Bibliographic record
Abstract
Introduction: Cretostimogene is an oncolytic immunotherapy with dual mechanisms of action.It replicates in and lyses cancer cells with Rb-E2F pathway alterations, while simultaneously amplifying an anti-tumor immune response, further mediated by the GM-CSF transgene.BOND-003 (NCT04452591) is a phase 3 study evaluating the efficacy and safety of cretostimogene in patients with HR BCG-unresponsive (UR) NMIBC.We report data on radical cystectomy performed post-recurrence or progression.Methods: A total of 112 patients with HR BCG-UR NMIBC with CIS were enrolled.Treatment included six weekly inductions, followed by three weekly maintenance cycles every three months at year 1 and every six months during years 2-3.Repeat induction was permitted at month 3. Response assessments included serial cystoscopy, urine cytology, and mandatory mapping biopsy at 12 months, with centralized pathology review.The primary endpoint is CR at any time.Cystectomy-free survival (CFS) and progression-free survival (PFS) are key secondary endpoints.Results: As of the June 23, 2025 data cutoff (median followup of 25.8 months), the CR rate at any time is 75.5% (83/110) (95% CI 66.3-83.2%).Kaplan-Meier estimates of 12-and 24-month DoR are 64.2%(95% CI 52.5-73.8%)and 60.1% (95% CI 48.2-70.0%),respectively, with a median DoR of 27.9 months (95% CI 14.3-NE%) and ongoing.The 12-and 24-month CR rate is 46.4% (51/110) (95% CI 36.8-56.2%)and 41.8% (46/110) (95% CI 32.5-51.6%),respectively.The 12and 24-month CFS rates are 89.2%(95% CI 81.3-93.9)and 81.3% (71.8-87.8%),respectively, with median CFS not reached.Among 18 patients who underwent radical cystectomy post-disease recurrence or progression, 15 (83.3%) had NMIBC or pT0 on final pathology.At 12 and 24 months, 96.4% (106/110) are free from ≥T2 progression.No grade 3+ TRAEs were reported.Conclusions: Cretostimogene may offer distinct advantages with its MOA, efficacy, durability, and safety profile for the treatment of HR BCG-UR NMIBC.
Fetched live from OpenAlex and de-inverted. Abstracts are not stored in this database: the inverted indexes are 8.6 GB of the frame’s 9.3 GB of text, and the host has 13 GB free.
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 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.003 | 0.002 |
| Open science | 0.001 | 0.003 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.707 | 0.476 |
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; the direct Gemma label and the distilled Codex classifier agree on what is shown here.
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".