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PEER-TO-PEER CLINICAL CONVERSATIONS |
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| KEYMAKER-U03 Trial: Combinatorial Therapies for IO-Refractory Kidney Cancer |
| Kathryn Beckermann, MD, PhD |
| Pedro Barata is joined by Kathryn Beckermann to discuss the KEYMAKER-U03 trial. This phase I/II umbrella platform study evaluates combinations in refractory clear-cell kidney cancer patients who progressed on both PD-1 and TKI therapy. |
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| TiNivo-2 Trial Results in Advanced Renal Cell Carcinoma Treatment |
| Toni Choueiri, MD |
| Toni Choueiri discusses the TiNivo-2 trial results, comparing tivozanib-nivolumab combination to tivozanib monotherapy in advanced clear cell renal cell carcinoma. |
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| HIF-2 Alpha Inhibitor NKT2152 Shows Impact in Renal Cell Carcinoma |
| Eric Jonasch, MD |
| Eric Jonasch discusses data on NKT2152, a novel HIF-2 alpha inhibitor for clear cell renal cell carcinoma. The phase 1/2 study shows promising results in heavily pre-treated patients, with objective response rates around 25% and median progression-free survival of 7.4 months. |
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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, PhD |
| Kathryn Beckermann presented results from KEYMAKER-U03 Substudy 03B, evaluating pembrolizumab and targeted therapy combinations for advanced ccRCC in patients previously treated with PD-(L)1 + VEGF-TKI therapies. The lenvatinib + belzutifan arm showed the highest response rate and median PFS, with manageable safety profiles across all regimens. These results support further investigation, including the ongoing phase 3 LITESPARK-011 trial. |
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| Systemic Treatment Options |
| Teresa Alonso Gordoa, MD |
| Teresa Alonso Gordoa discussed systemic treatment options for the management of advanced renal cell carcinoma. Alonso Gordoa concluded, IO-IO and IO-TKI combinations are foundational in the first-line treatment for advanced RCC. Differences in patient populations, efficacy outcomes, and QoL should be considered when selecting treatments across studies. These strategies enhance response rates and survival, potentially allowing for therapy interruptions or de-escalation approaches to improve tolerability, in collaboration with a multidisciplinary team. |
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| Cabozantinib in Combination with Nivolumab and Ipilimumab in Previously Untreated Advanced Renal Cell Carcinoma (aRCC): Final Results of COSMIC-313 |
| Laurence Albiges MD, PhD |
| Laurence Albiges presented final COSMIC-313 results showing that adding cabozantinib to nivolumab + ipilimumab improved PFS (16.6 vs 11.2 months) in untreated advanced RCC, particularly in IMDC intermediate-risk patients. However, no overall survival benefit was observed. Exploratory biomarker analysis suggested cabozantinib may counteract immune suppression in patients with high M2-like macrophage levels, a poor prognostic subgroup. |
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| Updated Results From the Phase 2 LITESPARK-003 Study of Belzutifan Plus Cabozantinib in Patients With Advanced Clear Cell Renal Cell Carcinoma
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| Toni K. Choueiri, MD
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| At ASCO GU 2025, updated results from the phase II LITESPARK-003 trial showed that belzutifan plus cabozantinib demonstrated durable antitumor activity in advanced clear cell RCC, with an ORR of 70% in treatment-naïve patients and 31% in previously treated patients. The combination showed consistent efficacy across IMDC risk groups and tumor burdens, with a manageable safety profile.
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| Final Analysis of the Phase 3 LITESPARK-005 Study of Belzutifan Versus Everolimus in Participants with Previously Treated Advanced Clear Cell RCC
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| Brian Rini, MD, FASCO
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| The final analysis of the phase 3 LITESPARK-005 trial confirmed that belzutifan significantly improved progression-free survival and objective response rate compared to everolimus in previously treated advanced clear cell RCC. Although overall survival improvement was not statistically significant, belzutifan showed durable responses, a favorable safety profile, and longer treatment duration, supporting its role as a treatment option after PD-(L)1 and VEGFR-TKI therapies.
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| Belzutifan in Patients with Advanced Clear Cell Renal Cell Carcinoma: Subgroup Analysis of the Phase 2 LITESPARK-013 Study |
| Michael Atkins, MD, FASCO |
| A subgroup analysis from the phase 2 LITESPARK-013 trial showed that belzutifan demonstrated durable responses across diverse subgroups of patients with previously treated advanced clear cell RCC, regardless of dose. The overall response rate was 23.4%, with trends favoring patients with fewer prior therapies, favorable-risk disease, and no sarcomatoid differentiation. |
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| Partitioned Overall Survival: Comprehensive Analysis of Survival States over 4 Years in CheckMate 9ER Comparing First-Line Nivolumab plus Cabozantinib Versus Sunitinib in Advanced Renal Cell Carcinoma |
| Charlene Mantia, MD |
| A 4-year partitioned survival analysis from CheckMate 9ER showed that first-line nivolumab plus cabozantinib improved overall survival and extended treatment-free survival compared to sunitinib in advanced renal cell carcinoma. Patients receiving the combination also spent significantly more time on first-line therapy and had longer TFS, particularly after discontinuation due to toxicity or protocol completion, with consistent benefits across most subgroups including those with aggressive disease. |
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