Trinity J. Bivalacqua, MD, PhD

Panelists discuss the evolving non–muscle-invasive bladder cancer (NMIBC) treatment landscape, emphasizing a shift away from BCG monotherapy for lower intermediate-risk patients toward combination and novel therapies for high-risk disease, while highlighting ongoing challenges related to toxicity, cost, BCG shortages, and the need for refined patient selection through biomarkers and precision medicine.

Panelists discuss novel intravesical drug delivery systems like TAR-200 and UGN-102 that enhance chemotherapy exposure and efficacy in non–muscle-invasive bladder cancer (NMIBC), while noting challenges in tolerability and administration, and highlighting their potential to improve patient outcomes and reduce invasive procedures.

Panelists discuss the expanding clinical development of cretostimogene across multiple NMIBC populations and treatment strategies, highlighting ongoing trials exploring its use as monotherapy and in combination with agents like gemcitabine or pembrolizumab, with the goal of optimizing efficacy, safety, and bladder preservation across diverse risk groups.

Panelists discuss the final BOND-3 trial results, highlighting intravesical cretostimogene’s strong efficacy, durable responses, and excellent safety profile in BCG-unresponsive carcinoma in situ (CIS), reinforcing its potential as a well-tolerated, bladder-preserving treatment option in a population with limited therapeutic choices.

Panelists discuss the promising results of the BOND-3 trial evaluating intravesical cretostimogene for BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), highlighting its high complete response rates, favorable safety profile, and potential to offer an effective, bladder-sparing alternative without the toxicity of systemic immunotherapy.

Panelists discuss emerging immunotherapy strategies for BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), particularly the combination of BCG with systemic checkpoint inhibitors, noting promising response rates but significant toxicity concerns that currently limit widespread adoption to select high-risk patients, pending further trial data and safety protocol development.

Panelists discuss current FDA-approved treatments for BCG-unresponsive carcinoma in situ, noting varying response rates among pembrolizumab, nadofaragene, and BCG combined with IL-15 superagonist, while highlighting promising investigational combination immunotherapies like oncolytic viruses and checkpoint inhibitors that may improve outcomes in this challenging patient population.

Panelists discuss emerging data comparing bladder-sparing therapies to radical cystectomy in BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), highlighting the nuanced trade-offs in oncologic outcomes and quality of life, and emphasizing the need for shared decision-making as prospective studies like CISTO refine patient selection for personalized treatment strategies.

Panelists discuss the expanding treatment options for BCG-unresponsive high-risk non–muscle-invasive bladder cancer, highlighting the benefits and limitations of FDA-approved therapies like pembrolizumab, nadofaragene, and nogapendekin, alongside off-label use of gemcitabine-docetaxel, as clinicians strive to balance efficacy, accessibility, and individualized care amid ongoing resource challenges.

Panelists discuss the evolving definition of BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), emphasizing its critical role in identifying patients who fail adequate BCG therapy, guiding next-line treatment decisions, and determining eligibility for clinical trials exploring novel therapeutic options.

Panelists discuss how the ongoing BCG shortage has forced clinicians to adapt treatment strategies for non–muscle-invasive bladder cancer (NMIBC), balancing resource constraints with patient outcomes through dose adjustments, chemotherapy substitution, and earlier cystectomy, while emphasizing the importance of maintaining trial eligibility and adhering as closely as possible to evidence-based protocols.

Panelists discuss evolving strategies for managing non–muscle-invasive bladder cancer (NMIBC), highlighting how risk stratification, resource limitations, and emerging therapies like gemcitabine-docetaxel are shaping treatment decisions, while emphasizing the urgent need for predictive tools and biomarkers to guide personalized care.