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Highlights from the 2025 American Society of Clinical Oncology Genitourinary Cancers Symposium |
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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
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| Matthew Galsky, MD
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| Matthew Galsky presented additional data from the NIAGARA study, showing that perioperative durvalumab with neoadjuvant chemotherapy significantly improved event-free survival (HR 0.68) and overall survival (HR 0.75) in patients with muscle-invasive bladder cancer. The combination also led to a 10% increase in pathologic complete response, reduced the risk of metastasis by 33%, and had a manageable safety profile, supporting its potential as a new treatment for cisplatin-eligible patients.
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| Upstaging and Risk Migration With Blue Light Cystoscopy for Non–Muscle-Invasive Bladder Cancer: Results From a Prospective Multi-Center Registry |
| Alireza Ghoreifi, MD |
| Alireza Ghoreifi presented data on the impact of blue light cystoscopy (BLC) for non-muscle-invasive bladder cancer (NMIBC), showing that BLC resulted in upstaging or risk-group migration in 9.3% of patients. The study revealed that BLC detected lesions missed by white-light cystoscopy, leading to significant changes in patient management, including alterations in treatment plans like intravesical therapy or decisions regarding radical cystectomy. |
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| Clinical Characteristics and Treatment Patterns of Patients with Muscle Invasive Bladder Cancer: A Real-World Cohort Study |
| John Gore, MD, MS |
| John Gore presented a real-world study on clinical characteristics and treatment patterns for muscle invasive bladder cancer. The study found that a significant portion of MIBC patients did not receive neoadjuvant or adjuvant therapy, though 78.5% of those who did receive neoadjuvant therapy were treated with cisplatin-based regimens, particularly cisplatin + gemcitabine. Additionally, immunotherapy, specifically pembrolizumab, was the most common treatment in the adjuvant and subsequent therapy settings. |
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| Real-World Effectiveness and Safety of Avelumab First-Line Maintenance Treatment in Patients with Locally Advanced or Metastatic Urothelial Carcinoma: Second Interim Analysis of the AVENUE Study |
| Peter J. Goebell, MD, PhD |
| Peter Goebell presented the second interim analysis of the AVENUE study, assessing the real-world effectiveness and safety of avelumab 1st-line maintenance treatment in patients with locally advanced or metastatic urothelial carcinoma who had no disease progression after 1L platinum-based chemotherapy. |
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| Understanding Patient Perspectives in the Management of Their Muscle-Invasive Bladder Cancer |
| Deepro Chowdhury, MD, MBBS |
| Deepro Chowdhury presented a study on patient perceptions regarding the diagnosis and treatment of muscle-invasive bladder cancer (MIBC). This study involved two cohorts: Cohort A (2012-2013) and Cohort B (2023-2024), with 337 patients completing the survey across both cohorts. The aim was to understand patient experiences, treatment perceptions, and the impact of advocacy efforts on MIBC management. |
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| Neoadjuvant Pembrolizumab and Accelerated Methotrexate, Vinblastine, Doxorubicin, Cisplatin (aMVAC) in Non-Urothelial Histologic Subtype Muscle Invasive Bladder Cancer: A Phase 2 Trial |
| Ruben Raychaudhuri, MD |
| Ruben Raychaudhuri presents a Phase 2 trial exploring the combination of neoadjuvant pembrolizumab and accelerated methotrexate, vinblastine, doxorubicin, and cisplatin for non-urothelial histologic subtype muscle-invasive bladder cancer. The trial demonstrated a promising 53% pathologic complete response rate and a 59% downstaging rate, with encouraging 2-year overall survival and event-free survival. |
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| Preliminary Results from LEGEND: A Phase 2 Study of Detalimogene Voraplasmid (EG-70), a Novel, Non-Viral Intravesical Gene Therapy for Patients with BCG-Unresponsive NMIBC with CIS |
| John Taylor, MD, MS |
| John Taylor presented preliminary results from the LEGEND Phase 2 study of detalimogene voraplasmid, a non-viral gene therapy for patients with BCG-unresponsive non-muscle invasive bladder cancer with carcinoma in situ. In Cohort 1, the study showed a promising 71% complete response rate, with 67% achieving a complete response at 3 months and 47% at 6 months. |
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| ETCTN 10483: Phase Ib Trial of Erdafitinib Combined with Enfortumab Vedotin Following Platinum and PD-1/L1 Inhibitors for Metastatic Urothelial Carcinoma with FGFR3/2 Genetic Alterations |
| Rohit Jain, MBBS, MD |
| Rohit Jain presented ETCTN 10483, a Phase Ib trial combining erdafitinib with enfortumab vedotin (EV) for metastatic urothelial carcinoma (mUC) with FGFR3/2 alterations, following prior platinum and PD-1/L1 inhibitors. The combination showed a promising 100% objective response rate in the first 9 patients, with 88.8% achieving partial responses and 11.1% achieving a complete response. |
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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 on how gene expression signatures of immune infiltration influence the response to sequential intravesical gemcitabine and docetaxel versus BCG in high-risk non-muscle-invasive bladder cancer. This retrospective analysis of 143 treatment-naïve HR-NMIBC patients revealed that patients with higher immune scores had significantly better high-grade recurrence-free survival with Gem/Doce compared to BCG. |
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| Outcomes of Enfortumab Vedotin and Pembrolizumab for Patients Previously Treated with Immune Checkpoint Inhibitors in the UNITE Study. |
