Elinzanetant for Vasomotor Symptoms from Endocrine Therapy for Breast Cancer

Author(s): Fatima Cardoso, M.D.¹; Susanne Parke, M.D.²; Donal J. Brennan, M.D.³; Paula Briggs, M.D.⁴; Gilbert Donders, M.D.⁵; Nick Panay, M.D.⁶; Nazanin Haseli-Mashhadi, M.D.⁷; Michael Block, M.D.⁸; Cecilia Caetano, M.D.⁹; Maja Francuski, M.D.¹⁰; Claudia Haberland, M.D.¹¹; Kaisa Laapas, M.D.¹²; Christian Seitz, M.D.¹³; Lineke Zuurman, M.D.¹⁴;

Source: N Engl J Med 2025;393:753-763

Dr. Maen Hussein's Thoughts

Elinzanitant, a neurokinin-targeted therapy, has been shown to reduce vasomotor symptoms compared to placebo. These symptoms are one of the reasons some of my patients discontinue aromatase inhibitor (AI) therapy, so Elinzanitant presents a promising alternative to help manage these side effects. Additionally, Fezolinetant is already approved and available on the market.

BACKGROUND

Women receiving endocrine therapy for hormone receptor (HR)–positive breast cancer or its prevention among those at high risk for breast cancer commonly have vasomotor symptoms. Data are lacking on the effects of elinzanetant, a neurokinin-targeted therapy shown to be effective in treating vasomotor symptoms, in this population.

METHODS

We performed a phase 3 trial involving women 18 to 70 years of age with moderate-to-severe vasomotor symptoms associated with endocrine therapy for HR-positive breast cancer or its prevention. Women were randomly assigned in a 2:1 ratio to receive once-daily elinzanetant at a dose of 120 mg for 52 weeks or once-daily placebo for 12 weeks followed by once-daily elinzanetant at a dose of 120 mg for 40 weeks. The primary end points were the change in the mean daily frequency of moderate-to-severe vasomotor symptoms from baseline to week 4 and to week 12. Research Summary Elinzanetant for Vasomotor Symptoms from Endocrine Therapy

RESULTS

A total of 316 participants were assigned to the elinzanetant group and 158 to the placebo–elinzanetant group. At baseline, the mean daily frequency of moderate-to-severe vasomotor symptoms was 11.4 episodes (95% confidence interval [CI], 10.7 to 12.2) in the elinzanetant group and 11.5 episodes (95% CI, 10.5 to 12.5) in the placebo–elinzanetant group. At week 4, the mean change from baseline in the mean daily frequency of moderate-to-severe vasomotor symptoms was −6.5 episodes (95% CI, −7.2 to −5.8) among those who were receiving elinzanetant and −3.0 episodes (95% CI, −3.9 to −2.2) among those who were receiving placebo (least-squares mean difference, −3.5 episodes; 95% CI, −4.4 to −2.6; P

CONCLUSIONS

Elinzanetant led to a significantly lower frequency of vasomotor symptoms associated with endocrine therapy than placebo. (Funded by Bayer; OASIS-4 ClinicalTrials.gov number, NCT05587296.)

Author Affiliations

¹Breast Unit, Champalimaud Clinical Center, Champalimaud Foundation, Lisbon, PortugalABC Global Alliance, Lisbon, Portugal; ²Bayer, Berlin; ³University College Dublin Gynaecological Oncology Group, UCD School of Medicine, Mater Misericordiae University Hospital, Dublin; ⁴Liverpool Women’s Hospital, Liverpool, United Kingdom; ⁵Department of Clinical Research for Women, Femicare, Tienen, BelgiumDepartment of Obstetrics and Gynecology, University Hospital, University of Antwerp, Antwerp, Belgium; ⁶Queen Charlotte’s and Chelsea Hospital, Imperial College London, London; ⁷Bayer, Reading, United Kingdom; ⁸Bayer, Leverkusen, Germany; ⁹Bayer, Basel, Switzerland; ¹⁰Bayer, Espoo, Finland; ¹¹Bayer, BerlinCharité–Universitätsmedizin Berlin, Berlin

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