China's National Medical Products Administration approved the new indication of Enzalutamide (XTANDI) for the treatment of metastatic hormone-sensitive prostate cancer.

PR Newswire · Jul 1 22:51

这是安可坦在中国获批的第三项晚期前列腺癌治疗的适应症
获批基于全球及中国ARCHES III期研究的积极结果，与安慰剂联合雄激素剥夺疗法（ADT）相比，安可坦联合ADT显著延缓了前列腺特异性抗原（PSA）的进展时间

东京2024年7月2日 /美通社/ -- 安斯泰来制药集团（TSE：4503，总裁兼首席执行官：冈村直树，"安斯泰来"）今日宣布，中国国家药品监督管理局（NMPA）药品审评中心（CDE）已批准安可坦（XTANDI，恩扎卢胺）用于治疗转移性激素敏感性前列腺癌（mHSPC）的适应症。

这项批准基于全球III期ARCHES研究和中国ARCHES研究的积极结果。中国ARCHES研究使用替代终点（PSA进展时间）来桥接全球ARCHES研究结果。在中国ARCHES研究中，180名中国大陆的mHSPC患者随机接受恩扎卢胺联合ADT治疗，或者安慰剂联合ADT治疗。结果显示，与安慰剂联合ADT相比，恩扎卢胺联合ADT显著降低了PSA进展风险87%（风险比为 0.130 [95% CI 0.076, 0.222]; P＜0.0001）。影像学无进展生存期（rPFS）、至去势抵抗时间（TTCR）和PSA不可测率等次要终点，恩扎卢胺联合ADT治疗组也优于安慰剂联合ADT组的治疗。这些研究发现再次显示出恩扎卢胺的积极结果，与全球III期ARCHES研究保持一致。中国ARCHES研究中，恩扎卢胺联合ADT治疗的安全性与已知的安全性一致。总体而言，这些发现支持恩扎卢胺在治疗中的早期应用。^[i],[ii]

叶定伟教授，复旦大学附属肿瘤医院前列腺癌首席专家

前列腺癌是中国男性泌尿生殖系统肿瘤中最常见的肿瘤。目前中国前列腺癌死亡率/发病率的比例高于发达国家，除了进一步提高前列腺癌的疾病诊断率，临床上迫切需要新的治疗选择，在减缓疾病进展的同时，进一步提高中国患者的生存获益。

周芳坚教授，中山大学附属肿瘤医院前列腺癌单病种首席专家

随着对激素敏感转移性前列腺癌（mHSPC）适应症的获批，恩扎卢胺已成为当前唯一涵盖晚期前列腺癌每个疾病阶段的新型内分泌治疗药物，为中国广大晚期前列腺癌患者的治疗和全病程管理*提供了选择。中国 ARCHES也是目前唯一一项针对中国前列腺癌患者展开的III期临床研究，其结果为中国医生治疗晚期前列腺癌提供了循证医学证据。

安斯泰来高级副总裁兼肿瘤学领域开发负责人、医学博士、公共卫生硕士Ahsan Arozullah

"经由三项大型III期临床研究ENZAMET、全球ARCHES和中国ARCHES，恩扎卢胺治疗mHSPC方面的疗效数据令人信服且具有一致性，这些数据是该产品在全球多地获得监管批准的基础。安斯泰来全心致力于将恩扎卢胺带给需要的患者，NMPA的批准拓展了中国晚期前列腺癌患者对获取该急需治疗方案的可及性。"

安斯泰来已在本财年（截止2025年3月31日）的财务预测中反应出此项获批带来的影响。

更多详细信息，请参考新闻稿中国国家药品监督管理局受理安可坦（XTANDI，恩扎卢胺）治疗转移性激素敏感性前列腺癌的新适应症申请(2023年9月19日), 以及安斯泰来宣布恩扎卢胺中国ARCHES研究达到主要终点（2023年3月14日）。

关于转移性激素敏感性前列腺癌

在中国，前列腺癌是男性泌尿生殖系统癌症中最常见的肿瘤疾病。^[iii]

