Bibliographic record
Abstract
Introduction: Patients (pts) with bacillus Calmette-Guérin (BCG)-unresponsive high-risk non-muscle-invasive bladder cancer (HR NMIBC) have a high risk of disease progression and limited treatment (tx) options.TAR-200 is an intravesical drug-releasing system designed to provide sustained delivery of gemcitabinein the bladder.SunRISe-1 (NCT04640623) is an ongoing phase 2b study assessing TAR-200 in pts with BCG-unresponsive HR NMIBC, ineligible for/refused radical cystectomy.Cohorts 1-3 enrolled pts with carcinoma in situ (CIS) ± papillary disease.We report one-year duration of response (DOR) and patient-reported outcomes (PRO) in pts receiving TAR-200 monotherapy (cohort 2).Methods: Pts (≥18 y; ECOG PS 0-2) had histologically confirmed CIS ± papillary disease (high-grade Ta, any T1) with last dose of adequate BCG ≤12 months of CIS diagnosis.TAR-200 was dosed Q3W to W24 then Q12W to W96.No re-induction for non-responders was allowed.Primary Endpoint was overall complete response (CR) rate.Secondary endpoints were DOR, overall survival, PROs, and safety.Response assessments included cystoscopy, centrally assessed urine cytology (Q12W), centrally assessed biopsy (W24/48), and local imaging (Q24W).Change from baseline in global health status (GHS) and physical functioning (PF) scores (0 [worse]-100 [better]) on EORTC-QLQ-C30, completed at W0, 6, 12, Q12W on tx, and at safety follow-up, was assessed.Results: On the September 4, 2024 data cutoff, 85 pts (median age, 71 y [range 40-88]; 80% male; 33% with concurrent papillary disease) received tx, wth a median followup 14 mo (range 2-41).Centrally confirmed and investigator-assessed CR rates were both 84% (95% CI 74-91).Estimated 12-month CR rate was 50% (95% CI 36-62).Estimated median DOR and one-year DOR rate were 26 months (95% CI 9-NE) and 55% (95% CI 40-68), respectively.Nine pts completed two years of tx; seven remain in response.Mean GHS (75 [SD 16.7]) and PF (86 [SD 17.3]) scores were high at baseline and stable on tx (did not exceed clinically meaningful change threshold of ≥10 points); 71 pts (84%) had tx-related adverse events (TRAEs); most were low-grade lower urinary tract AEs.Ten pts (12%) had grade ≥3 TRAEs; five (6%) had serious TRAEs; three (4%) had TRAEs leading to tx discontinuation.No tx-related deaths occurred.Conclusions: TAR-200 monotherapy was well-tolerated, with the highest CR rate reported in BCG-unresponsive HR NMIBC.Responses were highly durable, and most responders were disease-free at one year.Clinical benefit of TAR-200 was achieved with sustained overall health status and high PF.Data will be updated after final results in April.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.002 |
| Research integrity | 0.004 | 0.002 |
| Insufficient payload (model declined to judge) | 0.348 | 0.169 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".