First Patient Dosed in Phase III Study of Fezolinetant for Hot Flashes in Women with Breast Cancer
First-in-class option to reduce frequency and severity of VMS due to menopause will now be evaluated in women with breast cancer receiving adjuvant endocrine therapy.
Astellas has announced the dosing of the first patient in its HIGHLIGHT 1 Phase III pivotal study for fezolinetant. While the therapy is already approved for moderate to severe vasomotor symptoms (VMS) due to menopause, HIGHLIGHT 1 will evaluate it in women with breast cancer receiving adjuvant endocrine therapy.1
HIGHLIGHT 1 (NCT06440967) is a randomized, placebo-controlled, double-blind trial assessing the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. Astellas expects to enroll approximately 540 participants at up to 100 sites across the globe who will be randomized 1:1 to fezolinetant or placebo. The study’s four coprimary endpoints are change in the frequency and severity of VMS from baseline to weeks 4 and 12. Patients will receive treatment for 52 weeks with a final evaluation at 55 weeks.
In a press release, Marci English, vice president, head of biopharma development, Astellas said, “VMS can adversely affect quality of life, as well as compliance with treatment, for patients with breast cancer taking adjuvant endocrine therapy. We are excited to get the HIGHLIGHT 1 study underway, as currently there are no approved treatments for moderate to severe VMS that can be used by these patients.”
In May 2023, fezolinetant (Veozah) at a once daily dose of 45mg was approved by the FDA for the treatment of moderate to severe VMS due to menopause. It became the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause. The approval was based on results from the BRIGHT SKY program which included three Phase III studies. Over 3,000 participants were enrolled across the trials in Canada, Europe, and the US.2
In a press release from the time, Genevieve Neal-Perry, MD, PhD, chair, UNC School of Medicine, department of obstetrics and gynecology said, “Today’s approval of fezolinetant is a significant and, I believe, long awaited milestone for individuals in the US who experience moderate to severe vasomotor symptoms during the menopausal transition. This therapy is based on our understanding of the biology behind hot flashes. I’m excited to know that patients will have the option to choose this nonhormonal treatment.”
“Veozah uses a novel mechanism of action to target the root cause of VMS due to menopause,” English added. “FDA approval of this new treatment for moderate to severe VMS due to menopause is a testament to Astellas’ commitment to delivering innovative therapies in areas of unmet need that have been underserved, including women’s health.”
Fezolinetant is also being investigated in Japan through two Phase III trials for the treatment of VMS associated with menopause in Japanese women. STARLIGHT 2 is evaluating fezolinetant once-daily through 12 weeks and STARLIGHT 3 is evaluating fezolinetant once-daily through 52 weeks.3
“VMS associated with menopause affects millions of women in Japan. We are excited the STARLIGHT Phase III clinical studies are underway, bringing us one step closer to making this novel, nonhormonal treatment option available in Japan for women experiencing VMS associated with menopause,” English said in a press release.
References
1. Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy. News release. Astellas. August 27, 2024. Accessed August 27, 2024. https://www.astellas.com/en/news/29376
2. Astellas’ VEOZAH (fezolinetant) Approved by U.S. FDA for Treatment of Vasomotor Symptoms Due to Menopause. News release. Astellas. May 13, 2023. Accessed August 27, 2024. https://www.astellas.com/en/news/27756
3. Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan. News release. Astellas. March 4, 2024. Accessed August 27, 2024. https://www.astellas.com/en/news/28951
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