2f:I[703058,["/_next/static/immutable/chunks/3bhq_5eh1d760.js","/_next/static/immutable/chunks/1855-ogyi8eh4.js","/_next/static/immutable/chunks/2pfsjpn6k6zlg.js","/_next/static/immutable/chunks/26c7v3_3uwnwu.js","/_next/static/immutable/chunks/25a3ozcrvi1ff.js","/_next/static/immutable/chunks/2r4wx50nvjh_4.js","/_next/static/immutable/chunks/23fsw06hsi5b1.js","/_next/static/immutable/chunks/06_yt270h41rg.js","/_next/static/immutable/chunks/3ezsiz-7shkna.js","/_next/static/immutable/chunks/20x2y96ldu5wx.js","/_next/static/immutable/chunks/2lxntcm3pd1_h.js","/_next/static/immutable/chunks/00dgco8irq3jw.js","/_next/static/immutable/chunks/00nwe-kq0rboc.js","/_next/static/immutable/chunks/2051ffx3xzio9.js"],"PaperListPageClient"] 30:T7bf,TAR-200 is a first-in-class intravesical drug-releasing system designed to provide sustained delivery of gemcitabine in the bladder. TAR-200 alone or in combination with cetrelimab (PD-1 inhibitor) could improve outcomes in patients with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (NMIBC) ineligible for or refusing radical cystectomy. In this phase IIb parallel cohort study, patients with BCG-unresponsive carcinoma in situ (CIS) with/without papillary disease received TAR-200 monotherapy (Cohort 2 [C2]), TAR-200 plus cetrelimab (C1), or cetrelimab monotherapy (C3). Patients with BCG-unresponsive high-risk papillary disease-only NMIBC received TAR-200 monotherapy (C4). TAR-200 was dosed through month 24 and cetrelimab through month 18. Primary end points were centrally confirmed overall complete response (CR) rate (C1-3) or disease-free survival (DFS) rate (C4) (ClinicalTrials.gov number: NCT04640623). At data cutoff (March 31, 2025), 53, 85, 28, and 52 patients were treated in C1-4, respectively. In C2, CR rate and median duration of response were 82.4% (95% CI, 72.6 to 89.8) and 25.8 months (95% CI, 8.3 to not estimable), respectively. In C4, 6-, 9-, and 12-month DFS rates were 85.3% (95% CI, 71.6 to 92.7), 81.1% (95% CI, 66.7 to 89.7), and 70.2% (95% CI, 51.6 to 82.8), respectively. In C1 and C3, CR rates were 67.9% (95% CI, 53.7 to 80.1) and 46.4% (95% CI, 27.5 to 66.1), respectively. Rates of grade ≥3 treatment-related adverse events (AEs) were 12.9%, 13.5%, 37.7%, and 7.1% in C2, C4, C1, and C3, respectively, and of serious treatment-related AEs, 5.9%, 5.8%, 15.1%, and 3.6%. No treatment-related deaths occurred. TAR-200 monotherapy was well tolerated, with a high CR rate, durable responses, and prolonged DFS in patients with BCG-unresponsive high-risk NMIBC. TAR-200 monotherapy offered a more favorable risk-benefit profile versus TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS.31:Tb02, PURPOSE TAR-200 is a first-in-class intravesical drug-releasing system designed to provide sustained delivery of gemcitabine in the bladder. TAR-200 alone or in combination with cetrelimab (PD-1 inhibitor) could improve outcomes in patients with bacillus Calmette-Guérin (BCG)–unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC) ineligible for or refusing radical cystectomy. METHODS In this phase IIb parallel cohort study, patients with BCG-unresponsive carcinoma in situ (CIS) with/without papillary disease received TAR-200 monotherapy (Cohort 2 [C2]), TAR-200 plus cetrelimab (C1), or cetrelimab monotherapy (C3). Patients with BCG-unresponsive high-risk papillary disease–only NMIBC received TAR-200 monotherapy (C4). TAR-200 was dosed through month 24 and cetrelimab through month 18. Primary end points were centrally confirmed overall complete response (CR) rate (C1-3) or disease-free survival (DFS) rate (C4) (ClinicalTrials.gov number: NCT04640623 ). RESULTS At data cutoff (March 31, 2025), 53, 85, 28, and 52 patients were treated in C1-4, respectively. In C2, CR rate and median duration of response were 82.4% (95% CI, 72.6 to 89.8) and 25.8 months (95% CI, 8.3 to not estimable), respectively. In C4, 6-, 9-, and 12-month DFS rates were 85.3% (95% CI, 71.6 to 92.7), 81.1% (95% CI, 66.7 to 89.7), and 70.2% (95% CI, 51.6 to 82.8), respectively. In C1 and C3, CR