– Bayer today announced positive topline results of the Phase III study OASIS 4 investigating elinzanetant as non-hormonal treatment for moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy in women with breast cancer or at high risk of developing breast cancer. Elinzanetant successfully met the primary endpoints of the study demonstrating statistically significant reductions in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to week 4 and 12 compared to placebo.

–拜耳公司今天宣布了第三阶段研究OASIS 4的积极结果，该研究调查了依林扎尼坦作为非激素治疗乳腺癌或乳腺癌高危女性辅助内分泌治疗引起的中度至重度血管舒缩症状。Elinzanetant成功达到了研究的主要终点，表明与安慰剂相比，从基线到第4周和第12周，中度至重度血管舒缩症状（VMS，也称为潮热）的频率在统计学上显着降低。

The study also achieved all secondary endpoints demonstrating reductions in severity of VMS at week 4 and 12, VMS frequency reduction at week 1 as well as maintaining the effects over the study period. Elinzanetant also showed improvements of sleep disturbances and menopause-related quality of life at week 12 compared to placebo.

该研究还实现了所有次要终点，表明在第4周和第12周VMS的严重程度降低，在第1周VMS频率降低以及在研究期间保持效果。与安慰剂相比，Elinzanetant在第12周还显示出睡眠障碍和更年期相关生活质量的改善。

The safety profile over 52 weeks observed in the OASIS 4 study is generally consistent with previously conducted studies and published data.

在OASIS 4研究中观察到的52周以上的安全性概况通常与先前进行的研究和公布的数据一致。

on elinzanetant in postmenopausal women with VMS.

绝经后VMS患者服用依林扎尼坦。

“Elinzanetant has consistently demonstrated positive results across all four Phase III clinical trials that assessed the efficacy and safety for the treatment moderate to severe vasomotor symptoms associated with menopause or caused by adjuvant endocrine therapy,” said Dr. Christian Rommel, Head of Research and Development and Member of the Executive Committee of Bayer’s Pharmaceuticals Division.

拜耳制药部研发负责人兼执行委员会成员克里斯蒂安·隆美尔博士表示：“在所有四项III期临床试验中，埃利扎尼坦始终显示出积极的结果，这些试验评估了与更年期相关或由辅助内分泌治疗引起的中度至重度血管舒缩症状的治疗效果和安全性。”。

“Importantly, OASIS 4 is the first pivotal international study to assess the safety and efficacy of a non-hormonal treatment approach for women with or at high risk of breast cancer who are suffering from VMS caused by adjuvant endocrine therapy, reaffirming our commitment at Bayer to advancing innovative treatments for the different needs of women and their health.”.

“重要的是，OASIS 4是第一个关键的国际研究，用于评估非激素治疗方法对患有辅助内分泌治疗引起的VMS的乳腺癌或高危乳腺癌女性的安全性和有效性，重申了我们在拜耳的承诺，即推进针对女性不同需求及其健康的创新治疗。”。

Breast cancer is the most frequent cancer in women globally with 2.3 million new cases in 2020, with nearly 70% of tumors being hormone-receptor positive. Adjuvant endocrine therapy is well established in guidelines worldwide and routinely prescribed to all women with hormone-positive breast cancer.

乳腺癌是全球女性中最常见的癌症，2020年新增病例230万例，近70%的肿瘤为激素受体阳性。辅助内分泌治疗在世界范围内的指南中已经确立，并且常规用于所有激素阳性乳腺癌患者。

Treatment with adjuvant endocrine therapy (such as tamoxifen or aromatase inhibitors) for up to 10 years substantially reduces the breast cancer mortality rate throughout the 2 decades after diagnosis..

辅助内分泌治疗（如他莫昔芬或芳香化酶抑制剂）长达10年的治疗大大降低了诊断后20年的乳腺癌死亡率。。

Adjuvant endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. VMS (also referred to as hot flashes) is a common adverse reaction of the adjuvant endocrine therapy, which may affect quality of life and treatment compliance, with potential impact on recurrence and long term outcomes.

