Astellas Announces NMPA Approval of XTANDI (Enzalutamide) for Metastatic Hormone-Sensitive Prostate Cancer in China

Jul 02, 2024 20:02 CST Updated 20:02

Astellas

Pharmaceutical R&D Manufacturer

Source: Astellas China WeChat Official Account

· This is the third indication for advanced prostate cancer treatment approved for Astellas in China.

· Approved based on the positive results of the global and Chinese ARCHES Phase III studies, Enzalutamide combined with ADT significantly delayed compared to placebo combined with Androgen Deprivation Therapy (ADT).Prostate-Specific AntigenTime to Progression (PSA)

Tokyo, July 2, 2024– Astellas Pharma Group announced today that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) has approved Xtandi (enzalutamide) for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC).

This approval is based on the positive results of the global Phase III ARCHES study and the China ARCHES study. The China ARCHES study used an alternative endpoint (PSA progression time) to bridge the results of the global ARCHES study. In the China ARCHES study, 180 mHSPC patients from mainland China were randomly assigned to receive either enzalutamide plus ADT or placebo plus ADT. The results showed that, compared with placebo plus ADT, enzalutamide plus ADT significantly reduced the risk of PSA progression by 87% (hazard ratio 0.130 [95% CI 0.076, 0.222]; P<0.0001). Secondary endpoints such as radiographic progression-free survival (rPFS), time to castration resistance (TTCR), and PSA undetectable rate also favored the enzalutamide plus ADT treatment group over the placebo plus ADT group. These findings again demonstrate the positive outcomes of enzalutamide, consistent with the global Phase III ARCHES study. In the China ARCHES study, the safety profile of enzalutamide plus ADT was consistent with the known safety profile. Overall, these findings support the earlier use of enzalutamide in treatment.i,ii

Chief Expert of Prostate Cancer at the Tumor Hospital Affiliated to Fudan University

Professor Dingwei Ye

"Prostate cancer is the most common tumor in the urinary and reproductive systems among Chinese men. Currently, the mortality-to-incidence ratio of prostate cancer in China is higher than in developed countries. In addition to further improving the diagnostic rate of prostate cancer, there is an urgent clinical need for new treatment options that can slow disease progression while further enhancing survival benefits for Chinese patients."

Chief Expert of Prostate Cancer Single Disease at the Sun Yat-sen University Cancer Center

Professor Zhou Fangjian

"With the approval of the indication for hormone-sensitive metastatic prostate cancer (mHSPC), enzalutamide has become the only novel endocrine therapy drug currently covering every stage of advanced prostate cancer, providing treatment and comprehensive disease management for a large number of Chinese patients with advanced prostate cancer."^*"Provides options. The ARCHES study in China is also currently the only Phase III clinical trial targeting Chinese patients with prostate cancer, and its results offer evidence-based medical proof for Chinese doctors treating advanced prostate cancer."

* Enzalutamide is currently approved in China for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC); adult patients with non-metastatic castration-resistant prostate cancer (NM-CRPC) at high risk of metastasis; and adult patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or have mild symptoms and have not received chemotherapy after failure of androgen deprivation therapy (ADT).

Astellas Senior Vice President and Head of Oncology Development, M.D., M.P.H.

Ahsan Arozullah

"Through three large Phase III clinical trials—ENZAMET, global ARCHES, and China ARCHES—the efficacy data of enzalutamide in treating mHSPC has been convincing and consistent. These data form the basis for the product’s regulatory approval in multiple regions worldwide. Astellas is fully committed to bringing enzalutamide to patients in need. The NMPA’s approval expands the accessibility of this urgently needed treatment option for patients with advanced prostate cancer in China."

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

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About TransferSex Hormone SensitivitySenseSexual Prostate Cancer

In China, prostate cancer is the most common tumor disease in male urinary and reproductive system cancers.ⁱⁱⁱ

Prostate cancer is also the second most common cancer among men worldwide.^ivOnce prostate cancer spreads to other parts of the body beyond the prostate, such as distant lymph nodes, bones, lungs, and liver, it is considered metastatic cancer.^vIf male patients still respond to drugs or surgical treatments that lower testosterone levels, they are considered hormone (or castration) sensitive.^viThe median survival time for men with metastatic hormone-sensitive prostate cancer (mHSPC) after starting ADT treatment is approximately 3-4 years.^vii

About the Global ARCHES Study

It is a randomized, double-blind, placebo-controlled, multinational Phase III study that enrolled a total of 1,150 patients with metastatic hormone-sensitive prostate cancer (mHSPC). The study centers included the United States, Canada, Europe, South America, and the Asia-Pacific region. Patients in the ARCHES trial were randomly assigned to receive either 160 mg of enzalutamide daily or a placebo and continued the use of luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or had undergone bilateral orchiectomy. The ARCHES trial included patients with both low-volume and high-volume disease, as well as newly diagnosed mHSPC patients and those previously treated with definitive therapy who subsequently developed metastatic disease. The trial also included some patients recently treated with docetaxel for mHSPC but whose disease 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 radiologic disease progression, assessed by central review, or death within 24 weeks after treatment discontinuation.

