Astellas to Present Data on Long-Term Outcomes and Clinical Use of Its Portfolio Across Disease Stages at ASCO 2026

Rhea-AI Summary

Astellas (NYSE:PFE) will present 10 oncology-related abstracts at the ASCO 2026 meeting, including two oral presentations, covering urothelial carcinoma, prostate cancer, women’s health and pipeline programs.

Data span long-term outcomes, quality of life, subgroup analyses, and a trial-in-progress of fezolinetant and TROP2-targeted ADC ASP2998.

AI-generated analysis. Not financial advice.

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Key Figures

ASCO 2026 abstracts: 10 abstracts EV-302 follow-up: 3.5-year follow-up EV-302 phase: Phase 3 +5 more

8 metrics

ASCO 2026 abstracts 10 abstracts Astellas oncology portfolio presentations at ASCO 2026

EV-302 follow-up 3.5-year follow-up Phase 3 EV-302 (KEYNOTE-A39) urothelial carcinoma study

EV-302 phase Phase 3 EV-302 study of enfortumab vedotin plus pembrolizumab

KEYNOTE-905 phase Phase 3 KEYNOTE-905 neoadjuvant/adjuvant bladder cancer study

KEYNOTE-B15 phase Phase 3 KEYNOTE-B15 neoadjuvant-adjuvant bladder cancer trial

HIGHLIGHT 1 phase Phase 3 Fezolinetant trial in women with stage 0–3 HR+ breast cancer

ASP2998 trial phase Phase 1b/2 ASP2998 TROP2-targeted ADC study in solid tumors

ASCO 2026 dates May 29–June 2, 2026 American Society of Clinical Oncology Annual Meeting

Market Reality Check

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Peers on Argus

PFE is down 1.63%. Key peers mostly declined: GILD -2.04%, AMGN -2.82%, SNY -0.7...

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Historical Context

5 past events · Latest: May 13 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
May 13	EU drug approval	Positive	+0.3%	EU approval expanding HYMPAVZI use in hemophilia A or B with inhibitors.
May 05	Earnings and guidance	Positive	+0.6%	Q1 2026 results with $14.5B revenue and reaffirmed full‑year guidance.
Apr 29	Clinical trial success	Positive	-0.8%	ELREXFIO Phase 3 trial met primary PFS endpoint vs DPd regimen.
Apr 28	Patent settlements	Positive	-1.2%	VYNDAMAX patent settlements extending effective U.S. expiry to June 1, 2031.
Apr 24	Access/price strategy	Positive	+1.2%	Eliquis added to Mark Cuban Cost Plus platform at $345 per 30‑day supply.

Pattern Detected

Recent positive regulatory and clinical updates often led to modest gains, but some favorable clinical and IP news saw negative reactions, indicating mixed pricing of good news.

Recent Company History

Over the last month, Pfizer reported multiple positive developments. The European Commission approved HYMPAVZI for hemophilia A/B with inhibitors, and Q1 2026 revenue of $14.5B came with reaffirmed full‑year guidance. ELREXFIO achieved a significant progression‑free survival benefit in multiple myeloma, while VYNDAMAX patent settlements extended effective U.S. exclusivity to June 1, 2031. Access expansion for Eliquis via Mark Cuban Cost Plus further supported the portfolio. The current Astellas ASCO news is unrelated but sits against this backdrop of steady Pfizer pipeline and commercial updates.

Market Pulse Summary

This announcement highlights Astellas’ broad oncology and women’s health presence at ASCO 2026, with...

Analysis

This announcement highlights Astellas’ broad oncology and women’s health presence at ASCO 2026, with 10 abstracts spanning urothelial carcinoma, prostate cancer, vasomotor symptoms in breast cancer, and a TROP2‑targeted antibody‑drug conjugate. While the news centers on Astellas rather than Pfizer, it underscores ongoing innovation and competitive activity in oncology. Against Pfizer’s recent approvals, patent extensions to 2031, and positive Phase 3 data, investors may watch how cross‑company trial results shape therapeutic standards and market share over time.

Key Terms

urothelial carcinoma, phase 3, neoadjuvant, adjuvant, +4 more

8 terms

urothelial carcinoma medical

"In urothelial cancer, a key highlight will be a 3.5-year follow-up..."

Urothelial carcinoma is a type of cancer that starts in the urothelial cells lining the bladder and other parts of the urinary tract; imagine the inner lining of a pipe developing patches of damage that grow into invasive tissue. It matters to investors because its prevalence, available treatments, and clinical trial outcomes drive demand for new drugs, influence regulatory approvals and reimbursement decisions, and can materially affect the revenue and valuation of companies developing therapies.

phase 3 medical

"...3.5-year follow-up oral presentation from the Phase 3 EV-302 study..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

neoadjuvant medical

"Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin..."

"Neoadjuvant" describes treatments or interventions that are given before the main or primary procedure, such as surgery or a major decision. It’s like preparing the ground before planting seeds, aiming to improve the final outcome. For investors, understanding neoadjuvant approaches can provide insight into how companies enhance results or effectiveness in their processes or products.

adjuvant medical

"Health-related quality of life with neoadjuvant and adjuvant enfortumab vedotin..."

