Astellas Announces Phase 3 China ARCHES Study of XTANDI® Meets Primary Endpoint

XTANDI ® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT

Study enrolled 180 men with metastatic hormone-sensitive prostate cancer in mainland China

- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa Ph.D., "Astellas") today announced positive topline results from the Phase 3 China ARCHES study of XTANDI ® (enzalutamide) plus androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC) versus placebo plus ADT. The study met its primary endpoint, demonstrating a statistically significant improvement in time to prostate-specific antigen (PSA) progression (TTPP), defined as a ≥ 25% increase and an absolute increase of ≥ 2 µgL (2 ngmL) above the nadir (i.e., lowest PSA value observed post baseline or at baseline), which is confirmed by a second consecutive value at least 3 weeks later. At the topline analysis, the safety of XTANDI plus ADT was broadly consistent with the known safety profile for the medication.

Astellas stands on the forefront of healthcare change to turn innovative science into value for patients.(PRNewsFoto/Astellas Pharma Inc.)

The study also met key secondary endpoints, demonstrating that treatment with XTANDI plus ADT notably reduced the risk of radiographic progression-free survival (rPFS) and increased the rate of patients with undetectable PSA versus placebo plus ADT.

"With the rising incidence of prostate cancer diagnoses among men in China , there is a need for new and effective treatment options," said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. "As observed in our global Phase 3 ARCHES study, and now reaffirmed with China ARCHES, XTANDI significantly delays the time to disease progression in men with mHSPC and may provide an important treatment option for men in China if approved."

"While past global studies have supported the use of XTANDI plus ADT in men with mHSPC, it is encouraging to see these results replicated for patients in mainland China ," said Prof. Zhou Fangjian, Head of Urology Department, Sun Yat -sen University Cancer Center, Sun Yat -sen University.

"As an existing standard of care for Chinese men with castration-resistant prostate cancer, XTANDI has the potential to help men earlier in their treatment journey – before their disease stops responding to therapies that lower testosterone," said Prof. Ye, Dingwei, Vice President of the Fudan University Shanghai Cancer Center, Director of the Multi-disciplinary Team for GU Cancer.

Detailed results from China ARCHES will be submitted for publication in the near future. Data from China ARCHES will be shared with the China National Medical Products Administration (NMPA) to potentially support a regulatory filing.

XTANDI has not been approved by the NMPA for the treatment of mHSPC.

This result will have no impact on the financial forecasts of the current fiscal year ending March 31, 2023 .

About Metastatic Hormone-Sensitive Prostate Cancer
In China, prostate cancer is the most common tumor in male genitourinary cancers. 1 It is the second most common cancer in men worldwide. 2 Prostate cancer is considered metastatic once it has spread outside of the prostate gland to other parts of the body, such as distant lymph nodes, bones, lungs, and liver. 3 Men are considered hormone- (or castration-) sensitive if their disease still responds to medical or surgical treatment to lower testosterone levels. 4 Metastatic hormone-sensitive prostate cancer (mHSPC) has a median survival of approximately 3-4 years for men starting treatment with ADT. 5

About the China ARCHES Trial
The company-sponsored, multicenter, Phase 3, randomized, double-blind, placebo-controlled China ARCHES trial (NCT04076059) enrolled 180 Chinese patients with metastatic hormone-sensitive prostate cancer (mHSPC) across 30 sites in mainland China. Patients in the 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. The primary endpoint of the trial was time to prostate-specific antigen (PSA) progression (TTPP), defined as a ≥ 25% increase and an absolute increase of ≥ 2 ng/mL above the nadir, which is confirmed by a second consecutive value 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 antineoplastic therapy, PSA undetectable rate, which is defined as the percentage of subjects with detectable (≥ 0.2 ng/mL) PSA at baseline, which becomes undetectable (

For more information on the China ARCHES trial, go to www.clinicaltrials.gov .

About XTANDI ® (enzalutamide soft capsules)
Enzalutamide is an androgen receptor signaling inhibitor indicated for the treatment of adult men with non-metastatic castration-resistant prostate cancer (nmCRPC) with high-risk of metastasis or metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of ADT in whom chemotherapy is not yet clinically indicated. 6

Important Safety Information
For Important Safety Information for enzalutamide please see the Package Insert.

About Astellas
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. Furthermore, we are also looking beyond our foundational Rx focus to create 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 https://www.astellas.com/en .

