拜耳Elinzanetant在OASIS-4 III期研究中能明显降低与乳腺癌内分泌治疗相关的中度至重度血管运动症状的发生频率-动脉网

Elinzanetant significantly reduces frequency of moderate to severe vasomotor symptoms associated with endocrine therapy for breast cancer in Phase III OASIS-4 study

拜耳等信源发布 2025-06-02 20:38

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June

六月

2025

14:29 PM

Europe/Amsterdam

欧洲/阿姆斯特丹

Elinzanetant significantly reduces frequency of moderate to severe vasomotor symptoms associated with endocrine therapy for breast cancer in Phase III OASIS-4 study

Elinzanetant 在 III 期 OASIS-4 研究中显著减少了与乳腺癌内分泌治疗相关的中度至重度血管舒缩症状的频率。

Not intended for UK Media – Data from Phase III OASIS-4 study to be presented for the first time at 2025 ASCO Annual Meeting:

不适用于英国媒体——三期OASIS-4研究数据将在2025年ASCO年会上首次展示：

Summary

摘要

In the Phase III OASIS-4 study conducted outside of the U.S., the investigational compound elinzanetant significantly reduced the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to weeks 4 and 12, versus placebo, in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer / Elinzanetant has also shown in key secondary endpoints statistically significant improvements in sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo / Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 versus placebo / The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data on elinzanetant in postmenopausal women with VMS / Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily / This international study represents the fourth Phase III study in the clinical OASIS program and the results are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and have been simultaneously published in the .

在非美国地区开展的III期OASIS-4研究中，试验性化合物elinzanetant显著减少了接受内分泌治疗以治疗或预防激素受体阳性（HR+）乳腺癌的女性从基线到第4周和第12周中度至重度血管舒缩症状（VMS，也称为潮热）的发生频率，与安慰剂相比表现出显著差异。/ Elinzanetant在关键次要终点上也显示出统计学意义上的显著改善，相较于安慰剂，在基线到第12周内睡眠障碍和更年期相关生活质量均有所提升。/ 其他次要终点显示，相较于安慰剂，第1周VMS频率下降，第4周和第12周VMS严重程度降低。/ 在OASIS-4研究中观察到的52周安全性特征总体上与之前针对有VMS症状的绝经后女性进行的研究和已发表的elinzanetant数据一致。/ Elinzanetant是全球首个处于晚期临床开发阶段的双重神经激肽靶向疗法，通过拮抗NK-1和NK-3受体发挥作用，用于治疗因更年期或与乳腺癌内分泌治疗相关的中度至重度VMS，每日一次口服给药。/ 这项国际研究是OASIS临床项目的第四项III期研究，其结果正在美国临床肿瘤学会（ASCO）年会上展示，并已同步发表于。

New England Journal of Medicine (NEJM)

新英格兰医学杂志（NEJM）

Berlin, June 2, 2025

柏林，2025年6月2日

– Detailed results from the Phase III OASIS-4 study found that the investigational compound elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to weeks 4 and 12 compared to placebo, in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer.

– III 期 OASIS-4 研究的详细结果显示，与安慰剂相比，研究化合物 elinzanetant 在接受内分泌治疗以治疗或预防激素受体阳性 (HR+) 乳腺癌的女性中，从基线到第 4 周和第 12 周，显著减少了中度至重度血管舒缩症状（VMS，也称为潮热）的频率。

Key secondary endpoints showed statistically significant improvements of sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo. Additional secondary endpoints showed a reduction in VMS frequency at week 1 and improvements in VMS severity at weeks 4 and 12 versus placebo.

关键的次要终点显示，与安慰剂相比，从基线到第12周，睡眠障碍和更年期相关生活质量有统计学上的显著改善。其他次要终点显示，与安慰剂相比，第1周VMS频率降低，第4周和第12周VMS严重程度有所改善。

These data are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, taking place from May 30 – June 3 in Chicago, IL, USA, and have been simultaneously published in the .

这些数据正在美国临床肿瘤学会 (ASCO) 年会上展示，会议于 5 月 30 日至 6 月 3 日在美国伊利诺伊州芝加哥举行，并同时发布在。

New England Journal of Medicine

新英格兰医学杂志

(

NEJM

新英格兰医学杂志

). OASIS-4 is the first pivotal international Phase III study to assess the safety and efficacy of elinzanetant for the treatment of moderate to severe VMS associated with endocrine therapy for the treatment or prevention of HR+ breast cancer.

