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Highlights from the 2024 ASCO Genitourinary Cancers Symposium |
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| Overall Survival Results from the Phase 3 KEYNOTE-564 Study of Adjuvant Pembrolizumab vs Placebo for the Treatment of Clear Cell RCC |
| Toni K. Choueiri, MD |
| Toni Choueiri presented overall survival results from the phase 3 KEYNOTE-564 study of adjuvant pembrolizumab versus placebo for the treatment of clear cell RCC. The study, which included 994 patients, showed that adjuvant pembrolizumab significantly prolonged overall survival compared to placebo in participants with clear cell RCC at an increased risk of recurrence following surgery, with a 38% reduction in the risk of death. These results support adjuvant pembrolizumab as a standard of care after surgery in this disease setting. |
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| Adjuvant Nivolumab Monotherapy vs Placebo for Localized RCC at High-Risk of Relapse After Nephrectomy: Results from Part B of the Randomized, Phase 3 CheckMate 914 Trial |
| Robert J. Motzer, MD |
| Robert Motzer presented results from Part B of the CheckMate 914 trial, comparing adjuvant nivolumab monotherapy to placebo in localized renal cell carcinoma at high risk of relapse after nephrectomy. The trial, designed to complement Part A, did not show a significant disease-free survival benefit with nivolumab monotherapy, with a hazard ratio of 0.87. |
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| Discussant: Adjuvant Treatment for RCC – Strategies on How to Optimize Patient Selection for The New Standard of Care |
| Pedro C. Barata, MD, MSc |
| Pedro Barata discussed strategies for optimizing patient selection for the new standard of care in adjuvant treatment for renal cell carcinoma (RCC). He highlighted the results from the CheckMate 914 trial, which tested the activity of nivolumab and ipilimumab, and the KEYNOTE-564 trial, showing that adjuvant pembrolizumab significantly improved overall survival in high-risk RCC patients after nephrectomy. |
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| The Impact of Immunotherapy-Based Regimens in Primary Renal Tumors |
| Rana McKay, MD |
| Rana McKay discussed the impact of immunotherapy-based regimens in primary renal tumors, focusing on the heterogeneous responses across variant histologies of renal cell carcinoma (RCC). Dr. McKay highlighted the expanding list of RCC histologies, including molecularly defined entities, and emphasized the unmet need in treating variant histology RCC due to their exclusion or grouping in clinical trials. |
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| Nivolumab plus Cabozantinib vs Sunitinib for Previously Untreated Advanced RCC: Results from 55-Month Follow-up of the CheckMate 9ER Trial
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| Maria Bourlon, MD, MSc
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| Maria Bourlon presented the 55-month follow-up results of the CheckMate 9ER trial, evaluating nivolumab plus cabozantinib vs sunitinib for previously untreated advanced renal cell carcinoma (RCC). The study showed that nivolumab plus cabozantinib maintained superior progression-free survival, overall survival, and objective response rate over sunitinib, with meaningful long-term efficacy benefits, regardless of International Metastatic RCC Database Consortium risk.
