Astellas Dosing in HIGHLIGHT 1 Phase 3 Study of Fezolinetant for VMS for Breast Cancer

Astellas Dosing in HIGHLIGHT 1 Phase 3 Study of Fezolinetant for VMS for Breast Cancer

By, Admin 29 August 2024

Astellas begins patient dosing in HIGHLIGHT 1 phase 3 study of fezolinetant for VMS in women with breast cancer receiving adjuvant endocrine therapy

Overview

Astellas Pharma Inc. announced dosing of the first patient in the HIGHLIGHT 1 phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy.

About Breast Cancer

  • Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022. 
  • Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer. 
  • Approximately 77% of breast cancers can be treated with adjuvant endocrine therapies, most commonly tamoxifen and aromatase inhibitors, and up to 97% of breast cancer patients experience hot flashes or night sweats.

Words from the VP: Astellas

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.”

HIGHLIGHT 1 Trial

  • HIGHLIGHT 1 (NCT06440967) is a randomized, placebo-controlled, double-blind, phase 3 clinical study to assess 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. 
  • Approximately 540 participants are planned to be randomized 1:1 to fezolinetant or placebo at up to 100 sites globally. 
  • The four coprimary endpoints are change in the frequency and severity of moderate to severe VMS from baseline to weeks 4 and 12. 
  • Patients will be treated for 52 weeks with a final evaluation at 55 weeks.

About Fezolinetant

  • Fezolinetant is an investigational oral, nonhormonal medicine in clinical development for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. 
  • The safety and efficacy of fezolinetant have not been established in this patient population. VMS are also known as hot flashes or night sweats. 
  • Fezolinetant works by blocking neurokinin B (NKB) binding on the kisspeptin/neurokinin/dynorphin (KNDy) neuron, helping restore the balance in the brain’s temperature control center (the hypothalamus) to reduce the number and intensity of hot flashes and night sweats. 
  • There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.

About Astellas Pharma Inc.

  • Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. 
  • The company is promoting the Focus Area Approach that is designed to identify opportunities for the continuous creation of new drugs to address diseases with high unmet medical needs by focusing on Biology and Modality.

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