OASIS-4 是首个关键的国际 III 期研究，旨在评估 elinzanetant 治疗与内分泌治疗相关的中度至重度 VMS 的安全性和有效性，该内分泌治疗用于治疗或预防 HR+ 乳腺癌。

“Menopausal symptoms are frequent side effects of endocrine therapy for breast cancer, often leading to discontinuation, which is why management of these symptoms can play an important role in breast cancer treatment,” said Dr. Fatima Cardoso, Principal Investigator of OASIS-4, from Lisbon, Portugal.

“绝经症状是乳腺癌内分泌治疗的常见副作用，常常导致治疗中断，因此管理这些症状在乳腺癌治疗中可以发挥重要作用，”OASIS-4 首席研究员、来自葡萄牙里斯本的 Fatima Cardoso 博士说道。

“With no currently approved treatments for this indication, there is an unmet medical need for therapeutic options.”.

“由于目前尚无针对该适应症的获批治疗方案，因此存在未满足的医疗需求。”

In OASIS-4, elinzanetant showed statistically significant mean reductions in frequency of VMS compared to placebo from baseline at week 4 with −6.5 (95% confidence interval [CI], −7.2 to −5.8) with elinzanetant and −3.0 (95% CI, −3.9 to −2.2) with placebo, with statistical significance between elinzanetant and placebo (least squares [LS] mean difference [95% CI]: −3.5 [−4.4, −2.6]; p<0.001).

在OASIS-4试验中，elinazanetant在第4周时相较于安慰剂显示出统计学上显著的VMS频率平均减少，基线变化为−6.5（95%置信区间[CI]，−7.2至−5.8）（elinazanetant组）和−3.0（95% CI，−3.9至−2.2）（安慰剂组），elinazanetant与安慰剂之间的差异具有统计学意义（最小二乘[LS]均值差异[95% CI]：−3.5 [−4.4, −2.6]；p<0.001）。

At week 12, reductions in VMS frequency were −7.8 (95% CI, −8.5 to −7.1) with elinzanetant and −4.2 (95% CI, −5.2 to −3.2) with placebo, with statistical significance between elinzanetant and placebo (LS mean difference [95% CI]: −3.4 [−4.2, −2.5]; p<0.001). The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data .

在第12周，elinzanetant组的VMS频率减少为−7.8（95% CI，−8.5至−7.1），而安慰剂组为−4.2（95% CI，−5.2至−3.2），elinzanetant与安慰剂之间差异具有统计学意义（LS均值差 [95% CI]：−3.4 [−4.2, −2.5]；p<0.001）。OASIS-4研究中观察到的52周安全性特征总体上与之前进行的研究和已发表的数据一致。

1, 2, 3

on elinzanetant in postmenopausal women with fatigue, somnolence and diarrhea being the most frequent treatment emergent adverse events (TEAEs) in the elinzanetant group.

在绝经后妇女中使用elinzanetant，疲劳、嗜睡和腹泻是elinzanetant组最常见的治疗相关不良事件（TEAEs）。

The mean change in the PROMIS SD SF 8b total T score from baseline to week 12 was −10.6 points (95% CI, −11.5 to −9.6) in the elinzanetant group and −4.1 points (95% CI, −5.3 to −2.9) in the placebo (LS mean difference between the trial groups, −6.1 points; 95% CI, −7.5 to −4.8; p<0.001). The mean change in the MENQOL total score from baseline to week 12 was −1.3 points (95% CI, −1.4 to −1.2) in the elinzanetant group and −0.5 points (95% CI, −0.7 to −0.3) in the placebo group (LS mean difference between the trial groups, −0.7 points; 95% CI, −0.9 to −0.5; p<0.001).

在elinzanetant组中，从基线到第12周的PROMIS SD SF 8b总T分数平均变化为-10.6点（95% CI，-11.5至-9.6），而在安慰剂组中为-4.1点（95% CI，-5.3至-2.9）（试验组之间的最小二乘均值差异为-6.1点；95% CI，-7.5至-4.8；p<0.001）。在elinzanetant组中，从基线到第12周的MENQOL总分平均变化为-1.3点（95% CI，-1.4至-1.2），而在安慰剂组中为-0.5点（95% CI，-0.7至-0.3）（试验组之间的最小二乘均值差异为-0.7点；95% CI，-0.9至-0.5；p<0.001）。

Additional secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 with elinzanetant versus placebo..