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

Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These 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. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas' intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

References

1 Chinese guidelines for diagnosis and treatment of prostate cancer 2018. Chin J Cancer Res. 2019 Feb; 31(1): 67–83.
2 Rawla P. Epidemiology of Prostate Cancer. World J Oncol. 2019; 10(2): 63-89.
3 American Society of Clinical Oncology. ASCO Answers: Prostate Cancer (2021). https://www.cancer.net/sites/cancer.net/files/asco_answers_guide_prostate.pdf . Accessed September 17, 2021 .
4 Cancer.net. Prostate Cancer: Types of Treatment (09-2020). https://www.cancer.net/cancer-types/prostate-cancer/types-treatment . Accessed September 17, 2021 .
5 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.
6 Enzalutamide package insert. China. Astellas Pharma Inc.

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/astellas-announces-phase-3-china-arches-study-of-xtandi-meets-primary-endpoint-301770784.html

SOURCE Astellas Pharma Inc.

News Provided by PR Newswire via QuoteMedia

PFE
The Conversation (0)
Arvinas and Pfizer Announce Upcoming Vepdegestrant  Poster Presentations at the 2023 European Society for Medical Oncology  Breast Cancer Annual Congress

Arvinas and Pfizer Announce Upcoming Vepdegestrant Poster Presentations at the 2023 European Society for Medical Oncology Breast Cancer Annual Congress

Arvinas, Inc. (Nasdaq: ARVN) and Pfizer Inc. (NYSE: PFE) today announced they will present updated data related to vepdegestrant (ARV-471) at the 2023 European Society for Medical Oncology (ESMO) Breast Cancer Annual Congress. Vepdegestrant is a novel investigational PROTAC ® estrogen receptor (ER) protein degrader that is being jointly developed by Arvinas and Pfizer for the treatment of patients with early and locally advanced or metastatic ER positivehuman epidermal growth factor receptor 2 (HER2) negative (ER+HER2-) breast cancer. Four posters will be presented during the poster session at the annual congress, which will be held from May 11-13, 2023, in Berlin, Germany.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Pfizer Reports First-Quarter 2023 Results

Pfizer Reports First-Quarter 2023 Results

  • First-Quarter 2023 Revenues of $18.3 Billion
    • Expected Decline in Comirnaty (1) Revenue Drove 26% Operational Decrease in First-Quarter 2023 Revenues
    • First-Quarter 2023 Revenues from Comirnaty (1) and Paxlovid of $7.1 Billion
    • Excluding Contributions from Comirnaty (1) and Paxlovid, Revenues Grew 5% Operationally
  • First-Quarter 2023 Reported Diluted EPS (2) of $0.97, a Year-Over-Year Decline of 29%, and Adjusted Diluted EPS (3) of $1.23, a Year-Over-Year Decline of 24%
  • Pfizer Reaffirms Full-Year 2023 Financial Guidance (4)
  • Pfizer Continued to Make Significant Progress Toward an Unprecedented Number of Anticipated New Product and Indication Launches; Milestones Include FDA Approvals for Zavzpret, Cibinqo for Adolescents and Prevnar 20 in Pediatric Patients

Pfizer Inc. (NYSE: PFE) reported financial results for the first quarter of 2023 and reaffirmed full-year 2023 financial guidance.

The first-quarter 2023 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to Pfizer's R&D pipeline can be found at www.pfizer.com .

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
XTANDI®  plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

XTANDI® plus Leuprolide Reduced the Risk of Metastasis by 58% in Non-Metastatic Hormone-Sensitive Prostate Cancer versus Placebo plus Leuprolide

Data from Phase 3 EMBARK trial to be presented as a plenary session during the 2023 American Urological Association Annual Meeting

Results show the potential for XTANDI to add to the standard of care in prostate cancer, if approved

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

U.S. FDA Approves PREVNAR 20®, Pfizer's 20-valent Pneumococcal Conjugate Vaccine for Infants and Children

  • PREVNAR 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect against all 20 serotypes contained in the vaccine
  • PREVNAR 20 builds on PREVNAR 13 ® and includes seven additional serotypes shown to be associated with antibiotic resistance, heightened disease severity, invasive potential, and prevalence in pediatric pneumococcal cases. 1
  • The vaccine further advances Pfizer's pediatric pneumococcal vaccine portfolio and builds on more than 20 years of Pfizer leadership, legacy and innovation in developing pneumococcal conjugate vaccines

Pfizer Inc. (NYSE: PFE) announced today that the U.S. Food and Drug Administration (FDA) has approved PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for the prevention of invasive pneumococcal disease (IPD) caused by the 20 Streptococcus pneumoniae (pneumococcal) serotypes contained in the vaccine in infants and children six weeks through 17 years of age, and for the prevention of otitis media in infants six weeks through five years of age caused by the original seven serotypes contained in PREVNAR ® .

