– The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa™ (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001) in patients with mHSPC..

欧盟委员会已授予Nubeqa™（达洛鲁胺）在欧盟（EU）的上市许可，这是一种口服雄激素受体抑制剂（ARi），与雄激素剥夺疗法（ADT）联合用于治疗转移性激素敏感性前列腺癌（mHSPC）患者。该批准基于关键的III期ARANOTE试验的积极结果，结果显示，与安慰剂加ADT相比，达洛鲁胺加ADT显著降低了mHSPC患者的影像学进展或死亡风险达46%（HR 0.54；95% CI 0.41-0.71；P<0.0001）。

Darolutamide, under the brand name Nubeqa™, is already approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease.

达罗鲁胺（商品名：Nubeqa™）已在85多个国家获得批准，用于联合ADT和多西他赛治疗mHSPC，以及单独联合ADT治疗非转移性去势抵抗性前列腺癌（nmCRPC），适用于高风险发展为转移性疾病的患者。

“Today’s approval of darolutamide plus ADT means that it can now be used with or without chemotherapy, offering physicians greater flexibility to tailor treatment plans to meet the unique needs of their patients and improve clinical outcomes for men with mHSPC,” said Fred Saad, M.D., Professor and Chairman of Surgery and Director of Genitourinary Oncology at the University of Montreal Hospital Center (CHUM), and Principal Investigator of the ARANOTE trial.

“今天批准了达洛鲁胺加雄激素剥夺疗法（ADT），这意味着它现在可以与化疗联用或不联用，为医生提供了更大的灵活性，可以根据患者的不同需求量身定制治疗方案，并改善转移性激素敏感性前列腺癌（mHSPC）男性的临床结果，”蒙特利尔大学医院中心（CHUM）外科教授兼主任、泌尿生殖肿瘤科主任以及ARANOTE试验的首席研究员Fred Saad医学博士说道。

“Results from the ARANOTE trial demonstrate that darolutamide plus ADT delays disease progression and extends survival, and just as importantly, due to its high tolerability, enables patients to maintain their daily living with minimal disruption.”.

“ARANOTE 试验的结果表明，达罗鲁胺联合雄激素剥夺疗法（ADT）可延缓疾病进展并延长生存期，同样重要的是，由于其高耐受性，能使患者在日常生活中维持正常状态，几乎不受干扰。”

Prostate cancer is the second most common cancer and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. In Europe, there were almost 474,000 estimated new cases of prostate cancer in 2022 with approximately 115,000 deaths.

前列腺癌是全球男性中第二常见的癌症，也是第五大癌症死亡原因。2022年，估计有150万男性被诊断出患有前列腺癌，全球约有397,000人死于该疾病。在欧洲，2022年估计有近474,000例新发前列腺癌病例，约115,000人死亡。

Prostate cancer diagnoses are projected to increase to 2.9 million by 2040..

预计到2040年，前列腺癌的确诊病例将增加到290万。

“The third European approval of darolutamide represents a significant step forward for men with advanced prostate cancer,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer. “Darolutamide is the first androgen receptor inhibitor to show clinically meaningful health-related quality of life benefits, offering patients an effective and well tolerated treatment.

“达罗鲁胺的第三次欧洲批准代表了晚期前列腺癌男性患者的重要进步，”拜耳制药执行副总裁、全球产品战略与商业化负责人、制药领导团队成员克里斯汀·罗斯表示。“达罗鲁胺是首个显示出具有临床意义的健康相关生活质量益处的雄激素受体抑制剂，为患者提供了一种有效且耐受性良好的治疗选择。”

Backed by compelling clinical data from the ARANOTE, ARASENS, and ARAMIS trials, we believe darolutamide has the potential to become a leading therapy across various stages of prostate cancer. We are committed to ensuring its broad availability to benefit as many eligible patients as possible.”.

基于ARANOTE、ARASENS和ARAMIS试验中令人信服的临床数据，我们相信达洛鲁胺有潜力成为前列腺癌各个阶段的领先疗法。我们致力于确保其广泛可用性，以使尽可能多的符合条件的患者受益。

Darolutamide is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company.

