AUA South Central Section Meeting: Mark D. Tyson II, MD, MPH, recaps data in NMIBC

In this video, Mark D. Tyson II, MD, MPH, reviews the evolving treatment landscape for high-risk non–muscle-invasive bladder cancer (NMIBC), emphasizing that substantial unmet needs remain despite the expanding number of FDA-approved therapies for BCG-unresponsive disease. He notes the need for durable, well-tolerated treatments that can preserve bladder function while minimizing progression risk, and highlights treatment sequencing, cost, disease characteristics, and patient preferences as important considerations in therapy selection. Tyson also cautions against comparing efficacy results across single-arm trials because of differences in patient populations, trial designs, treatment schedules, and response assessments.

Tyson specifically highlights data for cretostimogene grenadenorepvec, an investigational oncolytic adenovirus designed to promote direct tumor-cell lysis while stimulating an immune response through a GM-CSF transgene. He reviews 24-month findings from the BOND-003 program (NCT04452591),¹ noting durable complete responses among responders and a high proportion of patients avoiding radical cystectomy, while emphasizing that cystectomy avoidance is influenced by patient and provider preferences and is not a hard oncologic end point. He also discusses early findings in papillary-only BCG-unresponsive disease and BCG-naive high-risk NMIBC, noting promising activity but the need for longer follow-up.

The interview also covers the potential of combining cretostimogene with intravesical gemcitabine in the CORE-008 (NCT06567743) cohort CX,² with Tyson describing the approach as one of the developments he is watching most closely in NMIBC. He highlights early efficacy signals from the combination and suggests that the sequential administration schedule may offer practical and tolerability advantages, while stressing that additional data are needed.

Looking ahead, Tyson identifies the forthcoming ARCUS trial and other prospective studies comparing intravesical approaches, along with continued maturation of cretostimogene data and potential regulatory decisions, as developments that could help clarify the role of bladder-sparing therapies.

REFERENCES
1. Kukreja J, Tyson M, Li R, Joshi S, Bivalacqua T, Steinberg G. Durable 24-month outcomes from BOND-003 cohort C: phase 3 study of intravesical cretostimogene grenadenorepvec for high-risk BCG-unresponsive nonmuscle invasive bladder cancer with carcinoma in situ. Presented at: 105th Annual Meeting of the South Central Section of the AUA; September 9-12, 2026; Tucson, AZ. Podium 81.

2. Taylor J, Bivalacqua T, Berger A, et al. Efficacy and safety of intravesical cretostimogene grenadenorepvec plus gemcitabine in high-risk BCG-exposed or BCG-unresponsive non–muscle-invasive bladder cancer (CORE-008 cohort CX) Presented at: 105th Annual Meeting of the South Central Section of the AUA; September 9-12, 2026; Tucson, AZ. Podium 80.