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Highlights from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium |
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| Adjuvant Nivolumab vs Placebo for High-Risk Muscle-Invasive Urothelial Carcinoma: Additional Efficacy Outcomes Including Overall Survival in Patients with MIBC from CheckMate 274 |
| Matthew I. Milowsky, MD, FASCO |
| The CheckMate 274 trial with a 3-year median follow-up demonstrated that adjuvant nivolumab significantly improved disease-free survival and showed a trend toward improved overall survival in patients with high-risk MIBC after surgery, regardless of prior neoadjuvant chemotherapy. The benefits were consistent across subgroups, including those with PD-L1 ≥ 1%, reinforcing nivolumab as a standard of care. Safety remained consistent with previous findings, and subcutaneous nivolumab may offer an alternative to IV administration. |
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| Additional Efficacy and Safety Outcomes and an Exploratory Analysis of the Impact of Pathological Complete Response on Long-Term Outcomes from NIAGARA |
| Matthew Galsky, MD |
| The phase 3 NIAGARA trial demonstrated that perioperative durvalumab plus neoadjuvant chemotherapy significantly improved event-free survival and overall survival in patients with cisplatin-eligible muscle-invasive bladder cancer compared to neoadjuvant chemotherapy alone. The durvalumab arm showed a 10% higher pathological complete response rate and a reduced risk of metastasis and disease-specific mortality. |
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| Discussant: Adjuvant Immunotherapy in High Risk Muscle Invasive Bladder Cancer |
| Elizabeth R. Plimack, MD |
| Elizabeth Plimack’s ASCO GU 2025 discussion highlighted the overall survival benefit of adjuvant nivolumab in high-risk muscle-invasive bladder cancer (MIBC) from CheckMate 274 and the potential of biomarkers to optimize patient selection. She questioned the NIAGARA trial’s “sandwich” chemoimmunotherapy approach, cautioning that the adjuvant phase may add unnecessary toxicity without clear additional benefit. |
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| iNDUCT: Safety and Efficacy of Neoadjuvant Immunotherapy with Durvalumab in Combination with Neoadjuvant Chemotherapy (Gemcitabine/cisplatin or Carboplatin) in Patients with Operable High-Risk Upper Tract Urothelial Carcinoma |
| Nadine Houede |
| Nadine Houede presented results from the phase 2 iNDUCT trial, evaluating neoadjuvant durvalumab plus chemotherapy in high-risk upper tract urothelial carcinoma. The study found the combination to be safe, with a pathological complete response rate of 13% in the cisplatin cohort and 5% in the carboplatin cohort. While the results are promising, limitations such as lack of a control arm and pending long-term survival data warrant further investigation, with a phase 3 trial (iNDUCT-3) planned for validation. |
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| Neoadjuvant Treatment with Disitamab Vedotin plus Perioperative Toripalimab in Patients with MIBC with HER2 Expression: Updated Efficacy and Safety Results from the Phase II RC48-C017 Trial |
| Xinan Sheng |
| Xinan Sheng presented updated results from the phase II RC48-C017 trial evaluating neoadjuvant disitamab vedotin plus perioperative toripalimab in HER2-expressing muscle-invasive bladder cancer (MIBC). The combination showed a high pathological complete response rate (63.6%, increasing to 84.6% in HER2 IHC 3+ patients) and a 1-year event-free survival rate of 92.5%. The regimen did not delay surgery and had a manageable safety profile, supporting further investigation into its potential as a neoadjuvant therapy for MIBC. |
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| Discussant: Advancements in Urothelial Cancer Perioperative Therapy |
| Scot Niglio, MD |
| Scot Niglio discussed advancements in perioperative therapy for urothelial carcinoma, focusing on two studies: one examining neoadjuvant immunotherapy with durvalumab and chemotherapy for high-risk upper tract urothelial carcinoma, and another investigating the combination of disitamab vedotin plus toripalimab in muscle-invasive bladder cancer with HER2 expression. The latter trial showed a promising pathological complete response rate of 63.6%, with even higher rates in HER2 IHC 3+ patients, suggesting potential for HER2-targeted therapies in bladder preservation strategies. |
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| The Changing World of Non-Muscle-Invasive Bladder Cancer
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| Bogdana Schmidt, MD, MPH
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| Bogdana Schmidt highlighted the evolving treatment landscape for NMIBC, emphasizing the limitations of BCG therapy and the growing role of novel treatments like the TARIS drug delivery system, UGN-102, and erdafitinib. She stressed the shift toward personalized, biomarker-driven approaches, with a focus on bladder-sparing options and combination therapies. Patient preferences and quality of life are becoming central to treatment decisions, particularly in cases of BCG-unresponsive disease.