前列腺癌也是全世界男性第二常见癌症^[iv]。一旦前列腺癌扩散到前列腺以外的身体其他部位，如远处淋巴结、骨骼、肺部和肝脏，就被视为转移性癌症。^[v]如果男性患者对降低睾酮水平的药物或手术治疗仍有效果，则被认为对激素（或去势）敏感。^[vi]转移性激素敏感性前列腺癌（mHSPC）男性患者开始接受ADT治疗后的中位生存期约为3-4年。^[vii]

关于全球ARCHES研究

是一项随机、双盲、安慰剂对照、多国参与的III期研究，共招募了1,150名转移性激素敏感性前列腺癌（mHSPC）患者，研究中心包括美国、加拿大、欧洲、南美洲和亚太地区。ARCHES试验的患者被随机分配接受每日160毫克的恩扎卢胺或安慰剂，并继续使用促黄体激素释放激素（LHRH）激动剂或拮抗剂，或曾接受过双侧睾丸切除术。ARCHES试验包括患有低体积和高体积疾病的患者，以及新诊断的mHSPC患者和之前接受过明确治疗随后发展为转移性疾病的患者。试验还包括一些最近接受过mHSPC的多西他赛治疗但病情未进展的患者。试验的主要终点是影像学无进展生存期（rPFS），定义为从随机化到首次客观证据显示放射学疾病进展的时间，由中心审查评估，或在治疗停止后24周内死亡。

有关全球ARCHES试验的更多信息，请访问。

关于中国ARCHES试验

中国ARCHES是一项由安斯泰来发起的多中心、随机、双盲、安慰剂对照中国III期试验（NCT04076059），中国大陆30个研究中心共入组180名中国转移性激素敏感性前列腺癌（mHSPC）患者。参与试验的患者随机每天服用160毫克恩扎卢胺或安慰剂，使用促黄体激素释放激素（LHRH）激动剂或拮抗剂或曾接受过双侧睾丸切除术。试验的主要终点是至前列腺特异性抗原（PSA）进展时间（TTPP），PSA进展定义为PSA水平较PSA最低值升高≥25%且绝对值≥2 µg/L (2 ng/mL)，并在至少3周后的第二次连续检测时被证实。次要终点包括影像学无进展生存期（rPFS）、至首发症状性骨骼事件（SSE）的时间、至去势抵抗的时间、PSA缓解（≥50%）、PSA缓解（≥90%）、至开始新的抗肿瘤治疗的时间、PSA不可检出率（即在基线时PSA可检测到（≥0.2纳克/毫升）的受试者，在研究治疗期间变得无法检测（<0.2纳克/毫升）的比例），以及客观缓解率（ORR）。

有关中国ARCHES试验的更多信息，请访问。

关于安可坦（恩扎卢胺软胶囊）

安可坦（恩扎卢胺）是一种雄激素受体信号抑制剂。XTANDI是标准治疗，并已在全球一个或多个国家和地区获得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）以及具有高风险生化复发（BCR）的非转移性激素敏感性前列腺癌（nmHSPC）的男性患者。XTANDI目前已在包括美国、欧盟和日本在内的90多个国家和地区获得一项或多项适应症的批准。全球已有超过一百万名患者接受了安可坦治疗。^[viii]

重要安全信息
有关恩扎卢胺的重要安全信息，请参阅产品说明书。

关于安斯泰来

安斯泰来制药集团是一家制药企业，业务遍及全球70多个国家和地区。目前，我们正在推进"焦点领域"研究策略（Focus Area Approach），旨在通过聚焦生理机制和治疗手段，确定持续研发新药的机会，解决尚未被满足的医疗需求。与此同时，我们正在将目光投向处方药以外的业务领域，将我们的专业技能和知识与不同领域外部合作伙伴的尖端技术相结合，打造Rx+医疗解决方案。通过这些努力，安斯泰来立志处于不断变化的医疗行业的最前沿，将科学的进步转变为患者的价值。欲了解更多信息，请访问我们的网站。

警示说明

本新闻稿中，有关当前计划、估计、战略和信念以及其他非历史事实的陈述，均为关于安斯泰来未来表现的前瞻性陈述。这些陈述是根据管理层结合当前可获得的信息而形成的当前假设和信念得出的，并涉及已知和未知的风险与不确定性。许多因素可能导致实际结果与前瞻性陈述中讨论的结果产生重大差异。这些因素包括但不限于：（i）与制药市场有关的一般经济条件和法律法规的变化，（ii）货币汇率波动，（iii）新产品上市的延迟，（iv）安斯泰来无法有效地销售现有产品和新产品，（v）安斯泰来无法继续有效地研究和开发在竞争激烈的市场中被客户接受的产品，以及（vi）第三方侵犯安斯泰来的知识产权。

