(UroToday.com) The 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain between March 21st and 24th 2025, was host to the Abstract Session 05: On the Horizon: Ongoing Trials in Urology. Dr. Sia Daneshmand presented A0083: Trial in Progress: BOND-003 Cohort P- A Multi-national, Single-arm Study of Intravesical Cretostimogene Grenadenorepvec for the Treatment of High-Risk, Papillary Only, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer.
Dr. Daneshmand highlighted that bladder cancer is the 9th most common cancer worldwide, with 75% of cases classified as NMIBC.1 Despite TURBT and intravesical BCG, recurrence occurs in up to 50% of cases, and 20–40% become BCG-unresponsive. While guidelines currently recommend radical cystectomy, some patients are ineligible or decline surgery.2-4 Although the US FDA has approved treatments for BCG-unresponsive patients with CIS, there remains a critical unmet need for effective, well-tolerated bladder-sparing therapies for those with BCG-unresponsive papillary-only NMIBC.
Cretostimogene grenadenorepvec is a conditionally replicating, highly immunogenic adenovirus regulated by the human E2F-1 promoter, making it highly selective for RB-E2F pathway alterations. This oncolytic immunotherapy encodes a GM-CSF transgene and exerts a dual mechanism of action: viral replication leads to tumor lysis, while GM-CSF stimulates an immune response, enhancing antitumor activity. The mechanism of action is illustrated in the graphic below.
BOND-003 is a Phase 3 trial evaluating cretostimogene monotherapy for high-risk, BCG-unresponsive NMIBC with papillary-only disease (HG Ta/T1). Enrollment is ongoing, and patients are required to undergo mandatory biopsies at the 12-month assessment. The primary endpoint is high-grade event-free survival, with additional study design and regimen and additional endpoints outlined below. Notably, there is a second induction 6-weekly course for non-responders.
This trial is ongoing, with the first sites opening and patient enrollment beginning in March 2024. More than 35 sites across North America and Japan are participating, with strong enrollment progress. Interim results are expected by the end of 2025.
Presented by: Sia Daneshmand, MD, Urologic Oncologist, Professor of Urology and Medicine at the University of Southern California (USC) in Los Angeles, CA.
Written by: Julian Chavarriaga, MD – Urologic Oncologist at Cancer Treatment and Research Center (CTIC) via Society of Urologic Oncology (SUO) Fellow at The University of Toronto. @chavarriagaj on Twitter during the 2025 European Association of Urology (EAU) Annual Meeting held in Madrid, Spain between March 21st and 24th 2025
References:- Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024; 74(3): 229-263. doi:10.3322/caac.21834
- European Association of Urology. EAU guidelines on non-muscle-invasive bladder cancer. 2025.
- Holzbeierlein J, Bixler BR, Buckley DI, et al. Diagnosis and treatment of non-muscle invasive bladder cancer: AUA/SUO guideline: 2024 amendment. J Urol. 2024;10.1097/JU.0000000000003846.
- NCCN Clinical Practice Guidelines in Oncology. Bladder Cancer. Version 6. 2024. 8 7