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| Postoperative Adjuvant Treatment of HER2 Overexpression in Upper Urinary Tract Urothelial Carcinoma with the Combination of Disitamab Vedotin and Toripalimab: A Real-World Retrospective Study |
| Shun Zhang, MD |
| Shun Zhang presented a real-world retrospective study on the combination of disitamab vedotin and toripalimab as adjuvant therapy for HER2-overexpressing upper urinary tract urothelial carcinoma (UTUC) following radical nephroureterectomy. The study found that the combination regimen significantly improved 12-month disease-free survival (DFS) rates compared to no adjuvant therapy. |
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| Real-World Analysis of the Efficacy and Safety of Enfortumab Vedotin in Patients with Locally Advanced or Metastatic Urothelial Carcinoma: A Multicenter Retrospective Study |
| Shingo Hatakeyama, MD |
| Shingo Hatakeyama presented a multicenter retrospective study evaluating enfortumab vedotin in patients with locally advanced or metastatic urothelial carcinoma. The study found that EV significantly improved overall survival compared to other treatment regimens, although there were no differences in progression-free survival between the groups. Skin adverse events, seen in 60% of patients, were associated with longer PFS and OS, suggesting that dose adjustments for EV may enhance long-term outcomes despite the occurrence of these AEs. |
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| Global Real-World Patients Characteristics, Treatment Patterns, and Impact of BCG Shortage in Patients with High-Risk Non-Muscle Invasive Bladder Cancer |
| Jens Bedke, MD |
| Jens Bedke presented a global real-world study on high-risk non-muscle invasive bladder cancer, focusing on treatment patterns and the impact of BCG shortages. The study found that while BCG is the standard of care, many patients do not receive the full recommended course of BCG, often due to patient refusal or global shortages, which affected 9% of treatments. Despite receiving BCG, nearly a third of patients experienced at least one recurrence, highlighting the need for new treatments that could reduce reliance on BCG without compromising outcomes. |
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| Treatment sequence and overall survival in patients with metastatic urothelial cancer: An observational, multicenter, real-life STATES-Bladder study
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| Philippe Barthelemy, MD
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| Philippe Barthelemy presented the STATES-Bladder study, a real-world, multicenter study evaluating treatment sequences and overall survival in metastatic urothelial carcinoma patients. The study found that real-world survival outcomes were consistent with phase III trials, with a median OS of 22.4 months overall, and 29 months for those receiving avelumab maintenance. High attrition rates were observed, particularly in patients with poor performance status, who had a significantly worse prognosis, underscoring the need for new treatment strategies for this underrepresented subgroup.
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| Treatment of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer With UGN-102: Results of the Phase 3 ATLAS and ENVISION Studies |
| Sandip Prasad, MD |
| Sandip Prasad presented the results of the phase 3 ATLAS and ENVISION studies, evaluating UGN-102 for treating low-grade intermediate-risk non-muscle-invasive bladder cancer. The studies showed that UGN-102, a reverse thermal hydrogel with mitomycin, resulted in high complete response rates and durable outcomes. In the ATLAS trial, UGN-102 was associated with a 54% reduction in the risk of recurrence, progression, or death compared to TURBT. After 12 months, 79.7% of patients in the UGN-102 group remained event-free, with the majority of recurrences being low-grade. |
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| Kidney-Sparing Approach for Selected Localized High-Risk Upper Tract Urothelial Carcinoma: A Pilot Study Combining Endoscopic Thulium Laser Ablation With Perioperative Disitamab Vedotin and Immune Checkpoint Inhibitors |
| Jianjun Ye, MD |
| Jianjun Ye presented the results of a pilot study, exploring a kidney-sparing treatment approach for patients with localized high-risk upper tract urothelial carcinoma. The study combined endoscopic thulium laser ablation with perioperative disitamab vedotin and immune checkpoint inhibitors in patients who were not candidates for radical nephroureterectomy, such as those with a solitary kidney or bilateral tumors. |
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| Phase II Study of Oral APL-1202 plus Tislelizumab or Tislelizumab Alone as Neoadjuvant Therapy in Patients with Muscle-Invasive Bladder Cancer (MIBC) |
| Matthew Galsky, MD |
| Matthew Galsky presented the results of a Phase II study evaluating oral APL-1202 (nitroxoline) combined with tislelizumab versus tislelizumab alone as neoadjuvant therapy for patients with muscle-invasive bladder cancer (MIBC). The study aimed to assess the efficacy and safety of this combination in cisplatin-ineligible patients scheduled for radical cystectomy. |
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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 |
| The RUTIVAC-1 trial presented by Dr. Oscar Buisan at evaluated a heterologous prime-boost strategy using the RUTI® vaccine to enhance BCG efficacy in high-risk non-muscle invasive bladder cancer (NMIBC) patients. Results showed that RUTI® vaccination before BCG therapy induced a robust immune response and improved progression-free survival and event-free survival compared to placebo. |
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