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Highlights from the 2026 ASCO Genitourinary Cancers Symposium
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| Belzutifan + Lenvatinib versus Cabozantinib for Advanced RCC after Anti-PD-(L)1 Therapy: Open-Label Phase 3 LITESPARK-011 Study
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| Robert Motzer, MD
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| Robert Motzer presented the LITESPARK-011 trial which found that belzutifan + lenvatinib improved progression-free survival and response rates compared with cabozantinib in advanced clear cell RCC previously treated with anti–PD-(L)1 therapy. Overall survival trended better and side effects were manageable, making this combination a promising new post-immunotherapy option.
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| Adjuvant Pembrolizumab + Belzutifan versus Pembrolizumab for Clear Cell RCC: The Randomized Phase 3 LITESPARK-022 Study
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| Toni Choueiri, MD
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| LITESPARK-022 showed that adding belzutifan to adjuvant pembrolizumab after nephrectomy for high‑risk clear cell RCC significantly improved disease‑free survival versus pembrolizumab alone, with 24‑month DFS of about 81% vs 74%. Overall survival data are still immature, and while combination therapy caused more grade ≥3 toxicity, adverse events were generally manageable, supporting this regimen as a new adjuvant option for patients at increased risk of recurrence.
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| PROs in Resected RCC: Active Monitoring versus Durvalumab and Tremelimumab in the RAMPART Trial
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| Sophie Merrick, MBCHB, MRCP
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| In RAMPART, adjuvant durvalumab plus tremelimumab after nephrectomy improved disease‑free survival in intermediate/high‑risk resected RCC but came with measurable, time‑dependent quality‑of‑life effects. At week 16, patients on combination immunotherapy reported small but clinically meaningful worsening in global health/quality of life, role function, fatigue, and insomnia versus active monitoring, while by month 15 these early decrements largely improved, with new small but meaningful declines emerging in pain and cognitive function that need to be weighed against the survival benefit when counseling patients.
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| Activity and Biomarker Analyses with Casdatifan, a Next-Generation HIF-2alpha Inhibitor, in Refractory Clear Cell RCC: Results from ARC-20
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| Toni Choueiri, MD
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| Casdatifan, a next‑generation HIF‑2α inhibitor, produced durable responses in heavily pretreated metastatic clear cell RCC in ARC‑20, with an objective response rate of about one‑third and median progression‑free survival around a year (not yet reached in the 100‑mg cohort). Treatment caused deep, sustained suppression of serum erythropoietin, and greater EPO reduction correlated with better disease control, supporting 100 mg once daily as the dose being taken forward into the phase 3 PEAK‑1 study.
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| A Phase 1/2 Study to Assess Peptidomimetic CA IX Imaging and Therapy with 68Ga-DPI-4452 and 177Lu-DPI-4452 in Patients with Advanced Clear Cell RCC and Other Solid Tumors
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| Michael Hofman, MBBS, FRACP, FAANMS, FICIS, GAICD
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| This ongoing multicenter phase 1/2 trial is evaluating a CA IX–targeted theranostic pair, 68Ga‑DPI‑4452 for PET imaging and 177Lu‑DPI‑4452 for radioligand therapy, in patients with advanced clear cell RCC and other CA IX–expressing tumors. Early imaging data show exceptional tumor uptake and favorable dosimetry with 68Ga‑DPI‑4452, and the trial’s dose‑escalation and expansion phases will define recommended 177Lu‑DPI‑4452 doses and assess antitumor activity, while additional cohorts test diagnostic performance in indeterminate renal masses and broader solid tumor settings.
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| Final Analysis of the Prospective AVION Study: Real-World Effectiveness and Safety of First Line Avelumab + Axitinib in Patients with Advanced RCC
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| Axel Merseburger, MD, PhD
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| The final AVION analysis confirms that first-line avelumab + axitinib delivers robust real-world outcomes in advanced RCC, with 12- and 24‑month overall survival rates of 81.8% and 69.2% and a median progression-free survival of 11.1 months. Objective response was 48.4% with durable disease control, grade ≥3 treatment-related events in under 20%, low discontinuation rates, and generally stable quality of life, aligning closely with JAVELIN Renal 101 and reinforcing this combination as a standard first-line option in routine practice.
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