An adjuvant is an ingredient added to a vaccine or other therapy to strengthen or shape the body’s response to the main active component, like a helper that makes the primary ingredient work better or longer. For investors, adjuvants matter because they can change how well a product performs, alter dosing and safety profiles, affect regulatory review, and therefore influence clinical success, market size and competitive advantage.

androgen-deprivation therapy (adt) medical

"Outcomes with androgen-deprivation therapy (ADT) plus androgen receptor pathway..."

Androgen-deprivation therapy (ADT) is a medical treatment that lowers or blocks male hormones that fuel certain cancers, most commonly prostate cancer, like turning down a faucet that feeds tumor growth. It matters to investors because ADT drives demand for drugs, devices and follow-up care, influences clinical trial outcomes and regulatory decisions, and can meaningfully affect a company’s revenue and long-term market potential in oncology.

androgen receptor pathway inhibitors (arpis) medical

"Outcomes with androgen-deprivation therapy (ADT) plus androgen receptor pathway inhibitors (ARPIs)..."

Androgen receptor pathway inhibitors (ARPIs) are medicines that block the cellular “antenna” that senses male hormones, cutting off growth signals many prostate cancer cells rely on. For investors, ARPIs matter because clinical trial outcomes, regulatory approvals, patent life and competition directly affect a developer’s future sales and valuation—similar to how winning rights to a key resource can make or break a business’s profits.

vasomotor symptoms medical

"...efficacy of fezolinetant for treatment of moderate to severe vasomotor symptoms (hot flashes)..."

Vasomotor symptoms are sudden feelings of intense heat, often with sweating and rapid heartbeat, commonly known as hot flashes and night sweats; they occur when the body’s mechanism for controlling blood vessel widening and narrowing becomes unstable. Investors should care because these symptoms affect large patient groups and drive demand for treatments, influence clinical trial design and regulatory decisions, and can materially affect sales and market value of therapies addressing quality-of-life conditions—think of them as a thermostat malfunction that creates a clear medical market need.

trophoblast cell-surface antigen 2 (trop2) medical

"ASP2998, a trophoblast cell-surface antigen 2 (TROP2)–targeted immunostimulatory..."

Trophoblast cell-surface antigen 2 (Trop2) is a protein found on the surface of many types of human cells that is often present at much higher levels on cancer cells; think of it as a distinctive flag tumors can wear. For investors, Trop2 matters because it is a common drug target and biomarker: therapies or tests that successfully use Trop2 can drive clinical value, affect trial outcomes, regulatory decisions and ultimately influence a company’s commercial prospects and stock value.

AI-generated analysis. Not financial advice.

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10 abstracts, including two oral presentations, reinforce Astellas' long-term commitment to advancing oncology care

TOKYO, May 18, 2026 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced it will present new data across its oncology portfolio at the 2026 American Society of Clinical Oncology (ASCO) 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.

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, 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 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

About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.

About the Pfizer, Astellas and Merck Collaboration
Seagen and Astellas previously entered a clinical collaboration agreement with Merck to evaluate the combination of Seagen's and Astellas' PADCEV^® (enfortumab vedotin-ejfv) and Merck's KEYTRUDA^® (pembrolizumab) in patients with previously untreated metastatic urothelial cancer and in patients with muscle-invasive bladder cancer (MIBC). Pfizer Inc. successfully completed its acquisition of Seagen on December 14, 2023. KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Rahway, NJ, USA (known as MSD outside of the United States and Canada).

About XTANDI and 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. Pfizer receives alliance revenues as a share of U.S. profits and receives royalties on sales outside the U.S.

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.

PADCEV Important Safety Information 

BOXED WARNING: SERIOUS SKIN REACTIONS

• PADCEV (enfortumab vedotin-ejfv) can cause severe and fatal cutaneous adverse reactions including Stevens-Johnson syndrome (SJS) and Toxic Epidermal Necrolysis (TEN), which occurred predominantly during the first cycle of treatment, but may occur later.
• Closely monitor patients for skin reactions.
• Immediately withhold PADCEV and consider referral for specialized care for suspected SJS or TEN or severe skin reactions.
• Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.

INDICATIONS

PADCEV, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, as neoadjuvant treatment and then continued after cystectomy as adjuvant treatment, is indicated for the treatment of adult patients with muscle invasive bladder cancer (MIBC) who are ineligible for cisplatin-containing chemotherapy.

PADCEV, in combination with pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph, is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer (mUC).

PADCEV, as a single agent, is indicated for the treatment of adult patients with locally advanced or mUC who:

• have previously received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and platinum-containing chemotherapy, or
• are ineligible for cisplatin-containing chemotherapy and have previously received one or more prior lines of therapy.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Skin reactions Severe cutaneous adverse reactions, including fatal cases of SJS or TEN occurred in patients treated with PADCEV. SJS and TEN occurred predominantly during the first cycle of treatment but may occur later.