额外的次要终点显示，与安慰剂相比，elinzanetant 在第 1 周减少了 VMS 频率，在第 4 周和第 12 周降低了 VMS 严重程度。

“The results from OASIS-4 represent a potential advancement in addressing a need for women undergoing breast cancer treatment. Vasomotor symptoms associated with endocrine therapy can impact patients’ quality of life and may impact their ability to adhere to other treatments,” said Dr. Christian Rommel, member of the Executive Committee of Bayer’s Pharmaceuticals Division and Global Head of Research and Development.

“OASIS-4 的结果代表了在满足接受乳腺癌治疗女性需求方面的潜在进展。与内分泌治疗相关的血管舒缩症状可能影响患者的生活质量，并可能影响她们坚持其他治疗的能力，”拜耳制药部门执行委员会成员、全球研发主管克里斯蒂安·罗梅尔博士表示。

“Advancing elinzanetant as an investigational, hormone-free treatment option for these patients reaffirms our commitment at Bayer to bring forward innovative treatments for the different health needs of women.”.

“推进elinazanetant作为一种研究性无激素治疗选择，重申了拜耳致力于为女性不同的健康需求带来创新治疗方案的承诺。”

Breast cancer is the most commonly diagnosed cancer in women globally with 2.3 million new cases in 2020, and 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被诊断出的癌症，2020年有230万新发病例，其中近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被充分确立，并常规用于所有激素受体阳性的乳腺癌女性患者。

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

辅助内分泌治疗（如他莫昔芬）持续长达10年可显著降低诊断后20年内的乳腺癌死亡率。

Endocrine therapy can also be used as primary prevention, in women at high risk of developing breast cancer. Side effects of endocrine therapy, such as VMS (also referred to as hot flashes), may affect quality of life and treatment compliance, with potential impact on recurrence

内分泌治疗也可用于乳腺癌高风险女性的一级预防。内分泌治疗的副作用，如血管舒缩症状（也称为潮热），可能会影响生活质量和治疗依从性，并对复发产生潜在影响。

. Currently, there are no approved treatment options available. There is an unmet medical need for an effective hormone-free treatment for VMS associated with endocrine therapy.

目前尚无获批的治疗方案。对于与内分泌治疗相关的VMS，有效的无激素治疗仍存在未满足的医疗需求。

Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. Data from OASIS-1 and -2 were published in the .

Elinzanetant 是首个双神经激肽靶向疗法，可拮抗 NK-1 和 NK-3 受体，目前在全球范围内处于晚期临床开发阶段，用于治疗因更年期或与乳腺癌内分泌治疗相关的中度至重度血管舒缩症状（VMS），每日一次口服给药。OASIS-1 和 OASIS-2 的数据已发布在。

Journal of the American Medical Association (

美国医学协会期刊 (

JAMA

美国医学会杂志

)

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。提供额外52周疗效和安全数据的III期OASIS-3研究详细结果已在2024年9月的北美更年期学会（TMS）年会上公布。基于III期临床开发项目的积极结果，elinzanetant在美国、欧盟及全球其他市场的上市授权申请正在进行中。

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.

Elinzanetant的III期临床开发项目OASIS目前包括四项III期研究：OASIS-1、-2、-3和-4。OASIS-1和-2研究评估了口服elinzanetant每日一次治疗与绝经相关的中重度VMS女性患者在26周内的疗效和安全性，并在15个国家的184个研究中心随机纳入了396名和400名年龄在40至65岁之间的绝经后女性。

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.

elinzanetant组的患者每日一次接受120 mg剂量的elinzanetant，持续26周，而对照组的患者每日一次接受匹配的安慰剂，持续12周，随后接受14周的120 mg剂量的elinzanetant。OASIS-3研究了elinzanetant在治疗与更年期相关的血管舒缩症状方面的疗效和安全性，持续52周，并在9个国家的83个研究中心随机选取了628名40至65岁的绝经后女性。

OASIS-4 is a double-blind, randomized, placebo-controlled multicenter study to investigate the efficacy and safety of elinzanetant for the treatment of vasomotor symptoms associated with endocrine therapy for treatment or prevention of hormone receptor positive (HR+) breast cancer over 52 weeks and optionally for an additional 2 years in women taking endocrine therapy, for treatment of breast cancer.

