Enfortumab Vedotin-Pembrolizumab’s Role in Muscle-Invasive Bladder Cancer Treatment
Key Points
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Enfortumab vedotin (EV) plus pembrolizumab has emerged as a dominant perioperative systemic therapy for muscle-invasive bladder cancer (MIBC).
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The NIAGARA trial established gemcitabine, cisplatin, and durvalumab as a new standard, but the EV-pembrolizumab regimen may be preferred, especially in cisplatin-ineligible patients.
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Additional clinical trials are needed to determine the most suitable treatment for patients who experience disease recurrence.
During a discussion at an event coinciding with the 2026 ASCO Genitourinary Cancers Symposium, Elias Chandran, MBBS, FRACP, of the National Cancer Institute, and Vishesh Khanna, MD, of Oregon Health & Science University, discussed recent clinical trials and how the data are changing treatment strategies for MIBC.
While the NIAGARA trial established perioperative gemcitabine, cisplatin, and durvalumab as an important advance two years ago, two recent studies demonstrated the significance of enfortumab vedotin combined with pembrolizumab.
In EV-303, the study results showed that the EV-pembrolizumab regimen benefited patients ineligible for cisplatin. Dr. Khanna explained that similar results are anticipated in cisplatin-eligible patients from the EV‑304 trial.
He added that although EV-pembrolizumab is increasingly viewed as a dominant perioperative option for many patients with MIBC, there are two clinical scenarios where he would use caution, such as in patients with brittle diabetes or severe skin conditions.
With EV-pembrolizumab moving into earlier lines of therapy, Dr. Khanna said that treatment sequencing in the metastatic setting remains uncertain, including whether EV-based therapy should be repeated. Platinum-based chemotherapy is an option for eligible patients, and for those who are cisplatin-ineligible, biomarker testing may help guide clinicians with treatment choices, Dr. Khanna said.