Astellas to Present VEOZA™ (fezolinetant) Data at IMS World Congress on Menopause
Astellas Pharma Inc. announced that VEOZA™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, will be featured in four oral and two poster presentations during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22.
The presentations will cover a range of topics, including:
- Patient-reported sleep outcomes and impact on work productivity from the SKYLIGHT 1 and 2 studies
- Response and quality of life in women treated with fezolinetant who are unsuitable for hormone therapy from the DAYLIGHT study
- Analyses showing no association between fezolinetant treatment and incidence of malignant neoplasm
- Study design for the HIGHLIGHT 1 phase 3 clinical study evaluating fezolinetant for VMS in breast cancer patients
The data presented aims to expand knowledge about fezolinetant beyond pivotal trials, highlighting its safety, efficacy, and positive impact on patient-reported outcomes.
Astellas Pharma Inc. ha annunciato che VEOZA™ (fezolinetant), il suo trattamento di prima classe per i sintomi vasomotori moderati e severi (VMS) associati alla menopausa, sarà presente in quattro presentazioni orali e due poster durante il 19° Congresso Mondiale sulla Menopausa della Società Internazionale della Menopausa (IMS) a Melbourne, Australia, dal 19 al 22 ottobre.
Le presentazioni copriranno una serie di argomenti, tra cui:
- Risultati riferiti dai pazienti sul sonno e impatto sulla produttività lavorativa dagli studi SKYLIGHT 1 e 2
- Risposta e qualità della vita nelle donne trattate con fezolinetant non idonee alla terapia ormonale dallo studio DAYLIGHT
- Analisi che mostrano assenza di associazione tra il trattamento con fezolinetant e l'incidenza di neoplasia maligna
- Design dello studio per lo studio clinico di fase 3 HIGHLIGHT 1 che valuta fezolinetant per VMS in pazienti con cancro al seno
I dati presentati mirano ad ampliare la conoscenza su fezolinetant oltre gli studi chiave, evidenziando la sua sicurezza, efficacia e impatto positivo sugli esiti riportati dai pazienti.
Astellas Pharma Inc. anunció que VEOZA™ (fezolinetant), su tratamiento de primera clase para síntomas vasomotores moderados a severos (VMS) asociados con la menopausia, será presentado en cuatro presentaciones orales y dos posters durante el 19° Congreso Mundial sobre Menopausia de la Sociedad Internacional de Menopausia (IMS) en Melbourne, Australia, del 19 al 22 de octubre.
Las presentaciones cubrirán una variedad de temas, incluyendo:
- Resultados del sueño informados por los pacientes y su impacto en la productividad laboral de los estudios SKYLIGHT 1 y 2
- Respuesta y calidad de vida en mujeres tratadas con fezolinetant no aptas para terapia hormonal del estudio DAYLIGHT
- Análisis que muestran falta de asociación entre el tratamiento con fezolinetant y la incidencia de neoplasia maligna
- Diseño del estudio para el estudio clínico de fase 3 HIGHLIGHT 1 que evalúa fezolinetant para VMS en pacientes con cáncer de mama
Los datos presentados tienen como objetivo ampliar el conocimiento sobre fezolinetant más allá de los ensayos pivotales, destacando su seguridad, eficacia y el impacto positivo en los resultados reportados por los pacientes.
Astellas Pharma Inc.는 VEOZA™ (fezolinetant)이 폐경과 관련된 중등도에서 중증의 혈관운동 증상(VMS)을 위한 최초의 치료제이며, 호주 멜버른에서 열리는 제19회 국제 폐경학회(IMS) 세계 폐경학회에서 4개의 구두 발표와 2개의 포스터 발표가 있을 것이라고 발표했습니다. 발표는 10월 19일부터 22일까지 진행됩니다.