For more information about the global ARCHES trial, please visitwww.clinicaltrials.gov。

About the ARCHES Trial in China

China ARCHES is a multicenter, randomized, double-blind, placebo-controlled Phase III trial in China (NCT04076059) initiated by Astellas. A total of 180 Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC) were enrolled across 30 research centers in mainland China. Participants in the trial were randomly assigned to take either 160 mg of enzalutamide or a placebo daily, in combination with a luteinizing hormone-releasing hormone (LHRH) agonist or antagonist, or had previously undergone bilateral orchiectomy. The primary endpoint was time to prostate-specific antigen (PSA) progression (TTPP), with PSA progression defined as a ≥25% increase from the nadir PSA level and an absolute value of ≥2 µg/L (2 ng/mL), confirmed by a second consecutive assessment at least three weeks later. Secondary endpoints included radiographic progression-free survival (rPFS) and time to first symptomatic skeletal event (SSE) Time to castration resistance, PSA response (≥50%), PSA response (≥90%), time to initiation of new anti-tumor therapy, PSA undetectable rate (i.e., the proportion of subjects with detectable PSA at baseline (≥0.2 ng/mL) who become undetectable (<0.2 ng/mL) during study treatment), and objective response rate (ORR).

For more information about the ARCHES trial in China, please visitwww.clinicaltrials.gov。

About Xtandi (Enzalutamide Soft Capsules)

XTANDI (Enzalutamide) is an androgen receptor signaling inhibitor. XTANDI is a standard treatment and has been approved in one or more countries and regions worldwide 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 recurrence (BCR). XTANDI has received approval for one or more indications in over 90 countries and regions, including the United States, the European Union, and Japan. Globally, more than one million patients have been treated with XTANDI.^viii

Important Safety Information

For important safety information about enzalutamide, please refer to the product说明书.

About Astellas

Astellas Pharma, Inc. is a pharmaceutical company with operations in more than 70 countries and regions worldwide. Currently, we are advancing our "Focus Area Approach" research strategy, which aims to identify continuous opportunities for new drug development by concentrating on physiological mechanisms and treatment methods to address unmet medical needs. At the same time, we are expanding our focus beyond prescription drugs by combining our expertise and knowledge with cutting-edge technologies from external partners in various fields to create Rx+® healthcare solutions. Through these efforts, Astellas is committed to staying at the forefront of the ever-evolving healthcare industry, transforming scientific advancements into value for patients.

Warning Description

In this press release, statements regarding current plans, estimates, strategies, and beliefs, as well as other statements that are not historical facts, are forward-looking statements about Astellas' future performance. These statements are based on current assumptions and beliefs of management in light of information currently available, and involve known and unknown risks and uncertainties. Many factors could cause actual results to differ materially from the results discussed in the forward-looking statements. These factors include, but are not limited to: (i) changes in general economic conditions and laws and regulations related to the pharmaceutical market, (ii) fluctuations in currency exchange rates, (iii) delays in the launch of new products, (iv) Astellas' inability to effectively market existing and new products, (v) Astellas' inability to continue to effectively research and develop products that are accepted by customers in a highly competitive market, and (vi) third-party infringement on Astellas' intellectual property rights.

The information contained in this press release regarding pharmaceuticals (including products currently under development) does not constitute advertising or medical advice.

1. This article is translated from an Astellas global press release, with the original text link being: https://www.astellas.com/en/news/29296

2. "The drug involved in this article is still under research and has not been approved for use in China. Astellas China does not recommend the use of any unapproved drugs (except for special regions in mainland China where approval has been granted)."

3. This article aims to convey cutting-edge information in the pharmaceutical field and does not constitute a recommendation or promotion of any drug or treatment plan.

4. If you want to learn more about disease knowledge or drug and treatment-related information, please consult a healthcare professional.

References:

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). https://www.cancerresearchuk.org/about-cancer/prostate-cancer/metastatic-cancer/what-is-metastatic-prostate-cancer. Accessed: July 1, 2024.

vi.Canadian Cancer Society. Treatments for metastatic castration-sensitive prostate cancer. (02-2021). https://cancer.ca/en/cancer-information/cancer-types/prostate/treatment/metastatic-castration-sensitive. 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.

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