{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,17]],"date-time":"2026-08-17T14:36:48Z","timestamp":1786977408422,"version":"build-2736575974"},"reference-count":211,"publisher":"Wiley","issue":"24","license":[{"start":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T00:00:00Z","timestamp":1701388800000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Cancer Medicine"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>High\u2010risk non\u2010muscle\u2010invasive bladder cancer (HR\u2010NMIBC) presents a challenge to many physicians due to its ability to resist Bacillus Calmette\u2013Gu\u00e9rin (BCG) intravesical therapy and the substantial rate of progression into muscle\u2010invasive bladder cancer (MIBC). Patients who are BCG\u2010unresponsive have worse prognosis and thus require further management including radical cystectomy (RC), which significantly impacts quality of life. Moreover, the ongoing worldwide shortage of BCG warrants the need for policies that prioritize drug use and utilize alternative treatment strategies. Hence, there is a significant unmet need for bladder preserving therapy in this subset of patients.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>To address this issue, we searched the relevant literature in PUBMED for articles published from 2019 through May of 2023 using appropriate keywords. All clinical trials of patients with HR\u2010NMIBC treated with immune\u2010related agents were retrieved from clinicaltrials.gov.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Findings and Future Perspectives<\/jats:title>\n                    <jats:p>Exploratory treatments for BCG\u2010Unresponsive HR\u2010NMIBC included immune checkpoint inhibitors (ICI), oncolytic viral therapy, cytokine agonists, and other immunomodulators targeting TLR, EpCaM, FGFR, MetAP2, and IDO1. Some combination therapies have been found to work synergistically and are preferred therapeutically over monotherapy. Three drugs\u2014pembrolizumab, valrubicin, and most recently, nadofaragene firadenovec\u2010vncg\u2014have been FDA approved for the treatment of BCG\u2010unresponsive NMIBC in patients who are ineligible for or decline RC. However, all explored treatment options tend to postpone RC rather than provide long\u2010term disease control. Additional combination strategies need to be studied to enhance the effects of immunotherapy. Despite the challenges faced in finding effective therapies, many potential treatments are currently under investigation. Addressing the landscape of biomarkers, mechanisms of progression, BCG resistance, and trial design challenges in HR\u2010NMIBC is essential for the discovery of new targets and the development of effective treatments.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.6768","type":"journal-article","created":{"date-parts":[[2023,12,1]],"date-time":"2023-12-01T04:30:56Z","timestamp":1701405056000},"page":"21944-21968","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":36,"title":["Novel immunotherapeutic options for BCG\u2010unresponsive high\u2010risk non\u2010muscle\u2010invasive bladder cancer"],"prefix":"10.1002","volume":"12","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4516-9526","authenticated-orcid":false,"given":"Zein Alabdin","family":"Hannouneh","sequence":"first","affiliation":[{"name":"Faculty of Medicine Al Andalus University for Medical Sciences  Tartus Syrian Arab Republic"},{"name":"Cancer 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