辅助内分泌治疗也可以用作乳腺癌高危女性的一级预防。VMS（也称为潮热）是辅助内分泌治疗的常见不良反应，可能会影响生活质量和治疗依从性，并可能影响复发和长期预后。

. There is unmet medical need for an effective non-hormonal treatment for VMS caused by adjuvant endocrine therapy as currently no approved treatment options are available.

。由于目前尚无批准的治疗方案，因此对辅助内分泌治疗引起的VMS进行有效的非激素治疗的医疗需求尚未得到满足。

“For women undergoing endocrine therapy against breast cancer, menopausal symptoms like VMS and sleep disturbances are very common and can significantly affect quality of life, potentially impacting treatment adherence,” said Dr. Fatima Cardoso, Principal Investigator of OASIS 4, from Lisbon, Portugal.

葡萄牙里斯本OASIS 4首席研究员Fatima Cardoso博士说：“对于接受乳腺癌内分泌治疗的女性来说，VMS和睡眠障碍等更年期症状非常常见，可能会严重影响生活质量，可能会影响治疗依从性。”。

“The positive results from OASIS 4 bring us one step closer to a much-needed non-hormonal option for managing VMS in breast cancer patients and women at risk of breast cancer.”.

“OASIS 4的积极结果使我们更接近于管理乳腺癌患者和乳腺癌风险女性VMS所急需的非激素选择。”。

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1,3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer, administered orally once daily. OASIS 4 (NCT05030584) is the first pivotal international Phase III study to assess the safety and efficacy of a non-hormonal treatment of moderate to severe VMS caused by adjuvant endocrine therapy.

Elinzanetant是第一种双重神经激肽-1和3（NK-1,3）受体拮抗剂，在晚期临床开发中用于非激素治疗与更年期相关或由乳腺癌辅助内分泌治疗引起的中重度VMS，每天口服一次。OASIS 4（NCT05030584）是第一个关键的国际III期研究，用于评估辅助内分泌治疗引起的中重度VMS的非激素治疗的安全性和有效性。

It is the fourth Phase III study in the OASIS clinical development program with positive topline results, with details planned to be presented at upcoming scientific congresses. Data from OASIS 1 and 2 were published in the Journal of the American Medical Association (.

这是OASIS临床开发计划的第四项III期研究，取得了积极的结果，计划在即将举行的科学大会上介绍详细信息。来自OASIS 1和2的数据发表在《美国医学会杂志》（the Journal of the American Medical Association）上。

in August 2024. Detailed results of the Phase III study OASIS 3 providing additional efficacy and safety data over 52 weeks were presented at The Menopause Society (TMS) annual meeting in September 2024. Based on the positive results from the Phase III clinical development program, submissions for marketing authorizations for elinzanetant are ongoing in the US, EU and other markets around the world..

2024年8月。2024年9月，更年期协会（TMS）年会上介绍了第三阶段研究OASIS 3的详细结果，该研究提供了52周的额外疗效和安全性数据。根据第三阶段临床开发计划的积极成果，elinzanetant的营销授权正在美国、欧盟和世界其他市场提交。。

About the Elinzanetant clinical development program

关于Elinzanetant临床开发计划

The Phase III clinical development program of elinzanetant, OASIS, currently comprises four Phase III studies: OASIS 1, 2, 3 and 4. OASIS 1 and 2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries.

绿洲elinzanetant的III期临床开发计划目前包括四项III期研究：绿洲1、2、3和4。OASIS 1和2调查了在26周内与更年期相关的中度至重度VMS女性每天口服一次依林扎尼坦的疗效和安全性，并在15个国家的184个地点随机分配了396名和400名40至65岁的绝经后女性。

Patients in the elinzanetant arm received a 120 mg dose of elinzanetant once daily for 26 weeks and patients in the control arm received a matching placebo once daily for 12 weeks, followed by elinzanetant 120 mg dose for 14 weeks. OASIS 3 investigated the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with menopause over 52 weeks and randomized 628 postmenopausal women between 40 and 65 years across 83 sites in 9 countries.

