On May 19, 2025 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present 16 abstracts featuring new data across its approved cancer therapies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (May 30 – June 3) (Press release, Astellas, MAY 19, 2025, View Source [SID1234653222]). The research underscores Astellas’ dedication as a pioneer in oncology and focus on clinical outcomes that matter to patients.

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The abstracts include new post hoc analyses of long-term overall survival (OS) data for XTANDI (enzalutamide) and two analyses for PADCEV (enfortumab vedotin), which demonstrate how these standard-of-care medicines can continue to treat patients in metastatic, non-metastatic, castration-resistant, or hormone-sensitive prostate cancer patients and unresectable, locally advanced or metastatic urothelial cancer patients, respectively.

Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Head of Oncology Development, Astellas
"At Astellas, we are dedicated to transforming cancer care through innovative treatment approaches. The data we will present at ASCO (Free ASCO Whitepaper) this year, including new long-term follow-up data for advanced prostate and bladder cancers, reflect the pioneering role we continue to play in delivering outcomes that matter to patients. We continue to push the boundaries of cancer treatment with our growing pipeline, using novel modalities and precision medicine approaches, to benefit all eligible patients now and in the future."

Highlights from Astellas at the 2025 ASCO (Free ASCO Whitepaper) Annual Meeting will include a strong focus on Overall Survival (OS) data updates, confirming the value that these therapies bring to patients:

Enzalutamide:

The ARCHES five-year follow-up OS analysis of enzalutamide plus androgen-deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC) will be featured in an oral presentation

In addition to the ARCHES five-year follow-up presentation, Astellas is supporting investigator-sponsored studies. Eight-year data assessing outcomes of enzalutamide vs non-steroidal anti-androgen (NSAA) in mHSPC will be presented from an independent, investigator-sponsored trial (ENZAMET) led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP).

Enfortumab vedotin
Urothelial carcinoma

Two analyses of the phase 3 EV-302 study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma (la/mUC)
Exploratory analysis of responders will be presented in an oral presentation
Poster presentation featuring long-term subgroup analysis
Bladder cancer

A systematic review and meta-analysis of surrogate endpoints in muscle-invasive bladder cancer trials will be featured in a poster presentation.

Shontelle Dodson, Executive Vice President, Head of Medical Affairs, Astellas
"Long-term overall survival is the gold standard endpoint in cancer research. New post hoc analysis data from the ARCHES enzalutamide trial demonstrates our mission to help patients live longer, healthier lives. We are committed to maximizing the impact of our therapies as we continue to pioneer the oncology medicines of tomorrow."

Astellas Presentations at 2025 ASCO (Free ASCO Whitepaper) Annual Meeting

Enzalutamide

Presentation Title

Lead Author

Presentation Details

ARCHES 5-year follow-up overall survival analysis of enzalutamide plus androgen deprivation therapy in patients with metastatic hormone-sensitive prostate cancer

A. Armstrong

Type: Oral Presentation

Abstract Number: 5005

Date: June 3, 2025, 9:45am – 12:45pm CDT

Cardiovascular event risk in patients with metastatic castration-resistant prostate cancer treated with enzalutamide or abiraterone acetate in the United States

A. Bryce

Type: Poster Presentation

Abstract Number: 5041

Date: June 2, 2025, 9:00am – 12:00pm CDT

Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer treated with enzalutamide monotherapy: EMBARK post hoc analysis

S. Freedland

Type: Poster Presentation

Abstract Number: 5103

Date: June 2, 2025, 9:00am – 12:00pm CDT

How low do you need to go? Association between various prostate-specific antigen response measures and clinical outcomes in metastatic castration‑sensitive prostate cancer in the Veteran Health Administration data

S. Freedland

Type: Poster Presentation

Abstract Number: 5092

Date: June 2, 2025, 9:00am – 12:00pm CDT

Abiraterone acetate is associated with shorter overall survival than enzalutamide in patients with chemotherapy naïve metastatic castration-resistant prostate cancer: Real world data from the Flatiron electronic health records database

D. George

Type: E-Publication Only

Abstract Number for Publication: e17033

Secondary outcomes by prior definitive treatment in patients with high-risk biochemically recurrent prostate cancer (treated with enzalutamide plus leuprolide (combo): EMBARK post hoc analysis

N. Shore

Type: E-Publication Only

Abstract Number for Publication: e17127

Corticosteroid Use and Risk of Adverse Events in Patients Treated for Metastatic Hormone-Sensitive Prostate Cancer

U. Swami

Type: E-Publication Only

Abstract Number for Publication: e17097

Enfortumab vedotin

Presentation Title

Lead Author

Presentation Details

EV-302: Long-term subgroup analysis from the phase 3 global study of enfortumab vedotin in combination with pembrolizumab vs chemotherapy in previously untreated locally advanced or metastatic urothelial carcinoma

J. Bedke

Type: Poster Presentation

Abstract Number: 4571

Date: June 2, 2025, 9:00am – 12:00pm CDT

Exploratory analysis of responders from the phase 3 EV-302 trial of enfortumab vedotin plus pembrolizumab vs chemotherapy (chemo) in previously untreated locally advanced or metastatic urothelial carcinoma

S. Gupta

Type: Oral Presentation

Abstract Number: 4502

Date: June 1, 2025, 9:45am – 12:45pm CDT

Evaluation of surrogate endpoints in muscle-invasive bladder cancer: A systematic review and meta-analysis

M. Galsky

Type: Poster Presentation

Abstract Number: 4580

Date: June 2, 2025, 9:00am – 12:00pm CDT

Study EV-103 Cohort H: Neoadjuvant treatment with enfortumab vedotin monotherapy in cisplatin-ineligible patients with muscle-invasive bladder cancer: 3-year efficacy results

N. Mar

Type: Poster Presentation

Abstract Number: 4583

Date: June 2, 2025, 9:00am – 12:00pm CDT

Recent trends in US real-world first-line treatment patterns for patients with locally advanced or metastatic urothelial carcinoma

G. Sonpavde

Type: E-Publication Only

Abstract Number for Publication: e16556

Patient and clinician expert perspectives on the impactful symptoms of head and neck squamous cell carcinoma and its treatment

E. Theodorou

Type: E-Publication Only

Abstract Number for Publication: e18001

Zolbetuximab

Presentation Title

Lead Author

Presentation Details

A real-world study on epidemiology, biomarker test results, clinical characteristics, and treatment patterns of unresectable locally advanced or metastatic gastric and gastroesophageal junction adenocarcinoma in China

Y. Chen

Type: E-Publication Only

Abstract Number for Publication: e16013

Gilteritinib

Presentation Title

Lead Author

Presentation Details

Real-world adherence and tolerability of FLT3 inhibitors s post-allogeneic transplant maintenance therapy in
older adults with AML: A Medicare claims cohort study

V. Kennedy

Type: E-Publication Only

Abstract Number: e18505

Pipeline

Presentation Title

Lead Author

Presentation Details

Trial in progress: Phase 1 study of the selective protein degrader ASP4396 in patients with locally advanced or metastatic solid tumors with KRAS G12D mutation

Shiraj Sen

Type: Poster Presentation

Abstract Number: TPS3178

Date: June 2, 2025, 1:30 – 4:30pm CDT