## Enfortumab Vedotin plus Pembrolizumab Shows Promise in Muscle-Invasive Bladder Cancer
In the interim analysis of the phase 3 EV-304 clinical trial, enfortumab vedotin (Padcev; astellas Pharma Inc), a Nectin-4 directed antibody-drug conjugate, in combination with pembrolizumab (Keytruda; merck & co), a PD-1 inhibitor, demonstrated positive results among patients with muscle-invasive bladder cancer (MIBC) who are eligible for cisplatin-based chemotherapy.This ongoing,open-label,randomized,controlled clinical trial is evaluating the combination’s use as a neoadjuvant and adjuvant treatment compared to standard-of-care neoadjuvant chemotherapy among this patient population.1
“Building on the recent US approval for cisplatin-ineligible patients living with MIBC, these positive EV-304 findings reinforce the potential of [enfortumab vedotin] plus pembrolizumab to improve survival.
Image credit: Matthieu | stock.adobe.com
1 Data on file, astellas. EV-304 interim analysis.
Enfortumab Vedotin Plus Pembrolizumab Improves Survival in Bladder Cancer
New data presented at the 2025 Genitourinary Cancers Symposium demonstrate that the combination of enfortumab vedotin and pembrolizumab substantially improves survival in patients with muscle-invasive bladder cancer (MIBC), nonetheless of cisplatin eligibility.1
The EV-304 trial showed a 42% reduction in the risk of disease progression or death with the combination therapy compared to standard neoadjuvant chemotherapy followed by radical cystectomy.1 The positive EV-304 data, together with results from the EV-303 trial, support the potential of this combination in earlier-stage bladder cancer. In EV-303, enfortumab vedotin plus pembrolizumab significantly improved event-free survival and overall survival compared to surgery alone. The findings suggest that the combination could become a new platinum-free standard of care for earlier bladder cancer.1
“The EV-304 results represent a key milestone in the new era of urothelial cancer treatment. Together, the EV-303 and EV-304 results show that perioperative enfortumab vedotin plus pembrolizumab can positively impact the treatment journey for patients with MIBC, offering meaningful survival gains across cisplatin-ineligible and cisplatin-eligible patients, signaling a shift from conventional platinum-based chemotherapy and the potential to transform the standard of care,” Chatterjee-Kishore said in the news release.1
REFERENCES
1. PADCEV™ Plus Keytruda® Significantly Improves Survival for Patients with Muscle-Invasive Bladder Cancer Regardless of Cisplatin Eligibility. News release. Astellas. December 17, 2025. Accessed December 18,2025. https://www.astellas.com/en/newsroom/news-releases/2025/december/padcev-plus-keytruda-significantly-improves-survival-patients-muscle-invasive-bladder-cancer-regardless-cisplatin-eligibility
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