— Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up results from an open-label extension of the Phase 3 ARCHES (

— 安斯泰来制药公司（东京证券交易所代码：4503，总裁兼首席执行官：冈村直树，“安斯泰来”）和辉瑞公司（纽约证券交易所代码：PFE）今天宣布了来自第三阶段ARCHES的开放标签扩展的较长期随访结果。

NCT02677896

NCT02677896

) study, reporting a five-year follow up of overall survival (OS) benefits and a 30% reduction in the risk of death in men with metastatic hormone-sensitive prostate cancer (mHSPC) treated with XTANDI™ (enzalutamide), an androgen receptor pathway inhibitor (ARPI), plus androgen deprivation therapy (ADT) compared to placebo plus ADT.

）研究报告，与使用安慰剂加雄激素剥夺疗法（ADT）相比，使用XTANDI™（恩扎鲁胺）这种雄激素受体通路抑制剂（ARPI）加雄激素剥夺疗法（ADT）治疗转移性激素敏感性前列腺癌（mHSPC）的男性，其五年总生存期（OS）获益，并将死亡风险降低了30%。

These data will be presented during an oral presentation (Abstract #5005) at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Tuesday, June 3, 9:45 a.m.- 12:45 p.m. US CT)..

这些数据将在美国临床肿瘤学会 (ASCO) 年会上进行口头报告（摘要 #5005），会议于芝加哥举行（6 月 3 日星期二，美国中部时间上午 9:45 至下午 12:45）。

“Historically, the likelihood of survival at five years for men with metastatic hormone-sensitive prostate cancer was low, but with advancements in initial treatment intensification like what we’ve seen with XTANDI, this is now becoming the standard,”

“历史上，患有转移性激素敏感性前列腺癌的男性五年存活率很低，但随着像XTANDI这样的初始治疗强化的进步，这现在正成为标准。”

said Andrew J. Armstrong, MD, ScM, Director of Research at the Center for Prostate & Urologic Cancers, Duke Cancer Institute, Durham, NC, and ARCHES primary investigator.

杜克癌症研究所前列腺和泌尿生殖系统癌症中心研究主任、北卡罗来纳州达勒姆市的安德鲁·J·阿姆斯特朗医学博士、理学硕士，ARCHES 首席研究员表示。

“In our five-year follow up of the global ARCHES trial, two-thirds of men are now surviving five years, representing a 13% absolute and 30% relative improvement over standard hormonal therapy alone, with benefits in patients with high and low disease burden that are meaningful to our patients.”

“在我们对全球ARCHES试验的五年随访中，三分之二的男性现在存活了五年，这比单独使用标准激素疗法提高了13%的绝对生存率和30%的相对生存率，无论患者的疾病负担高或低，都带来了对患者有意义的益处。”

In patients with high-volume disease (HR: 0.70; 95% CI: 0.56-0.88) a 36-month improvement in median OS was observed. Additional clinically relevant subgroups of patients were evaluated, showing consistently improved survival: low-volume disease (HR: 0.71; 95% CI, 0.49-1.05); patients who had previously received docetaxel therapy (HR: 0.67; 95% CI, 0.43- 1.05) and those who had not received prior docetaxel therapy (HR: 0.71; 95% CI, 0.57-0.88).

在高肿瘤负荷患者中（HR：0.70；95% CI：0.56-0.88），观察到中位总生存期（OS）在36个月内有所改善。对其他临床相关的患者亚组进行了评估，显示出一致的生存改善：低肿瘤负荷（HR：0.71；95% CI，0.49-1.05）；既往接受过多西他赛治疗的患者（HR：0.67；95% CI，0.43-1.05）以及未接受过多西他赛治疗的患者（HR：0.71；95% CI，0.57-0.88）。

The incidence of treatment-emergent adverse events in the five-year follow-up is consistent with prior ARCHES analyses and no new safety signals were identified..

五年随访中治疗相关不良事件的发生率与之前的ARCHES分析一致，且未发现新的安全性信号。

“The survival benefits of intervention with XTANDI in advanced prostate cancer are well-recognized,”

“XTANDI在晚期前列腺癌治疗中的生存益处已得到广泛认可，”

added Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas.

添加了安斯泰来医药事务执行副总裁、主管肖恩特尔·多德森。

“The collective – and growing – body of data for XTANDI continues to reinforce its long-term efficacy and patient impact in prostate cancer, including in the metastatic setting, and shows that XTANDI is changing the trajectory of those living with the disease.”

“XTANDI不断积累且日益增长的数据集体进一步证实了其在前列腺癌（包括转移性环境）中的长期疗效和对患者的影响，并表明XTANDI正在改变患者的生活轨迹。”

These results of the five-year follow-up from the ARCHES study will be submitted for publication in a peer-reviewed journal in the near future.