依林扎尼坦组患者每天服用120 mg剂量的依林扎尼坦，持续26周，对照组患者每天服用一次匹配的安慰剂，持续12周，然后服用120 mg剂量的依林扎尼坦，持续14周。OASIS 3研究了elizanetant治疗52周以上绝经相关血管舒缩症状的有效性和安全性，并在9个国家的83个地点随机分配了628名40至65岁的绝经后妇女。

OASIS 4 is a double-blind, randomized, placebo-controlled multicenter study to investigate efficacy and safety of elinzanetant for the treatment of vasomotor symptoms caused by adjuvant endocrine therapy, over 52 weeks and optionally for an additional 2 years in women with, or at high risk for developing hormone-receptor positive breast cancer.

OASIS 4是一项双盲，随机，安慰剂对照的多中心研究，旨在研究依林扎尼坦治疗辅助内分泌治疗引起的血管舒缩症状的有效性和安全性，对于患有或患有激素受体阳性乳腺癌的高风险女性，为期52周，可选择再延长2年。

474 patients at 90 centers in 16 countries (excluding the US) were randomized..

在16个国家（不包括美国）的90个中心的474名患者被随机分组。。

About Elinzanetant

关于Elinzanetant

Elinzanetant is the first dual neurokinin-1 and 3 (NK-1, 3) receptor antagonist, in late-stage clinical development for the non-hormonal treatment of moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy, administered orally once daily. Elinzanetant may address moderate to severe VMS by modulating a group of estrogen sensitive neurons in the hypothalamus region of the brain (the KNDy neurons) which, with the decrease of estrogen, become hypertrophic and lead to a hyperactivation of the thermoregulatory pathway, consequently disrupting body heat control mechanisms resulting in VMS.

Elinzanetant是第一种双重神经激肽-1和3（NK-1,3）受体拮抗剂，在晚期临床开发中用于非激素治疗与更年期相关或由辅助内分泌治疗引起的中度至重度VMS，每天口服一次。Elinzanetant可以通过调节大脑下丘脑区域（KNDy神经元）中的一组雌激素敏感神经元来解决中度至重度VMS，这些神经元随着雌激素的减少而变得肥大并导致体温调节途径的过度激活，从而破坏导致VMS的体温控制机制。

Based on key secondary endpoints of OASIS 1 and 2, Elinzanetant may also decrease sleep disturbances associated with menopause..

根据OASIS 1和2的关键次要终点，Elizanetant还可以减少与更年期相关的睡眠障碍。。

About Vasomotor Symptoms

关于血管舒缩症状

Vasomotor symptoms (VMS; also referred to as hot flashes) result from hyperactivation of the thermoregulatory pathway mediated by hypertrophy of the KNDy neurons. This is due to a decrease of estrogen, which can result from the progressive reduction of ovarian function due to natural menopause or medical intervention by bilateral oophorectomy or adjuvant endocrine therapy..

血管舒缩症状（VMS；也称为潮热）是由KNDy神经元肥大介导的体温调节途径过度激活引起的。这是由于雌激素减少，这可能是由于自然绝经或双侧卵巢切除术或辅助内分泌治疗的药物干预导致卵巢功能逐渐降低所致。。

VMS are reported by up to 80% of women at some point during the menopausal transition and are one of the leading causes for seeking medical attention during this phase of a woman’s life. Over one-third of menopausal women report severe symptoms, which can last 10 years or more after the last menstrual period, with relevant impact on quality of life..

在更年期过渡期间的某个时候，多达80%的女性报告了VMS，并且是女性在此阶段寻求医疗照顾的主要原因之一。超过三分之一的更年期女性报告有严重症状，可能在最后一次月经后持续10年或更长时间，并对生活质量产生相关影响。。

VMS may also be caused by adjuvant endocrine therapy, for the treatment or prevention of breast cancer, impacting quality of life and treatment adherence. For these women, there are currently no approved treatment options.