rates were 67.9% (95% CI, 53.7 to 80.1) and 46.4% (95% CI, 27.5 to 66.1), respectively. Rates of grade ≥3 treatment-related adverse events (AEs) were 12.9%, 13.5%, 37.7%, and 7.1% in C2, C4, C1, and C3, respectively, and of serious treatment-related AEs, 5.9%, 5.8%, 15.1%, and 3.6%. No treatment-related deaths occurred. CONCLUSION TAR-200 monotherapy was well tolerated, with a high CR rate, durable responses, and prolonged DFS in patients with BCG-unresponsive high-risk NMIBC. TAR-200 monotherapy offered a more favorable risk-benefit profile versus TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS. 25:[[["$","script","0",{"type":"application/ld+json","dangerouslySetInnerHTML":{"__html":"{\"@context\":\"https://schema.org\",\"@type\":\"CollectionPage\",\"name\":\"Intravesical Chemotherapy: modality Research & Clinical Takeaways\",\"description\":\"Explore peer-reviewed papers on Intravesical Chemotherapy (modality). Clinician-written summaries and actionable practice insights. 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Grade/stage progression was rare (<5%), and cancer-specific survival was 99% at 60 months. Independent predictors of recurrence were prior recurrence (HR 1.75), multifocality (HR 1.49), and higher grade (HR 1.57).","limitations":"- Pooled data from four trials not originally designed to address surveillance frequency, introducing potential heterogeneity.\n- Median follow-up of only 34 months limits confidence in the 60-month estimates.\n- All patients received mitomycin C; findings may not generalize to other adjuvant regimens.","practice_takeaway":"For IR-NMIBC patients treated with mitomycin C, the highest recurrence burden occurs within the first 36 months — focus surveillance intensity there. After 60 months, noncumulative recurrence risk drops below 5%, supporting a reduction or cessation of routine cystoscopy in this group."}},{"doi":"10.1097/ju.0000000000005179","pmid":"42330429","title":"Phase 2 Trial of Intravesical Gemcitabine and Docetaxel as First-Line Treatment of Bacillus Calmette-Guérin‒Naïve Nonmuscle-Invasive Urothelial Carcinoma: Updated, 3-Year Outcomes","journal_title":"Journal of Urology","journal_issn":"0022-5347","published_at":"2026-06-22T00:00:00.000Z","url":"https://doi.org/10.1097/ju.0000000000005179","source_score":23,"is_retracted":false,"is_open_access":false,"raw_metadata":{"pubmed":true,"crossref":true,"unpaywall":true},"created_at":"2026-09-14T06:23:22.291Z","updated_at":"2026-09-14T06:23:22.291Z","tags":[{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"age_group","value":"adult","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"category","value":"Urology & Nephrology","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"condition","value":"Non-Muscle-Invasive Bladder Cancer","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"condition","value":"Urothelial Carcinoma","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"generic","value":"docetaxel","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"generic","value":"gemcitabine","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"impact_flag","value":"limited_evidence","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"level_of_evidence","value":"3","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"modality","value":"Intravesical Chemotherapy","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"sample_size","value":"n=25","value_numeric":25},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"sex","value":"mixed","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"study_design","value":"Phase 2 Single-Arm Trial","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"warning","value":"No randomized comparator arm (e.g., BCG) was included, so comparative efficacy cannot be established.","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"warning","value":"Sex distribution and detailed patient demographics (e.g., age range, performance status) are not reported in the abstract or available full text, limiting full characterization of the