Skin reactions occurred in 61% (all grades) of the 167 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC in clinical trials. The majority of skin reactions that occurred included rash and maculo-papular rash. Grade 3-4 skin reactions occurred in 10% of patients (Grade 3: 9%, Grade 4: 1.2%), including rash, maculo-papular rash, toxic skin eruption, dermatitis exfoliative generalized, erythema, exfoliative rash, skin toxicity, toxic epidermal necrolysis, and toxic erythema of chemotherapy. A fatal reaction of toxic epidermal necrolysis occurred in one patient (0.6%). The median time to onset of severe skin reactions was 0.6 months (range: 0.2 to 8.8 months). Skin reactions led to discontinuation of PADCEV in 10% of patients. Of the patients who experienced a skin reaction and had data regarding resolution (n=102), 83% had complete resolution and 17% had residual skin reactions at their last evaluation. Of the patients with residual skin reactions at last evaluation, 29% (5/17) had Grade ≥2 skin reactions.

Skin reactions occurred in 70% (all grades) of the 564 patients treated with PADCEV in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC in clinical trials. The majority of skin reactions that occurred included maculo-papular rash, macular rash, and papular rash. Grade 3-4 skin reactions occurred in 17% of patients (Grade 3: 16%, Grade 4: 1%), including maculo-papular rash, bullous dermatitis, dermatitis, exfoliative dermatitis, pemphigoid, rash, erythematous rash, macular rash, and papular rash. A fatal reaction of bullous dermatitis occurred in one patient (0.2%). The median time to onset of severe skin reactions was 1.7 months (range: 0.1 to 17.2 months). Skin reactions led to discontinuation of PADCEV in 6% of patients. Of the patients who experienced a skin reaction and had data regarding resolution (n= 391), 59% had complete resolution and 41% had residual skin reactions at their last evaluation. Of the patients with residual skin reactions at last evaluation, 27% (43/159) had Grade ≥2 skin reactions.

Skin reactions occurred in 58% (all grades) of the 720 patients treated with PADCEV as a single agent in clinical trials. Twenty-three percent (23%) of patients had maculo-papular rash and 34% had pruritus. Grade 3-4 skin reactions occurred in 14% of patients, including maculo-papular rash, erythematous rash, rash or drug eruption, symmetrical drug-related intertriginous and flexural exanthema (SDRIFE), bullous dermatitis, exfoliative dermatitis, and palmar-plantar erythrodysesthesia. The median time to onset of severe skin reactions was 0.6 months (range: 0.1 to 8 months). Among patients experiencing a skin reaction leading to dose interruption who then restarted PADCEV (n=75), 24% of patients restarting at the same dose and 24% of patients restarting at a reduced dose experienced recurrent severe skin reactions. Skin reactions led to discontinuation of PADCEV in 3.1% of patients. Of the patients who experienced a skin reaction and had data regarding resolution (n=328), 58% had complete resolution and 42% had residual skin reactions at their last evaluation. Of the patients with residual skin reactions at last evaluation, 39% (53/137) had Grade ≥2 skin reactions.

Monitor patients closely throughout treatment for skin reactions. Consider topical corticosteroids and antihistamines, as clinically indicated. For persistent or recurrent Grade 2 skin reactions, consider withholding PADCEV until Grade ≤1. Withhold PADCEV and refer for specialized care for suspected SJS, TEN or for Grade 3 skin reactions. Permanently discontinue PADCEV in patients with confirmed SJS or TEN; or Grade 4 or recurrent Grade 3 skin reactions.

Hyperglycemia and diabetic ketoacidosis (DKA), including fatal events, occurred in patients with and without pre‑existing diabetes mellitus, treated with PADCEV. Patients with baseline hemoglobin A1C ≥8% were excluded from clinical trials. In clinical trials of PADCEV as a single agent, 17% of the 720 patients treated with PADCEV developed hyperglycemia of any grade; 7% of patients developed Grade 3-4 hyperglycemia (Grade 3: 6.5%, Grade 4: 0.6%). Fatal events of hyperglycemia and diabetic ketoacidosis occurred in one patient each (0.1%). The incidence of Grade 3-4 hyperglycemia increased consistently in patients with higher body mass index and in patients with higher baseline A1C. The median time to onset of hyperglycemia was 0.5 months (range: 0 to 20 months). Hyperglycemia led to discontinuation of PADCEV in 0.7% of patients. Five percent (5%) of patients required initiation of insulin therapy for treatment of hyperglycemia. Of the patients who initiated insulin therapy for treatment of hyperglycemia, 66% (23/35) discontinued insulin by the time of last evaluation. Closely monitor blood glucose levels in patients with, or at risk for, diabetes mellitus or hyperglycemia. If blood glucose is elevated (>250 mg/dL), withhold PADCEV.

Pneumonitis/Interstitial lung disease (ILD) Severe, life-threatening or fatal pneumonitis/ILD occurred in patients treated with PADCEV.

When PADCEV was given in combination with intravenous pembrolizumab for the treatment of MIBC, 4.2% of the 167 patients had pneumonitis/ILD of any grade. All events were Grade 1-2. The median time to onset of any grade pneumonitis/ILD was 2.5 months (range: 1.9 to 9.7 months).

When PADCEV was given in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC, 10% of the 564 patients had pneumonitis/ILD of any grade and 4% had Grade 3-4. A fatal event of pneumonitis/ILD occurred in two patients (0.4%). The median time to onset of any grade pneumonitis/ILD was 4 months (range: 0.3 to 26 months).

