On May 18, 2026 Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") reported it will present new data across its oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place May 29 – June 2 in Chicago, reinforcing Astellas’ sustained commitment to improving outcomes for people living with cancer. The data will provide further insight into the durable efficacy of established treatment approaches, their use in clinical practice, and ongoing areas of research and development.
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Urothelial carcinoma
In urothelial cancer, a key highlight will be a 3.5-year follow-up oral presentation from the Phase 3 EV-302 study (also known as KEYNOTE-A39), evaluating enfortumab vedotin in combination with pembrolizumab in previously untreated locally advanced or metastatic disease. These data provide additional insight into the durability of outcomes with this treatment approach in advanced disease, an important consideration in clinical management.
Additional data from multiple studies exploring the use of this combination in earlier settings will be presented during the congress. Together, these findings contribute to a broader understanding of how this treatment approach may be applied across advanced disease settings, as well as across patient subgroups.
Prostate cancer
In advanced prostate cancer, additional analyses from established clinical programs in non-metastatic hormone- (or castration-) sensitive prostate cancer (nmHSPC or nmCSPC) with high-risk biochemical recurrence (BCR) and hormone- (or castration-) sensitive prostate cancer (mHSPC or mCSPC), including EMBARK and ARCHES, will provide further insight into treatment outcomes in patients with varying clinical characteristics, supporting clinical decision-making in practice.
Women’s health
For the first time at ASCO (Free ASCO Whitepaper), Astellas will present an update on HIGHLIGHT 1, a trial-in-progress investigating the safety and efficacy of fezolinetant for the treatment of moderate to severe vasomotor symptoms in women with stage 0 to 3 hormone receptor-positive breast cancer who are receiving adjuvant endocrine therapy. The safety and efficacy of fezolinetant have not been established in this patient population. Fezolinetant is currently approved by the U.S. Food and Drug Administration for the treatment of moderate to severe vasomotor symptoms due to menopause.
Astellas Presentations at the 2026 ASCO (Free ASCO Whitepaper) Annual Meeting
Enfortumab vedotin
Presentation Title
Lead Author
Presentation Details
Enfortumab vedotin plus pembrolizumab vs chemotherapy for previously untreated locally advanced or
metastatic urothelial carcinoma: 3.5-year follow-up and response analyses from the phase 3 EV-302 study
T. Powles
Type: Oral Presentation
Abstract Number: 4507
Date: May 29, 2026, 2:45 PM-5:45 PM CDT
Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in
participants with muscle-invasive bladder cancer who are cisplatin ineligible: Phase 3 KEYNOTE-905 study
P. O’Donnell
Type: Oral Presentation
Abstract Number: 4510
Date: May 30, 2026, 8:00 AM-9:30 AM CDT
Neoadjuvant and adjuvant enfortumab vedotin plus pembrolizumab in participants with cisplatin-ineligible
muscle-invasive bladder cancer: An analysis of clinically relevant subgroups in KEYNOTE-905
N. Adra
Type: Poster Presentation
Abstract Number: 4613
Date: May 31, 2026, 9:00 AM-12:00 PM CDT
Exploratory subgroup outcomes in the phase 3 KEYNOTE-B15 study of neoadjuvant-adjuvant enfortumab
vedotin plus pembrolizumab for participants with muscle-invasive bladder cancer eligible for cisplatin
C. Hoimes
Type: Poster Presentation
Abstract Number: 4614
Date: May 31, 2026, 9:00 AM-12:00 PM CDT
Enzalutamide
Presentation Title
Lead Author
Presentation Details
Predictors of treatment duration in patients with metastatic hormone-sensitive prostate cancer treated with
enzalutamide: a post hoc analysis of ARCHES
A. Armstrong
Type: Poster Presentation
Abstract Number: 5093
Date: May 31, 2026, 9:00 AM-12:00 PM CDT
Efficacy and safety of enzalutamide in patients with metastatic hormone-sensitive prostate cancer and
cardiometabolic comorbidities and/or related concomitant medications: ARCHES post hoc
A. Stenzl
Type: Poster Presentation
Abstract Number: 5092
Date: May 31, 2026, 9:00 AM-12:00 PM CDT
EMBARK: Testosterone recovery to >250 ng/dL following treatment suspension
S. Freedland
Type: Poster Presentation
Abstract Number: 5088
Date: May 31, 2026, 9:00 AM-12:00 PM CDT
Outcomes with androgen-deprivation therapy (ADT) plus androgen receptor pathway inhibitors (ARPIs) in
veterans with de novo metastatic castration-sensitive prostate cancer (mCSPC) who were elderly, frail,
or had high comorbidity: a subgroup analysis of enzalutamide and high-volume disease
M. Schoen
Type: Poster Presentation
Abstract Number: 5094
Date: May 31, 2026, 9:00 AM-12:00 PM CDT
Fezolinetant
Presentation Title
Lead Author
Presentation Details
HIGHLIGHT 1: A randomized, placebo-controlled, double-blind, phase 3 clinical study to investigate the
efficacy and safety of fezolinetant for treatment of moderate to severe vasomotor symptoms (hot flashes)
in women with stage 0 to 3 hormone receptor–positive breast cancer who are receiving adjuvant
endocrine therapy
C. Bouchard
Type: Poster Presentation
Abstract Number: TPS642
Date: June 1, 2026, 1:30 PM-4:30 PM CDT
Pipeline
Presentation Title
Lead Author
Presentation Details
Trial in progress: ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory
antibody-drug conjugate with dual payloads, in patients with locally advanced unresectable or metastatic
solid tumors: A phase 1b/2 study.
G. Sonpavde
Type: Poster Presentation
Abstract Number: TPS2665
Date: May 30, 2026, 1:30 PM-4:30 PM CDT
(Press release, Astellas, MAY 18, 2026, View Source [SID1234665837])