{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T06:00:04Z","timestamp":1785218404992,"version":"3.55.0"},"reference-count":52,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T00:00:00Z","timestamp":1785196800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Immunol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Bacillus Calmette\u2013Gu\u00e9rin (BCG) is the standard adjuvant therapy for high-risk non\u2013muscle-invasive bladder cancer (NMIBC); however, a substantial proportion of patients develop BCG-unresponsive disease with limited bladder-preserving options. The objective of this study was to determine whether combination immunotherapy provides superior clinical efficacy and safety compared with single-agent immunotherapy for patients with BCG-unresponsive NMIBC.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      We conducted a systematic analysis of studies retrieved from PubMed, the Cochrane Library, Web of Science, Embase, Google Scholar, and MEDLINE searched up to December 2025. Eligible studies included single-arm trials and randomized controlled trials (RCTs) enrolling patients with pathologically confirmed BCG-unresponsive NMIBC treated with single-agent or combination immunotherapy. The intervention featured eight core drugs, including immune checkpoint inhibitors (PD-1 inhibitors), adenovirus vectors, and IL-15 superagonist Nogapendekin alfa inbakicept (N-803), administered primarily every 3 weeks. Primary outcomes were complete response rate (CRR) and progression-free survival (PFS). Secondary outcomes included high-grade recurrence, bladder preservation rate (BPR), and adverse events (AEs). Pooled analysis utilized fixed or random-effects models based on I\n                      <jats:sup>2<\/jats:sup>\n                      heterogeneity.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Ten studies (7 single-arm, 3 RCTs) involving 768 patients were included. For combination versus single-agent immunotherapy, the 3-month CRRs were 68% (95% CI: 63\u201375%) and 47% (95% CI: 43\u201351%), respectively. At 12 months, CRRs were 50% (95% CI: 43\u201359%) for combination and 28% (95% CI: 23\u201334%) for monotherapy. The 12-month PFS rate was significantly higher with combination therapy (90%; 95% CI: 85\u201394%) than with monotherapy (66%; 95% CI: 60\u201371%). Combination therapy achieved a BPR of 92.5% (95% CI: 87\u201398%). Regarding safety, any AEs occurred in 29.6% (95% CI: 14\u201346%) of the combination group compared with 87.4% (95% CI: 85\u201390%) in the monotherapy group. Limitations include the use of single-arm trial data, which lacks blinded evaluation, and moderate-to-severe heterogeneity in efficacy outcomes.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>Combination immunotherapy is associated with improved short and intermediate-term oncologic outcomes compared with single-agent immunotherapy in BCG-unresponsive NMIBC, with acceptable safety profiles. These findings support further investigation of combination strategies as bladder-preserving treatments; however, well-designed randomized trials are required before routine clinical adoption.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Systematic Review Registration<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link>https:\/\/www.crd.york.ac.uk\/prospero\/<\/jats:ext-link>\n                      , identifier CRD420251269272.\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fimmu.2026.1896444","type":"journal-article","created":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T05:34:11Z","timestamp":1785216851000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Efficacy and safety of combination versus single-agent immunotherapy for BCG-unresponsive non-muscle-invasive bladder 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