"Today's FDA approval of our vaccine, PREVNAR 20, now offers parents the ability to help protect their children against 20 pneumococcal serotypes in circulation, which represent the majority of pneumococcal disease in U.S. infants and children," 1,2 said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Scientific Officer, Vaccine Research and Development, Pfizer. "This important PREVNAR 20 approval builds on more than 20 years of real-world impact with PREVNAR and PREVNAR 13, safety data, and effectiveness; highlighting Pfizer's leadership in developing groundbreaking pneumococcal conjugate vaccines to help protect infants and their families from life threatening infections. We are grateful to the families and clinical investigators who participated in this research and our colleagues who have worked tirelessly to develop this breakthrough vaccine."

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Pfizer Declares Second-Quarter 2023 Dividend

Pfizer Declares Second-Quarter 2023 Dividend

Board of Directors approves quarterly cash dividend of $0.41 per share

Pfizer Inc. (NYSE: PFE) today announced that its board of directors declared a $0.41 second-quarter 2023 dividend on the company's common stock, payable June 9, 2023, to holders of the Common Stock of record at the close of business on May 12, 2023. The second-quarter 2023 cash dividend will be the 338th consecutive quarterly dividend paid by Pfizer.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Jamieson Wellness Publishes Inaugural Sustainability Impact Report

From values to action, the Company details progress towards its sustainability commitments in its "Inspiring Better Lives Every Day: 2023 Sustainability Impact Report"

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today announces the release of its "Inspiring Better Lives Every Day: 2023 Sustainability Impact Report". The comprehensive report underscores the Company's commitment to creating a sustainable future while aligning with its core values of Respect, Excellence, Accountability, and Agility. The Company's new purpose, "Inspiring Better Lives Every Day," serves as its guiding light as it navigates the path toward positive impact.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Pills spilling out of a pill bottle on a yellow background.

Pharma Stocks: 5 Biggest Companies in 2024

The pharmaceutical industry is a major player in the overall life science sector, responsible for developing and manufacturing the majority of prescription drugs.

Companies in this space are constantly researching and creating innovative treatments for various medical conditions. In recent years, there has been a particular focus on developing new treatments for diabetes, weight loss and cancer.

With the pharmaceutical sector projected to reach a staggering US$1.6 trillion in total revenue by 2028, there is an opportunity for investors to gain exposure to the growth potential of this industry while also benefiting from the diversification and stability provided by established companies.

Keep reading...Show less

Jamieson Wellness Inc. Reports Strong Fourth Quarter and Full Year 2023 Results

Profitable revenue growth of 23.5% in 2023 demonstrates successful execution of global strategy;
Canadian consumer consumption reaches record levels in Q4

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX: JWEL) today reported financial results for its fourth quarter and full year results for the period ended December 31, 2023. All amounts are expressed in Canadian dollars. Certain metrics, including those expressed on an adjusted basis, are non-IFRS and other financial measures. See "Non-IFRS and Other Financial Measures" below.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Jamieson Wellness Inc. Announces Date of Fourth Quarter and Full Year 2023 Financial Results and Conference Call

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX:JWEL) announced today that the Company will release its fourth quarter and full year 2023 financial results after the market close on Wednesday, March 13, 2024. The Company will host a conference call for investors at 5:00 p.m. Eastern Time to discuss the fourth quarter and full year 2023 results.

The call can be accessed live over the telephone by dialing 1-888-886-7786 from Canada and the U.S. or 1-416-764-8658 from international locations. A replay will be available shortly after the call and can be accessed by dialing 1-844-512-2921 from Canada and the U.S. or 1-412-317-6671 from international locations. The passcode for the replay is 82012546 and it will be available until Thursday, March 27, 2024.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less

Jamieson Wellness Inc. Declares Fourth Quarter 2023 Dividend

Jamieson Wellness Inc. ("Jamieson Wellness" or the "Company") (TSX:JWEL) announced today that the board of directors of the Company has declared a cash dividend for the fourth quarter of 2023 of $0.19 per common share, or approximately $8.0 million in the aggregate. The dividend will be paid on March 15, 2024 to all common shareholders of record at the close of business on March 1, 2024. The Company has designated this dividend as an "eligible dividend" for the purposes of the Income Tax Act (Canada).

About Jamieson Wellness Inc.

News Provided by Business Wire via QuoteMedia

Keep reading...Show less
Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx for Recurrent Pericarditis

Cardiol Therapeutics Completes Patient Enrollment in its Phase II MAvERIC-Pilot Study Investigating CardiolRx for Recurrent Pericarditis

Topline Results Expected in Q2 2024

This is a Designated News Release.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×