From Trial to Practice: Key Findings from the SKYLIGHT and OASIS Studies

In 'From Trial to Practice: Key Findings from the SKYLIGHT and OASIS Studies,' our panel of experts delve into the following critical questions:

1. The SKYLIGHT and OASIS trials aimed to study the safety and efficacy of fezolinetant and elinzanetant, respectively. What were the primary and secondary endpoints of these studies?
2. How quickly did patients in the trials see symptom improvement?
3. What did each study report in terms of sleep disturbance improvements?

Led by the moderator, the panelists discussed the design and key findings of the SKYLIGHT 1 and 2 trials for fezolinetant and the OASIS 1, 2, and 3 trials for elinzanetant, noting that both sets of trials shared a similar Phase III framework requiring replicated results across independent sites, with primary endpoints focused on reductions in the frequency and severity of vasomotor symptoms from baseline at weeks 4 and 12. The discussion highlighted a particularly compelling efficacy finding shared across both agents, that participants in the trials began reporting meaningful symptom improvement as early as week one, with post-hoc analyses of SKYLIGHT data suggesting some patients experienced relief as early as day one, a notably faster onset than the several weeks typically required for hormone therapy to produce results. The panelists also examined sleep as a secondary endpoint across both trial programs, noting that fezolinetant demonstrated limited statistically significant sleep benefit in the SKYLIGHT trials, whereas elinzanetant's dual NK1 and NK3 mechanism positioned sleep improvement as a more prominent outcome, with the ongoing NIRVANA trial specifically designed to objectively measure sleep changes using polysomnography rather than self-reporting, representing an important step toward rigorous, evidence-based understanding of this benefit.

Throughout the conversation, the experts provide a comprehensive reflection on the field and the factors that may shape how clinicians approach care moving forward.

Our next episode, 'From Trial Data to Real-World Practice: Safety, Monitoring, and Patient Selection for VMS Treatment,' further explores vasomotor symptoms and menopause, highlighting the most common adverse events reported in the trials of each agent, how long-term safety data inform clinical confidence in these therapies, and which patient profiles are best suited for fezolinetant versus elinzanetant in real-world practice.