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Those with BCG\u2010unresponsive 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\u2010unresponsive NMIBC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a comprehensive literature review of clinical trials and preclinical studies through August 2025, focusing on therapeutic strategies for BCG\u2010unresponsive NMIBC. Mechanisms of BCG resistance, regulatory definitions, and results from recent Phase II\/III trials were analyzed.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Multiple novel therapies have demonstrated efficacy in BCG\u2010unresponsive patients. Immune checkpoint inhibitors (e.g., pembrolizumab) achieved complete response (CR) rates of 41% in carcinoma in\u00a0situ (CIS) patients. Gene therapies such as nadofaragene firadenovec and CG0070 induced CR rates of 51% and 75%, respectively. Device\u2010assisted therapies including hyperthermic intravesical chemotherapy (HIVEC) showed 24\u2010month recurrence\u2010free survival of 57.4%. The IL\u201015 superagonist Anktiva (nogapendekin alfa inbakicept), recently FDA\u2010approved, achieved a 71% CR rate with a median duration of 26.6\u2009months when combined with BCG.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>The treatment landscape for BCG\u2010unresponsive NMIBC is rapidly evolving, with immune checkpoint inhibitors, gene therapies, targeted agents, and advanced drug delivery systems showing promising efficacy. These innovations provide bladder\u2010preserving options for patients ineligible for radical cystectomy. Future directions include biomarker\u2010driven therapy selection, combination regimens, and optimized intravesical delivery platforms to improve long\u2010term outcomes.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1002\/cam4.71243","type":"journal-article","created":{"date-parts":[[2025,9,15]],"date-time":"2025-09-15T10:37:05Z","timestamp":1757932625000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":12,"title":["Mechanisms, Clinical Trials, and New Treatments for\n                    <scp>BCG<\/scp>\n                    \u2010Unresponsive in Nonmuscle Invasive Bladder Cancer"],"prefix":"10.1002","volume":"14","author":[{"given":"Xiaotong","family":"Huang","sequence":"first","affiliation":[{"name":"Second Affiliated Hospital (Guangdong Provincial Hospital of Chinese Medicine) Guangzhou University of Chinese Medicine  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xuan","family":"Wang","sequence":"additional","affiliation":[{"name":"Zhongshan Institute for Drug Discovery, Shanghai Institute of Materia Medica, Chinese Academy of Sciences  Zhongshan China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zihe","family":"He","sequence":"additional","affiliation":[{"name":"Xi'an Jiaotong\u2010Liverpool University  Suzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yishu","family":"Huang","sequence":"additional","affiliation":[{"name":"Guangdong Pharmaceutical University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bing","family":"Hu","sequence":"additional","affiliation":[{"name":"Guangdong Pharmaceutical University  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Weiying","family":"Chen","sequence":"additional","affiliation":[{"name":"Second Affiliated Hospital (Guangdong Provincial Hospital of Chinese Medicine) Guangzhou University of Chinese Medicine  Guangzhou China"},{"name":"Guangdong Provincial Key Laboratory of Chinese Medicine for Prevention and Treatment of Refractory Chronic Diseases  Guangzhou China"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5721-1779","authenticated-orcid":false,"given":"Haifang","family":"Du","sequence":"additional","affiliation":[{"name":"Second Affiliated Hospital (Guangdong Provincial Hospital of Chinese Medicine) Guangzhou University of Chinese Medicine  Guangzhou China"},{"name":"Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome  Guangzhou China"},{"name":"Hunan Yueyang Maternal &amp; Child Health\u2010Care Hospital  Yueyang China"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2025,9,15]]},"reference":[{"key":"e_1_2_15_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2016.06.010"},{"key":"e_1_2_15_3_1","doi-asserted-by":"publisher","DOI":"10.1007\/s00345-024-04949-8"},{"key":"e_1_2_15_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.clgc.2023.03.002"},{"key":"e_1_2_15_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.eururo.2012.07.033"},{"key":"e_1_2_15_6_1","doi-asserted-by":"publisher","DOI":"10.1038\/s41585-022-00578-1"},{"key":"e_1_2_15_7_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(16)30512-8"},{"key":"e_1_2_15_8_1","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2022.0041"},{"key":"e_1_2_15_9_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2017.04.086"},{"key":"e_1_2_15_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.biopha.2007.05.004"},{"key":"e_1_2_15_11_1","doi-asserted-by":"publisher","DOI":"10.3390\/ijms241612596"},{"key":"e_1_2_15_12_1","volume-title":"Bacillus Calmette\u2010Guerin\u2010Unresponsive Nonmuscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment","author":"US Food and Drug Administration (FDA)","year":"2022"},{"key":"e_1_2_15_13_1","volume-title":"European Association of Urology Guidelines on Non\u2010Muscle\u2010Invasive Bladder Cancer (Ta, T1, and Carcinoma In\u00a0Situ)","author":"European Association of Urology (EAU)","year":"2025"},{"key":"e_1_2_15_14_1","first-page":"681","article-title":"Novel Treatments in BCG Failure. 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