Timothy Clinton, MD, reviews bladder cancer data from 2026 AUA Northeastern Section Meeting

In this interview, Timothy N. Clinton, MD, a urologic surgeon at Mass General Brigham and Dana-Farber Cancer Institute in Boston, Massachusetts, recapped bladder cancer data presented at the 2026 Northeastern Section of the AUA Annual Meeting in Rochester, New York. Clinton said the past few years have brought several bladder-sparing options for non-muscle invasive bladder cancer (NMIBC), including new intravesical therapies for high-risk BCG-unresponsive disease and the first FDA-approved option for recurrent low-grade intermediate-risk disease.

At the meeting, Clinton presented top-line results from cohort P of the phase 3 BOND-003 trial (NCT04452591). Cohort P involved a single-arm study of intravesical cretostimogene grenadenorepvec in 56 patients with high-risk BCG-unresponsive, papillary-only (high-grade Ta or T1) NMIBC.¹ As of a September 2025 data cut, the high-grade event-free survival rate was 84.6% (95% CI, 68.6 to 92.9) at 6 months and 80.4% (95% CI, 62.3 to 90.4) at 9 months. No patient progressed to muscle-invasive disease or underwent cystectomy.

In cohort C, which included 110 patients with BCG-unresponsive CIS with or without papillary disease, the complete response (CR) rate at any time was 75.5%, with a 12-month landmark CR rate of 46.4%.² Subgroup analyses showed any-time CR rates of 69.6% in 23 patients who received additional therapy after adequate BCG and 64.7% in 34 patients who received prior intravesical chemotherapy. Across both cohorts, no grade 3 or higher treatment-related adverse events were reported.

Clinton also discussed new safety data for mitomycin intravesical solution (Zusduri; formerly UGN-102),³ approved in June 2025 for recurrent low-grade intermediate-risk NMIBC, noting that no high-grade treatment-emergent adverse events were reported.

“The thing to remember with this is that it's actually a chemoablative treatment. So, even with the tumor present, it's actually trying to kill or eliminate that tumor that's growing inside the bladder, whereas a lot of these other agents are working towards CIS and more of a field effect, if you will,” Clinton explained. “The safety data looked fantastic, and just as I echoed for cretostimogene, it's extremely well-tolerated.”

Additionally, he highlighted research on urinary biomarkers that may help guide treatment sequencing, as well as emerging efforts to preserve the bladder in patients with muscle-invasive disease treated with neoadjuvant enfortumab vedotin plus pembrolizumab. Looking ahead, Clinton said that head-to-head trials, durability, tolerability, and biomarkers will be key to tailoring treatment selection, and that the rising cost of these agents is becoming an important consideration in sequencing decisions.

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REFERENCES
1. Clinton TN, Tyson MD, Shah PH, et al. TOPLINE RESULTS FROM BOND-003 COHORT P- A MULTI-NATIONAL, SINGLEARM STUDY OF INTRAVESICAL CRETOSTIMOGENE GRENADENOREPVEC FOR TREATMENT OF HIGH-RISK BCG-UNRESPONSIVE NMIBC WITH HG TA/T1 (WITHOUT CIS). Presented at: 78th Annual Meeting of the Northeastern Section of the AUA. September 17 - 19, 2026. Rochester, New York. Podium #34

2. Preston MA, Tyson MD, Joshi SS, et al. OUTCOMES OF CRETOSTIMOGENE GRENADENOREPVEC IN SECOND-LINE HIGHRISK BCG-UNRESPONSIVE NON-MUSCLE INVASIVE BLADDER CANCER WITH CARCINOMA IN SITU: ANALYSIS FROM BOND-003 COHORT C. Presented at: 78th Annual Meeting of the Northeastern Section of the AUA. September 17 - 19, 2026. Rochester, New York. Podium #48

3. Prasad SM, Tabayoyong WB, Shore ND, et al. SAFETY PROFILE OF UGN-102 IN THE TREATMENT OF ADULT PATIENTS WITH RECURRENT LOW-GRADE INTERMEDIATE-RISK NON-MUSCLE INVASIVE BLADDER CANCER. Presented at: 78th Annual Meeting of the Northeastern Section of the AUA. September 17 - 19, 2026. Rochester, New York. Podium #46