Astellas Pharma Inc. (Tokyo Stock Exchange: 4503) will bring 21 abstracts to the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, running October 23 to 27, the company said in a press release issued October 6. Titles, presenters and time slots are all there. Results are not. The release does not contain a single efficacy or safety figure.

The lineup still tells investors something. Most of it sits behind three marketed drugs: the bladder cancer drug Padcev (enfortumab vedotin), the stomach cancer drug Vyloy (zolbetuximab) and the prostate cancer drug Xtandi (enzalutamide). That mix tracks the problem Astellas is trying to solve. Xtandi brings in roughly $6 billion a year and is set to lose U.S. patent protection in 2027, according to Fierce Pharma. Astellas expects Xtandi revenue to fall 5.3% in the fiscal year ending March 2027 and is counting on five newer “strategic brands,” led by Padcev and Vyloy, to make up the gap.

Padcev Gets the Most Airtime

Nine of the 21 abstracts involve Padcev, mostly paired with Merck’s immunotherapy Keytruda (pembrolizumab). Padcev is an antibody-drug conjugate, or ADC: an antibody that delivers a chemotherapy payload to cells carrying a specific surface protein, in this case Nectin-4. Astellas co-commercializes it with Pfizer.

Astellas says one presentation, a final analysis from the EV-103 study, includes the longest follow-up reported to date in locally advanced or metastatic urothelial cancer. That is the company’s claim. BioTech Stocks Daily could not independently confirm it, and EV-103 is an early-stage Phase 1b/2 study rather than a randomized Phase 3 trial. No survival numbers from it appear in the release.

What EV-302 Already Showed

The bigger Padcev data are already public. In the Phase 3 EV-302 trial in previously untreated advanced urothelial cancer, adding Padcev to Keytruda cut the risk of death by 49% versus chemotherapy at about 2.5 years of median follow-up (hazard ratio 0.51), with median overall survival of 33.8 months versus 15.9 months. A later cut at roughly 3.5 years, reported in May, showed 44.0% of combination patients alive at 42 months versus 24.6% on chemotherapy. Two ESMO posters add exploratory looks at older patients, patients with other illnesses and disease-related subgroups. Exploratory analyses can raise questions. They are not designed to settle them.

The Push Into Earlier Bladder Cancer

Commercially, the more important abstracts cover muscle-invasive bladder cancer, where the tumor has grown into the bladder wall but has not spread. Here the regimen is given before and after surgery to remove the bladder.

The FDA approved that approach in November 2025 for patients who cannot take cisplatin chemotherapy, based on the EV-303 trial. EV-303 showed a 60% reduction in the risk of recurrence, progression or death versus surgery alone, and a 50% reduction in the risk of death. On July 10, 2026, the FDA widened the label to cisplatin-eligible patients based on EV-304, an 808-patient trial against standard gemcitabine-cisplatin chemotherapy. The event-free survival hazard ratio was 0.53. For overall survival it was 0.65.

A note on names. Each of these trials carries two labels: an “EV” number used by Astellas and Pfizer, and a “KEYNOTE” number used by Merck. EV-303 is KEYNOTE-905. EV-304 is KEYNOTE-B15. Same studies.

In Madrid, Astellas will show an ad hoc analysis from EV-303, along with circulating tumor DNA (ctDNA, tumor genetic material picked up in a blood test) and quality-of-life results from EV-304. Two more posters describe trials still enrolling, EV-209 and EV-309, which test whether the combination can let some patients keep their bladders.

Vyloy and the Testing Bottleneck

Vyloy targets claudin 18.2 (CLDN18.2), a protein found on some stomach and gastroesophageal junction (GEJ) tumors. The FDA approved it in October 2024, with chemotherapy, for first-line HER2-negative, CLDN18.2-positive disease. In its two pivotal Phase 3 trials, SPOTLIGHT and GLOW, about 38% of screened patients tested positive.

So the drug only works commercially if doctors test. Both Vyloy abstracts point there: a ctDNA analysis from SPOTLIGHT and real-world use data from a Canadian patient support program. Astellas says they reinforce CLDN18.2-guided treatment decisions. It gave no figures to back that up.

Xtandi Abstracts Lean on Indirect Comparisons

Five abstracts cover Xtandi. Two need a caution flag. One compares the safety of Xtandi and Bayer’s darolutamide indirectly, using data from two separate trials, ARCHES and ARANOTE. Another is a network meta-analysis built from German drug-assessment (AMNOG) dossiers. Neither is a head-to-head study. The trials enrolled different patients under different conditions, so any comparison is suggestive at best.

The Pipeline: Trial Designs Only

Most pipeline entries are “trials in progress” posters. They explain how a study is built. They say nothing about how it is going.

The headliner is setidegrasib (ASP3082), a protein degrader. Rather than blocking the mutant KRAS G12D protein, it flags it for destruction by the cell’s own disposal system. Astellas dosed the first patient in a first-line Phase 3 pancreatic cancer trial in April 2026 and has since opened a second Phase 3 trial in previously treated lung cancer, against docetaxel.