In clinical trials of PADCEV as a single agent, 3% of the 720 patients treated with PADCEV had pneumonitis/ILD of any grade and 0.8% had Grade 3-4. The median time to onset of any grade pneumonitis/ILD was 2.9 months (range: 0.6 to 6 months).

Monitor patients for signs and symptoms indicative of pneumonitis/ILD such as hypoxia, cough, dyspnea or interstitial infiltrates on radiologic exams. Evaluate and exclude infectious, neoplastic and other causes for such signs and symptoms through appropriate investigations. Withhold PADCEV for patients who develop Grade 2 pneumonitis/ILD and consider dose reduction. Permanently discontinue PADCEV in all patients with Grade 3 or 4 pneumonitis/ILD.

Peripheral neuropathy (PN) When PADCEV was given in combination with intravenous pembrolizumab for the treatment of MIBC, 39% of the 167 patients had PN of any grade, 12% had Grade 2 neuropathy, and 3% had Grade 3 neuropathy. The median time to onset of Grade ≥2 PN was 4.7 months (range: 0.2 to 11 months). Of the patients who experienced neuropathy and had data regarding resolution (n=65), 32% had complete resolution, and 68% of patients had residual neuropathy at last evaluation. Of the patients with residual neuropathy at last evaluation, 27% (12/44) had Grade ≥2 neuropathy.

When PADCEV was given in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC, 67% of the 564 patients had PN of any grade, 36% had Grade 2 neuropathy, and 7% had Grade 3 neuropathy. The median time to onset of Grade ≥2 PN was 6 months (range: 0.3 to 25 months). Of the patients who experienced neuropathy and had data regarding resolution (n= 373), 13% had complete resolution, and 87% of patients had residual neuropathy at last evaluation. Of the patients with residual neuropathy at last evaluation, 45% (146/326) had Grade ≥2 neuropathy.

PN occurred in 53% of the 720 patients treated with PADCEV as a single agent in clinical trials including 38% with sensory neuropathy, 8% with muscular weakness, and 7% with motor neuropathy. Thirty percent of patients experienced Grade 2 reactions and 5% experienced Grade 3-4 reactions. PN occurred in patients treated with PADCEV with or without preexisting PN. The median time to onset of Grade ≥2 PN was 4.9 months (range: 0.1 to 20 months). Neuropathy led to treatment discontinuation in 6% of patients. Of the patients who experienced neuropathy who had data regarding resolution (n= 296), 11% had complete resolution, and 89% had residual neuropathy at the time of their last evaluation. Of the patients with residual neuropathy at last evaluation, 50% (132/262) had Grade ≥2 neuropathy.

Monitor patients for symptoms of new or worsening PN and consider dose interruption or dose reduction of PADCEV when PN occurs. Permanently discontinue PADCEV in patients who develop Grade >3 PN.

Ocular disorders were reported in 40% of the 384 patients treated with PADCEV as a single agent in clinical trials in which ophthalmologic exams were scheduled. The majority of these events involved the cornea and included events associated with dry eye such as keratitis, blurred vision, increased lacrimation, conjunctivitis, limbal stem cell deficiency, and keratopathy. Dry eye symptoms occurred in 30% of patients, and blurred vision occurred in 10% of patients, during treatment with PADCEV. The median time to onset to symptomatic ocular disorder was 1.7 months (range: 0 to 30.6 months). Monitor patients for ocular disorders. Consider artificial tears for prophylaxis of dry eyes and ophthalmologic evaluation if ocular symptoms occur or do not resolve. Consider treatment with ophthalmic topical steroids, if indicated after an ophthalmic exam. Consider dose interruption or dose reduction of PADCEV for symptomatic ocular disorders.

Infusion site extravasation Skin and soft tissue reactions secondary to extravasation have been observed after administration of PADCEV. Of the 720 patients treated with PADCEV as a single agent in clinical trials, 1% of patients experienced skin and soft tissue reactions, including 0.3% who experienced Grade 3-4 reactions. Reactions may be delayed. Erythema, swelling, increased temperature, and pain worsened until 2-7 days after extravasation and resolved within 1-4 weeks of peak. Two patients (0.3%) developed extravasation reactions with secondary cellulitis, bullae, or exfoliation. Ensure adequate venous access prior to starting PADCEV and monitor for possible extravasation during administration. If extravasation occurs, stop the infusion and monitor for adverse reactions.

Embryo-fetal toxicity PADCEV can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risk to the fetus. Advise female patients of reproductive potential to use effective contraception during PADCEV treatment and for 2 months after the last dose. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with PADCEV and for 4 months after the last dose.