| Tanya Jindal |
| Tanya Jindal presented the results of the UNITE study, which evaluated the effectiveness of enfortumab vedotin and pembrolizumab in patients who had previously been treated with immune checkpoint inhibitors. Among 220 patients, 43 had prior ICI exposure, with 9% having received ICIs in the perioperative setting. The study found an objective response rate of 54%, with 9% achieving a complete response and 40% achieving a partial response. |
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| EORTC GUCG 2418 - STARBURST: Strategies for Treatment Adaptation Following Re-Evaluation of the Bladder After Using Primary Neoadjuvant Systemic therapies—An EORTC Platform Trial |
| Guillaume Grisay, MD |
| Guillaume Grisay presented the ongoing EORTC GUCG 2418 STARBURST platform trial, which aims to refine treatment strategies for muscle-invasive bladder cancer (MIBC) following neoadjuvant systemic therapy (NAT). The STARBURST-1 (SB-1) phase II study is enrolling 237 patients to validate a multimodal clinical signature for predicting treatment response. |
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| ABLE-32: A Randomized, Controlled, Phase 3b Clinical Trial of Nadofaragene Firadenovec-Vncg Versus Observation in Patients With Intermediate-Risk NMIBC |
| Neal D. Shore, MD, FACS |
| The ABLE-32 phase 3b trial is evaluating the efficacy of nadofaragene firadenovec, a non-replicating adenoviral vector-based gene therapy, versus observation in patients with intermediate-risk. The study aims to determine whether maintenance therapy with nadofaragene firadenovec can improve recurrence-free survival after tumor resection. With 454 participants across approximately 100 global sites, the trial will assess recurrence, progression, and safety over five years, with final results expected in 2031. |
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| A Phase 2/3 Multicenter Trial Evaluating Safety and Efficacy of a New Mucoadhesive Gemcitabine Suspension for Ablation of Upper Tract Urothelial Carcinoma |
| Marie-Pier St-Laurent, MD |
| This phase 2/3 multicenter trial evaluates the safety and efficacy of ST-02, a mucoadhesive gemcitabine suspension, for chemo-ablation of low-grade UTUC. The study aims to provide a kidney-sparing alternative to nephroureterectomy, with a primary endpoint of complete response at three months. If promising results are observed in the phase 2 cohort (30 patients), the trial will expand to phase 3 with an additional 40 participants, assessing durability of response, safety, and tolerability over 12 months. |
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| ABLE-22: Safety and Efficacy Evaluation of Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy—a Randomized, Open-Label, Phase 2 Study |
| Sia Daneshmand, MD |
| The ABLE-22 trial is a randomized, open-label phase 2 study evaluating the safety and efficacy of nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine/docetaxel) or immunotherapy (pembrolizumab) in patients with high-risk, BCG-unresponsive NMIBC. The primary objective is to assess efficacy, with secondary endpoints including durability of complete response, cystectomy-free survival, and overall survival. |
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| INTerpath-005: Phase 2 Study of Pembrolizumab With V940 (mRNA-4157) Versus Pembrolizumab With Placebo for Adjuvant Treatment of Resected High-Risk Muscle-Invasive Urothelial Carcinoma |
| Guru Sonpavde, MD |
| The INTerpath-005 trial is a phase 2, randomized, double-blind study evaluating pembrolizumab with V940 (mRNA-4157), an individualized neoantigen therapy, versus pembrolizumab with placebo in patients with resected high-risk MIUC. The primary objective is to assess disease-free survival, with secondary endpoints including distant metastasis-free survival, overall survival, and safety. |
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| A Phase Ⅱ Study of Disitamab Vedotin (RC48) Intravenous Injection Combined with BCG Intravesical Instillation in High-Risk Non-Muscle Invasive Bladder Cancer with HER2 High Expression |
| Xingliang Tan, MD |
| The Formula-01 trial is a phase 2, open-label study evaluating the combination of disitamab vedotin (RC48), a HER2-targeting antibody-drug conjugate, with BCG intravesical instillation in patients with high-risk NMIBC and HER2 overexpression. Given that HER2 overexpression is associated with poor BCG efficacy, this study aims to improve recurrence-free survival compared to historical outcomes. The single-arm trial, conducted at Sun Yat-sen University Cancer Center, has completed enrollment of 78 patients and will assess 2-year RFS as the primary endpoint, with secondary outcomes including progression-free survival (PFS), bladder preservation, and safety. |
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| CORE-008: A Phase 2, Multi-Arm, Multi-Cohort, Open-Label Study To Evaluate Intravesical Cretostimogene Grenadenorepvec in Participants With High-Risk NMIBC |
| Trinity Bivalacqua, MD |
| The CORE-008 trial is a phase 2, multi-arm, multi-cohort study evaluating intravesical cretostimogene grenadenorepvec, an oncolytic immunotherapy, in high-risk NMIBC patients who are either BCG-naïve or BCG-exposed. The study aims to assess safety and efficacy, with primary endpoints including complete response in CIS patients and high-grade event-free survival in papillary-only patients. |
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| Expanded Access Program of Cretostimogene Grenadenorepvec in Patients with NMIBC Unresponsive to BCG |
| Sarah P. Psutka, MD, MSc |
| Sarah Psutka presented the Expanded Access Program (EAP) for cretostimogene grenadenorepvec in BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) patients at ASCO GU 2025. This open-label program offers cretostimogene to real-world patients with high-risk BCG-unresponsive disease, providing a bladder-sparing alternative to radical cystectomy. |
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