Competition got there first in one setting. On August 26, the FDA approved Revolution Medicines’ (Nasdaq: RVMD) daraxonrasib, sold as Rasonque, for previously treated metastatic pancreatic cancer. It hits multiple forms of RAS rather than G12D alone. Setidegrasib’s pancreatic trial targets newly diagnosed patients, a different setting, but daraxonrasib is being studied earlier in the disease too.

Also listed: ASP5834 in Phase 1, ASP546C (a CLDN18.2-targeting ADC) in Phase 1b/2, and ASP1570 in microsatellite-stable colorectal cancer. ASP1570 is the only pipeline abstract labeled as clinical data rather than a trial design. The release’s highlights skip it entirely.

What Wasn’t Disclosed

None of the 21 abstracts is quantified in the release. No hazard ratios, response rates, follow-up lengths or safety figures. The “durable survival benefit” in its subheadline is Astellas’ own description, and readers will need the Madrid presentations to judge it. The release also gives no word on regulatory filings or sales tied to these data. This article covers conference abstracts and is not medical or investment advice.

Sources

• Astellas Pharma Inc.: Astellas Highlights Data Advancing Cancer Care and Innovation for Patients with Hard-to-Treat Cancers at ESMO 2026, PRNewswire, October 6, 2026. Primary source release.
• U.S. FDA: FDA approves pembrolizumab or pembrolizumab and berahyaluronidase alfa-pmph each with enfortumab vedotin-ejfv for muscle invasive bladder cancer, cited for the July 10, 2026 cisplatin-eligible approval and EV-304 (KEYNOTE-B15) efficacy figures.
• Pfizer: U.S. FDA Approves PADCEV plus Keytruda for Certain Patients with Bladder Cancer, cited for the November 2025 approval in cisplatin-ineligible muscle-invasive bladder cancer.
• Astellas and Pfizer: PADCEV Plus KEYTRUDA, Given Before and After Surgery, Cuts the Risk of Recurrence, Progression or Death by 60%, cited for EV-303 (KEYNOTE-905) results and the Astellas OTC ticker.
• EV-302/KEYNOTE-A39 2.5-year median follow-up (journal abstract via MSK), cited for EV-302 overall survival hazard ratio and medians.
• Pharmacy Times: Enfortumab Vedotin Plus Pembrolizumab Sustains Survival Advantage at 3.5 Years, cited for the 42-month EV-302 survival rates.
• Pharmaceutical Technology: FDA approves Astellas’ VYLOY for gastric cancer treatment, cited for the Vyloy approval and the 38% CLDN18.2 positivity rate.
• Astellas: First Patient Dosed in Phase 3 Study of Setidegrasib in KRAS G12D-Mutated Pancreatic Cancer, cited for setidegrasib’s mechanism and the April 2026 Phase 3 start.
• AGA News: FDA approves first RAS-targeted therapy for metastatic pancreatic cancer, cited for the August 26, 2026 daraxonrasib (Rasonque) approval as competitive context.
• Fierce Pharma: Astellas CEO resists ‘rescue BD’ as $6B Xtandi patent cliff nears, cited for Xtandi’s sales scale and 2027 U.S. patent expiry.
• Fierce Pharma: Astellas counts on new medicines to offset projected Xtandi decline in fiscal 2026, cited for the projected 5.3% Xtandi revenue decline and the strategic-brands plan.

Editorial Disclosure

This article reports on a press release issued by Astellas Pharma Inc. on October 6, 2026, announcing abstracts to be presented at the European Society for Medical Oncology (ESMO) Congress 2026. Securities and corporate structures discussed: Astellas Pharma Inc. (Tokyo Stock Exchange: 4503; OTC: ALPMY), Pfizer Inc. (NYSE: PFE), Merck & Co., Inc. (NYSE: MRK, known as MSD outside the United States and Canada), Bayer AG (Xetra: BAYN) and Revolution Medicines, Inc. (Nasdaq: RVMD). BioTech Stocks Daily has not received, nor will it accept, any compensation, direct or indirect, from Astellas, Pfizer, Merck, Bayer, Revolution Medicines, or any other corporate or third-party sponsor for the preparation or publication of this coverage. No staff member, principal, or affiliate of BioTech Stocks Daily holds a position, option, or financial interest in any of the securities mentioned as of the date of publication. Prior trial results, regulatory approvals, competitive context, and sales figures cited in this article were drawn from the FDA, company releases, peer-reviewed literature, and independent reporting, cited above, since the original release did not include them. Statements regarding the content of forthcoming conference presentations, future clinical trial outcomes, regulatory decisions, patent expirations, revenue projections, and competitive positioning are forward-looking statements. They involve substantial risks, regulatory uncertainties, and scientific variables; actual clinical outcomes, development timelines, and commercial results may differ materially. Biopharmaceutical investments carry a high degree of financial risk. Drug development is subject to high rates of clinical failure, regulatory rejection, and market competition, which can result in the total loss of invested capital. This article is published strictly for independent news reporting, market context, and educational purposes only. It does not constitute an investment recommendation, endorsement, or professional financial, legal, or tax advice. Furthermore, this content is not medical advice; patients and healthcare providers should consult appropriate clinical professionals for medical guidance.

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