达洛鲁胺由拜耳公司和芬兰全球运营的制药公司 Orion 共同开发。

About the ARANOTE Trial

关于ARANOTE试验

The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus ADT in patients with mHSPC. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT.

ARANOTE 试验是一项随机、双盲、安慰剂对照的 III 期研究，旨在评估达罗鲁胺联合雄激素剥夺疗法 (ADT) 在 mHSPC 患者中的疗效和安全性。669 名患者以 2:1 的比例随机分配，接受每日两次 600 毫克达罗鲁胺或匹配的安慰剂，并同时接受 ADT 治疗。

The primary endpoint is radiological progression free survival (rPFS), measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments..

主要终点是影像学无进展生存期（rPFS），定义为从随机分组到首次记录的影像学疾病进展或因任何原因导致死亡的时间，以先发生者为准。次要终点包括总生存期（因任何原因死亡的时间）、首次去势抵抗事件的时间、开始后续抗癌治疗的时间、前列腺特异性抗原（PSA）进展时间、PSA不可检测率、疼痛进展时间以及安全性评估。

Results from the Phase III ARANOTE trial presented at ESMO 2024 and published in

在2024年欧洲肿瘤内科学会（ESMO）上公布的III期ARANOTE试验结果，并发表在

The Journal of Clinical Oncology

临床肿瘤学杂志

showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41–0.71; P<0.0001), in patients with mHSPC. Consistent benefits in rPFS were observed across prespecified subgroups, including patients with high-volume (HR 0.60, 95% CI: 0.44-0.80) and low-volume (HR 0.30, 95% CI: 0.15-0.60) mHSPC.

显示在mHSPC患者中，与安慰剂加ADT相比，达洛鲁胺加ADT显著降低了46%的影像学进展或死亡风险（HR 0.54；95% CI 0.41-0.71；P<0.0001）。在预先设定的各个亚组中均观察到rPFS的一致益处，包括高负荷（HR 0.60，95% CI：0.44-0.80）和低负荷（HR 0.30，95% CI：0.15-0.60）mHSPC患者。

The incidence of all adverse events (AE), including the incidence of serious and grade 3 and grade 4 AE, in the treatment group with darolutamide plus ADT in the ARANOTE study was comparable to placebo plus ADT. Darolutamide plus ADT was generally well tolerated and showed lower discontinuation rates due to adverse events compared to placebo plus ADT..

在ARANOTE研究中，接受达洛鲁胺联合雄激素剥夺疗法（ADT）的治疗组中，所有不良事件（AE）的发生率，包括严重和3级、4级AE的发生率，与安慰剂联合ADT相当。达洛鲁胺联合ADT总体耐受性良好，并且因不良事件导致的停药率较安慰剂联合ADT更低。

About darolutamide (Nubeqa™)

关于达洛鲁胺（Nubeqa™）

Darolutamide is an oral ARi with a unique chemical structure that binds with high affinity to the androgen receptor and exhibits a strong antagonistic effect against the androgen receptor inhibiting the receptor function and growth of prostate cancer cells. Additionally, preclinical models and neuroimaging data in healthy humans, support darolutamide's low potential for blood-brain barrier penetration..

达罗鲁胺是一种口服ARi，具有独特的化学结构，能够以高亲和力与雄激素受体结合，并对雄激素受体表现出强烈的拮抗作用，抑制受体功能和前列腺癌细胞的生长。此外，临床前模型和健康人类的神经影像数据支持达罗鲁胺穿透血脑屏障的潜力较低。

Darolutamide (plus ADT or plus ADT and docetaxel) demonstrated a side effect profile, in both mHSPC registrational studies where the incidences of adverse events were similar to the respective comparator arm. With this tolerability profile and limited risk of interactions with other medications, Nubeqa offers an advancement in treatment management for physicians and patients..

