# EV-303 / KEYNOTE-905

Source: https://onco.cc/trials/ev-303/  
OnCo record `ev-303` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

For patients who cannot have cisplatin, the ADC-immunotherapy pair around surgery cut the risk of recurrence or death by 60% and the risk of death by half.

## Summary

EV-303, also KEYNOTE-905, trial NCT03924895 sponsored by Astellas, Pfizer and Merck and reported at ESMO 2025 and in the New England Journal of Medicine, showed that for patients with muscle-invasive bladder cancer who cannot have cisplatin, perioperative enfortumab vedotin plus pembrolizumab around cystectomy cut the risk of recurrence or death by sixty percent and the risk of death by half. It randomised 344 patients, met its primary event-free survival endpoint, improved overall survival and raised the pathologic complete response rate from under a tenth to more than half, the largest effect yet seen in a perioperative bladder trial, leading to FDA approval in November 2025. Whether responders can keep their bladders is the open question.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-07
- Also known as: EV-303; KEYNOTE-905
- Registry id: NCT03924895
- Phase: 3
- Setting: Cisplatin-ineligible MIBC: perioperative enfortumab vedotin + pembrolizumab with cystectomy vs cystectomy alone
- Sponsor: Astellas / Pfizer / Merck
- Enrolled: 344
- Result: EFS HR 0.40; OS HR 0.50; pCR 57.1% vs 8.6%.
- Outcomes: Event-free survival: EV + pembrolizumab, perioperative vs Cystectomy alone, HR 0.4; Overall survival: EV + pembrolizumab vs Cystectomy alone, HR 0.5; Pathologic complete response: EV + pembrolizumab 57.1% vs Cystectomy alone 8.6%
- Replication: EV-304 (cisplatin-eligible) reported positive EFS, OS, and pCR versus neoadjuvant chemotherapy in December 2025, confirming the perioperative EV + pembrolizumab effect in a second population.

## Sources

- ClinicalTrials.gov NCT03924895: https://clinicaltrials.gov/study/NCT03924895
- FDA approval (Nov 2025): https://www.cancernetwork.com/view/fda-oks-pembrolizumab-enfortumab-vedotin-in-muscle-invasive-bladder-cancer

## Connected records

- collections: [CancerNetwork (ONCOLOGY)](https://onco.cc/collections/src-cancer-network/)
- cancers: [Bladder & urothelial cancer](https://onco.cc/cancers/urothelial/)
- technologies: [Antibody-drug conjugate (ADC)](https://onco.cc/technologies/adc/)
- targets: [Nectin-4](https://onco.cc/targets/nectin4/)
- drugs: [Enfortumab vedotin](https://onco.cc/drugs/enfortumab-vedotin/), [Pembrolizumab](https://onco.cc/drugs/pembrolizumab/)
- companies: [Astellas](https://onco.cc/companies/astellas/)
- terms: [Neoadjuvant / adjuvant / perioperative](https://onco.cc/terms/neoadjuvant-adjuvant/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)
- pairings: [Enfortumab vedotin + pembrolizumab across the bladder cancer continuum](https://onco.cc/pairings/ev-pembro-continuum/)
- ideas: [Bladder preservation for MIBC after perioperative EV + pembrolizumab complete response](https://onco.cc/ideas/idea-bladder-preservation-mibc/)

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