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Highlights from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium |
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| Case-Based Session: Non-Muscle Invasive Bladder Cancer: Exploring Therapies Beyond Bacillus Calmette-Guérin |
| Brian Baumann, MD, Mark Tyson II, MD, MPH, Girish Kulkarni, MD, PhD, and Tracy Rose, MD, MPH |
| The ASCO GU 2025 case-based session on non-muscle invasive bladder cancer (NMIBC) explored therapies beyond Bacillus Calmette-Guérin (BCG) for BCG-unresponsive disease. Experts discussed clinical trial options, intravesical chemotherapy (Gemcitabine/Docetaxel), systemic immunotherapy (Pembrolizumab, Atezolizumab), and novel FDA-approved treatments like Nadofaragene Firadenovec and Nogapendekin alfa inbakicept (N803). |
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| Mental Health Monitoring in Clinical Trials for FDA-Approved Genitourinary Cancer Treatments: A Decade Review |
| Parnian Jabbari, MD |
| Parnian Jabbari presented a study underscoring the significant gap in mental health monitoring in clinical trials for FDA-approved genitourinary cancer treatments. Despite the increasing recognition of psychiatric symptoms in cancer patients, most trials from 2015-2024 lacked comprehensive mental health assessments beyond standard quality-of-life questionnaires. |
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| Real-World Outcomes of Nadofaragene Firadenovec in BCG-Unresponsive NMIBC
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| Jacob Moyer, MD
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| Early real-world data on nadofaragene firadenovec in BCG-unresponsive NMIBC shows promising complete response rates, with 79% of CIS patients achieving a complete response at three months and 68% of papillary-only patients remaining recurrence-free. At a median follow-up of 8.2 months, cystectomy-free survival was 95%, and overall survival was 100%, with no treatment discontinuations due to adverse events.
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| Real-World Time on Treatment with First-Line Enfortumab Vedotin and Pembrolizumab After U.S. FDA Approval for Advanced Urothelial Cancer |
| Aram Babcock, PharmD, MS, MBA |
| A real-world study of first-line enfortumab vedotin + pembrolizumab for advanced urothelial cancer found a median time on treatment of 8.1 months, closely matching the 9.4 months reported in the EV-302 trial. Among 111 patients, 41.4% discontinued both therapies, 23.9% began second-line treatment, and 65% of those who discontinued had died by the data cutoff. |
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| Real-World Toxicity Profile of Enfortumab Vedotin with or Without Pembrolizumab in Ultra Elderly Urothelial Carcinoma Patients
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| Nataliya Mar, MD
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| A real-world analysis of ultra-elderly urothelial carcinoma patients treated with enfortumab vedotin, with or without pembrolizumab, found no unexpected toxicities. Among 26 patients, 50% required dose reductions, 42.3% had dose delays, and 30.8% discontinued treatment due to adverse events, with neuropathy and ocular symptoms being the most common. The findings suggest that upfront dose reduction, particularly in older patients, may help mitigate toxicity while maintaining treatment viability.