达罗鲁胺（加ADT或加ADT和多西他赛）在mHSPC注册研究中显示出副作用特征，不良事件的发生率与各自的对照组相似。凭借这种耐受性特征以及与其他药物相互作用风险有限，Nubeqa为医生和患者提供了治疗管理上的进步。

A robust clinical development program is underway investigating darolutamide across various stages of prostate cancer. The program includes the Phase III ARASTEP trial evaluating darolutamide plus ADT compared to ADT alone in hormone-sensitive high-risk biochemical recurrence (BCR) prostate cancer, who have no evidence of metastatic disease by conventional imaging and a positive PSMA PET/CT at baseline.

一项强大的临床开发计划正在进行中，研究达洛鲁胺在前列腺癌各个阶段的应用。该计划包括III期ARASTEP试验，评估达洛鲁胺联合雄激素剥夺疗法（ADT）与单独使用ADT治疗激素敏感性高风险生化复发（BCR）前列腺癌的效果，这些患者通过常规影像学检查无转移性疾病证据，但在基线时PSMA PET/CT呈阳性。

Furthermore, darolutamide is also being investigated in the collaborative Phase III DASL-HiCaP (ANZUP1801) trial led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). The study evaluates darolutamide as a treatment for localized prostate cancer in combination with radiotherapy..

此外，darolutamide 还在澳大利亚和新西兰泌尿生殖及前列腺癌试验组 (ANZUP) 主导的 III 期合作试验 DASL-HiCaP (ANZUP1801) 中进行研究。该研究评估了 darolutamide 联合放疗治疗局部前列腺癌的效果。

About Metastatic Hormone-Sensitive Prostate Cancer

关于转移性激素敏感性前列腺癌

At the time of diagnosis, most men have localized prostate cancer, meaning their cancer is confined to the prostate gland and can be treated with curative surgery or radiotherapy. mHSPC is a stage in the disease where the cancer has spread outside of the prostate to other parts of the body. Up to 10% of men will present with mHSPC when first diagnosed.

在诊断时，大多数男性患有局部前列腺癌，这意味着他们的癌症局限于前列腺腺体，可以通过根治性手术或放射治疗进行治疗。mHSPC是疾病的一个阶段，其中癌症已经扩散到前列腺以外的身体其他部位。高达10%的男性在初次诊断时会表现为mHSPC。

For patients with mHSPC, ADT is the cornerstone of treatment, in combination with chemotherapy docetaxel and/or an ARi..

对于患有mHSPC的患者，ADT是治疗的基石，与化疗多西他赛和/或ARi联合使用。

Despite treatment, most men with mHSPC will eventually progress to castration-resistant prostate cancer, a condition with limited survival.

尽管接受治疗，大多数患有 mHSPC 的男性最终会进展为去势抵抗性前列腺癌，这是一种生存期有限的疾病。

About Prostate Cancer at Bayer

关于拜耳的前列腺癌信息

Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. Prostate cancer is the second most commonly diagnosed cancer in men and a key area of focus for Bayer.

拜耳致力于通过推进一系列创新疗法来实现科学改善生活的目标。该公司满怀热情和决心，开发有助于改善和延长癌症患者生命的新药。前列腺癌是男性中第二常见的癌症，也是拜耳重点关注的领域。

The company’s franchise includes two products on the market (Nubeqa™ and Xofigo™) and several compounds in development. Bayer is focused on addressing the unique needs of patients with prostate cancer, providing treatments that extend their lives throughout the different stages of the disease and allowing them to continue with their everyday activities, so that patients can live longer, better lives..

公司的特许经营包括市场上两种产品（Nubeqa™ 和 Xofigo™）以及几种正在开发的化合物。拜耳致力于满足前列腺癌患者的独特需求，提供贯穿疾病不同阶段的治疗方案，延长患者生命，同时让他们能够继续日常活动，从而让患者活得更长、更好。

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，该公司的产品和服务旨在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，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，该集团拥有约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 .

研发费用达62亿欧元。欲了解更多信息，请访问 。