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SAS Journal of Medicine | Volume-12 | Issue-04
Neoadjuvant Immunotherapy in Muscle-Invasive Bladder Cancer: Current Evidence and Future Directions
Mohammed Amine Elafari, Ayoub Mamad, Mohammed Amine Bibat, Amine Slaoui, Tariq Karmouni, Abdellatif Koutani, Khalid Elkadir
Published: April 21, 2026 |
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10
Pages: 323-329
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Abstract
Muscle-invasive bladder cancer (MIBC) remains a significant oncological challenge, with approximately 50% of patients experiencing recurrence within 3 years despite standard neoadjuvant cisplatin-based chemotherapy and radical cystectomy. The integration of immune checkpoint inhibitors (ICIs) into the perioperative management of MIBC has transformed the treatment landscape. The landmark phase 3 NIAGARA trial demonstrated that perioperative durvalumab combined with neoadjuvant gemcitabine–cisplatin significantly improves event-free survival (EFS) and overall survival (OS) in cisplatin-eligible patients, leading to FDA approval and NCCN Category 1 preferred status. For cisplatin-ineligible patients, the phase 3 KEYNOTE-905 trial established perioperative enfortumab vedotin plus pembrolizumab as a new standard of care. Multiple phase 2 studies have further explored ICI monotherapy and chemoimmunotherapy combinations, with pooled pathological complete response (pCR) rates ranging from 24% to 43% depending on the strategy employed. Emerging biomarkers, including tumor mutational burden (TMB), PD-L1 expression, molecular subtypes, and circulating tumor DNA (ctDNA), hold promise for patient selection and response monitoring. This mini review synthesizes the current evidence supporting neoadjuvant immunotherapy in MIBC, discusses ongoing challenges, and highlights future directions.


