ReviewCancer medicine2025
Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer.
Review in Cancer medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
8 citing papers in PubMed.
- Diagnosis, evaluation, and management of patients with non-muscle invasive bladder cancer.Future science OA · 2026Review
- Molecular Classifications and Candidate Biomarkers for Personalizing BCG Therapy in Non-Muscle-Invasive Bladder Cancer.Biomedicines · 2026Review
- Beyond the BCG Paradox: Biological Rationale and Clinical Evidence for Combining Intravesical BCG with Immune Checkpoint Inhibitors in High-Risk Non-muscle-Invasive Bladder Cancer.Oncology and therapy · 2026Review
- Hyperthermic Intravesical Chemotherapy as a Bladder-Sparing Alternative to BCG in the Management of Non-Muscle-Invasive Bladder Cancer: A Systematic Review of Oncological Outcomes in the Era of BCG Shortage.Journal of clinical medicine · 2026Review
- Deep learning-based automated identification of papillary bladder cancer from endoscopic still images using SE-ResNeXt-50.World journal of urology · 2026Article
- Narrative Review of Potential Non-Surgical Treatments for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.Journal of clinical medicine · 2026Review
- Mechanisms, Clinical Trials, and New Treatments for BCG-Unresponsive in Nonmuscle Invasive Bladder Cancer.Cancer medicine · 2025Review
- Intra- and extravesical recurrence after epirubicin-based hyperthermic intravesical chemotherapy (HIVEC) in patients with NMIBC and BCG failure: A multicenter retrospective Observational Study.Bladder cancer (Amsterdam, Netherlands)Article
Corrections and comments
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Authors and funding
7 authors.
Funding
Abstract
backgroundBacillus Calmette-Guérin (BCG) is the standard adjuvant therapy for high-risk non-muscle invasive bladder cancer (NMIBC), yet treatment failure occurs in 30% to 40% of patients. Those with BCG-unresponsive disease face a high risk of progression and represent a critical unmet need in urologic oncology. This review summarizes the mechanisms of BCG failure and evaluates emerging therapies for BCG-unresponsive NMIBC.
methodsWe conducted a comprehensive literature review of clinical trials and preclinical studies through August 2025, focusing on therapeutic strategies for BCG-unresponsive NMIBC. Mechanisms of BCG resistance, regulatory definitions, and results from recent Phase II/III trials were analyzed.
resultsMultiple novel therapies have demonstrated efficacy in BCG-unresponsive patients. Immune checkpoint inhibitors (e.g., pembrolizumab) achieved complete response (CR) rates of 41% in carcinoma in situ (CIS) patients. Gene therapies such as nadofaragene firadenovec and CG0070 induced CR rates of 51% and 75%, respectively. Device-assisted therapies including hyperthermic intravesical chemotherapy (HIVEC) showed 24-month recurrence-free survival of 57.4%. The IL-15 superagonist Anktiva (nogapendekin alfa inbakicept), recently FDA-approved, achieved a 71% CR rate with a median duration of 26.6 months when combined with BCG.
conclusionsThe treatment landscape for BCG-unresponsive NMIBC is rapidly evolving, with immune checkpoint inhibitors, gene therapies, targeted agents, and advanced drug delivery systems showing promising efficacy. These innovations provide bladder-preserving options for patients ineligible for radical cystectomy. Future directions include biomarker-driven therapy selection, combination regimens, and optimized intravesical delivery platforms to improve long-term outcomes.
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