발표 내용은 다음과 같은 다양한 주제를 포함합니다:
- SKYLIGHT 1 및 2 연구에서 환자가 보고한 수면 결과와 업무 생산성에 미치는 영향
- 호르몬 치료에 적합하지 않은 여성에게 fezolinetant으로 치료한 결과와 삶의 질에 대한 DAYLIGHT 연구
- fezolinetant 치료와 악성 신생물 발생 간의 연관성이 없음을 보여주는 분석
- 유방암 환자의 VMS를 평가하는 3상 임상 연구 HIGHLIGHT 1의 연구 설계
발표된 데이터는 fezolinetant에 대한 지식을 주요 임상 시험을 넘어 확장하는 것을 목표로 하며, 환자가 보고한 결과에 대한 안전성, 효능 및 긍정적인 영향을 강조합니다.
Astellas Pharma Inc. a annoncé que VEOZA™ (fezolinetant), son traitement de première classe pour les symptômes vasomoteurs modérés à sévères (VMS) associés à la ménopause, sera présenté dans quatre présentations orales et deux posters lors du 19e Congrès Mondial sur la Ménopause de la Société Internationale de Ménopause (IMS) à Melbourne, Australie, du 19 au 22 octobre.
Les présentations aborderont une variété de sujets, notamment :
- Résultats de sommeil rapportés par les patients et impact sur la productivité au travail des études SKYLIGHT 1 et 2
- Réponse et qualité de vie des femmes traitées par fezolinetant qui ne sont pas adaptées à une thérapie hormonale de l'étude DAYLIGHT
- Analyses montrant aucune association entre le traitement par fezolinetant et l'incidence de néoplasie maligne
- Conception de l'étude pour l'étude clinique de phase 3 HIGHLIGHT 1 évaluant le fezolinetant pour les VMS chez les patientes atteintes de cancer du sein
Les données présentées visent à élargir les connaissances sur le fezolinetant au-delà des études pivot, mettant en évidence sa sécurité, son efficacité et son impact positif sur les résultats rapportés par les patients.
Astellas Pharma Inc. hat angekündigt, dass VEOZA™ (fezolinetant), seine Therapie der ersten Klasse für mittelschwere bis schwere vasomotorische Symptome (VMS), die mit der Menopause verbunden sind, in vier mündlichen und zwei Posterpräsentationen während des 19. Weltkongresses zur Menopause der International Menopause Society (IMS) in Melbourne, Australien, vom 19. bis 22. Oktober vorgestellt wird.
Die Präsentationen werden eine Reihe von Themen abdecken, darunter:
- Vom Patienten berichtete Schlafresultate und Auswirkungen auf die Arbeitsproduktivität aus den Studien SKYLIGHT 1 und 2
- Antwort und Lebensqualität bei Frauen, die mit fezolinetant behandelt wurden und für eine Hormontherapie nicht geeignet sind, aus der DAYLIGHT-Studie
- Analysen, die keine Assoziation zwischen der Behandlung mit fezolinetant und der Inzidenz von bösartigen Neoplasien zeigen
- Studien-Design für die HIGHLIGHT 1 Phase 3-Studie zur Evaluierung von fezolinetant für VMS bei Brustkrebspatientinnen
Die präsentierten Daten zielen darauf ab, das Wissen über fezolinetant über grundlegende Studien hinaus zu erweitern und seine Sicherheit, Wirksamkeit und positive Auswirkungen auf die vom Patienten berichteten Ergebnisse hervorzuheben.
- None.
- None.
Marci English, Vice President, Head of BioPharma Development, Astellas
"Astellas is committed to advancing innovative science, and the data at the World Congress on Menopause further our understanding of how VMS impacts individuals and women's preferences for treatment. In addition, we are excited to share trial design for our recently initiated HIGHLIGHT study assessing fezolinetant for the treatment of moderate to severe VMS in patients with breast cancer taking adjuvant endocrine therapy."
Emad Siddiqui, M.D., Vice President, Head of Specialty Therapeutic Area for Medical Affairs, Astellas
"We are dedicated to continuing to expand the knowledge about fezolinetant beyond the pivotal trials. Our presentations at the World Congress on Menopause encompass a broad range of clinical and health-related quality of life analyses that further highlight the safety and efficacy of fezolinetant, as well as its positive impact on patient-reported outcomes including sleep and productivity at work."