这些来自ARCHES研究的五年随访结果将在不久的将来提交给同行评审的期刊发表。

“Until recently, patients with metastatic hormone-sensitive prostate cancer faced a poor prognosis, particularly in advanced stages, often due to treatment resistance,”

“直到最近，转移性激素敏感型前列腺癌患者，尤其是在晚期阶段，往往由于治疗耐药性而面临不良预后。”

said Johanna Bendell, M.D., Oncology Chief Development Officer, Pfizer.

辉瑞肿瘤学首席开发官约翰娜·本德尔博士说。

“As the only androgen receptor inhibitor demonstrating sustained five-year survival in this patient population, these data further reinforce XTANDI combined with androgen deprivation therapy as the standard-of-care for treating this advanced disease.”

“作为唯一一种在该患者群体中显示出持续五年生存率的雄激素受体抑制剂，这些数据进一步巩固了XTANDI联合雄激素剥夺疗法作为治疗这种晚期疾病的标准方案。”

In addition to five-year data from the follow-up ARCHES study, eight-year data from the ENZAMET study assessing outcomes of enzalutamide versus non-steroidal anti-androgen (NSAA) – both plus testosterone suppression with or without docetaxel – in mHSPC will also be presented during a poster session at ASCO (Monday, June 2, 9:00 a.m.

除了来自ARCHES研究的五年数据外，还将展示ENZAMET研究的八年数据，该研究评估了恩杂鲁胺与非甾体抗雄激素（NSAA）在mHSPC中的结果——两者均加上睾酮抑制，伴或不伴多西他赛——这些数据将在ASCO的海报会议（6月2日星期一上午9:00）上展示。

US CT). This independent, Phase 3 trial sponsored by the University of Sydney (.

美国CT）。这项由悉尼大学赞助的独立的第三阶段试验（。

NCT02446405

NCT02446405

), led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group Limited (ANZUP), demonstrated a reduction in risk of death in men with mHSPC.

由澳大利亚和新西兰泌尿生殖及前列腺癌试验组有限公司（ANZUP）领导的试验表明，对于患有转移性激素敏感性前列腺癌（mHSPC）的男性，死亡风险有所降低。

“Data from the eight-year follow-up of XTANDI are highly encouraging, as they show the progression-free survival and overall survival benefits are sustained out to at least eight years,”

“XTANDI八年随访的数据非常令人鼓舞，因为它们显示无进展生存期和总生存期的益处至少持续了八年。”

said Christopher Sweeney, MBBS, DHS, FRACP, ANZUP Cancer Trials Group Limited, Sydney, Australia, and ENZAMET follow-up primary investigator.

克里斯托弗·斯威尼 (Christopher Sweeney)，医学学士，健康科学博士，澳大利亚皇家内科医学院院士，澳大利亚和新西兰泌尿生殖肿瘤试验组 (ANZUP Cancer Trials Group Limited)，悉尼，澳大利亚，ENZAMET 随访研究主要负责人。

“These results further support the value of XTANDI as a treatment regimen for metastatic hormone-sensitive prostate cancer.”

“这些结果进一步支持了XTANDI作为转移性激素敏感型前列腺癌治疗方案的价值。”

With a median follow-up of 98 months, patients with mHSPC were treated with XTANDI plus testosterone suppression or NSAA plus testosterone suppression, each group with or without docetaxel. The median OS in the XTANDI group was 8.0 years and 5.8 years in the NSAA group (HR: 0.73; 95% CI, 0.63-0.86).

中位随访98个月，mHSPC患者接受XTANDI联合睾酮抑制治疗或NSAA联合睾酮抑制治疗，每组均分为是否联合多西他赛。XTANDI组的中位总生存期为8.0年，NSAA组为5.8年（HR：0.73；95% CI，0.63-0.86）。

OS at 96 months was 50% with XTANDI and 40% for NSAA; progression-free survival (PFS) also favored XTANDI over NSAA (HR: 0.49; 95% CI, 0.42-0.57). Prostate cancer accounted for 468 of all 622 deaths and were less frequent among those assigned XTANDI than NSAA (207 versus 261). Other causes accounted for a total of 154 deaths and were similarly frequent among those assigned XTANDI versus NSAA (78 versus 76).

在96个月时，XTANDI组的OS为50%，NSAA组为40%；无进展生存期（PFS）同样显示XTANDI优于NSAA（HR：0.49；95% CI，0.42-0.57）。在总共622例死亡中，前列腺癌导致了468例，且在接受XTANDI治疗的患者中比NSAA组更少（207例对比261例）。其他原因导致的死亡总计154例，在XTANDI组和NSAA组之间频率相似（78例对比76例）。

Mean duration of treatment was longer for XTANDI (58 months) than NSAA (36 months), with 33% remaining on XTANDI and 88% of these patients remained at the full dose of 160 mg..

