Intravesical cretostimogene grenadenorepvec oncolytic immunotherapy in high-risk, BCG-unresponsive, non-muscle-invasive bladder cancer with carcinoma in situ (BOND-003 Cohort C): a single-arm, phase 3 trial.
Three-quarters of patients with treatment-resistant bladder cancer achieved complete response with a new oncolytic immunotherapy, offering a bladder-saving option previously unavailable to this population.
This international phase 3 trial enrolled 112 patients with high-risk BCG-unresponsive non-muscle-invasive bladder cancer with CIS across 41 centres in North America, Asia, and Australia; cretostimogene was delivered as 6-week intravesical induction plus maintenance with permitted re-induction. Complete response at any time was achieved in 75% of evaluable patients with a manageable adverse event profile, providing a bladder-sparing alternative to radical cystectomy for a population with very few effective options.
What the study was
- Study design
- phase_3_single_arm_trial
- Population
- Adults with high-risk BCG-unresponsive NMIBC with carcinoma in situ (n=112)
- Sample size
- 112
- Category
- Treatment Innovation
- Maturity
- Potentially Practice-Changing
- Journal
- Lancet Oncol
Why it surfaced
Phase 3 clinical trial in Lancet Oncol reporting 75% complete response in BCG-unresponsive bladder cancer—a high-unmet-need setting where radical cystectomy remains the only established alternative; dual-mechanism oncolytic immunotherapy represents a novel class in this indication.
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