cohort.","value_numeric":null},{"paper_doi":"10.1097/ju.0000000000005179","tag_type":"warning","value":"Very small sample size (n=25) limits statistical power; confidence intervals are wide and results should be interpreted with caution.","value_numeric":null}],"summaries":{"what_studied":"This prospective, single-arm, open-label phase 2 trial evaluated intravesical gemcitabine plus docetaxel (Gem/Doce) as first-line therapy in 25 BCG-naïve high-risk (HR) NMIBC patients (64% HGT1, 32% HGTa, 36% with CIS), with 6-week induction followed by monthly maintenance for 2 years and a median follow-up of 50 months.","key_result":"High-grade recurrence-free survival (HG-RFS) was 84% at 24 months (21/25; 95% CI 63%–94%) and 80% at 36 months (20/25; 95% CI 58%–91%); no patients progressed during Gem/Doce, and only 2 (8%) required cystectomy. Grade 3 adverse events occurred in 5 patients (20%), including hematuria and UTI.","limitations":"Very small cohort (n=25) from a single-arm trial without a BCG comparator arm limits generalizability and causal inference. Single-institution design with no randomization may introduce selection bias.","practice_takeaway":"For BCG-naïve HR NMIBC patients, intravesical Gem/Doce appears durable at 3 years with an 80% HG-RFS and a manageable safety profile. It may serve as a viable alternative when BCG is unavailable or contraindicated, though larger randomized trials are needed."}},{"doi":"10.1200/jco-25-01651","pmid":"40737582","title":"TAR-200 for Bacillus Calmette-Guérin–Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study","journal_title":"Journal of Clinical Oncology","journal_issn":"0732-183X","published_at":"2025-07-30T00:00:00.000Z","url":"https://doi.org/10.1200/jco-25-01651","source_score":338,"is_retracted":false,"is_open_access":true,"raw_metadata":{"ooir":{"day":"2025-11-18","doi":"10.1200/jco-25-01651","days":"30","issn":"0732-183X","rank":"5","field":"Clinical Medicine","score":"338","category":"Oncology","categories":["Oncology"],"_categories":["Oncology"]},"pubmed":{"doi":"10.1200/JCO-25-01651","title":"TAR-200 for Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study.","journal":"Journal of clinical oncology : official journal of the American Society of Clinical Oncology","methods":"","results":"At data cutoff (March 31, 2025), 53, 85, 28, and 52 patients were treated in C1-4, respectively. In C2, CR rate and median duration of response were 82.4% (95% CI, 72.6 to 89.8) and 25.8 months (95% CI, 8.3 to not estimable), respectively. In C4, 6-, 9-, and 12-month DFS rates were 85.3% (95% CI, 71.6 to 92.7), 81.1% (95% CI, 66.7 to 89.7), and 70.2% (95% CI, 51.6 to 82.8), respectively. In C1 and C3, CR rates were 67.9% (95% CI, 53.7 to 80.1) and 46.4% (95% CI, 27.5 to 66.1), respectively. Rates of grade ≥3 treatment-related adverse events (AEs) were 12.9%, 13.5%, 37.7%, and 7.1% in C2, C4, C1, and C3, respectively, and of serious treatment-related AEs, 5.9%, 5.8%, 15.1%, and 3.6%. No treatment-related deaths occurred.","abstract":"$30","keywords":[],"pubmed_id":"40737582","conclusions":"TAR-200 monotherapy was well tolerated, with a high CR rate, durable responses, and prolonged DFS in patients with BCG-unresponsive high-risk NMIBC. TAR-200 monotherapy offered a more favorable risk-benefit profile versus TAR-200 plus cetrelimab or cetrelimab alone in BCG-unresponsive CIS.","publication_date":"2025-07-30T00:00:00"},"crossref":{"DOI":"10.1200/jco-25-01651","URL":"https://doi.org/10.1200/jco-25-01651","ISSN":["0732-183X","1527-7755"],"link":[{"URL":"https://ascopubs.org/doi/pdfdirect/10.1200/JCO-25-01651","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"page":"3578-3588","type":"journal-article","issue":"33","score":1,"title":["TAR-200 for Bacillus Calmette-Guérin–Unresponsive High-Risk Non–Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study"],"author":[{"given":"Siamak","family":"Daneshmand","sequence":"first","affiliation":[{"name":"University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA"}]},{"given":"Michiel S.","family":"Van der