(UroToday.com) The 2026 SESAUA annual meeting featured a bladder cancer session and presentation by Dr. Shreyas Joshi discussing durable 24-month outcomes from BOND-003 Cohort C assessing intravesical cretostimogene grenadenorepvec for high risk BCG-unresponsive non muscle invasive bladder cancer with CIS. A significant treatment gap exists for efficacious, well-tolerated bladder-sparing options for patients with high risk BCG-unresponsive non muscle invasive bladder cancer with CIS. Cretostimogene grenadenorepvec is an oncolytic immunotherapy designed to replicate in bladder cancer cells with Rb-E2F pathway alterations:
In addition, cretostimogene expresses GM-CSF adding to local and systemic cancer control. BOND-003 is a phase-3 study evaluating the efficacy and safety of cretostimogene in patients with high risk BCG-unresponsive non muscle invasive bladder cancer with CIS +/- HG Ta/T1 (Cohort C) and HG Ta/T1 only (Cohort P). At the SESAUA 2026 annual meeting, Dr. Joshi and colleagues reported the updated 24-month outcomes from Cohort C.
There were 112 adults with histologically confirmed high risk BCG-unresponsive non muscle invasive bladder cancer with CIS enrolled. Participants had previously received adequate BCG and were considered BCG-unresponsive by the FDA definition. Cretostimogene treatment consisted of 6 weekly induction, followed by 3 weekly maintenance cycles at months 3, 6, 9, 12 and 18. Repeat induction was permitted at month 3 if there was persistent HG Ta or CIS:
Response assessments included serial cystoscopy, urine cytology, and mandatory mapping biopsy, with centralized review of all pathology. The primary endpoint was complete response at any time, with secondary and exploratory endpoints assessed.
Of the 112 patients, the majority were male (74%), white (62%), and > 65 years of age (83%), with 63.4% of patients from the United States. This was a highly pre-treated population, with 41% having had prior chemotherapy, and 6% prior systemic immunotherapy:
As of the June 23, 2025 data cutoff (median follow-up of 25.8 months), the complete response rate at any time is 75.5% (83/110) (95% CI 66.3-83.2%):
The Kaplan-Meier estimates of 12- and 24-month duration of response are 64.2% (95% CI 52.5-73.8%) and 60.1% (95% CI 48.2-70.0%), respectively, with an ongoing median duration of response of 27.9 months (95% CI 14.3-NE).
The 12-month complete response rate is 46.4% (51/110) (95% CI 36.8-56.1%). Updated results include landmark and Kaplan-Meier estimated 24-month complete response rates of 41.8% (46/110) (95% CI 32.5-51.6%) and 42.4% (95% CI: 32.7–51.7%), respectively:
At 24 months, 96.4% (106/110) are free from ≥T2 progression, and 83.6% (92/110) have avoided a radical cystectomy for bladder cancer. Of note, 83.3% (15/18) of patients who underwent radical cystectomy had T0 or non muscle invasive bladder cancer. All complete responses have been centrally confirmed.
Dr. Joshi highlighted that 50% of patients re-induced with oncolytic immunotherapy converted to a complete response, with 64.3% of patients remaining in durable response after a conversion to complete response; patients also remain in response after treatment completion:
There was also a high complete response rate consistent across patient subgroups, including patients treated with prior chemotherapy:
Cretostimogene has a well-tolerated safety profile, with no grade ≥3 treatment-related adverse events. Most adverse events were grade 1-2, with a median time to treatment related adverse event resolution of 1 day, and no treatment related discontinuations. Overall, 1.8% had serious treatment-related adverse events (grade 2), and 97.3% received all protocol defined treatments:
Dr. Joshi concluded his presentation discussing durable 24-month outcomes from BOND-003 Cohort C with the following take-home points:
- Cretostimogene grenadenorepvec provides a compelling complete response rate (75.5%)
- There were durable responses, including a median duration of response not reached but exceeding 27 months, and 90% of 12-month responders sustained durable outcomes at year 2
- Cretostimogene was a very well tolerated regimen, with no grade 3+ treatment related adverse events or discontinuations, and 97.3% of patients completed all protocol defined treatments
- Cretostimogene easily fits and is scalable within the existing clinic workflow and is administered by MAs and RNs
- Future and ongoing clinical trials are evaluating cretostimogene monotherapy and rational combinations as backbone therapy
Presented by: Shreyas Joshi, MD, MPH, Emory University, Atlanta, GA
Written by: Zachary Klaassen, MD, MSc – Urologic Oncologist, Associate Professor of Urology, Georgia Cancer Center, Wellstar MCG Health, @zklaassen_md on Twitter during the 2026 Southeastern Section of the American Urological Association (SESAUA) Annual Meeting, San Juan, PR, Wed, Mar 18 – Sat, Mar 21, 2026.
Related Content:
ASCO GU 2026: Cystectomy Free Survival Following Cretostimogene Grenadenorepvec in High Risk BCG Unresponsive NMIBC with CIS: Results from the Phase 3 BOND-003 Trial Cohort C