Elinzanetant (2) – Lynkuet®

• Clinical trials
  • To conduct a benefit assessment of elinzanetant for the treatment of moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in connection with breast cancer, the pharmaceutical manufacturer is submitting data from the OASIS-4 study.
  • This is a study comprising a double-blind, randomised, controlled treatment phase comparing elinzanetant with placebo over 12 weeks, followed by a 40-week single-arm treatment phase in which all enrolled patients receive elinzanetant.

Patients with moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in connection with breast cancer

• For patients with moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in connection with breast cancer, the additional benefit is not proven.
• Consequently, there are no suitable data available for the benefit assessment in patients with moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in the context of breast cancer.
• Overall assessment
  • In summary, due to the insufficient duration of the comparative study phase, the OASIS-4 study is not suitable for establishing the additional benefit of elinzanetant compared with the appropriate comparator therapy.

Courtesy translation only, please refer to the German original.