disturbance and quality of life were also improved significantly at week 12 with elinzanetant.
In OASIS 1, James A. Simon, MD, CCD, MSCP, IF, FACOG, medical director and founder of IntimMedicine Specialists and clinical professor at George Washington University, and colleagues analyzed data from 199 participants in the treatment group and 197 in the placebo group.
At weeks 4 and 12, elinzanetant was associated with reductions in vasomotor symptom frequency (week 4: –3.29; week 12: –3.22; P < .0001 for both) vs. placebo. As in OASIS 2, researchers said the reduction in frequency was clinically relevant at two events per day and apparent at week 1 (P < .0001). Elinzanetant was also associated with decreased severity of vasomotor symptoms (week 4: –0.33; week 12: –0.4; P < .0001 for both). Sleep disturbance and quality of life were also improved significantly at week 12 with elinzanetant.
In both trials, participants in the elinzanetant group reported headache and fatigue more often than the placebo group.
"While results are consistent with topline results shared earlier this year, we are excited to present for the first time in a scientific symposium that elinzanetant successfully met all four primary endpoints demonstrating statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms from baseline to week 4 and 12 compared to placebo. Also, the safety profile in the study was favorable. The findings from the secondary outcomes on sleep and quality of life are promising and deserve additional research, but are a big plus for patients," Simon told Healio. "I am excited by the positive detailed results of OASIS 1 and 2 and positive topline results of OASIS 3 which reinforce the potential of elinzanetant as a novel non-hormonal treatment option for moderate-to-severe vasomotor symptoms associated with menopause."
Reference:
- Simon J, et al. Second phase 3 trial OASIS 1 confirms efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause - IP05-D. Presented at: ACOG Annual Clinical & Scientific Meeting; May 17-19, 2024; San Francisco.