{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,28]],"date-time":"2026-09-28T21:19:51Z","timestamp":1790630391922,"version":"4.1.0"},"reference-count":51,"publisher":"MDPI AG","issue":"21","license":[{"start":{"date-parts":[[2025,11,2]],"date-time":"2025-11-02T00:00:00Z","timestamp":1762041600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Cancers"],"abstract":"<jats:p>Background\/Objectives: Systemic immunotherapy, previously used mainly for advanced urothelial carcinoma, now plays an important role in the treatment of non-muscle invasive bladder cancer (NMIBC), either alone or combined with intravesical BCG instillations. Methods: We conducted a collaborative, comprehensive review to summarize the key evidence and future perspectives on therapeutic intensification strategies involving immune checkpoint inhibitors in NMIBC. A total of 51 references published between 2000 and 2025 were included. Results: Four phase II studies evaluated pembrolizumab, atezolizumab, durvalumab, and cetrelimab as monotherapy in 28 to 132 BCG-unresponsive NMIBC patients. They reported complete response rates ranging from 12% to 43% after 3 to 12 months of treatment, with a durable response rate ranging from 49% to 57.4% at 12 months. To improve these results, a phase II trial launched this year tests a new systemic combination targeting both the PD-1\/PD-L1 axis and the emerging HLA-E\/NKG2A pathway. Regarding BCG-na\u00efve high-risk (HR) NMIBC, four phase III studies are evaluating BCG instillations combined with systemic immunotherapy: sasanlimab (CREST), durvalumab (POTOMAC), atezolizumab (ALBAN), and pembrolizumab (KEYNOTE-676), with significant results reported for the CREST and POTOMAC trials. The key challenge remains selecting patients most likely to benefit from this combination therapy while avoiding overtreatment. Identifying predictive biomarkers of tumor aggressiveness and response to immunotherapy also represents a major future challenge. Conclusions: Therapeutic intensification using systemic immunotherapy applies to both BCG-unresponsive NMIBC, with a new target pathway (HLA-E\/NKG2A), and BCG-na\u00efve HR NMIBC, where the combination of BCG instillations and immunotherapy represents a major breakthrough.<\/jats:p>","DOI":"10.3390\/cancers17213555","type":"journal-article","created":{"date-parts":[[2025,11,3]],"date-time":"2025-11-03T14:40:48Z","timestamp":1762180848000},"page":"3555","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":2,"title":["Therapeutic Intensification Based on Immune Checkpoint Inhibitors in Non-Muscle Invasive Bladder Cancer: State of the Art and Future Perspectives"],"prefix":"10.3390","volume":"17","author":[{"given":"Pierre-Etienne","family":"Gabriel","sequence":"first","affiliation":[{"name":"Department of Urology, Bichat Claude-Bernard Hospital, Assistance Publique-H\u00f4pitaux de Paris Nord, University Paris Cit\u00e9, 75018 Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amir","family":"Horowitz","sequence":"additional","affiliation":[{"name":"Department of Oncological Sciences, Tisch Cancer Institute, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0767-3465","authenticated-orcid":false,"given":"Felix","family":"Guerrero-Ramos","sequence":"additional","affiliation":[{"name":"Department of Urology, 12 de Octubre University Hospital, Av C\u00f3rdoba s\/n, 28041 Madrid, Spain"},{"name":"Department of Urology, Hospital Universitario HM Sanchinarro, 28050 Madrid, Spain"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Francesco","family":"Soria","sequence":"additional","affiliation":[{"name":"Division of Urology, AOU Citta della Salute e della Scienza di Torino, Torino School of Medicine, 10126 Torino, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marco","family":"Moschini","sequence":"additional","affiliation":[{"name":"Department of Urology, San Raffaele Hospital, Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), 20132 Milan, Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"D\u2019Andrea","sequence":"additional","affiliation":[{"name":"Department of Urology, Medical University of Vienna, 1090 Vienna, Austria"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-7768-8558","authenticated-orcid":false,"given":"Benjamin","family":"Prad\u00e8re","sequence":"additional","affiliation":[{"name":"Department of Urology, La Croix Du Sud Hospital, 31130 Quint Fonsegrives, France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John P.","family":"Sfakianos","sequence":"additional","affiliation":[{"name":"Department of Urology, Icahn School of Medicine at Mount Sinai, New York, NY 10029, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evanguelos","family":"Xylinas","sequence":"additional","affiliation":[{"name":"Department of Urology, Bichat Claude-Bernard Hospital, Assistance Publique-H\u00f4pitaux de Paris Nord, University Paris Cit\u00e9, 75018 Paris, France"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2025,11,2]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"1895","DOI":"10.1007\/s00345-019-02984-4","article-title":"The global burden of urinary bladder cancer: An update","volume":"38","author":"Richters","year":"2020","journal-title":"World J. 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