Topline Phase 3 Data Released for Elinzanetant Efficacy for Moderate-to-Severe VMS

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Elinzanetant (NT-814; Bayer) demonstrated statistically significant reduction in the frequency of moderate-to-severe vasomotor symptoms (VMS) from baseline to week 12 compared to placebo, according to new topline results from the phase III study OASIS 3.

The long-term safety profile of elinzanetant observed in OASIS 3 was consistent with previous efficacy and long-term safety findings from OASIS 1 and OASIS 2 studies, according to Bayer’s March 19, 2024, press release. OASIS 3 was designed specifically to evaluate the long-term profile of the investigational agent, said Bayer.

“These results, coupled with the recent announcement of topline data for OASIS 1 and OASIS 2, strengthen our confidence in the proposed efficacy and safety of elinzanetant as a potential novel non-hormonal solution for women experiencing menopause-related symptoms,” said Nick Panay, MD, principal investigator for OASIS 3, in the press release.

Elinzanetant is a novel dual neurokinin-1,3 (NK-1,3) receptor antagonist administered orally once daily. It is in late-stage clinical development for the nonhormonal treatment of moderate-to-severe VMS associated with menopause. Elinzanetant modulates estrogen-sensitive neurons associated with thermoregulatory pathway hyperactivation, according to the manufacturer. The agent may also mitigate sleep disturbance often seen during menopause.

OASIS 3 is the third study in the OASIS clinical development program and randomized 628 postmenopausal women aged 40 to 65 years across 83 sites in 9 countries, according to the press release. OASIS 4 is an expansion of the clinical phase III program and investigates the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for treatment or prevention of breast cancer.

Earlier this year, Bayer announced topline data from OASIS 1 and 2, which met all primary and secondary key endpoints for elinzanetant 120 mg . Bayer plans on sharing results from all 3 studies at upcoming medical conferences and submit the data to health authorities for approval of marketing authorizations of elinzanetant.

Source: Positive topline results from Phase III long-term study OASIS 3 support submissions for marketing authorization for Bayer’s elinzanetant. News release. Bayer. March 19, 2024. Accessed March 19, 2024. https://www.bayer.com/media/en-us/positive-topline-results-from-phase-iii-long-term-study-oasis-3-support-submissions-for-marketing-authorization-for-bayers-elinzanetant/