VMS也可能是由辅助内分泌治疗引起的，用于治疗或预防乳腺癌，影响生活质量和治疗依从性。对于这些女性，目前还没有批准的治疗选择。

About Menopause

关于更年期

By 2030, the global population of women experiencing menopause is projected to increase to 1.2 billion, with 47 million women entering this phase each year. Menopause is a transitional phase in women’s lives, related to the progressive decline of ovarian function. It usually occurs in women during their 40s or early 50s.

到2030年，全球更年期妇女人口预计将增加到12亿，每年有4700万妇女进入这一阶段。更年期是女性生活的过渡阶段，与卵巢功能的逐渐下降有关。它通常发生在40多岁或50多岁的女性身上。

The hormonal decline can lead to various symptoms which can substantially affect a woman’s health, quality of life, healthcare utilization and work productivity. The most frequently reported and disruptive symptoms during the menopausal transition are VMS, sleep disturbances and mood changes. Menopausal symptoms can also be the result of surgical or medical treatment.

荷尔蒙下降会导致各种症状，这些症状会严重影响女性的健康、生活质量、医疗保健利用率和工作效率。更年期过渡期间最常报告和破坏性症状是VMS，睡眠障碍和情绪变化。更年期症状也可能是手术或药物治疗的结果。

Addressing the symptoms is key to maintaining functional ability and quality of life which is highly relevant from both a healthcare and socio-economic perspective..

解决症状是维持功能能力和生活质量的关键，这从医疗保健和社会经济的角度来看都是高度相关的。。

About Women’s Healthcare at Bayer

关于拜耳的女性保健

Women’s Health is in Bayer’s DNA. As a global leader in women’s healthcare Bayer has a long-standing commitment to delivering science for a better life by advancing a portfolio of innovative treatments. Bayer offers a wide range of effective short- and long-acting birth control methods as well as therapies for menopause management and gynecological diseases.

拜耳的DNA决定了女性的健康。作为女性医疗保健领域的全球领导者，拜耳长期致力于通过推进创新治疗组合，为更好的生活提供科学。拜耳公司提供了一系列有效的短效和长效节育方法，以及更年期管理和妇科疾病的治疗方法。

Bayer is also focusing on innovative options to address the unmet medical needs of women worldwide and to broadening treatment choices such as in menopause. Additionally, Bayer intends to provide 100 million women per year in low-and-middle income countries by 2030 with access to family planning by funding multi-stakeholder aid programs for capacity building and by ensuring the supply of affordable modern contraceptives.

拜耳还专注于创新选择，以解决全球女性未满足的医疗需求，并扩大更年期等治疗选择。此外，拜耳计划到2030年，通过资助多方利益相关者的能力建设援助计划，并确保提供负担得起的现代避孕药具，每年为中低收入国家的1亿妇女提供计划生育服务。

This is part of the comprehensive sustainability measures and commitments from 2020 onwards and in line with the Sustainable Development Goals of the United Nations..

这是2020年以后全面可持续性措施和承诺的一部分，符合联合国的可持续发展目标。。

About Bayer

拜耳简介

Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, “Health for all, Hunger for none,” the company’s products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population.

拜耳是一家全球性企业，在医疗保健和营养等生命科学领域拥有核心竞争力。根据其“人人健康，无人饥饿”的使命，该公司的产品和服务旨在通过支持应对全球人口不断增长和老龄化带来的重大挑战，帮助人们和地球繁荣发展。

Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2023, the Group employed around 100,000 people and had sales of 47.6 billion euros.

拜耳致力于推动可持续发展，并对其业务产生积极影响。与此同时，该集团旨在通过创新和增长来提高其盈利能力和创造价值。拜耳品牌代表着全世界的信任、可靠性和质量。2023财年，该集团雇佣了约10万人，销售额476亿欧元。