Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy
Astellas Pharma has initiated the HIGHLIGHT 1™ Phase 3 clinical study for fezolinetant, an investigational oral, nonhormonal compound aimed at treating moderate to severe vasomotor symptoms (VMS) in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy. VMS, including hot flashes and night sweats, affect up to 97% of breast cancer patients and are a major side effect of adjuvant endocrine therapies. The study is significant as there are currently no approved treatments for moderate to severe VMS in this patient population. Breast cancer is the most common cancer in women globally, with about 2.3 million new cases in 2022, and approximately 77% of breast cancers can be treated with adjuvant endocrine therapies.
Astellas Pharma ha avviato lo studio clinico di Fase 3 HIGHLIGHT 1™ per fezolinetant, un composto orale non ormonale in fase di sperimentazione, destinato al trattamento dei symptoms vasomotori (VMS) da moderati a gravi nelle donne con cancro al seno positivo ai recettori ormonali di stadio 0-3 che stanno ricevendo terapia endocrina adiuvante. I VMS, che includono vampate di calore e sudorazioni notturne, colpiscono fino al 97% delle pazienti affette da cancro al seno e rappresentano un effetto collaterale significativo delle terapie endocrine adiuvanti. Lo studio è di grande importanza poiché attualmente non esistono trattamenti approvati per VMS da moderati a gravi in questa popolazione di pazienti. Il cancro al seno è il tipo di cancro più comune tra le donne a livello globale, con circa 2,3 milioni di nuovi casi nel 2022, e circa il 77% dei tumori al seno può essere trattato con terapie endocrine adiuvanti.
Astellas Pharma ha iniciado el estudio clínico HIGHLIGHT 1™ de Fase 3 para fezolinetant, un compuesto oral no hormonal en investigación destinado a tratar los síntomas vasomotores (VMS) de moderados a graves en mujeres con cáncer de mama positivo a receptores hormonales en etapas 0-3 que están recibiendo terapia endocrina adyuvante. Los VMS, que incluyen sofocos y sudores nocturnos, afectan hasta el 97% de las pacientes con cáncer de mama y son un efecto secundario importante de las terapias endocrinas adyuvantes. El estudio es significativo ya que actualmente no hay tratamientos aprobados para VMS de moderados a graves en esta población de pacientes. El cáncer de mama es el tipo de cáncer más común en mujeres a nivel mundial, con aproximadamente 2.3 millones de nuevos casos en 2022, y aproximadamente el 77% de los cánceres de mama pueden ser tratados con terapias endocrinas adyuvantes.
Astellas Pharma는 HIGHLIGHT 1™ 3상 임상 연구를 페졸리네탄에 대해 시작했습니다. 이는 호르몬 수용체 양성 유방암 스테이지 0-3의 여성들이 보조적 내분비 치료를 받는 중에 발생하는 중등도에서 중증의 혈관운동 증상(VMS)을 치료하기 위한 경구 비호르몬 약물입니다. VMS는 안면홍조와 야간 발한을 포함하며 유방암 환자의 최대 97%에 영향을 미치고, 보조적 내분비 치료의 주요 부작용입니다. 현재 이 환자 집단에 대한 승인된 치료법이 없다는 점에서 이 연구는 중요합니다. 유방암은 전 세계 여성에서 가장 흔한 암으로, 2022년에 약 230만 건의 새로운 사례가 발생했으며, 유방암의 약 77%는 보조적 내분비 치료로 치료할 수 있습니다.
Astellas Pharma a lancé l'étude clinique HIGHLIGHT 1™ de Phase 3 pour fezolinetant, un composé oral non hormonal en cours d'investigation visant à traiter les symptômes vasomoteurs (VMS) modérés à graves chez des femmes atteintes de cancer du sein positif aux récepteurs hormonaux au stade 0-3 recevant une thérapie endocrinienne adjuvante. Les VMS, y compris les bouffées de chaleur et les sueurs nocturnes, touchent jusqu'à 97 % des patientes atteintes de cancer du sein et représentent un effet secondaire majeur des thérapies endocriniennes adjuvantes. L'étude est significative car il n'existe actuellement aucun traitement approuvé pour les VMS modérés à sévères dans cette population de patientes. Le cancer du sein est le cancer le plus courant chez les femmes dans le monde, avec environ 2,3 millions de nouveaux cas en 2022, et environ 77 % des cancers du sein peuvent être traités par des thérapies endocriniennes adjuvantes.
Astellas Pharma hat die HIGHLIGHT 1™ Phase 3 klinische Studie für fezolinetant gestartet, eine orale nicht-hormonelle Substanz, die darauf abzielt, mäßige bis schwere vasomotorische Symptome (VMS) bei Frauen mit hormonrezeptor-positivem Brustkrebs im Stadium 0-3 zu behandeln, die eine adjuvante endokrine Therapie erhalten. VMS, einschließlich Hitzewallungen und Nachtschweiß, betreffen bis zu 97 % der Brustkrebspatientinnen und sind eine wesentliche Nebenwirkung der adjuvanten endokrinen Therapien. Die Studie ist bedeutend, da es derzeit keine zugelassenen Behandlungen für mäßige bis schwere VMS in dieser Patientengruppe gibt. Brustkrebs ist die häufigste Krebsart bei Frauen weltweit, mit etwa 2,3 Millionen neuen Fällen im Jahr 2022, und ungefähr 77 % der Brustkrebserkrankungen können mit adjuvanten endokrinen Therapien behandelt werden.
- Initiation of Phase 3 clinical study for fezolinetant, addressing an unmet medical need
- Potential to improve quality of life and treatment compliance for breast cancer patients
- Targeting a large market with 2.3 million new breast cancer cases globally in 2022
- Addressing a side effect that affects up to 97% of breast cancer patients
- No approved treatments currently available for the target condition
- Potential regulatory hurdles for approval in a sensitive patient population
- HIGHLIGHT 1™ study to evaluate fezolinetant for treatment of moderate to severe vasomotor symptoms in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy -
Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022.1 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
Marci English, Vice President, Head of BioPharma Development, Astellas
"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."
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 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.4,5,6 There is no guarantee the agent will receive regulatory approval or become commercially available for the uses being investigated.
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 World Cancer Research Fund International. Breast cancer statistics. https://www.wcrf.org/cancer-trends/breast-cancer-statistics/.
2 American Cancer Society. Breast Cancer Facts & Figures 2022-2024.
3 Fenlon D, Morgan A, Khambaita P, et al. NCRI CSG Breast Cancer Symptom Working Party. Management of hot flushes in
4 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.
5 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.
6 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.
FAQ
What is the purpose of Astellas' HIGHLIGHT 1™ Phase 3 study for fezolinetant (ALPMY)?
How common are vasomotor symptoms in breast cancer patients treated with adjuvant endocrine therapy (ALPMY)?
What percentage of breast cancers can be treated with adjuvant endocrine therapies according to Astellas' press release (ALPMY)?
Are there currently any approved treatments for moderate to severe VMS in breast cancer patients on adjuvant endocrine therapy (ALPMY)?
