Safety and tolerability of elinzanetant: a pooled analysis from four randomized clinical trials

Summary: Background: Elinzanetant is a dual neurokinin (NK)-1 and NK-3 receptor antagonist approved for the treatment of moderate-to-severe vasomotor symptoms (VMS) associated with menopause, or those caused by adjuvant endocrine therapy for breast cancer treatment.

Methods

In this pooled safety analysis, safety data were pooled from four randomized, placebo-controlled studies: the phase IIb SWITCH-1 trial (2018–2019) and phase III OASIS-1–3 trials (2021–2024). All four studies were multicentre, multinational, double-blind trials that included postmenopausal women aged 40–65 years experiencing moderate-to-severe VMS due to natural or surgical menopause. Data were analysed exploratively. Assessments included frequency of treatment-emergent adverse events (TEAEs) over 12 and 52 weeks, and exposure-adjusted incidence rates (EAIRs, with 95% confidence intervals [CIs]) over 52 weeks. EAIRs were calculated by weighting event counts against total exposure time (person-years) across studies. Additionally, liver safety and incidence of neoplasms were evaluated.