ADVERSE REACTIONS

Most common adverse reactions, including laboratory abnormalities (≥20%):

• PADCEV in combination with intravenous pembrolizumab for the treatment of MIBC: increased glucose, decreased hemoglobin, increased aspartate aminotransferase (AST), rash, increased alanine aminotransferase (ALT), fatigue, pruritus, increased creatinine, decreased sodium, decreased lymphocytes, peripheral neuropathy, increased potassium, alopecia, dysgeusia, diarrhea, decreased appetite, constipation, nausea, decreased phosphate, urinary tract infection, dry eye, and decreased weight.
• PADCEV in combination with intravenous pembrolizumab for the treatment of locally advanced or mUC: increased AST, increased creatinine, rash, increased glucose, peripheral neuropathy, increased lipase, decreased lymphocytes, increased ALT, decreased hemoglobin, fatigue, decreased sodium, decreased phosphate, decreased albumin, pruritus, diarrhea, alopecia, decreased weight, decreased appetite, increased urate, decreased neutrophils, decreased potassium, dry eye, nausea, constipation, increased potassium, dysgeusia, urinary tract infection, and decreased platelets.
• PADCEV as a single agent: increased glucose, increased AST, decreased lymphocytes, increased creatinine, rash, fatigue, peripheral neuropathy, decreased albumin, decreased hemoglobin, alopecia, decreased appetite, decreased neutrophils, decreased sodium, increased ALT, decreased phosphate, diarrhea, nausea, pruritus, increased urate, dry eye, dysgeusia, constipation, increased lipase, decreased weight, decreased platelets, abdominal pain, and dry skin.

EV-303 Study: Patients with cisplatin-ineligible MIBC (PADCEV in combination with intravenous pembrolizumab)

• Neoadjuvant phase: Of a total of 167 patients, serious adverse reactions occurred in 27% of patients receiving PADCEV in combination with intravenous pembrolizumab. The most frequent (≥2%) serious adverse reactions were urinary tract infection (3.6%) and hematuria (2.4%). Fatal adverse reactions occurred in 1.2% of patients including myasthenia gravis and toxic epidermal necrolysis (0.6% each). Additional fatal adverse reactions were reported in 2.7% of patients in the post-surgery phase before adjuvant treatment started, including sepsis and intestinal obstruction (1.4% each). Adverse reactions leading to discontinuation of PADCEV occurred in 22% of patients. The most common adverse reactions (≥1%) leading to discontinuation of PADCEV were rash (4.8%), peripheral neuropathy (2.4%), and diarrhea, dysgeusia, fatigue, pruritus, and toxic epidermal necrolysis (1.2% each). Adverse reactions leading to dose interruption of PADCEV occurred in 29% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were rash (8%), neutropenia (3.6%), and hyperglycemia (3%), and fatigue and peripheral neuropathy (2.4% each). Adverse reactions leading to dose reduction of PADCEV occurred in 13% of patients. The most common adverse reactions (≥1%) leading to dose reduction of PADCEV were rash (4.8%), pruritus (1.8%), and peripheral neuropathy, increased alanine aminotransferase, increased aspartate aminotransferase, decreased appetite, fatigue, neutropenia, and decreased weight (1.2% each). Seven (4.2%) patients did not receive surgery due to adverse reactions. The adverse reactions that led to cancellation of surgery were acute myocardial infarction, bile duct cancer, colon cancer, respiratory distress, urinary tract infection and deaths due to myasthenia gravis and toxic epidermal necrolysis (0.6% each). Of the 146 patients who received neoadjuvant treatment with PADCEV in combination with intravenous pembrolizumab and underwent RC, 6 (4.1%) patients experienced delay of surgery due to adverse reactions.
• Adjuvant phase: Of the 149 patients who underwent surgery, 100 patients received adjuvant treatment with PADCEV in combination with intravenous pembrolizumab. Of the 49 patients who did not receive adjuvant treatment, discontinuation of treatment with PADCEV in combination with intravenous pembrolizumab prior to the adjuvant phase was due to an adverse event in 21 patients. Serious adverse reactions occurred in 43% of patients receiving PADCEV in combination with pembrolizumab. The most frequent (≥2%) serious adverse reactions were urinary tract infection (8%), acute kidney injury and pyelonephritis (5% each), urosepsis (4%), and hypokalemia, intestinal obstruction, and sepsis (2% each). Fatal adverse reactions occurred in 7% of patients, including urosepsis, hemorrhage intracranial, death, myocardial infarction, multiple organ dysfunction syndrome, and pneumonia pseudomonal (1% each). Adverse reactions leading to discontinuation of PADCEV occurred in 26% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were peripheral neuropathy (5%) and rash (4%). Adverse reactions leading to dose interruption of PADCEV occurred in 36% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were rash (6%), diarrhea and urinary tract infection (5% each), fatigue (4%), pruritus (3%), and peripheral neuropathy and pyelonephritis (2% each). Adverse reactions leading to dose reduction of PADCEV occurred in 7% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV was weight decreased (2%).

EV-302 Study: 440 patients with previously untreated la/mUC (PADCEV in combination with intravenous pembrolizumab)

Serious adverse reactions occurred in 50% of patients treated with PADCEV in combination with intravenous pembrolizumab. The most common serious adverse reactions (≥2%) were rash (6%), acute kidney injury (5%), pneumonitis/ILD (4.5%), urinary tract infection (3.6%), diarrhea (3.2%), pneumonia (2.3%), pyrexia (2%), and hyperglycemia (2%). Fatal adverse reactions occurred in 3.9% of patients treated with PADCEV in combination with intravenous pembrolizumab including acute respiratory failure (0.7%), pneumonia (0.5%), and pneumonitis/ILD (0.2%).