OASIS-4 是一项双盲、随机、安慰剂对照的多中心研究，旨在评估 elinzanetant 治疗与内分泌治疗相关的血管舒缩症状的疗效和安全性，针对激素受体阳性 (HR+) 乳腺癌的治疗或预防，研究周期为 52 周，并可选择性延长至额外 2 年，适用于接受内分泌治疗的女性乳腺癌患者。

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名患者被随机分配。

About Elinzanetant

关于Elinzanetant

Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK- 3 receptors, globally in late-stage clinical development for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, 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 是首个双重神经激肽靶向疗法，可拮抗 NK-1 和 NK-3 受体，目前在全球范围内处于晚期临床开发阶段，用于治疗因更年期或与乳腺癌内分泌治疗相关的中度至重度血管舒缩症状（VMS），每日口服一次。Elinzanetant 可能通过调节大脑下丘脑区域的一组雌激素敏感神经元（KNDy 神经元）来缓解中度至重度 VMS，这些神经元在雌激素水平下降时变得肥大，导致体温调节通路的过度激活，从而破坏身体热量控制机制并引发 VMS。

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 endocrine therapy..

血管舒缩症状（VMS；也称为潮热）是由KNDy神经元肥大所介导的体温调节通路的过度激活引起的。这是由于雌激素的减少，这可能是由于自然绝经或双侧卵巢切除术、内分泌治疗等医疗干预导致的卵巢功能逐渐减退所致。

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..

据报道，在更年期过渡期间，高达80%的女性在某个阶段会出现血管舒缩症状（VMS），这是女性在此生命阶段寻求医疗关注的主要原因之一。超过三分之一的更年期女性报告有严重症状，这些症状可能在最后一次月经后持续10年或更久，并对生活质量产生显著影响。

VMS may also be caused by 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也可能由内分泌治疗引起，这些治疗用于乳腺癌的治疗或预防，影响生活质量和治疗依从性。对于这些女性，目前尚无获批的治疗选择。

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，全球经历更年期的女性人口预计将增加到12亿，每年有4700万女性进入这一阶段。更年期是女性生命中的一个过渡阶段，与卵巢功能的逐步衰退有关，通常发生在女性的40多岁或50岁出头。

It can also be the result of surgical or medical treatment such as breast cancer treatment. 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.

它也可能是外科或医疗治疗（如乳腺癌治疗）的结果。激素水平下降会导致各种症状，这些症状可能严重影响女性的健康、生活质量、医疗资源利用和工作效率。在绝经过渡期，最常见的且最具干扰性的症状包括血管舒缩症状（VMS）、睡眠障碍和情绪变化。

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

解决这些症状是保持绝经期女性的功能能力和生活质量的关键，这在医疗保健和社会经济角度都具有高度相关性。

About Women’s Healthcare at Bayer

拜耳女性健康护理

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.

女性健康深植于拜耳的DNA中。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一系列创新治疗方案来实现科学改善生活的目标。拜耳提供多种有效的短效和长效避孕方法，以及针对更年期管理和妇科疾病的治疗方案。

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.

拜耳还在关注创新方案，以应对全球女性未满足的医疗需求，并拓宽如绝经期等方面的治疗选择。此外，拜耳计划到2030年，通过资助多利益相关方的援助项目进行能力建设，并确保提供价格合理的现代避孕药具，使低收入和中等收入国家每年1亿女性获得计划生育服务。

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..

这是自2020年以来全面可持续发展措施和承诺的一部分，并与联合国可持续发展目标一致。

About Bayer

关于拜耳

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.

拜耳是一家在医疗保健和营养等生命科学领域具有核心竞争力的全球性企业。秉承“人人健康，无饥饿”的使命，公司通过支持应对不断增长和老龄化的全球人口所带来的重大挑战，设计其产品和服务以帮助人类和地球繁荣发展。

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 2024, the Group employed around 93,000 people and had sales of 46.6 billion euros.

拜耳致力于通过其业务推动可持续发展并产生积极影响。同时，集团旨在通过创新和增长提高盈利能力并创造价值。拜耳品牌在全球范围内代表着信任、可靠性和质量。在2024财年，集团拥有约93,000名员工，销售额达466亿欧元。

R&D expenses amounted to 6.2 billion euros. For more information, go to .

