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Recent Advances in Immunotherapy for Non-Muscle-Invasive Bladder Cancer
Journal article   Open access   Peer reviewed

Recent Advances in Immunotherapy for Non-Muscle-Invasive Bladder Cancer

Abby L. Grier, Jeffrey Y. Zhong, Spyridon Basourakos, Adam Calaway, Parminder Singh, Yousef Zakharia, Fabrice Lucien, R. Jeffrey Karnes, Vidit Sharma, Paras Shah, …
Cancers, Vol.18(4), 623
02/14/2026
DOI: 10.3390/cancers18040623
PMCID: PMC12938786
PMID: 41749876
url
https://doi.org/10.3390/cancers18040623View
Published (Version of record) Open Access

Abstract

Bladder cancer confined to the lining usually has a good prognosis, but it often returns or becomes more aggressive. Standard treatment involves repeated procedures to remove tumors and placing weakened bacteria into the bladder to activate the immune system. Some patients whose cancers do not respond to standard treatment may need bladder removal, which can greatly affect quality of life. Over the past decade, several immune-based treatments have been developed and approved, including therapies delivered into the bladder or given through the bloodstream. This narrative review summarizes these advances, ongoing studies, and the challenges in deciding the best treatment approach for these patients. Non-muscle-invasive bladder cancer (NMIBC) comprises approximately 75% of new bladder cancer cases and generally carries a favorable prognosis, yet high rates of recurrence and progression necessitate close surveillance with frequent cystoscopies and repeated transurethral resections. Upfront treatment for high-risk disease is typically Bacillus Calmette-Guérin (BCG), although combinations with immune checkpoint inhibitors have reported results. Patients with BCG-unresponsive, intolerant, or refractory disease represent a subset of patients with high risk of progression, with early radical cystectomy being the standard approach for this setting. Global BCG shortages and the substantial impact of cystectomy on quality of life underscore the need for therapeutic alternatives. Over the past decade, investigational trials in immunotherapy have expanded treatment options for BCG-unresponsive NMIBC with CIS, leading to FDA approval of intravesical nadofaragene firadenovec, nogapendekin alfa-inbakicept, and systemic pembrolizumab. This narrative review summarizes developments in intravesical and systemic immunotherapies for NMIBC, highlights ongoing trials, and addresses controversies in trial design, treatment sequencing, comparative efficacy, and safety.
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