本新闻稿中包含的有关药品（包括当前正在开发的产品）的信息并不构成广告或医疗建议。

1.本文翻译自安斯泰来全球新闻稿，原文链接为：

2."本文所涉及的药品为研究中的药品，尚未在中国获批适应症, 安斯泰来中国不推荐任何未获批的药品使用（除中国大陆已获批的特殊地域外）。

3.本文旨在传递医药前沿信息，不构成对任何药物或诊疗方案的推荐或推广。

4.如您想了解更多疾病知识或药品、诊疗相关信息，请咨询医疗卫生专业人士。

* 恩扎卢胺目前在中国获批的适应症——适用于转移性激素敏感性前列腺癌（mHSPC）成年患者；有高危转移风险的非转移性去势抵抗性前列腺癌（NM-CRPC）成年患者；雄激素剥夺治疗（ADT）失败后无症状或有轻微症状且未接受化疗的转移性去势抵抗性前列腺癌（CRPC）成年患者的治疗。

^[i] Armstrong AJ, et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer. J Clin Oncol. 2019;37(32):2974-2986.

^[ii] Zhou F, et al. 1795P China ARCHES: A multicenter phase III randomized double-blind placebo (PBO)-controlled efficacy and safety trial of enzalutamide (ENZA) + androgen deprivation therapy (ADT) vs PBO + ADT in Chinese patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). Ann Oncol. 2023;34 (supplement 2):s971.

^[iii] Chinese guidelines for diagnosis and treatment of prostate cancer 2018. Chin J Cancer Res. 2019 Feb; 31(1): 67–83.

^[iv] Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019; 10(2): 63-89.

^[v] Cancer Research UK. What is metastatic prostate cancer? (02-2023). Accessed: July 1, 2024.

^[vi] Canadian Cancer Society. Treatments for metastatic castration-sensitive prostate cancer. (02-2021). Accessed: July 1, 2024.

^[vii] Mottet N, et al. Updated Guidelines for Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate Combined with Castration Is Another Standard. Eur Urol. 2018;3:316-321.

^[viii] Astellas. Data on file. XTANDI patient. January 2023.

This is the third indication of late-stage prostate cancer treatment approved by Ankestan in China.
Approved based on global and China.ARCHES IIIPositive results from phase III study compared to placebo combined with androgen deprivation therapy (ADT).ADTSignificantly delayed prostate-specific antigen (PSA) progression time compared to placebo combined with ADT.ADTSignificantly slowed the progression of prostate-specific antigen (PSA) compared to placebo combined with ADT.PSA

TOKYO, July 2, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced that the China National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved XTANDI (enzalutamide) for the indication of treatment of metastatic hormone-sensitive prostate cancer (mHSPC) in China.

This approval is based on positive results from the global phase III ARCHES study and the China-specific ARCHES study.^[i],[ii]

Professor Ye Dingwei, Chief Prostate Cancer Expert, Fudan University Shanghai Cancer Center

Prostate cancer is the most common tumor in the male genitourinary system in China. Currently, the ratio of mortality/incidence rate of prostate cancer in China is higher than that in developed countries. In addition to further improving the diagnosis rate of prostate cancer, there is an urgent need for new treatment options in clinical practice to further improve survival benefits for Chinese patients while slowing down the progression of the disease.

Professor Zhou Fangjian, Chief Prostate Cancer Expert, Sun Yat-Sen University Cancer Center

With the approval of the indication for use in metastatic hormone-sensitive prostate cancer (mHSPC), enzalutamide has become the only new type of endocrine therapy drug that covers every stage of advanced prostate cancer, offering a new choice for the treatment and whole-course management of Chinese patients with advanced prostate cancer. China's ARCHES is also the only phase III clinical trial for Chinese prostate cancer patients, and its results provide evidence-based medicine for Chinese doctors to treat advanced prostate cancer.

