Single-arm phase 3 trial (BOND-003 Cohort C) evaluating intravesical cretostimogene grenadenorepvec — an oncolytic adenoviral immunotherapy — in 110–112 patients with high-risk, BCG-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), across 41 international centers, with a median follow-up of 25.8 months.
Complete response at any time was achieved in 83 of 110 evaluable patients (75%; 95% CI 66.3–83.2%). Treatment-related adverse events occurred in 71 of 112 patients (63%), most commonly bladder spasm (25%), pollakiuria (22%), and micturition urgency (21%); there were **no grade 3–4 treatment-related adverse events** and no treatment-related discontinuations or deaths.
- Single-arm design with no comparator arm, limiting causal inference. - Selective enrollment at qualified sites may not reflect real-world community practice broadly. - Duration of complete response data is not fully mature given the ongoing trial status.
For patients with high-risk, BCG-unresponsive NMIBC with CIS who are seeking bladder-sparing options, intravesical cretostimogene achieved a 75% complete response rate with a favorable, low-grade toxicity profile. Clinicians should consider this agent as a potential alternative to radical cystectomy in this difficult-to-treat population.
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