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| Health-Related Quality of Life Outcomes from the NIAGARA Trial in Bladder Cancer |
| Michiel Simon Van Der Heijden, MD, PhD |
| Michiel Van der Heijden discusses NIAGARA trial health-related quality of life outcomes, demonstrating perioperative durvalumab added to neoadjuvant chemotherapy significantly improves event-free survival and overall survival without adversely impacting patient-reported outcomes. |
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Analysis of MRI Use in the Diagnostic Pathway for Bladder Cancer
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Nicholas James, MD, FRCP, FRCR, PhD
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| Nicholas James discusses final BladderPath trial survival analyses with Ashish Kamat, demonstrating multiparametric MRI introduced upstream of TURBT significantly improves bladder cancer-specific survival with statistically significant hazard ratio driven entirely by muscle-invasive disease outcomes.
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Highlights from the 2025 European Society for Medical Oncology Annual Meeting |
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| Health Related Quality of Life Outcomes from the NIAGARA Trial of Perioperative Durvalumab + Neoadjuvant Chemotherapy in MIBC
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| Michiel Van der Heijden, MD, PhD
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| The NIAGARA trial found that adding perioperative durvalumab to neoadjuvant chemotherapy in muscle-invasive bladder cancer significantly improved event-free and overall survival without negatively affecting health-related quality of life. Patients in both treatment arms experienced temporary declines during neoadjuvant therapy and surgery, followed by recovery during adjuvant treatment.
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| FORAGER-1: A Phase 1 Study of LY3866288, a Potent, Highly Isoform-Selective FGFR3 Inhibitor in FGFR3-Altered Advanced Solid Tumors |
| Alexandra Drakaki, MD, PhD |
| The phase 1 FORAGER-1 trial showed that LY3866288 (vepugratinib), a selective FGFR3 inhibitor, was well-tolerated and demonstrated encouraging antitumor activity in patients with FGFR3-altered metastatic urothelial cancer. The optimal dose was 200 mg twice daily, achieving a 34% objective response rate with mostly mild side effects. Early combination data with enfortumab vedotin and pembrolizumab showed strong responses, supporting ongoing evaluation in the global phase 2 FORAGER-2 trial. |
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| Datopotamab Deruxtecan + Rilvegostomig in Patients with Locally Advanced or Metastatic Urothelial Cancer: Results from the Phase 2 TROPION-PanTumor03 Study |
| Sun Young Rha, MD |
| Sun Young Rha presented results from the phase 2 TROPION-PanTumor03 trial evaluating datopotamab deruxtecan + rilvegostomig in locally advanced or metastatic urothelial cancer. The combination showed promising efficacy, with a 68% objective response rate in first-line cisplatin-ineligible patients and 39% in second-line patients previously treated with platinum chemotherapy. The regimen was well tolerated, with mainly mild adverse events and no new safety signals, supporting further study in first-line metastatic urothelial cancer. |
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| From Quality of Life to Next-Generation Therapies in Urothelial Cancer
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| Shilpa Gupta, MD
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| Shilpa Gupta highlighted that perioperative durvalumab in the NIAGARA trial preserved quality of life in muscle-invasive bladder cancer, supporting the tolerability of immunotherapy. The FORAGER-1 trial showed promising efficacy of the selective FGFR3 inhibitor vepugratinib, while combination strategies need validation. In TROPION-PanTumor03, datopotamab deruxtecan + rilvegostomig demonstrated encouraging activity, though the added value of TIGIT blockade remains uncertain and warrants further randomized evaluation.
