Opinion
Video
Author(s):
Panelists discuss the final BOND-3 trial results, highlighting intravesical cretostimogene’s strong efficacy, durable responses, and excellent safety profile in BCG-unresponsive carcinoma in situ (CIS), reinforcing its potential as a well-tolerated, bladder-preserving treatment option in a population with limited therapeutic choices.
The final results of the BOND-3 trial, recently presented at major urology conferences, have reinforced the promise of intravesical cretostimogene as a treatment for patients with BCG-unresponsive CIS with or without papillary disease. In this study, patients received an initial induction course of weekly installations of cretostimogene, and those with persistent high-grade disease could undergo a second induction phase before moving to a maintenance protocol similar to what has been seen in prior BCG trials. With 112 participants, BOND-3 became the largest trial conducted in this specific patient population to date.
The efficacy data are particularly compelling. The trial demonstrated a complete response rate of approximately 46% at 12 months, with an overall response rate at any time nearing 76%. Among responders, the durability was impressive, with a median duration of response exceeding 28 months. This suggests that for those who benefit from the treatment, the response is not only meaningful but also long-lasting. Furthermore, with a 97% freedom from progression to muscle-invasive bladder cancer and a 90% cystectomy-free survival rate at 1 year, the therapy supports bladder preservation in a majority of patients—an outcome that is often highly prioritized in this setting.
Safety and tolerability were also key strengths of the BOND-3 study. The vast majority of adverse events were mild (grade 1/2), with no grade 3 or higher treatment-related events reported. Additionally, these adverse effects were short-lived, with a median duration of just one day, and no patients had to discontinue therapy due to adverse events. These findings reinforce cretostimogene’s potential as a safe, durable, and effective immunotherapeutic option for managing BCG-unresponsive disease, highlighting the value of ongoing innovation in intravesical therapies.
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