Adverse reactions leading to discontinuation of PADCEV occurred in 35% of patients. The most common adverse reactions (≥2%) leading to discontinuation of PADCEV were PN (15%), rash (4.1%) and pneumonitis/ILD (2.3%). Adverse reactions leading to dose interruption of PADCEV occurred in 73% of patients. The most common adverse reactions (≥2%) leading to dose interruption of PADCEV were PN (22%), rash (16%), COVID-19 (10%), diarrhea (5%), pneumonitis/ILD (4.8%), fatigue (3.9%), hyperglycemia (3.6%), increased ALT (3%) and pruritus (2.5%). Adverse reactions leading to dose reduction of PADCEV occurred in 42% of patients. The most common adverse reactions (≥2%) leading to dose reduction of PADCEV were rash (16%), PN (13%) and fatigue (2.7%).

EV-301 Study: 296 patients previously treated with a PD-1/L1 inhibitor and platinum-based chemotherapy (PADCEV monotherapy)

Serious adverse reactions occurred in 47% of patients treated with PADCEV; the most common (≥2%) were urinary tract infection, acute kidney injury (7% each), and pneumonia (5%). Fatal adverse reactions occurred in 3% of patients, including multiorgan dysfunction (1%), hepatic dysfunction, septic shock, hyperglycemia, pneumonitis/ILD, and pelvic abscess (0.3% each). Adverse reactions leading to discontinuation occurred in 17% of patients; the most common (≥2%) were PN (5%) and rash (4%). Adverse reactions leading to dose interruption occurred in 61% of patients; the most common (≥4%) were PN (23%), rash (11%), and fatigue (9%). Adverse reactions leading to dose reduction occurred in 34% of patients; the most common (≥2%) were PN (10%), rash (8%), decreased appetite, and fatigue (3% each).

EV-201, Cohort 2 Study: 89 patients previously treated with a PD-1/L1 inhibitor and not eligible for cisplatin-based chemotherapy (PADCEV monotherapy)

Serious adverse reactions occurred in 39% of patients treated with PADCEV; the most common (≥3%) were pneumonia, sepsis, and diarrhea (5% each). Fatal adverse reactions occurred in 8% of patients, including acute kidney injury (2.2%), metabolic acidosis, sepsis, multiorgan dysfunction, pneumonia, and pneumonitis/ILD (1.1% each). Adverse reactions leading to discontinuation occurred in 20% of patients; the most common (≥2%) was PN (7%). Adverse reactions leading to dose interruption occurred in 60% of patients; the most common (≥3%) were PN (19%), rash (9%), fatigue (8%), diarrhea (5%), increased AST, and hyperglycemia (3% each). Adverse reactions leading to dose reduction occurred in 49% of patients; the most common (≥3%) were PN (19%), rash (11%), and fatigue (7%).

DRUG INTERACTIONS

Effects of other drugs on PADCEV (Dual P-gp and Strong CYP3A4 Inhibitors)

Concomitant use with dual P-gp and strong CYP3A4 inhibitors may increase unconjugated monomethyl auristatin E exposure, which may increase the incidence or severity of PADCEV toxicities. Closely monitor patients for signs of toxicity when PADCEV is given concomitantly with dual P-gp and strong CYP3A4 inhibitors.

SPECIFIC POPULATIONS

Lactation Advise lactating women not to breastfeed during treatment with PADCEV and for 3 weeks after the last dose.

Hepatic impairment Avoid the use of PADCEV in patients with moderate or severe hepatic impairment.

Full Prescribing Information for PADCEV (enfortumab vedotin-ejfv)

XTANDI Important Safety Information
Indications

XTANDI (enzalutamide) is indicated for the treatment of patients with:

• castration-resistant prostate cancer (CRPC)
• metastatic castration-sensitive prostate cancer (mCSPC)
• nonmetastatic castration‑sensitive prostate cancer (nmCSPC) with biochemical recurrence at high risk for metastasis (high-risk BCR)

Important Safety Information

Warnings and Precautions
Seizure occurred in 0.6% of patients receiving XTANDI in eight randomized clinical trials. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Patients in the study had one or more of the following predisposing factors: use of medications that may lower the seizure threshold, history of traumatic brain or head injury, history of cerebrovascular accident or transient ischemic attack, and Alzheimer's disease, meningioma, or leptomeningeal disease from prostate cancer, unexplained loss of consciousness within the last 12 months, history of seizure, presence of a space occupying lesion of the brain, history of arteriovenous malformation, or history of brain infection. Advise patients of the risk of developing a seizure while taking XTANDI and of engaging in any activity where sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.

Posterior Reversible Encephalopathy Syndrome (PRES) There have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder that can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.

Hypersensitivity reactions, including edema of the face (0.5%), tongue (0.1%), or lip (0.1%) have been observed with XTANDI in eight randomized clinical trials. Pharyngeal edema has been reported in post-marketing cases. Advise patients who experience any symptoms of hypersensitivity to temporarily discontinue XTANDI and promptly seek medical care. Permanently discontinue XTANDI for serious hypersensitivity reactions.

