Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2025
TAR-200 for Bacillus Calmette-Guérin-Unresponsive High-Risk Non-Muscle-Invasive Bladder Cancer: Results From the Phase IIb SunRISe-1 Study.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04640623 (Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer), which is not on this map. Cited by 27 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 2b Clinical Study Evaluating Efficacy and Safety of TAR-200 in Combination With Cetrelimab, TAR-200 Alone, or Cetrelimab Alone in Participants With High-Risk Non-Muscle Invasive Bladder Cancer (NMIBC) Unresponsive to Intravesical Bacillus Calmette-Guérin (BCG) Who Are Ineligible for or Elected Not to Undergo Radical Cystectomy
Who cites it
27 citing papers in PubMed.
- Diagnosis, evaluation, and management of patients with non-muscle invasive bladder cancer.Future science OA · 2026Review
- PMDA regulatory update on approval and revision of the precautions for use of anticancer drugs in Japan; sevabertinib for lung cancer, gemcitabine intravesical system and durvalumab for bladder cancer, azacitidine for leukemia, cemiplimab for skin cancer, and ropeginterferon alfa-2b for essential thrombocythemia.International journal of clinical oncology · 2026Article
- Molecular Classifications and Candidate Biomarkers for Personalizing BCG Therapy in Non-Muscle-Invasive Bladder Cancer.Biomedicines · 2026Review
- Can manual gemcitabine instillation or tumor microenvironment-based selection enhance the efficacy of TAR-200 in bladder cancer?Translational oncology · 2026Article
- Overcoming barriers to bladder preservation: Emerging intravesical therapies for high-risk non-muscle-invasive bladder cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2026Article
- Hyperthermic Intravesical Chemotherapy as a Bladder-Sparing Alternative to BCG in the Management of Non-Muscle-Invasive Bladder Cancer: A Systematic Review of Oncological Outcomes in the Era of BCG Shortage.Journal of clinical medicine · 2026Review
- Deep learning-based automated identification of papillary bladder cancer from endoscopic still images using SE-ResNeXt-50.World journal of urology · 2026Article
- Gemcitabine-Based Bladder Preservation in BCG-Unresponsive High-Risk NMIBC: Evidence, Limitations, and Clinical Positioning.Biomedicines · 2026Review
- 'BJUI Clinical Dilemma': Recurrent high-grade non-muscle-invasive bladder cancer in 2026.BJU international · 2026Article
- A multi-modal approach for decision making in bladder cancer.Nature reviews. Urology · 2026Review
- Early Efficacy and Exploratory Biomarker Data of Bel-sar in Patients with Intermediate-risk and High-risk Non-muscle-invasive Bladder Cancer.European urology open science · 2026Article
- [Advances in intravesical therapy for nonZhong nan da xue xue bao. Yi xue ban = Journal of Central South University. Medical sciences · 2026Review
- A Phase I trial of PLZ4-coated paclitaxel-loaded micelles in patients with refractory non-muscle-invasive bladder cancer.Nanomedicine (London, England) · 2026Article
- Patterns of adjuvant intracavitary instillation and recurrence after endoscopic management of upper tract urothelial carcinoma.World journal of urology · 2026Article
- ASO Practice Guidelines Series: Surgical Management of Bladder Cancer Relapse.Annals of surgical oncology · 2026Review
- The changing landscape of urothelial carcinoma: on the edge of a paradigm shift.The Journal of clinical investigation · 2026Review
- Neoadjuvant Therapy in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer: Recent Progress, Challenges, and Future Directions in the Era of TAR-200 and Enfortumab Vedotin Plus Pembrolizumab.Oncology and therapy · 2026Review
- Gemcitabine Intravesical System Plus Cetrelimab or Cetrelimab Alone as Neoadjuvant Therapy in Muscle-Invasive Bladder Cancer: SunRISe-4 Primary Analysis and Biomarker Results.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2026Article
- [Treatment of non-muscle-invasive bladder cancer].Urologie (Heidelberg, Germany) · 2026Review
- Review
Corrections and comments
- Erratum issued
Authors and funding
24 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTAR-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.
methodsIn 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).
resultsAt 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.
conclusionTAR-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.
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.