XTANDI（58个月）的平均治疗时间比NSAA（36个月）更长，其中33%的患者继续使用XTANDI，且这些患者中有88%保持了160毫克的全剂量。

XTANDI is currently approved in more than 90 countries, including in the United States, European Union and Japan. Since its initial approval in 2012, over one million patients have been treated with XTANDI globally.

XTANDI目前已在90多个国家获得批准，包括美国、欧盟和日本。自2012年首次获批以来，全球已有超过一百万名患者接受了XTANDI治疗。

About Metastatic Hormone-Sensitive Prostate Cancer (mHSPC)

关于转移性激素敏感性前列腺癌 (mHSPC)

Metastatic hormone-sensitive prostate cancer, also known as metastatic castration-sensitive prostate cancer, refers to prostate cancer that still responds to hormonal therapy and has spread outside of the prostate gland to other parts of the body, such as the lymph nodes, bones, lungs and liver.

转移性激素敏感性前列腺癌，也称为转移性去势敏感性前列腺癌，是指仍然对激素治疗有反应并已扩散到前列腺以外身体其他部位（如淋巴结、骨骼、肺和肝）的前列腺癌。

About the ARCHES Study

关于ARCHES研究

The Phase 3, randomized, double-blind, placebo-controlled, multi-national trial enrolled 1,150 patients with metastatic hormone-sensitive prostate cancer (mHSPC) at sites in the United States, Canada, Europe, South America and the Asia-Pacific region. Patients in the ARCHES trial were randomized to receive XTANDI 160 mg daily or placebo and continued on a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist or had a history of bilateral orchiectomy.

该三期随机、双盲、安慰剂对照的多国试验在美国、加拿大、欧洲、南美和亚太地区的试验点招募了1150名转移性激素敏感性前列腺癌（mHSPC）患者。ARCHES试验中的患者被随机分配每天接受160毫克XTANDI或安慰剂，并继续使用促黄体生成素释放激素（LHRH）激动剂或拮抗剂，或有双侧睾丸切除史。

The ARCHES trial included patients with both low- and high-volume disease and both newly diagnosed patients with mHSPC and patients who had prior definitive therapy and subsequently developed metastatic disease. The trial also included some patients who had received recent treatment with docetaxel for mHSPC, but whose disease had not progressed.

ARCHES 试验包括低肿瘤负荷和高肿瘤负荷的患者，既包括新诊断的 mHSPC 患者，也包括之前接受过根治性治疗但随后发生转移的患者。试验还包括一些近期因 mHSPC 接受多西他赛治疗但疾病未进展的患者。

The primary endpoint of the trial was radiographic progression-free survival (rPFS), defined as the time from randomization to the first objective evidence of radiographic disease progression as assessed by central review, or death within 24 weeks of treatment discontinuation..

试验的主要终点是影像学无进展生存期 (rPFS)，定义为从随机分组到由中心审查评估的影像学疾病进展的首次客观证据，或在治疗停止后24周内死亡的时间。

In addition to the key secondary endpoint of overall survival at final analysis, a post hoc 5-year analysis was executed with the intent to further quantify long-term overall survival at a clinically meaningful landmark follow-up of five years.

除了在最终分析时的关键次要终点总生存期外，还进行了一项事后5年分析，目的是在具有临床意义的5年里程碑随访中进一步量化长期总生存期。

For more information on the global ARCHES trial, go to

有关全球ARCHES试验的更多信息，请访问

About ENZAMET

关于ENZAMET

ENZAMET is a trial led by ANZUP Cancer Trials Group Limited in collaboration with the NHMRC (National Health and Medical Research Council) Clinical Trials Centre at the University of Sydney with trial sites in Australia, Canada, Ireland, New Zealand, UK and United States. The trial evaluates the potential of enzalutamide plus androgen deprivation therapy (ADT) versus a conventional non-steroidal anti androgen (NSAA) plus ADT in 1,125 men with mHSPC.

ENZAMET 是由 ANZUP 癌症试验组有限公司牵头，与悉尼大学 NHMRC（国家健康与医学研究委员会）临床试验中心合作开展的试验，试验地点分布在澳大利亚、加拿大、爱尔兰、新西兰、英国和美国。该试验评估了恩杂鲁胺联合雄激素剥夺疗法 (ADT) 与传统非甾体抗雄激素 (NSAA) 联合 ADT 在 1,125 名 mHSPC 患者中的潜力。

The primary endpoint for the trial is overall survival (OS). Additional details about ENZAMET (NCT02446405) are available on .