Ischemic Heart Disease In the combined data of five randomized, placebo-controlled clinical studies, ischemic heart disease occurred more commonly in patients on the XTANDI arm compared to patients on the placebo arm (3.5% vs 2%). Grade 3-4 ischemic events occurred in 1.8% of patients on XTANDI versus 1.1% on placebo. Ischemic events led to death in 0.4% of patients on XTANDI compared to 0.1% on placebo. Monitor for signs and symptoms of ischemic heart disease. Optimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue XTANDI for Grade 3-4 ischemic heart disease.

Falls and Fractures occurred in patients receiving XTANDI. Evaluate patients for fracture and fall risk. Monitor and manage patients at risk for fractures according to established treatment guidelines and consider use of bone-targeted agents. In the combined data of five randomized, placebo-controlled clinical studies, falls occurred in 12% of patients treated with XTANDI compared to 6% of patients treated with placebo. Fractures occurred in 13% of patients treated with XTANDI and in 6% of patients treated with placebo.

Embryo-Fetal Toxicity The safety and efficacy of XTANDI have not been established in females. XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI and for 3 months after the last dose of XTANDI.

Dysphagia or Choking Severe dysphagia or choking, including events that could be life-threatening requiring medical intervention or fatal, can occur due to XTANDI product size. Advise patients to take each capsule or tablet whole with a sufficient amount of water to ensure that all medication is successfully swallowed. Consider use of a smaller tablet size of XTANDI in patients who have difficulty swallowing. Discontinue XTANDI for patients who cannot swallow capsules or tablets.  

Interference with Immunoassay Measurement of Digoxin XTANDI can interfere with certain digoxin immunoassays (e.g., Chemiluminescent Microparticle Immunoassays), resulting in falsely elevated digoxin plasma concentration results. Notify the laboratory conducting the digoxin plasma concentration assay to use an appropriate method in patients receiving XTANDI and digoxin.

Adverse Reactions (ARs)
In the data from the five randomized placebo-controlled trials, the most common ARs (≥ 10%) that occurred more frequently (≥ 2% over placebo) in XTANDI-treated patients were musculoskeletal pain, fatigue, hot flush, constipation, decreased appetite, diarrhea, hypertension, hemorrhage, fall, fracture, and headache. In the bicalutamide-controlled study, the most common ARs (≥ 10%) reported in XTANDI-treated patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, diarrhea, upper respiratory tract infection, and weight loss.

In AFFIRM, the placebo-controlled study of metastatic CRPC (mCRPC) patients who previously received docetaxel, Grade 3 and higher ARs were reported among 47% of XTANDI-treated patients. Discontinuations due to ARs were reported for 16% of XTANDI-treated patients. In PREVAIL, the placebo-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to ARs were reported for 6% of XTANDI-treated patients. In TERRAIN, the bicalutamide-controlled study of chemotherapy-naive mCRPC patients, Grade 3-4 ARs were reported in 39% of XTANDI patients and 38% of bicalutamide patients. Discontinuations with an AR as the primary reason were reported for 8% of XTANDI patients and 6% of bicalutamide patients.

In PROSPER, the placebo-controlled study of nonmetastatic CRPC (nmCRPC) patients, Grade 3 or higher ARs were reported in 31% of XTANDI patients and 23% of placebo patients. Discontinuations with an AR as the primary reason were reported for 9% of XTANDI patients and 6% of placebo patients.

In ARCHES, the placebo-controlled study of metastatic CSPC (mCSPC) patients, Grade 3 or higher ARs were reported in 24% of XTANDI-treated patients. Permanent discontinuation due to ARs as the primary reason was reported in 5% of XTANDI patients and 4% of placebo patients.

In EMBARK, the placebo-controlled study of nonmetastatic CSPC (nmCSPC) with high-risk biochemical recurrence (BCR) patients, Grade 3 or higher adverse reactions during the total duration of treatment were reported in 46% of patients treated with XTANDI plus leuprolide, 50% of patients receiving XTANDI as a single agent, and 43% of patients receiving placebo plus leuprolide. Permanent treatment discontinuation due to adverse reactions during the total duration of treatment as the primary reason was reported in 21% of patients treated with XTANDI plus leuprolide, 18% of patients receiving XTANDI as a single agent, and 10% of patients receiving placebo plus leuprolide.

Lab Abnormalities: Lab abnormalities that occurred in ≥ 5% of patients, and more frequently (> 2%) in the XTANDI arm compared to placebo in the pooled, randomized, placebo-controlled studies are hemoglobin decrease, neutrophil count decreased, white blood cell decreased, hyperglycemia, hypermagnesemia, hyponatremia, hypophosphatemia, and hypercalcemia.

Hypertension: In the combined data from five randomized placebo-controlled clinical trials, hypertension was reported in 14.2% of XTANDI patients and 7.4% of placebo patients. Hypertension led to study discontinuation in < 1% of patients in each arm.

Drug Interactions

Effect of Other Drugs on XTANDI Avoid coadministration with strong CYP2C8 inhibitors. If coadministration cannot be avoided, reduce the dosage of XTANDI.

Avoid coadministration with strong CYP3A4 inducers. If coadministration cannot be avoided, increase the dosage of XTANDI.

