Elinzanetant long-term safety data with JoAnn Pinkerton, MD, FACOG, NCMP

At the 2024 Menopause Society meeting being held in Chicago,Illinois through September 14, 2024, JoAnn Pinkerton, MD, FACOG, NCMP, joined us to discuss phase 3 data of elinzanetant from the OASIS 3 trial.

The trail sought to evaluate the safety and efficacy of elinzanetant in postmenopausal women with moderate-to-severe vasomotor symptoms (VMS).

"OASIS 3 is a clinical trial that built on OASIS 1 and 2, which were 26 week trials that were just published in JAMA," said Pinkerton, who is a professor of Obstetrics and Gynecology at The University of Virginia Health System in Charlottesville, Virginia.

"OASIS 3 was a longer clinical trial, 52 weeks, that took primarily women who are having bothersome menopausal symptoms of moderate to severe, and they observed them over a year for safety and efficacy. The primary endpoint was the reduction in hot flushes from baseline to 12 weeks, but then we really wanted to look at the safety and efficacy across 52 weeks," Pinkerton said.

"The good news was that Oasis we met its primary objective," she added. "Hot flushes were significantly reduced at 12 weeks in this population of women who were not as severe as those in OASIS 1 and 2—more like you would see in your clinical practice—significantly reduced compared to placebo at 12 weeks, and then maintained that efficacy throughout the 52 weeks.

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Reference:

Panay N, Joffe H, Maki P, et al. Efficacy and Long-term Safety of Elinzanetant for the Treatment of VMS Associated with Menopause: A Phase 3 Randomized Trial (OASIS 3). Abstract. Presented at: The Menopause Society 2024 Annual Meeting. September 10 - September 14, 2024. Chicago, Illinois.