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Highlights from the 2023 ASCO Genitourinary Cancers Symposium
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Oral Abstract Session B: Urothelial Carcinoma
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| Atezolizumab + Platinum/gemcitabine vs Placebo + Platinum/Gemcitabine for First-Line Treatment of Locally Advanced or Metastatic Urothelial Carcinoma: Final OS from the Randomized Phase 3 IMvigor130 Study
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| Enrique Grande, MD, PhD, Msc
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| Enrique Grande discussed the final overall survival results from the randomized phase 3 IMvigor130 study, assessing atezolizumab + platinum/gemcitabine vs placebo + platinum/gemcitabine for first-line treatment of locally advanced or metastatic urothelial carcinoma.
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| Final OS Analysis of Atezolizumab Monotherapy vs Chemotherapy in Untreated Locally Advanced or Metastatic Urothelial Carcinoma from the Phase 3 IMvigor130 Study
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| Aristotelis Bamias, MD
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| Data from the final overall survival analysis of the IMvigor130 study of first-line atezolizumab in metastatic urothelial carcinoma was consistent with finding from the first and second interim OS analyses.
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| IMvigor130 and the Future of Immune Checkpoint Inhibitors in the First-Line Treatment of Metastatic Urothelial Carcinoma |
| Andrea B. Apolo, MD
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| Andrea Apolo discussed two abstracts: “Atezolizumab + platinum/gemcitabine vs placebo + platinum/gemcitabine for first-line treatment of locally advanced or metastatic urothelial carcinoma: Final OS from the randomized Phase 3 IMvigor130 study” and “Final OS analysis of atezolizumab monotherapy vs chemotherapy in untreated locally advanced or metastatic urothelial carcinoma from the Phase 3 IMvigor130 study”.
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| Pembrolizumab Monotherapy for Patients with High-Risk Non–muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette–Guérin (BCG): Results from Cohort B of the Phase 2 KEYNOTE-057 Trial
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| Andrea Necchi, MD |
| Andrea Necchi discussed results of pembrolizumab monotherapy in patients with high-risk non–muscle-invasive bladder cancer (HR NMIBC) unresponsive to bacillus Calmette–Guérin (BCG) in the context of cohort B of the phase 2 KEYNOTE-057 trial.
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| Extended Follow-up Results from the CheckMate 274 Trial
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| Matt D. Galsky, MD, FASCO |
| This extended follow-up of CheckMate 274 demonstrates ongoing DFS, NUTRFS, and DMFS benefits of adjuvant nivolumab compared to placebo. Compared to the initial report of these data, the magnitude of the effect has increased somewhat for DFS and NUTRFS in PD-L1 ≥ 1% patients and for DMFS in both ITT and PD-L1 ≥ 1% patients without any additional safety signals.
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| Pembrolizumab Monotherapy for Patients with High-Risk Non–muscle-Invasive Bladder Cancer Unresponsive to Bacillus Calmette–Guérin (BCG): Results from Cohort B of the Phase 2 KEYNOTE-057 Trial
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| Michiel Van Der Heijden, MD, Ph.D.
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| Michiel Van Der Heijden provided an invited discussant perspective following two oral presentations from Matt Galsky highlighting updated data from the CheckMate 274 trial with extended follow-up results. As well as, Andrea Necchi discussing results of pembrolizumab monotherapy in patients with high-risk HR NMIBC unresponsive to BCG in the context of cohort B of KEYNOTE-057.
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| Supportive Care for Patients With Urothelial Carcinoma |
| Patient-Reported Outcomes in Cisplatin-Ineligible Patients with Locally Advanced or Metastatic Urothelial Cancer Treated with Enfortumab Vedotin Alone or in Combination with Pembrolizumab in the Phase 1b/2 EV-103 Cohort K
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| Matthew I. Milowsky, MD, FASCO
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| This analysis aimed to describe the impact of 1st line enfortumab vedotin plus pembrolizumab or EV monotherapy on QoL, functioning, and symptoms from the patient's perspective. These PRO data complement the encouraging efficacy and safety profile of EV + pembrolizumab in 1st line cisplatin-ineligible patients with locally advanced/metastatic urothelial carcinoma.