Ahsan Arozullah, Senior Vice President and Head of Oncology Development at Astellas, M.D., M.P.H."Data on the efficacy of enzalutamide in the treatment of mHSPC from three large phase III clinical studies, ENZAMET, global ARCHES and China ARCHES, are convincing and consistent, forming the basis for regulatory approvals around the world. Astellas is fully committed to bringing enzalutamide to patients in need, and the approval by the NMPA expands the accessibility of this urgently needed treatment option to Chinese patients with advanced prostate cancer."

AstraZeneca has reflected the impact of this approval in its financial estimates for the current fiscal year (ending March 31, 2025).

For more detailed information, please refer to the press release 'Chinese National Medical Products Administration Accepts Enzalutamide's (XTANDI) New Indications for the Treatment of Hormone-Sensitive Metastatic Prostate Cancer (September 19, 2023)', as well as AstraZeneca's announcement of the successful results of the Enzalutamide Chinese ARCHES study (March 14, 2023).

About metastatic hormone-sensitive prostate cancer

In China, prostate cancer is the most common tumor disease in the male urogenital system.^[iii]

Prostate cancer is also the second most common cancer in men worldwide^[iv]Once prostate cancer spreads to other parts of the body outside the prostate, such as distant lymph nodes, bones, lungs, and liver, it is considered metastatic cancer.^[v]If male patients still respond to drugs or surgical treatments that lower testosterone levels, they are considered hormone (or castration) sensitive.^[vi]The median survival time of male patients with metastatic hormone-sensitive prostate cancer (mHSPC) after starting ADT therapy is about 3-4 years.^[vii]

About the worldARCHESstudy

The ARCHES study is a randomized, double-blind, placebo-controlled, multicenter Phase III study that enrolled 1,150 male patients with metastatic hormone-sensitive prostate cancer (mHSPC) from the United States, Canada, Europe, South America, and the Asia-Pacific region. Patients in the ARCHES trial were randomly assigned to receive daily 160mg of enzalutamide or placebo, and continued to use luteinizing hormone-releasing hormone (LHRH) agonists or antagonists, or had previously undergone bilateral orchiectomy. The ARCHES trial included patients with low-volume and high-volume disease, newly diagnosed mHSPC patients, and patients previously treated with definitive therapy who subsequently developed metastatic disease. The trial also included some patients with mHSPC who had recently received docetaxel therapy but had not progressed. 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 after treatment discontinuation.

For more information about the global ARCHES trial, please visit the website.

About ChinaARCHEStrial

China ARCHES is a multicenter, randomized, double-blind, placebo-controlled Phase III trial (NCT04076059) initiated by Astellas, with a total of 180 Chinese metastatic hormone-sensitive prostate cancer (mHSPC) patients enrolled in 30 research centers in Mainland China. Patients participating in the trial receive either 160 mg of Enzalutamide or placebo per day, randomly, and use luteinizing hormone-releasing hormone (LHRH) agonists or antagonists or have undergone bilateral orchiectomy. The primary endpoint of the trial is the time to prostate-specific antigen (PSA) progression (TTPP), defined as a PSA level increase of ≥25% from the lowest PSA level AND an increase of ≥2 µg/L (2 ng/mL) confirmed by a second consecutive measurement at least 3 weeks later. Secondary endpoints include radiographic progression-free survival (rPFS), time to first symptomatic skeletal event (SSE), time to castration resistance, PSA response (≥50%), PSA response (≥90%), time to initiation of new antitumor therapy, PSA undetectable rate (i.e., the proportion of subjects who are detectable for PSA (≥0.2 ng/ml) at baseline and become undetectable (<0.2 ng/ml) during the study treatment period), and objective response rate (ORR).

For more information about the China ARCHES trial, please visit [the website].

About enzalutamide (Xtandi).

Enzalutamide is an androgen receptor signaling inhibitor. Xtandi is the standard of care and has been approved for the treatment of 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) in male patients with high-risk biochemical relapse (BCR) in one or more countries and regions worldwide. Xtandi has now been approved for one or more indications in more than 90 countries and regions worldwide, including the United States, the European Union, and Japan. More than one million patients worldwide have received treatment with enzalutamide.^[VIII]

Important Safety Information
For important safety information about enzalutamide, please see the product label.