Fezolinetant data will be featured in four oral and two poster presentations:
- Two oral presentations from the SKYLIGHT 1 and 2 studies focus on patient-reported sleep outcomes and impact on work productivity with fezolinetant (Menopause New Treatments 1 and 2; Monday, Oct. 21, 3:50-5:20 p.m.; A. Cano and R. Nappi, respectively).
- Two oral presentations from the DAYLIGHT study highlight response and quality of life in women treated with fezolinetant who are unsuitable for hormone therapy (Menopause New Treatments 1; Monday, Oct. 21, 3:50-5:20 p.m.; A. Hirschberg and M. Shapiro, respectively).
- Poster highlights analyses of clinical and nonclinical data demonstrating no association between fezolinetant treatment and incidence of malignant neoplasm (P073; Sunday, Oct. 20, 7:40-9 p.m.; M. Shapiro).
- Poster reviews study design for the recently initiated HIGHLIGHT 1 phase 3 clinical study designed to evaluate 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 receiving adjuvant endocrine therapy (P055; Sunday, Oct. 20, 7:40-9 p.m.; P. Briggs).
Two additional oral presentations highlight Australian women's preferences for treatment of VMS associated with menopause and results of a literature review designed to identify and characterize concepts relevant to individuals' experiences of VMS with a goal of informing the development of a culturally sensitive self-assessment tool for VMS.
*VEOZA: Approved as "VEOZAH™" in
About the BRIGHT SKY™ Phase 3 Program
The BRIGHT SKY pivotal trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142), enrolled over 1,000 menopausal women with moderate to severe VMS. The trials are double-blinded, placebo-controlled for the first 12 weeks followed by a 40-week treatment extension period. Women were enrolled at over 180 sites within the U.S., Canada and Europe. SKYLIGHT 4™ (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. For SKYLIGHT 4, over 1,800 menopausal women with VMS were enrolled at over 180 sites within the U.S., Canada and Europe.
About DAYLIGHT
DAYLIGHT (NCT05033886) is a Phase 3b, randomized, double-blind, placebo-controlled, 24-week study to assess the efficacy and safety of fezolinetant in menopausal women aged 40-65 suffering from moderate to severe VMS and considered unsuitable for hormone therapy. A total of 453 women were enrolled at 69 sites in
About HIGHLIGHT 1™
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 in
About VEOZA™ (fezolinetant)
VEOZA (fezolinetant) is a nonhormonal neurokinin 3 (NK3) receptor antagonist indicated in
Important Safety Information
The full Australian Product Information and Australian Public Assessment Report (AusPAR) for fezolinetant is available from the Australian Government Therapeutic Goods Administration.
About Astellas
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are 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. Furthermore, we are also looking beyond our foundational Rx focus to create Rx+® healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. Through these efforts, Astellas stands on the forefront of healthcare change to turn innovative science into VALUE for patients. For more information, please visit our website at https://www.astellas.com/en.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
References
1 Utian WH. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. Health Qual Life Outcomes. 2005;3:47.
2 Jones RE, Lopez KH, eds. Human Reproductive Biology. 4th ed.
3 Depypere H, Timmerman D, Donders G, et al. Treatment of menopausal vasomotor symptoms with fezolinetant, a neurokinin 3 receptor antagonist: a phase 2a trial. J Clin Endocrinol Metab. 2019;104:5893-5905.
4 Fraser GL, Lederman S, Waldbaum A, et al. A phase 2b, randomized, placebo-controlled, double-blind, dose-ranging study of the neurokinin 3 receptor antagonist fezolinetant for vasomotor symptoms associated with menopause. Menopause. 2020;27:382-392.
5 Fraser GL, Hoveyda HR, Clarke IJ, et al. The NK3 receptor antagonist ESN364 interrupts pulsatile LH secretion and moderate levels of ovarian hormones throughout the menstrual cycle. Endocrinology. 2015;156:4214-4225.
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SOURCE Astellas Pharma Inc.
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