研发费用总计达62亿欧元。欲了解更多信息，请访问。

www.bayer.com

。

Find more information at

更多信息请访问

https://pharma.bayer.com

关注我们的Facebook：

http://www.facebook.com/bayer

在LinkedIn上关注我们：

Bayer | Pharmaceuticals

拜耳 | 制药

Forward-Looking Statements

前瞻性声明

This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here.

本发行版本可能包含基于拜耳管理层当前假设和预测的前瞻性声明。各种已知和未知的风险、不确定性和其他因素可能导致公司实际未来结果、财务状况、发展或业绩与本文提供的估计存在重大差异。

These factors include those discussed in Bayer’s public reports which are available on the Bayer website at .

这些因素包括拜耳公开报告中讨论的因素，这些报告可在拜耳网站上查阅。

www.bayer.com

. The company assumes no liability whatsoever to update these forward-looking statements or to conform

公司不承担更新这些前瞻性声明或使其符合的任何责任。

them to future events or developments.

将它们应用于未来的事件或发展。

References

参考文献

Simon JA, Anderson RA, Ballantyne E, Bolognese J, Caetano C, Joffe H, Kerr M, Panay N, Seitz C, Seymore S, Trower M, Zuurman L, Pawsey S. Efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist for vasomotor symptoms: a dose-finding clinical trial (SWITCH-1). Menopause. 2023 Mar 1;30(3):239-246..

Simon JA、Anderson RA、Ballantyne E、Bolognese J、Caetano C、Joffe H、Kerr M、Panay N、Seitz C、Seymore S、Trower M、Zuurman L、Pawsey S。Elinzanetant（一种选择性神经激肽-1,3受体拮抗剂）治疗血管舒缩症状的疗效与安全性：一项剂量探索临床试验（SWITCH-1）。《绝经》。2023年3月1日；30(3):239-246。

Trower M, et al. Effects of NT-814, a dual neurokinin 1 and 3 receptor antagonist, on vasomotor symptoms in postmenopausal women: a placebo-controlled, randomized trial. Menopause: The Journal of The North American Menopause Society. 2020; 27 (5): 498-505.

Trower M, 等。NT-814（一种双重神经激肽1和3受体拮抗剂）对绝经后女性血管舒缩症状的影响：一项安慰剂对照、随机试验。《更年期：北美更年期学会杂志》。2020年；27卷（5期）：498-505页。

Pinkerton JV, et al. Elinzanetant for the treatment of vasomotor symptoms associated with menopause: OASIS 1 and 2 randomized clinical trials. JAMA. 2024 Oct 22;332(16):1343-54.

Pinkerton JV, 等。Elinzanetant 治疗与更年期相关的血管舒缩症状：OASIS 1 和 2 随机临床试验。《美国医学会杂志》。2024 年 10 月 22 日；332(16):1343-54。

Davies C, et al. Long-term effects of continuing adjuvant tamoxifen to 10 years versus stopping at 5 years after diagnosis of oestrogen receptor-positive breast cancer: ATLAS, a randomised trial. The Lancet. 2013 Mar 9;381(9869):805-16.

Davies C, 等。延长辅助他莫昔芬治疗至10年与在诊断雌激素受体阳性乳腺癌后5年停止的长期效果比较：ATLAS，一项随机试验。《柳叶刀》。2013年3月9日；381(9869):805-16。

Smith, K.L., Verma, N., Blackford, A.L. et al. Association of treatment-emergent symptoms identified by patient-reported outcomes with adjuvant endocrine therapy discontinuation. npj Breast Cancer 8, 53 (2022). https://doi.org/10.1038/s41523-022-00414-0

Smith, K.L., Verma, N., Blackford, A.L. 等。患者报告结果识别的治疗相关症状与辅助内分泌治疗中断的关联。《npj乳腺癌》8卷，53页（2022年）。https://doi.org/10.1038/s41523-022-00414-0

Contact for global media inquiries:

全球媒体查询联系方式：

Katja Wiggers, phone +49 30 221541614

卡特娅·维格斯，电话 +49 30 221541614

Email:

电子邮件：

katja.wiggers@bayer.com

Contact for US media inquiries:

美国媒体查询联系方式：

Colleen Murphy, phone +1 904.631 0442

科尔琳·墨菲，电话 +1 904.631 0442