Immunotherapy in NMIBC: Key Results Safety Profile From BOND-003 Trial

EP: 1.Current Standards of Care and Shifting Strategies in NMIBC

EP: 2.NMIBC Treatment Decisions in the Age of BCG Shortages

EP: 3.Expert Discussion on BCG-Unresponsive NMIBC

EP: 4.Bladder-Sparing Breakthroughs: Novel FDA-Approved Treatment Options for NMIBC

EP: 5.Weighing the Risks and Benefits of Bladder-Sparing Agents vs Cystectomy

EP: 6.What’s Next for NMIBC: The Immunotherapy and Gene Therapy Pipeline

EP: 7.Topline Data From the BOND-003 Trial in NMIBC

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EP: 8.Immunotherapy in NMIBC: Key Results Safety Profile From BOND-003 Trial

EP: 9.Diving Deeper: Discussing Results From Cohort C in the BOND-003 Trial

EP: 10.Ongoing Investigations: Expanding the Role of Cretostimogene in NMIBC Care

EP: 11.In the Pipeline: Novel Treatment Delivery Methods for NMIBC

EP: 12.Rethinking First-Line Treatments: Will BCG Continue to Be the Standard in NMIBC?

EP: 13.Optimizing NMIBC Treatment Through Sequencing and Patient Preference

EP: 14.The Growing Call for Combination Therapy in NMIBC Treatment

The BOND-3 trial represents a significant advancement in the treatment of BCG-unresponsive non–muscle-invasive bladder cancer through the use of intravesical cretostimogene. This phase 3, single-arm study focused on high-risk patients and demonstrated promising efficacy and tolerability. The trial enrolled over 100 patients, with a complete response (CR) rate of nearly 75% at any time. Among those who responded, approximately 64% remained in CR at 12 months and over half at 24 months. Notably, cystectomy-free survival at 12 months was around 90%, a meaningful result for patients seeking to preserve their bladders.

A key strength of the therapy is its safety profile. No grade 3 or 4 adverse events were reported, and most adverse effects were mild and typical of intravesical therapies—bladder spasms, dysuria, urgency, and hematuria. This is particularly important in a population with already compromised bladder health due to prior BCG exposure. Another important aspect of the trial was its inclusion of reinduction for nonresponders, which aligns with current practices in bladder cancer immunotherapy and reflects the drug’s mechanism of action—stimulating both innate and adaptive immune responses. The durability of response, especially in those who did initially respond, suggests sustained immunologic activity even beyond the active treatment period.

Overall, the findings from BOND-3 highlight cretostimogene as a well-tolerated and effective monotherapy option. The lack of cumulative toxicity with reinduction is particularly noteworthy and differentiates it from repeat BCG therapy, which can exacerbate bladder irritation. These data support cretostimogene’s potential role in future treatment paradigms, especially for patients desiring bladder preservation without systemic immunotherapy. As more follow-up data become available, this agent may help bridge the gap between efficacy and tolerability in a field still searching for optimal bladder-sparing solutions.