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Highlights from the 2025 European Society for Medical Oncology Annual Meeting |
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| First-Line Pembrolizumab-Based Regimens for Advanced Clear Cell Renal Cell Carcinoma: KEYMAKER-U03 Substudy 03A
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| Cristina Suarez Rodriguez, MD, PhD
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| Cristina Suarez Rodriguez presented results from KEYMAKER-U03 Substudy 03A, evaluating first-line pembrolizumab-based triplet regimens for advanced clear cell renal cell carcinoma. The belzutifan + pembrolizumab + lenvatinib arm showed the most promising outcomes, with improved PFS and DOR compared to the standard pembrolizumab + lenvatinib combination, while maintaining manageable safety.
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| LenCabo: A Randomized Phase II Multicenter Trial of Lenvatinib plus Everolimus versus Cabozantinib in Patients with Metastatic Clear Cell RCC that Progressed on PD-1 Immune Checkpoint Inhibition |
| Andrew Hahn, MD |
| Andrew Hahn presented the LenCabo phase II trial, comparing lenvatinib + everolimus versus cabozantinib in patients with metastatic clear cell RCC progressing after PD-1 inhibitor therapy. The combination of lenvatinib + everolimus showed significantly longer PFS and a higher response rate, though OS was similar between arms. Toxicities were more frequent with the combination, but the study supports lenvatinib + everolimus as an effective post–immunotherapy option for advanced RCC. |
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| Efficacy of Cabozantinib and Nivolumab in Cluster 1/2 Metastatic Clear Cell Renal Cell Carcinoma: Results from OPTIC RCC, a Phase II Trial of a Novel RNAseq-based Biomarker |
| Scott Haake, MD, PhD |
| Scott Haake presented results from OPTIC RCC, a phase II study using a novel RNAseq-based biomarker to guide therapy selection in metastatic clear cell RCC. In cluster 1/2 (“angiogenic”) tumors, patients treated with cabozantinib + nivolumab achieved an impressive 76% objective response rate, with all patients showing some tumor shrinkage and no progressive disease. |
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| Invited Discussant - Perioperative Immunotherapy Strategies in RCC: Evidence from the RAMPART and NESCIO Trials |
| Rana McKay, MD |
| Rana McKay discussed perioperative immunotherapy in RCC, focusing on the RAMPART and NESCIO trials. In RAMPART, durvalumab + tremelimumab significantly improved 3-year DFS versus active monitoring, mainly in high-risk patients, though OS data and toxicity outcomes remain pending. The NESCIO trial showed early signals of efficacy for ipilimumab + nivolumab and relatlimab + nivolumab as neoadjuvant therapy, but Dr. McKay emphasized the need to optimize patient selection, treatment duration, and standardized trial designs for future perioperative RCC studies. |
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| First Results from RAMPART: An International Phase 3 Randomized Controlled Trial of Adjuvant Durvalumab Monotherapy or Combined with Tremelimumab for Resected Primary Renal Cell Carcinoma (RCC) |
| James Larkin, PhD, FRCP, F Med Sci |
| James Larkin presented the RAMPART phase III trial, showing that adjuvant durvalumab + tremelimumab after RCC resection significantly improved 3-year disease-free survival compared to active monitoring, particularly in high-risk patients. Treatment was associated with higher rates of grade ≥3 adverse events and treatment discontinuation, but quality of life at 15 months was similar between arms. |
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| Neoadjuvant Immunotherapy in Locally Advanced Clear Cell Renal Cell Carcinoma at Risk for Recurrence or Distant Metastases: The Randomized Phase II NESCIO Trial |
| Femke Brugers, MD |
| The NESCIO phase II trial showed that a short course of neoadjuvant immunotherapy in locally advanced ccRCC produced pathologic responses in select patients, particularly with ipilimumab + nivolumab and relatlimab + nivolumab. Treatment was generally safe, minimally delayed surgery, and early follow-up demonstrated promising event-free and recurrence-free survival, especially among those with pathologic responses. |
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| Association of Circulating Kidney Injury Molecule-1 (KIM-1) Levels with Clinical Outcomes in Advanced Renal Cell Carcinoma (aRCC): Retrospective Analysis of COSMIC-313 |
| Wenxin Xu, MD |
| A retrospective analysis of COSMIC-313 demonstrated that higher baseline circulating KIM-1 levels in advanced RCC were associated with greater tumor burden, poor-risk features, and worse overall survival. Early reductions in KIM-1 during treatment with nivolumab plus ipilimumab correlated with improved objective response rates, progression-free survival, and overall survival, highlighting KIM-1 as a potential dynamic biomarker of ICI efficacy. |
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| Exploratory Analysis of Chromophobe Renal Cell Carcinoma in the SUNNIFORECAST Trial Comparing Ipilimumab plus Nivolumab vs Standard of Care as First Line Treatment |
| Marit Ahrens, MD |
| Marit Ahrens presented an exploratory analysis of chromophobe RCC in the SUNNIFORECAST trial showed that first-line nivolumab plus ipilimumab led to numerically longer median overall survival and higher objective response rates compared to standard of care, though differences were not statistically significant. Patients with PD-L1 CPS >1 appeared to derive greater benefit, with higher response rates and a trend toward improved survival, suggesting that PD-L1 expression may help identify chromophobe RCC patients more likely to respond to immunotherapy. |
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| Genomic Analysis of Papillary Renal Cell Carcinoma (PRCC): MET Alterations Are Uncommon and Enriched in Patients of African Ancestry |
| Miguel Zugman, MD |
| A genomic analysis of papillary RCC showed that MET alterations were relatively uncommon and primarily consisted of missense short variants, with amplifications less frequent and rearrangements rare. MET alterations were nearly twice as prevalent in patients of African ancestry and often co-occurred with cell-cycle and telomerase pathway alterations. The study also found that chromosome 7q gain was frequent in both MET⁺ and MET⁻ tumors, suggesting that broader definitions of “functionally MET⁺” disease may be needed, highlighting the importance of standardized biomarker criteria for future trials. |
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