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| Randomized Comparison of Upfront MRI versus Transurethral Resection for Staging New Bladder Cancers: Final Survival Analysis from the BladderPath Trial |
| Nicholas James, MD, FRCP, FRCR, PhD |
| Nicholas James presented final results from the BladderPath trial, which compared upfront MRI-based staging versus traditional TURBT for new bladder cancers. The MRI pathway significantly reduced time to treatment and showed a statistically significant improvement in bladder cancer–specific survival (HR 0.36, p = 0.046) without compromising overall outcomes. These findings support MRI as a faster, accurate, and potentially superior approach to initial staging in bladder cancer. |
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| Disitamab Vedotin plus Tislelizumab as Nephron-Sparing Therapy for High-Risk Upper Tract Urothelial Carcinoma: The Phase II DISTINCT-I Trial
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| Jiwei Huang, MD
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| The phase II DISTINCT-I trial presented at ESMO 2025 evaluated disitamab vedotin plus tislelizumab as a kidney-sparing treatment for high-risk upper tract urothelial carcinoma. Among 20 patients, the 1-year kidney-intact event-free survival was 70%, with a 75% clinical complete response after surgery and no grade ≥3 toxicities. Results suggest this HER2-targeted immunotherapy combination may safely enable nephron preservation and challenge the need for radical nephroureterectomy in selected patients. |
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| Neoadjuvant Gemcitabine Intravesical System (TAR-200) + Cetrelimab or Cetrelimab Alone in Patients with MIBC: SunRISe-4 Primary Analysis and Biomarker Results |
| Andrea Necchi, MD |
| Andrea Necchi presented the phase 2 SunRISe-4 trial showing that neoadjuvant TAR-200 plus cetrelimab achieved a 38% pathologic complete response and 77% 1-year recurrence-free survival in cisplatin-ineligible MIBC patients, outperforming cetrelimab alone. Both regimens were well tolerated with no new safety signals. Biomarker analyses revealed that utDNA negativity at week 12 strongly correlated with complete response, while ctDNA negativity predicted longer recurrence-free survival. |
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| Individualizing Care for Patients with Localized Urothelial Carcinoma
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| Stefanie Zschäbitz, MD
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| Stefanie Zschäbitz discussed advances in individualizing care for localized urothelial carcinoma, highlighting data from the BladderPath, DISTINCT-I, and SunRISe-4 trials. mpMRI showed promise in improving staging and outcomes versus TURBT but is not yet practice-changing due to implementation barriers. Novel strategies such as disitamab vedotin + tislelizumab for nephron-sparing therapy and TAR-200 + cetrelimab for muscle-invasive bladder cancer demonstrated encouraging efficacy and biomarker correlations, supporting a move toward more personalized and organ-preserving treatment approaches. |
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| FRUSICA-2: Fruquintinib + Sintilimab Versus Axitinib or Everolimus Monotherapy as Second Line Treatment in Patients with Locally Advanced or Metastatic RCC |
| Zhenhua Liu |
| Zhenhua Liu presented results from the phase 3 FRUSICA-2 trial, showing that fruquintinib + sintilimab significantly outperformed axitinib or everolimus as second-line therapy for patients with advanced or metastatic RCC following prior VEGFR-TKI treatment. The combination achieved a median PFS of 22.2 vs 6.9 months and an objective response rate of 60.5% vs 24.3%, with a manageable safety profile. |
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| Phase 1b/2 Trial of Ipilimumab, Nivolumab, and Ciforadenant in First-Line Advanced RCC: A Kidney Cancer Research Consortium Study
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| Kathryn Beckermann, MD, PHD
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| Kathryn Beckermann presented a phase 1b/2 trial evaluating ipilimumab, nivolumab, and ciforadenant as first-line therapy in advanced RCC. Among 51 patients, the triplet therapy was feasible and showed an objective response rate of 46% with a median PFS of 11.0 months, though the addition of ciforadenant did not clearly enhance deep responses compared to historical ipilimumab/nivolumab data.
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| Final Efficacy Data and Biomarker Analysis from the Clear Cell Cohort of CALYPSO |
| Sara Coca Membribes, MD |
| Sara Coca Membribes presented final data from the clear cell cohort of CALYPSO, evaluating durvalumab ± tremelimumab or durvalumab + savolitinib in previously VEGF-treated advanced RCC. While durvalumab + tremelimumab showed higher response rates and greater KIM-1 reduction, this did not translate into improvements in progression-free or overall survival, and PD-L1 status did not clearly predict benefit. |
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| Kidney Cancer Discussant: Can We Combine More in Line 1 and Line 2?
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| Laurence Albiges, MD, PhD
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| Laurence Albiges discussed first- and second-line combination strategies in advanced RCC, reviewing FRUSICA-2, the ipilimumab/nivolumab/ciforadenant trial, and CALYPSO. She highlighted that first-line triplet therapy with ciforadenant added to ipilimumab/nivolumab showed similar efficacy and safety to standard immunotherapy, with no clear added benefit, while second-line fruquintinib + sintilimab after VEGFR-TKI failure significantly improved PFS and ORR, though OS follow-up is ongoing.
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