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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| Dual Immune Activation with EG-70 Targets Non-Muscle Invasive Bladder Cancer |
| Vikram Narayan, MD |
| Vikram Narayan discusses detalimogene voraplasmid (EG-70), a non-viral therapy for bladder cancer that uses a proprietary delivery mechanism to introduce DNA plasmid into the bladder. EG-70 employs a dual approach by activating both the innate immune system through RIG-1 agonists and the adaptive immune system via IL-12 secretion. |
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| ABLE-32 Trial Explores Nadofaragene Firadenovec for Intermediate-Risk NMIBC |
| Neal Shore, MD, FACS |
| Neal Shore joins Zachary Klaassen to discuss the ABLE-32 trial investigating nadofaragene firadenovec in intermediate-risk non-muscle invasive bladder cancer. The global phase III study aims to evaluate quarterly dosing of this gene therapy against observation in a previously underserved patient population. |
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| Phase II Trial Explores Gemcitabine Plus BCG for BCG-Exposed Bladder Cancer |
Eugene Pietzak, MD and Gal Wald, MD
Sam Chang hosts a discussion with Gal Wald and Eugene Pietzak about intravesical gemcitabine and BCG combination therapy for BCG-exposed non-muscle-invasive bladder cancer. The phase II trial demonstrates promising results with a 94% complete response rate at six months and 81% at twelve months using an alternating schedule of gemcitabine and BCG over ten weeks. |
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| Emerging Treatments for NMIBC |
| Neema Navai, MD |
| Neema Navai discusses emerging treatments for non-muscle invasive bladder cancer (NMIBC) in light of BCG therapy's limitations. He highlights several promising alternatives, including pembrolizumab for BCG-unresponsive cases, as well as therapies targeting FGFR, such as erdafitinib, and gene therapies like nadofaragene firadenovec. |
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| A Phase 1/2 Trial of Durvalumab plus Intravesical Gemcitabine and Docetaxel in BCG-Unresponsive Non-Muscle Invasive Bladder Cancer Patients (HCRN GU16-243: ADAPT-BLADDER Cohort 4) |
| Noah Hahn, MD |
| Noah Hahn presents results from the HCRN GU16-243: ADAPT-BLADDER Cohort 4 trial, which investigated the combination of durvalumab with intravesical gemcitabine and docetaxel in BCG-unresponsive non-muscle invasive bladder cancer. The trial showed a high complete response rate of 89% among evaluable patients, with similar results observed in patients with carcinoma in situ and papillary disease. |
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| A Heterologous Prime-Boost Strategy Using RUTI Vaccine to Improve the BCG Response in Non–muscle-Invasive Bladder Cancer Patients (RUTIVAC-1 Trial) |
| Oscar Buisan, MD |
| Oscar Buisan presents the results of the RUTIVAC-1 trial, investigating a heterologous prime-boost strategy using the RUTI® vaccine to enhance the BCG response in high-risk non-muscle invasive bladder cancer (NMIBC) patients. The trial demonstrated that RUTI® vaccination before intravesical BCG therapy significantly modulated the immune response, with increased levels of activated T cells and a more balanced, polyfunctional immune profile compared to placebo. |
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| Gene Expression Signatures of Immune Infiltration Portend Differential Response to Gem/Doce Versus BCG in High-Risk Non-Muscle-Invasive Bladder Cancer |
| Ian McElree, MD |
| Ian McElree presented a study examining how gene expression signatures of immune infiltration impact responses to sequential intravesical gemcitabine and docetaxel (Gem/Doce) versus BCG in HR-NMIBC. The study found that patients with higher immune scores had significantly better high-grade recurrence-free survival when treated with Gem/Doce compared to BCG, suggesting that immune signature analysis could be a valuable biomarker for guiding treatment selection in HR-NMIBC. |
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| The Changing World of Non-Muscle-Invasive Bladder Cancer |
| Bogdana Schmidt, MD, MPH |
| Bogdana Schmidt discussed evolving treatment paradigms for non-muscle-invasive bladder cancer (NMIBC), emphasizing the limitations of current BCG-based therapy due to treatment intensity, side effects, and ongoing shortages. She highlighted emerging alternatives like intravesical therapies, drug-delivery systems, and systemic treatments, including gene therapies and checkpoint inhibitors, which offer more personalized, bladder-sparing options. |
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| Case-Based Session: Non-Muscle Invasive Bladder Cancer: Exploring Therapies Beyond Bacillus Calmette-Guérin |
| Brian Baumann, MD Name, MD, Mark Tyson II, MD, MPH, Girish S. Kulkarni, MD, PhD, and Tracy L. Rose, MD, MPH
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| At the 2025 ASCO GU symposium, experts discussed treatments for NMIBC unresponsive to BCG, exploring alternatives like Gemcitabine/Docetaxel, immune checkpoint inhibitors, and novel therapies such as Nadofaragene Firadenovec and Nogapendekin alfa inbakicept. While radical cystectomy remains the standard for BCG-refractory disease, promising clinical trial data and FDA-approved options like pembrolizumab and N803 offer alternatives, though challenges in long-term efficacy and adverse events persist. |
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| HER2 Antibody Drug Conjugate Therapy: A New Frontier in Bladder Cancer |
| Funda Meric-Bernstam, MD |
| Funda Meric-Bernstam highlights promising developments. HER2 alterations, including amplification and expression, are seen in 12.4% of bladder cancer cases, and targeting this pathway with ADCs is emerging as a new therapeutic frontier. Dr. Meric-Bernstam concluded that HER2 ADCs represent a new frontier in bladder cancer treatment, with potential for first-line therapy and the need for precise sequencing to guide therapy choices. |
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