该试验的主要终点是总生存期（OS）。ENZAMET（NCT02446405）的更多详情可在以下网址获取。

www.clinicaltrials.gov

www.clinicaltrials.gov

. Astellas provided funding and support for the ENZAMET trial.

安斯泰来为ENZAMET试验提供了资金和支持。

About XTANDI™ (enzalutamide)

关于XTANDI™（恩杂鲁胺）

XTANDI (enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard of care and has received regulatory approvals in one or more countries around the world for use in men with metastatic hormone-sensitive prostate cancer (mHSPC), metastatic castration-resistant prostate cancer (mCRPC), non-metastatic castration-resistant prostate cancer (nmCRPC) and non-metastatic hormone-sensitive prostate cancer (nmHSPC) with high-risk biochemical recurrence (BCR).

XTANDI（恩扎鲁胺）是一种雄激素受体信号抑制剂。XTANDI 是一种标准治疗方案，已在世界范围内一个或多个国家获得监管批准，用于治疗转移性激素敏感性前列腺癌 (mHSPC)、转移性去势抵抗性前列腺癌 (mCRPC)、非转移性去势抵抗性前列腺癌 (nmCRPC)，以及具有高危生化复发 (BCR) 的非转移性激素敏感性前列腺癌 (nmHSPC) 的男性患者。

XTANDI is currently approved for one or more of these indications in more than 90 countries, including in the United States, European Union and Japan. Over one million patients have been treated with XTANDI globally..

XTANDI目前已在90多个国家获得批准，适应症包括在美国、欧盟和日本。全球已有超过一百万名患者接受了XTANDI治疗。

About XTANDI (enzalutamide) and Important Safety Information

关于XTANDI（恩杂鲁胺）的重要安全信息

XTANDI (enzalutamide) is indicated for the treatment of patients with:

XTANDI（恩杂鲁胺）适用于治疗以下患者：

• castration-resistant prostate cancer (CRPC)

• 去势抵抗性前列腺癌 (CRPC)

• metastatic castration-sensitive prostate cancer (mCSPC)

转移性去势敏感性前列腺癌 (mCSPC)

• nonmetastatic castration sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)

非转移性去势敏感性前列腺癌（nmCSPC），伴有高风险生化复发（高危BCR）可能转移。

About Astellas

关于安斯泰来

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.

安斯泰来制药株式会社是一家在全球70多个国家开展业务的制药公司。我们正在推进聚焦领域方法，该方法旨在通过专注于生物学和模态，识别持续创制新药的机会，以应对那些未满足医疗需求的疾病。

Furthermore, we are also looking beyond our foundational Rx focus to create Rx+.

此外，我们还在基础的Rx焦点之外，着眼于创建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 .

结合我们与不同领域外部合作伙伴的尖端技术和专业知识的医疗保健解决方案。通过这些努力，安斯泰来站在医疗变革的前沿，将创新科学转化为对患者的 VALUE。欲了解更多信息，请访问我们的网站。

About Pfizer Oncology

辉瑞肿瘤事业部简介

At Pfizer Oncology, we are at the forefront of a new era in cancer care. Our industry-leading portfolio and extensive pipeline includes three core mechanisms of action to attack cancer from multiple angles, including small molecules, antibody-drug conjugates (ADCs), and bispecific antibodies, including other immune-oncology biologics.

在辉瑞肿瘤事业部，我们正处于癌症治疗新时代的前沿。我们行业领先的资产组合和广泛的研发管线包括三种核心作用机制，从多个角度攻击癌症，包括小分子、抗体药物偶联物 (ADC) 和双特异性抗体，以及其他免疫肿瘤生物制品。

We are focused on delivering transformative therapies in some of the world’s most common cancers, including breast cancer, genitourinary cancer, hematology-oncology, and thoracic cancers, which includes lung cancer. Driven by science, we are committed to accelerating breakthroughs to help people with cancer live better and longer lives..

我们专注于在一些世界上最常见的癌症中提供变革性的治疗方法，包括乳腺癌、生殖泌尿系统癌症、血液肿瘤学以及包括肺癌在内的胸部癌症。受科学驱动，我们致力于加速突破，以帮助癌症患者过上更好、更长寿的生活。

About the Pfizer/Astellas Collaboration

关于辉瑞/安斯泰来合作

In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE: PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize XTANDI (enzalutamide). The companies jointly commercialize XTANDI in the United States, and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States..

2009年10月，当时隶属于辉瑞（纽交所代码：PFE）的Medivation公司与安斯泰来（东京证券交易所代码：4503）达成了一项全球协议，共同开发和商业化XTANDI（恩杂鲁胺）。两家公司在美国共同推广XTANDI，而安斯泰来负责全球的生产和所有其他监管文件的提交工作，以及在美国以外地区推广XTANDI。