Consistency of efficacy and safety of elinzanetant for vasomotor symptoms and sleep disturbance associated with menopause across different populations: a review of the OASIS clinical trial program.

Elinzanetant, a dual neurokinin-1/-3 receptor antagonist, is approved for the treatment of moderate-to-severe vasomotor symptoms. The double-blind, randomized, placebo-controlled Phase III OASIS-1-4 studies evaluated elinzanetant's efficacy and safety in diverse populations of women, including those with vasomotor symptoms associated with natural or surgical menopause (OASIS-1, -2, and -3) and caused by endocrine therapy for breast cancer (OASIS-4). Results were similar across all trials for the respective primary and key secondary endpoints (included in the statistical testing hierarchy). Significant reductions vs. placebo in the frequency of vasomotor symptoms appeared from as early as week 1 in OASIS-1 and -2 (analyzed descriptively in OASIS-3 and -4), and at week 4 in OASIS-1, -2, and -4 (analyzed descriptively in OASIS-3). By week 12, all studies showed significant reductions vs. placebo, with benefits maintained for up to 50 weeks. In OASIS-1 and -2, the severity of vasomotor symptoms significantly decreased vs. placebo at weeks 4 and 12 (analyzed descriptively in OASIS-3 and -4). Elinzanetant treatment improved sleep disturbance, assessed by the Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T-score, and menopause-related quality of life, measured as total score on the Menopause-specific Quality of Life questionnaire, across all four trials as early as week 1. Significant reductions vs. placebo were seen at week 12 in OASIS-1, -2, and -4 (key secondary endpoints; analyzed descriptively in OASIS-3 as a secondary endpoint). Elinzanetant was generally well tolerated with consistent efficacy across all OASIS trials in diverse populations of women experiencing vasomotor symptoms.