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| Clinical Efficacy of Enfortumab Vedotin + Pembrolizumab in Locally Advanced or Metastatic Urothelial Carcinoma: A Real-World Retrospective Study |
| Prateek Jain, MD, MS |
| A real-world retrospective study of enfortumab vedotin + pembrolizumab in locally advanced or metastatic urothelial carcinoma showed clinical efficacy consistent with the EV-302 trial. The best overall response included a 28.3% complete response rate and a 46.6% partial response rate. Median progression-free survival was 12.7 months, and median overall survival was 25.1 months. These findings highlight the combination’s therapeutic potential across disease subtypes, though longer follow-up is needed to assess long-term outcomes. |
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| Phase Ib/II Clinical Trial of Oncolytic Virus Intravesical Irrigation for Preventing Recurrence After TURBT in Patients with Recurrent High-Risk NMIBC |
| Youyan Guan, MD |
| A Phase Ib/II clinical trial evaluated the safety and preliminary efficacy of OH2, an oncolytic virus therapy, as intravesical irrigation for preventing recurrence in high-risk NMIBC patients post-TURBT. Among nine analyzed patients, the 6-month recurrence-free survival rate was 66.7%, and the 12-month RFS rate was 55.6%, with a median RFS of 353 days. OH2 was well-tolerated with no significant safety concerns, but further research is needed to assess its long-term efficacy. |
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| Preliminary Efficacy and Safety of Disitamab Vedotin Combined With BCG in the Treatment of High-Risk NMIBC With HER2 Expression: A Prospective, Open Label, Single-Center Study |
| Yijun Shen, MD |
| A prospective, single-center study evaluated the combination of disitamab vedotin and BCG in high-risk NMIBC patients with HER2 expression who were ineligible for or refused radical cystectomy. Among 20 enrolled patients, the 3-month and 6-month complete response rates in Cohort A were 100%, while the 6-month event-free survival rate in Cohort B was also 100%. |
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| Targeting Bladder Cancer with Antibody Drug Conjugates |
| Di Maria Jiang, MD, MSc, FRCPC |
| Di Maria Jiang discussed the evolving role of antibody drug conjugates (ADCs) in bladder cancer treatment, highlighting their potential to improve outcomes in metastatic urothelial carcinoma. Key ADCs like enfortumab vedotin and sacituzumab govitecan have shown promising results in clinical trials, with combination therapies, such as enfortumab vedotin with pembrolizumab, significantly extending progression-free survival and overall survival compared to traditional chemotherapy. |
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| HER2 Antibody Drug Conjugate Therapy: A New Frontier in Bladder Cancer |
| Funda Meric-Bernstam, MD |
| Funda Meric-Bernstam’s ASCO GU 2025 presentation highlighted the expanding role of HER2 antibody-drug conjugates (ADCs) in bladder cancer, emphasizing the need for both next-generation sequencing (NGS) and IHC testing for HER2 status. Trastuzumab deruxtecan has shown promising efficacy in HER2-positive bladder cancer, leading to its recent FDA approval. Additionally, disitamab vedotin has demonstrated strong response rates and is now in phase III trials as a potential first-line therapy. |
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| Overcoming Challenges of Antibody Drug Conjugate Toxicity in Bladder Cancer |
| Daniel Castellano, MD |
| Daniel Castellano’s presentation focused on managing the toxicities associated with antibody drug conjugates (ADCs) in bladder cancer, particularly those targeting Nectin-4, Trop-2, and HER2. Key toxicities include skin reactions, peripheral neuropathy, and interstitial lung disease, with varying adverse event profiles depending on the payload. |
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| Better Together? Exploring Novel Drug Combinations with Antibody Drug Conjugates |
| Terence Friedlander, MD |
| Terence Friedlander's presentation focused on exploring novel drug combinations with ADCs for metastatic urothelial carcinoma. He highlighted the potential of combining ADCs with immunotherapy, chemotherapy, and targeted therapies, emphasizing the need for synergy, minimal overlapping toxicity, and optimized patient selection. Dr. Friedlander discussed ongoing trials and the importance of rational partner therapy selection, as well as the challenges of high real-world costs and the need for better biomarkers to improve efficacy while minimizing toxicity. |
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| Potential Impact of ctDNA on Perioperative Management of Muscle-Invasive Bladder Cancer |
| Nimira Alimohamed, MD, FRCPC |
| Nimira Alimohamed discussed the potential impact of circulating tumor DNA (ctDNA) on the perioperative management of muscle-invasive bladder cancer. She highlighted ctDNA's prognostic value, particularly in the context of neoadjuvant chemotherapy, radical cystectomy, and immunotherapy. ctDNA can serve as an early marker for disease recurrence, even before radiographic evidence, and guide treatment decisions. |
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