About Astellas

Astellas Pharma Inc. is a pharmaceutical company with operations in more than 70 countries and regions worldwide. We are currently pursuing a 'Focus Area Approach' research strategy aimed at identifying continual opportunities to develop new drugs by focusing on physiological mechanisms and therapeutic modalities, addressing unmet medical needs. At the same time, we are expanding beyond prescription drugs into areas beyond our core therapeutic fields, combining our expertise and knowledge with state-of-the-art technologies from external partners to create Rx+ medical solutions. Through these efforts, Astellas aims to be at the forefront of the ever-evolving healthcare industry, transforming scientific progress into value for patients. For more information, please visit our website.Cautionary Notes

Certain statements in this press release regarding our current plans, estimates, strategies and beliefs, and other statements that are not historical facts, are forward-looking statements about Astellas' future performance. These forward-looking 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.

Many factors could cause actual results to differ materially from those discussed in these forward-looking statements. These factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations relating to the pharmaceutical market, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) Astellas' inability to market existing and new products effectively, (v) Astellas' inability to continue to effectively research and develop accepted products and methods of treatment in competitive markets, and (vi) third-party infringement of Astellas' intellectual property rights. These statements reflect the current views of Astellas' management regarding future events and are subject to risks, uncertainties and assumptions.

The information about drugs (including products under development) contained in this press release is not intended as advertising or medical advice.

This article is translated from Astellas Global News Release, and the original link is [the website].

This drug (including products under development) mentioned in this article is under investigation and has not been approved for any indication in China. Astellas China does not recommend the use of any unapproved drug (except for special regions already approved in Mainland China).

The purpose of this article is to convey the latest medical information and does not constitute a recommendation or promotion of any drug or diagnosis and treatment plan.

If you want to learn more about diseases, drugs, diagnosis and treatment-related information, please consult medical and health professionals.

*Enzalutamide is currently approved for use in adult patients with metastatic hormone-sensitive prostate cancer (mHSPC), non-metastatic castration-resistant prostate cancer (nmCRPC) with high-risk metastasis, and metastatic castration-resistant prostate cancer (CRPC) adult patients who are either asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT), in China.

^{[i] In severely obese patients, the incidence and mortality of cardiovascular disease, diabetes, and certain tumors are significantly increased. In 2019, deaths caused by overweight and obesity accounted for 11.1% of deaths related to chronic non-communicable diseases, significantly increasing from 5.7% in 1990.}Armstrong AJ, et al. ARCHES: A Randomized, Phase III Study of Androgen Deprivation Therapy With Enzalutamide or Placebo in Men With Metastatic Hormone-Sensitive Prostate Cancer.J Clin OncolVolume 37, Issue 32 of 2019, pages 2974-2986.

^[ii]1795P China ARCHES: A multicenter phase III randomized double-blind placebo-controlled efficacy and safety trial of enzalutamide (ENZA) + androgen deprivation therapy (ADT) vs PBO + ADT in Chinese patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC). Zhou F, et al.Annals of OncologyVolume 34 supplement 2 of 2023, page s971.

^[iii]Chinese guidelines for diagnosis and treatment of prostate cancer 2018. Chinese Journal of Cancer Research, February 2019; 31(1): 67-83.

^[iv]Epidemiology of Prostate Cancer. World Journal of Oncology, 2019; 10(2): 63-89. Rawla P.

^[v]What is metastatic prostate cancer? (02-2023). Accessed: July 1, 2024. Cancer Research UK.

^[vi]Treatments for metastatic castration-sensitive prostate cancer. (02-2021). Accessed: July 1, 2024. Canadian Cancer Society.

^[vii]Updated Guidelines for Metastatic Hormone-sensitive Prostate Cancer: Abiraterone Acetate Combined with Castration Is Another Standard. Mottet N, et al.European UrologyVolume 3 of 2018, pages 316-321.

^[viii]XTANDI patient. January 2023. Astellas. Data on file.

Disclaimer: This content is for informational and educational purposes only and does not constitute a recommendation or endorsement of any specific investment or investment strategy. Read more

中国国家药品监督管理局批准安可坦（XTANDI，恩扎卢胺）治疗转移性激素敏感性前列腺癌的新适应症

China's National Medical Products Administration approved the new indication of Enzalutamide (XTANDI) for the treatment of metastatic hormone-sensitive prostate cancer.

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