Heijden","sequence":"additional","affiliation":[{"name":"Netherlands Cancer 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Cádiz, Spain"}]},{"given":"Daniel","family":"Zainfeld","sequence":"additional","affiliation":[{"name":"Urology San Antonio, San Antonio, TX"}]},{"given":"Philipp","family":"Spiegelhalder","sequence":"additional","affiliation":[{"name":"Urologie Neandertal, Gemeinschaftspraxis für Urologie, Mettmann, Germany"}]},{"given":"Evanguelos","family":"Xylinas","sequence":"additional","affiliation":[{"name":"Bichat-Claude Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université de Paris Cité, Paris, France"}]},{"given":"David","family":"Cahn","sequence":"additional","affiliation":[{"name":"Colorado Urology, Lakewood, CO"}]},{"given":"Yair","family":"Lotan","sequence":"additional","affiliation":[{"name":"UT Southwestern Medical Center, Dallas, TX"}]},{"given":"Katie S.","family":"Murray","sequence":"additional","affiliation":[{"name":"NYU Langone Health, New York, NY"}]},{"given":"Takashi","family":"Kawahara","sequence":"additional","affiliation":[{"name":"Yokohama City University Medical Center, Yokohama, Japan"}]},{"given":"Katharine","family":"Stromberg","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Raritan, NJ"}]},{"given":"Jason","family":"Martin","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, High Wycombe, UK"}]},{"given":"Abhijit","family":"Shukla","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Lexington, MA"}]},{"given":"Christopher J.","family":"Cutie","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Lexington, MA"}]},{"given":"Kristi","family":"Bertzos","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Horsham, PA"}]},{"given":"Shalaka","family":"Hampras","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Raritan, NJ"}]},{"given":"Hussein","family":"Sweiti","sequence":"additional","affiliation":[{"name":"Johnson & Johnson, Spring House, PA"}]},{"given":"Andrea","family":"Necchi","sequence":"additional","affiliation":[{"name":"IRCCS San Raffaele Hospital, Milan, Italy"},{"name":"Vita-Salute San Raffaele University, Milan, Italy"}]},{"given":"Manish","family":"Patel","sequence":"additional","affiliation":[]},{"given":"Thierry","family":"Roumeguere","sequence":"additional","affiliation":[]},{"given":"Charles","family":"Van Praet","sequence":"additional","affiliation":[]},{"given":"Harm","family":"Arentsen","sequence":"additional","affiliation":[]},{"given":"Bart","family":"De 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TAR‑200 was dosed up to 24 months and cetrelimab up to 18 months; at the March 31, 2025 data cutoff, 218 patients were treated across four cohorts (C1 n=53; C2 n=85; C3 n=28; C4 n=52).","key_result":"In BCG‑unresponsive CIS, TAR‑200 monotherapy achieved a CR rate of 82.4% (95% CI 72.6–89.8) with median response duration 25.8 months (95% CI 8.3–not estimable), versus 67.9% (95% CI 53.7–80.1) with TAR‑200+cetrelimab and 46.4% (95% CI 27.5–66.1) with cetrelimab alone. In papillary-only disease, TAR‑200 yielded 6‑, 9‑, and 12‑month DFS rates of 85.3%, 81.1%, and 70.2%; grade ≥3 treatment‑related AEs were 12.9% (C2) and 13.5% (C4) versus 37.7% with the combination and 7.1% with cetrelimab alone; no treatment‑related deaths occurred.","practice_takeaway":"For BCG‑unresponsive CIS, TAR‑200 monotherapy produced a high and durable CR with fewer severe treatment‑related AEs than the combination and higher CR than PD‑1 monotherapy. For papillary‑only disease, TAR‑200 showed a 12‑month DFS of 70.2% with low rates of serious toxicity."}}],"initialOffset":3,"fetchConfig":{"kind":"tags","tags":[{"tag_type":"modality","value":"Intravesical Chemotherapy"}]},"breadcrumbItems":[{"name":"Home","href":"/"},{"name":"Research Hub","href":"/hub"},{"name":"Modalities","href":"/hub/tag/modality"},{"name":"Intravesical Chemotherapy"}],"hrefConfig":{"basePath":"/hub/papers","webViewQueryParams":{"hub_ctx":"tag","hub_tag_type":"modality","hub_tag_value":"Intravesical Chemotherapy"}}}]]

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