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| Rapid Abstracts: Biomarkers of Response and Risk Stratification in Genitourinary Cancers |
| Biomarkers of Response to Enfortumab Vedotin in Patients with Advanced Urothelial Carcinoma : Analysis of the UNITE Study
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| Tanya Jindal, BS, BA
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| Tanya Jindal presented on behalf of the UNITE study collaborators and helped identify potential biomarkers of response to enfortumab vedotin (EV) in patients with advanced urothelial carcinoma. In this abstract, they specifically looked at genetic biomarkers of response from available next-generation sequencing (NGS) testing. |
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| Overall Survival and Efficacy Results of Second-Line Treatment in Patients with Metastatic Clear Cell Renal Cell Carcinoma (mRCC) Treated in the Randomized Phase II BIONIKK Trial
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| Yann-Alexandre Vano, MD, Ph.D.
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| In this abstract, the authors provide updated data assessing overall survival and efficacy results according to second-line (L2) treatment in the randomized phase II BIONIKK trial. These data demonstrate that molecular selection also has an impact on treatment efficacy in the second-line setting.
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| European Association of Urology Testicular Cancer Guidelines Panel: A New Prognostic Factor Risk Group Classification for Patients with Clinical Stage 1 Seminoma in Active Surveillance
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| Robert J. Hamilton, MD, MPH, FRCSC
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| The objectives of the present study were to identify the most important pathological prognostic factors predicting relapse in clinical stage 1 seminoma patients with normal post-orchidectomy serum tumor marker levels in active surveillance and to construct risk groups for guiding treatment decision-making and follow-up.
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| Trials in Progress: Renal Cell Cancer; Adrenal, Penile, Urethral, and Testicular Cancers |
| STARLITE 1: Phase 1b/2 Study of Combination 177Lu Girentuximab plus Cabozantinib and Nivolumab in Treatment Naïve Patients with Advanced Clear Cell RCC
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| Elshad Hasanov, MD, PhD |
Elshad Hasanov discussed the trial design of a phase 1b/2 study of combination 177Lu girentuximab plus cabozantinib and nivolumab in treatment naïve patients with advanced clear cell RCC. To explore the effects of the treatment on inducing activated T cell infiltration, patients will undergo pre/post-treatment PET scan with [18F]F-AraG radiotracer, as well as biopsies for single cell, spatial transcriptomics and proteomics studies.
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| STARLITE 2: Phase 2 Study of Nivolumab plus 177lutetium-Labeled Anti–carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (177Lu-Girentuximab) in Patients with Advanced Clear Cell Renal Cell Carcinoma
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| Darren R. Feldman, MD |
| Feldman presents a trial in progress, STARLITE 2, which is a phase 2 study of nivolumab plus 177lutetium-labeled anti–carbonic anhydrase IX (CAIX) monoclonal antibody girentuximab (177Lu-girentuximab) in patients with advanced clear cell renal cell carcinoma.
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| Poster Session C: Renal Cell Cancer; Adrenal, Penile, Urethral and Testicular Cancers |
| CaboPoint: Interim Results from a Phase 2 Study of Cabozantinib After Checkpoint Inhibitor Therapy in Patients with Advanced Renal Cell Carcinoma
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| Laurence Albiges MD, PhD
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| The objective of this study was to evaluate the efficacy and safety of cabozantinib in adults with unresectable, locally advanced, or metastatic RCC with a clear-cell component whose disease progressed after 1st line CPI-based therapy. In this report, Dr. Albiges reported the results of the pre-planned interim analysis, which aimed to describe baseline demographics and characteristics, as well as investigator-assessed ORR at 3 months.
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| Outcomes by IMDC Risk in the COSMIC-313 Phase 3 Trial Evaluating Cabozantinib plus Nivolumab and Ipilimumab in First-Line Advanced RCC of IMDC Intermediate or Poor Risk
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| Thomas Powles, MBBS, MRCP, MD
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Subgroup analyses suggested that the PFS and objective response rate (ORR) benefit with the triplet regimen versus control was primarily in IMDC intermediate risk patients. In this report, the authors presented updated PFS results, as well as outcomes and exposure by IMDC risk group.
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| Cabozantinib in Combination with Atezolizumab in Non-Clear Cell Renal Cell Carcinoma: Extended Follow-up Results of Cohort 10 of the COSMIC-021 Study
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| Bradley McGregor, MD
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| In the COSMIC-021 phase 1b study, which evaluated cabozantinib plus atezolizumab in advanced solid tumors, this combination therapy demonstrated encouraging clinical activity in patients with advanced non-clear cell renal cell carcinoma (nccRCC) with a median follow-up of 13 mo.
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