The HIGHLIGHT 1MD study aims to evaluate fezolinetant for the treatment of moderate to severe vasomotor symptoms in women with stage 0 to 3 hormone receptor-positive breast cancer receiving adjuvant endocrine therapy.
The Canadian team has started treating the first patient in the Phase 3 HIGHLIGHT 1MD study.
MARKHAM, ON, Aug. 27, 2024 /CNW/ – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”), the parent company of Astellas Pharma Canada Inc., today announced the dosing of the first patient in the pivotal Phase 3 HIGHLIGHT 1® study of fezolinetant, an investigational, non-hormonal oral compound being studied for the treatment of moderate-to-severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy.
Breast cancer is the most common cancer in women worldwide, with an estimated 2.3 million new cases in 20221. In 2022, an estimated 28,600 Canadian women were diagnosed with breast cancer.2
Hot flashes and night sweats, also known as vasomotor symptoms, are recognized as the most important side effect of adjuvant endocrine therapies used to treat breast cancer. Adjuvant endocrine therapies,3 especially tamoxifen and aromatase inhibitors, can treat approximately 77% of breast cancers, and up to 97% of breast cancer patients experience hot flashes or night sweats.4
Marci English, Vice President, Head of Biopharmaceutical Development, Astellas
“Vasomotor symptoms can negatively impact quality of life and treatment adherence in breast cancer patients receiving adjuvant endocrine therapy. We are excited to initiate the HIGHLIGHT 1 study because there are currently no approved treatments for moderate to severe vasomotor symptoms that these patients can use.”
Dr. Céline Bouchard, Women’s Health Research Clinic
“We are pleased and proud to launch this important research. The HIGHLIGHT 1 study will help us better understand the relationship between breast cancer, vasomotor symptoms and treatment, which will help us address this important issue for breast cancer patients around the world. As Canadians, we are excited to lead the way.”
About the HIGHLIGHT 1 study
HIGHLIGHT 1 (NCT06440967) is a phase 3, randomized, placebo-controlled, double-blind clinical study to evaluate the efficacy and safety of fezolinetant for the treatment of moderate to severe vasomotor symptoms in women with stage 0 to 3 hormone receptor-positive breast cancer receiving adjuvant endocrine therapy. Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at approximately 100 sites worldwide. The four co-primary endpoints are change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12. Patients will be treated for 52 weeks, with a final assessment at 55 weeks.
About fezolinetant
Fezolintant is an investigational, oral, non-hormonal drug in clinical development for the treatment of moderate to severe vasomotor symptoms in women with breast cancer receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not yet been established in this patient population. Vasomotor symptoms are also known as hot flashes or night sweats. Fezolintant works by blocking the binding of neurokinin B (NKB) to the kisspeptin/neurokinin/dynorphin (KNDy) neuron, which helps restore balance in the brain’s temperature control center (the hypothalamus) to reduce the number and severity of hot flashes and night sweats. 5,6,7 There is no guarantee that this substance will receive regulatory approval or will be commercially available for the uses being studied.
About Astellas Pharma Canada inc.
Astellas Pharma Canada Inc. is a Canadian subsidiary of Astellas Pharma Inc., a Tokyo-based pharmaceutical company with operations in over 70 countries worldwide. At Astellas, we aspire to be a leading value-driven life sciences innovator. This means working at the forefront of healthcare evolution to transform innovative science into VALUE for patients. What sets us apart is our patient focus, our innovation, our collaborative culture and the passion of our talented people. Learn more: https://www.astellas.com/ca/fr/.
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References
SOURCE Astellas Pharma Canada, Inc.
For more information, please contact: Dara Willis, Director, Products and Corporate Communications, Astellas Pharma Canada Inc., Cell: 647-207-3033, Email: [email protected]
