Three years out from enrollment, roughly twice as many patients treated with enfortumab vedotin plus pembrolizumab were alive compared with those who received platinum-based chemotherapy in the EV-302 trial. That durability number is the thread running through Astellas’ 21 abstracts at ESMO 2026 in Madrid, where the company’s presentations span bladder, gastric, prostate, lung, and pancreatic cancers across the week of October 23.
The EV-302 data at ESMO represent the longest follow-up reported to date in locally advanced or metastatic urothelial cancer for this combination, with additional analyses breaking out older patients, those with comorbidities, and disease-specific subgroups. Two trials-in-progress presentations add a different dimension: EV-209 (a Phase 2 single-arm study) and the Phase 3 EV-309 are testing enfortumab vedotin plus pembrolizumab specifically for bladder preservation in muscle-invasive disease, an endpoint that shifts the conversation from survival extension to organ retention. A ctDNA analysis from KEYNOTE-B15 also runs in parallel, giving investigators a potential biomarker lens on neoadjuvant and adjuvant treatment response in cisplatin-eligible patients.
The zolbetuximab presentations take a different angle. Rather than new efficacy readouts, they concentrate on CLDN18.2 testing methodology, patient identification in clinical practice, and early real-world use patterns. That focus makes sense: SPOTLIGHT trial data already showed a hazard ratio of 0.75 for overall survival versus placebo with mFOLFOX6 in CLDN18.2-positive gastric cancer, but translating a biomarker-driven approval into routine oncology practice depends on reliable, consistent patient selection. How consistently centers are actually running CLDN18.2 testing is the operational question these presentations begin to answer.
On the pipeline side, Phase 3 trials of setidegrasib in KRAS G12D-mutated pancreatic and non-small cell lung cancers are presented as trials-in-progress, alongside early-phase studies of ASP5834 and ASP546C targeting KRAS-altered and CLDN18.2-expressing tumors. The practical marker to watch from Madrid is the bladder preservation data from KEYNOTE-905: that ad hoc analysis of cisplatin-ineligible muscle-invasive patients is presented as a proffered paper, and if the organ-preservation signal holds, it will complicate how surgeons and oncologists jointly sequence treatment in a population where radical cystectomy currently sets the standard.
EV-302: the facts in one place
- Also written: KEYNOTE-A39, EV302
- Sponsor: Astellas Pharma Global Development, Inc.; Seagen Inc. (now Pfizer); Merck
- Mechanism: Nectin-4-directed antibody-drug conjugate (enfortumab vedotin-ejfv) plus PD-1 immune checkpoint inhibitor (pembrolizumab)
- Indication studied: First-line locally advanced or metastatic urothelial carcinoma
- Phase: Phase 3
- Enrollment: 886
- Primary endpoint: Progression-free survival (PFS) and overall survival (OS) (co-primary endpoints)
- Headline result: Median OS 33.6 months vs 15.9 months (HR 0.53); median PFS 12.5 months vs 6.3 months (HR ~0.45) versus platinum-based chemotherapy at median follow-up of 42.8 months
- Registry identifier: NCT04223856
- Current status: FDA traditional approval granted December 15, 2023 for first-line la/mUC regardless of cisplatin eligibility; considered standard of care.
- FDA traditional approval: December 15, 2023
- Initial results presented at ESMO Congress 2023: October 22, 2023
- Publication in New England Journal of Medicine (Powles et al.): March 7, 2024
- Updated 3.5-year follow-up data presented at ASCO Annual Meeting: May 27, 2026
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