Effect of XTANDI on Other Drugs Avoid coadministration with certain CYP3A4, CYP2C9, and CYP2C19 substrates for which minimal decrease in concentration may lead to therapeutic failure of the substrate. If coadministration cannot be avoided, increase the dosage of these substrates in accordance with their Prescribing Information. In cases where active metabolites are formed, there may be increased exposure to the active metabolites.

Full Prescribing Information for XTANDI (enzalutamide)

VEOZAH Important Safety Information

INDICATIONS AND USAGE

VEOZAH™ (fezolinetant) is a neurokinin 3 (NK3) receptor antagonist indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

IMPORTANT SAFETY INFORMATION

WARNING: RISKS OF HEPATOTOXICITY

Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting. Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory. Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment. Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain). Discontinue VEOZAH if transaminase elevations are > 5x ULN, or if transaminase elevations are > 3x ULN and the total bilirubin level is > 2x ULN. If transaminase elevations > 3x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution.

CONTRAINDICATIONS

VEOZAH is contraindicated in women with any of the following: • Known cirrhosis • Severe renal impairment or end-stage renal disease • Concomitant use with CYP1A2 inhibitors

WARNINGS AND PRECAUTIONS

Hepatotoxicity

In 3 clinical trials, elevations in serum transaminase [alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)] levels > 3x ULN occurred in 2.3% of women receiving VEOZAH and 0.9% of women receiving placebo. No elevations in serum total bilirubin (> 2x ULN) occurred. Women with ALT or AST elevations were generally asymptomatic. Transaminase levels returned to pretreatment levels (or close to these) without sequelae with dose continuation, and upon dose interruption, or discontinuation. Women with cirrhosis were not studied.

In the postmarketing setting, cases of drug-induced liver injury with elevations of ALT, AST, alkaline phosphatase (ALP), and total bilirubin occurred within 40 days of starting VEOZAH. Patients reported a general sense of feeling unwell and symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine. The patients' signs and symptoms gradually resolved after discontinuation of VEOZAH.

Perform baseline hepatic laboratory tests to evaluate for hepatic function and injury [including serum ALT, serum AST, serum ALP, and serum bilirubin (total and direct)] prior to VEOZAH initiation. Do not start VEOZAH if ALT or AST is ≥ 2x ULN or if the total bilirubin is ≥ 2x ULN for the evaluating laboratory.

Perform follow-up hepatic laboratory tests monthly for the first 3 months, at 6 months, and 9 months after initiation of therapy.

See BOXED WARNING for full hepatic laboratory testing protocol and discontinuation criteria. Exclude alternative causes of hepatic laboratory test elevations.

ADVERSE REACTIONS

The most common adverse reactions with VEOZAH ≥ 2% and > placebo (VEOZAH % vs. placebo %) are: abdominal pain (4.3% vs. 2.1%), diarrhea (3.9% vs. 2.6%), insomnia (3.9% vs. 1.8%), back pain (3.0% vs. 2.1%), hot flush (2.5% vs. 1.6%), and hepatic transaminase elevation (2.3% vs. 0.8%).

Full Prescribing Information for VEOZAH (fezolinetant)

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SOURCE Astellas Pharma Inc.

FAQ

What will Astellas (PFE) present at the ASCO 2026 annual meeting?

Astellas will present 10 oncology-related abstracts at ASCO 2026, including two oral presentations. According to Astellas, these cover urothelial carcinoma, prostate cancer, women’s health and pipeline assets, focusing on long-term outcomes, quality of life and clinical practice insights.

Which enfortumab vedotin plus pembrolizumab data from Astellas (PFE) will be shown at ASCO 2026?

Astellas will present 3.5-year follow-up Phase 3 EV-302 (KEYNOTE-A39) data in previously untreated advanced urothelial carcinoma. Additional KEYNOTE-905 and KEYNOTE-B15 subgroup and quality-of-life analyses will explore neoadjuvant and adjuvant use in muscle-invasive bladder cancer across clinically relevant patient groups.

What prostate cancer studies from Astellas (PFE) feature enzalutamide at ASCO 2026?

Astellas will share multiple ARCHES and EMBARK post hoc analyses involving enzalutamide in hormone-sensitive prostate cancer. According to Astellas, topics include predictors of treatment duration, cardiometabolic comorbidities, testosterone recovery after treatment suspension and outcomes in elderly, frail or highly comorbid veterans.

What is the HIGHLIGHT 1 fezolinetant trial Astellas (PFE) is presenting at ASCO 2026?

HIGHLIGHT 1 is a randomized, placebo-controlled Phase 3 study of fezolinetant for vasomotor symptoms in women with stage 0–3 hormone receptor–positive breast cancer on adjuvant endocrine therapy. According to Astellas, this trial-in-progress evaluates efficacy and safety in this specific patient population.

Which pipeline asset from Astellas (PFE) will be highlighted at ASCO 2026?

Astellas will present a trial-in-progress poster on ASP2998, a TROP2-targeted immunostimulatory antibody-drug conjugate with dual payloads. According to Astellas, this Phase 1b/2 study enrolls patients with locally advanced unresectable or metastatic solid tumors to evaluate safety and antitumor activity.