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Highlights from the American Society of Clinical Oncology Genitourinary Cancers Symposium |
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| Real-World Outcomes of First-Line Dual Immunotherapy Versus Combination VEGF Immunotherapy in Intermediate-Poor Risk Metastatic Renal Cell Carcinoma: Results from the International Metastatic Renal Cell Carcinoma Data Consortium (IMDC) |
| David Maj, MBBS, MSc |
| David Maj presented real-world data from the IMDC comparing first-line dual immunotherapy versus combination VEGF-immunotherapy in intermediate-poor risk metastatic renal cell carcinoma. While IOVE had a higher objective response rate and longer time to next treatment (18.6 vs. 10.4 months), overall survival was similar between the two regimens. The study suggests both approaches offer comparable long-term outcomes, with IPI-NIVO having a higher discontinuation rate but no significant difference in immune-related adverse events. |
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| Modeling Survival Outcomes of KEYNOTE-564 with Standard of Care Control Arm Treatment: A Simulation Study |
| Fady Ghali, MD |
| Fady Ghali presented a simulation study using Gated Counterfactual Simulation to model survival outcomes in KEYNOTE-564, adjusting for the non-standard of care treatments received by the control arm. By estimating survival outcomes had control patients received standard-of-care therapy (checkpoint inhibitor + tyrosine kinase inhibitor), the re-simulated overall survival hazard ratio for adjuvant pembrolizumab was 0.80 (95% CI 0.56 – 1.14), suggesting its survival benefit may be overestimated. |
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| Phase III Randomized Trial of Stereotactic Ablative Radiotherapy (SAbR) for Oligometastatic Advanced Renal Carcinoma (EA8211-SOAR)
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| Suzanne Cole, MD
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| The EA8211-SOAR phase III trial, presented by Dr. Suzanne Cole is investigating stereotactic ablative radiotherapy as a potential alternative to systemic therapy for oligometastatic renal cell carcinoma. This non-inferiority trial randomizes patients to either SAbR with delayed systemic therapy upon progression or immediate ST, with overall survival and grade ≥3 toxicity as co-primary endpoints.
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| Cabozantinib in Combination with Nivolumab and Ipilimumab in Previously Untreated Advanced Renal Cell Carcinoma (aRCC): Final Results of COSMIC-313
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| Laurence Albiges MD, PhD
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| The final results of the COSMIC-313 trial, presented by Dr. Laurence Albiges, confirm a progression-free survival benefit with cabozantinib plus nivolumab and ipilimumab in previously untreated advanced renal cell carcinoma, but no overall survival advantage. The PFS benefit was restricted to IMDC intermediate-risk patients, while poor-risk patients saw no benefit. Notably, the triplet therapy did not improve OS in any subgroup.
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| Nivolumab plus Cabozantinib vs Sunitinib for Previously Untreated Advanced Renal Cell Carcinoma: Final Follow-up Results from the CheckMate 9ER Trial |
| Robert Motzer, MD |
| The final results of the CheckMate 9ER trial with a 67.6-month median follow-up confirmed the long-term efficacy of nivolumab + cabozantinib (NIVO + CABO) over sunitinib (SUN) in previously untreated advanced renal cell carcinoma (aRCC). NIVO + CABO showed superior progression-free survival, overall survival, and objective response rate. |
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| KEYMAKER-U03 Substudy 03B: Pembrolizumab and Targeted Therapy Combinations for Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
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| Kathryn Beckermann, MD
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| The KEYMAKER-U03 Substudy 03B trial, presented by Kathryn Beckermann evaluated pembrolizumab and targeted therapy combinations for advanced clear cell renal cell carcinoma after progression on PD-(L)1 and VEGF-TKI therapy. While all combinations had manageable toxicity, anemia was common in the belzutifan arms. The findings suggest lenvatinib + belzutifan as a promising regimen, now being further evaluated in the phase 3 LITESPARK-011 trial against cabozantinib.
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| Evaluation of Circulating Kidney Injury Marker-1 (KIM-1) as a Prognostic and Predictive Biomarker in Advanced Renal Cell Carcinoma: Post-Hoc Analysis of CheckMate 214 |
| Wenxin Xu, MD |
| Wenxin Xu presented a post-hoc analysis of the CheckMate 214 trial, highlighting that a decrease in circulating KIM-1 after 3 weeks of nivolumab + ipilimumab treatment was strongly associated with better OS and PFS in advanced RCC patients. Elevated baseline KIM-1 levels were linked to worse clinical outcomes, supporting its potential as a biomarker for immunotherapy response. |
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| Casdatifan Monotherapy in Patients with Previously Treated Clear Cell Renal Cell Carcinoma (ccRCC): Safety, Efficacy and Subgroup Analysis Across Multiple Doses from ARC-20, a Phase 1 Open-Label Study |
| Toni Choueiri, MD |
| The phase 1 ARC-20 study evaluated casdatifan monotherapy in previously treated ccRCC patients, showing promising efficacy across doses. The highest ORR was observed in the 100 mg once-daily group, with a rapid response and tumor shrinkage trends. Casdatifan was well-tolerated, with manageable anemia and hypoxia rates, supporting its further development, including the phase 3 PEAK-1 trial assessing casdatifan plus cabozantinib in metastatic ccRCC. |
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| Racial Disparities in Renal Cell Carcinoma Histology and Outcomes: Insights from the French Kidney Cancer Research Network (UroCCR-191) |
| Xiaofan Lu, MD |
| A study from the French Kidney Cancer Research Network (UroCCR-191) analyzed racial disparities in RCC histology and outcomes in France, finding that non-clear cell RCC subtypes were significantly more common in Black patients. Despite differences in histology and disease presentation, race was not an independent prognostic factor for clinical outcomes in a universal healthcare system. |
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| Lenvatinib plus Tislelizumab as First-Line Therapy for Advanced Fumarate Hydratase-Deficient Renal Cell Carcinoma: A Single-Center, Single-Arm, Phase II Study |
| Wen Kong, MD |
| A phase II study evaluating lenvatinib plus tislelizumab as first-line therapy for advanced fumarate hydratase-deficient RCC showed promising efficacy, with a 90% objective response rate and a 100% disease control rate. No primary progression was observed, and median progression-free survival and overall survival were not reached at a median follow-up of 9.7 months. |
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| Final Overall Survival and New ctDNA Analysis in MET-Driven Advanced Papillary Renal Cancer (CALYPSO) |
| Frankie Jackson-Spence, MBChB, BMedSc, PCGAP |
| Frankie Jackson-Spence presented the final overall survival and ctDNA analysis from the CALYPSO trial, showing that savolitinib + durvalumab demonstrated activity in MET-driven metastatic papillary renal cancer, with a median OS of 27.4 months in this group. ctDNA positivity at baseline was associated with shorter OS, but ctDNA clearance during treatment correlated with improved survival, providing a potential prognostic biomarker for this disease. |
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