Immunotherapy in NMIBC: Key Results Safety Profile From BOND-003 Trial
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.
Topline Data From the BOND-003 Trial in NMIBC
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.
What’s Next for NMIBC: The Immunotherapy and Gene Therapy Pipeline
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.
Weighing the Risks and Benefits of Bladder-Sparing Agents vs Cystectomy
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.
Reflecting on NMIBC Progress: Highlights From AUA 2025 and What’s Ahead
June 12th 2025Panelists discuss how recent advancements in NMIBC treatment, including the approval of nadofaragene firadenovec, pembrolizumab, and intravesical therapies like TAR-200, have reshaped care for BCG-unresponsive patients, with promising developments and ongoing trials at AUA 2025 paving the way for more personalized and effective treatment strategies in the future.
Navigating Access Barriers: Resources to Support New Treatment Access
June 12th 2025Panelists discuss how leveraging resources such as patient assistance programs, insurance navigators, clinical trial databases, advocacy groups, and oncology support services can help overcome access barriers, ensuring that NMIBC patients receive timely access to novel treatments like nadofaragene firadenovec and pembrolizumab.
Overcoming Challenges in Accessing New Therapies for NMIBC
June 12th 2025Panelists discuss how overcoming challenges such as cost, insurance coverage, regulatory hurdles, patient selection, and the need for education is crucial for improving access to novel therapies like nadofaragene firadenovec and pembrolizumab, ultimately enhancing outcomes for NMIBC patients.
Case 3: A 49-Year-Old Man With Recurrent Non–Muscle-Invasive Bladder Cancer
June 9th 2025Panelists discuss how to approach treatment for a younger (49-year-old) male veteran with bladder cancer, focusing on the rising rates among veterans, challenges with recurrent disease despite BCG therapy, various second- and third-line treatment options, including gemcitabine-docetaxel combination therapy and the importance of thorough monitoring for disease progression.
Bladder-Sparing Breakthroughs: Novel FDA-Approved Treatment Options for NMIBC
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.
Expert Discussion on BCG-Unresponsive NMIBC
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.
Topline Results From Recent NMIBC Trials
June 5th 2025Panelists discuss how recent trials, including KEYNOTE-057, QUILT-3.032, and CORE-001, highlight the promising efficacy, durability, and manageable safety profiles of novel treatments like pembrolizumab, nogapendekin alfa inbakicept, and nadofaragene firadenovec, while also exploring the potential of combination therapies and novel intravesical options like TAR-200 and UGN-102 for improving outcomes in non–muscle-invasive bladder cancer (NMIBC).
Exploring Nadofaragene Firadenovec: Ongoing Trials and Study Designs
June 5th 2025Panelists discuss how the ongoing ABLE-32 and ABLE-41 trials are exploring the efficacy and safety of nadofaragene firadenovec in different NMIBC patient populations, with ABLE-32 focusing on intermediate-risk patients and ABLE-41 examining real-world effectiveness and safety.
Case 2: A 68-Year-Old Woman With Non–Muscle-Invasive Bladder Cancer
June 2nd 2025Panelists discuss how to manage the treatment of a 68-year-old woman with painless intermittent hematuria and positive cytology for high-grade urothelial cancer, addressing gender differences in diagnosis timing, the importance of repeat transurethral resection (TURBT) procedures, BCG therapy options, and considerations for radical cystectomy with pelvic organ preservation when BCG fails.
NMIBC Treatment Decisions in the Age of BCG Shortages
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.
Current Standards of Care and Shifting Strategies in NMIBC
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.
Real-World Outcomes With Nadofaragene in BCG-Unresponsive NMIBC
May 29th 2025Panelists discuss how real-world data from a recent Mayo Clinic study confirms the promising efficacy and favorable safety profile of nadofaragene firadenovec in BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), highlighting high cystectomy-free and overall survival rates, with longer follow-up needed to assess response durability.
An Overview of Nogapendekin Alfa Inbakicept for High-Risk, BCG-Unresponsive NMIBC
May 29th 2025Panelists discuss how nogapendekin alfa, an intravesical immunotherapy that stimulates a localized immune response, combined with BCG therapy, provides a novel dual approach for treating BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC), targeting both local and systemic immune responses.
Case 1: A 79-Year-Old Man With Non–Muscle-Invasive Bladder Cancer
May 23rd 2025Panelists discuss how they approach a typical bladder cancer case of a 79-year-old man with hematuria, including initial diagnostic procedures, the importance of proper tumor measurement during resection, BCG therapy protocols, and management options for BCG-unresponsive disease with a focus on nadofaragene firadenovec (Adstiladrin).
An Overview Of Pembrolizumab for High-Risk BCG Unresponsive NMIBC
May 22nd 2025Panelists discuss how pembrolizumab, a PD-1 inhibitor, offers a systemic immunotherapy option for high-risk, BCG-unresponsive non–muscle-invasive bladder cancer (NMIBC) by enhancing the immune system’s ability to target cancer cells, with intravenous administration and careful monitoring for immune-related adverse effects.
FDA-Approved Options for High-Risk BCG-Unresponsive NMIBC
May 22nd 2025Panelists discuss how recently FDA-approved therapies, including nadofaragene firadenovec, gemcitabine, and docetaxel, offer alternative treatment options for BCG-unresponsive high-risk non–muscle-invasive bladder cancer (NMIBC), each with distinct mechanisms and administration methods.