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| Nivolumab plus Ipilimumab vs Sunitinib for First-Line Treatment of Advanced RCC: Long-Term Follow-up Data from the Phase 3 CheckMate 214 Trial |
| Nizar Tannir, MD, FACP |
| Nizar Tannir presented long-term follow-up data from the phase 3 CheckMate 214 trial, assessing first-line nivolumab plus ipilimumab versus sunitinib in advanced renal cell carcinoma (RCC). The study demonstrated that nivolumab plus ipilimumab provided substantial long-term survival benefits over sunitinib, with consistent overall survival benefits in the intermediate/poor risk group and improved outcomes over time in the favorable risk group. |
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| Subgroup Analyses of Efficacy Outcomes by Baseline Tumor Size in the Phase 3, Open-label CLEAR Trial |
| Viktor Grünwald, MD |
| Viktor Grünwald presented a subgroup analysis of efficacy outcomes by baseline tumor size in the phase 3 CLEAR trial. Results showed that progression-free survival, overall survival, and objective response rate benefits with lenvatinib + pembrolizumab were observed across patients, supporting its use for first-line treatment of advanced RCC irrespective of baseline tumor size. |
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| Development of a Patient-Centered HRQOL Measure for Metastatic RCC: A Three-Phase Study |
| Cristiane Bergerot, Ph.D. |
| Cristiane Bergerot discussed the development of a patient-centered HRQOL measure for metastatic RCC through a three-phase study. The research involved patient engagement, expert input, and advocacy. The study identified areas of priority for patients with kidney cancer receiving treatment, created a new model using a multidisciplinary team, and highlighted the need for validation in upcoming trials, including the PRISM and CARE-1 studies. |
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| Cabozantinib plus Atezolizumab in Locally Advanced/metastatic Adrenocortical Carcinoma: Results from a Multi-Cohort Basket Phase II Trial, CABATEN/GETNE-T1914
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| Enrique Grande, MD, Ph.D., MSc
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| Enrique Grande presented the results of the CABATEN/GETNE-T1914 trial, a multi-cohort basket phase II trial evaluating cabozantinib plus atezolizumab in patients with locally advanced/metastatic adrenocortical carcinoma. The trial found that the combination had limited activity in refractory advanced/metastatic adrenocortical carcinoma, with a disease control rate of 33.3%. The safety profile was consistent with previous reports, and further investigation is warranted to identify predictive factors for potential benefits from this combination. |
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| First-Line Pembrolizumab plus Lenvatinib for Non–Clear Cell RCC: Extended Follow-Up of the Phase 2 KEYNOTE-B61 Study |
| Martin H. Voss, MD |
| Martin Voss presented extended follow-up results from the phase 2 KEYNOTE-B61 trial, evaluating first-line pembrolizumab plus lenvatinib for non–clear cell renal cell carcinoma (RCC). With a median follow-up of 23 months, the combination demonstrated durable antitumor activity and a manageable safety profile in patients with advanced non–clear cell RCC. |
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| Evaluating Intermediate Endpoints for Overall Survival in Metastatic Renal Cell Carcinoma Treated with Immune Checkpoint Inhibitors: An IMDC Study |
| Renee Saliby, MD, MSc |
| Renee Saliby presented an analysis from the IMDC, evaluating intermediate endpoints for overall survival in metastatic renal cell carcinoma treated with immune checkpoint inhibitors. The study aimed to determine if shorter-term/intermediate endpoints, such as time to treatment failure and time to next therapy, are significantly correlated with overall survival in patients receiving first-line ICI-based therapy. |
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| The Role of Cytoreductive Nephrectomy in the Immune Checkpoint Inhibitor Era of Metastatic Renal Cell Carcinoma: A Systematic Review and Individual Patient Data Meta-Analysis of 2319 Patients |
| Dimitrios Makrakis, MD |
| Dimitrios Makrakis presented a systematic review and individual patient data meta-analysis evaluating the role of cytoreductive nephrectomy for metastatic renal cell carcinoma (RCC) in the immune checkpoint inhibitor (ICI) era. This study aimed to determine the potential survival benefits of cytoreductive nephrectomy in metastatic RCC patients treated with ICIs. |
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| First-in-Human Safety, Imaging and Dosimetry of [68Ga]Ga-DPI-4452, a Novel CA IX-Targeting Peptide, in Patients with Clear Cell RCC |
| Michael S. Hofman, MD |
| Michael Hofman presented the first-in-human safety, imaging, and dosimetry of [68Ga]Ga-DPI-4452, a novel carbonic anhydrase IX-targeting peptide, in patients with ccRCC. [68Ga]Ga-DPI-4452, a radiolabeled peptide, demonstrated exceptional images in patients with ccRCC without clinically significant toxicity. The study suggests the potential use of [68Ga]Ga-DPI-4452 in both diagnostics and patient selection for therapy, supporting further evaluation of treatment with [177Lu]Lu-DPI-4452. |
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| Treatment-Free Survival After First-line Therapies for Metastatic Renal Cell Carcinoma: An International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) analysis |
| Mehul Gupta, MD |
| Mehul Gupta presented an analysis of treatment-free survival after first-line therapies for metastatic renal cell carcinoma. The study utilized the International Metastatic Renal Cell Carcinoma Database Consortium dataset and identified patients initiating first-line systemic therapy with various agents |
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