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Highlights from the American Society of Clinical Oncology Genitourinary Cancers Symposium |
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| 18F-PSMA-1007 PET/CT for Response Assessment in Patients with mRCC Undergoing First Line Tyrosine Kinase or Checkpoint Inhibitor Therapy |
| Michael D. Staehler, MD, PhD |
| Dr. Michael Staehler presented promising data on the use of 18F-PSMA-1007 PET/CT for response assessment in metastatic renal cell carcinoma (mRCC) patients undergoing first-line treatment with tyrosine kinase inhibitors (TKIs) or checkpoint inhibitors at ASCO GU 2025. The study found that a >10% reduction in SUVmax (a marker of PSMA uptake) was significantly associated with longer progression-free survival (PFS) and overall survival (OS). Specifically, patients with SUVmax reduction had a median PFS of 23.1 months and OS of 36.2 months, compared to 3.6 and 11.1 months, respectively, in those without the reduction. |
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| Exploring the Efficacy of Belzutifan in the Treatment of Renal Cell Carcinoma Associated With Von Hippel-Lindau Disease: A Comparative Analysis With External Control Arm |
| Marston Linehan, MD |
| Marston Linehan presented data from a comparative analysis of belzutifan in the treatment of von Hippel-Lindau renal cell carcinoma (VHL-RCC) at ASCO GU 2025. The analysis compared the results of the phase 2 LITESPARK-004 trial (LS-004) with an external control arm (ECA) derived from a natural history study of VHL-RCC patients. |
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| Real-World Treatment Patterns and Clinical Outcomes in Patients with Metastatic Renal Cell Carcinoma (mRCC) in the US Community Setting. |
| Cherrishe Brown-Bickerstaff, PhD, MPH |
| Cherrishe Brown-Bickerstaff presented a real-world study on treatment patterns and clinical outcomes in patients with metastatic renal cell carcinoma (mRCC) receiving first-line immunotherapy (IO) combinations at ASCO GU 2025. The study involved 308 patients treated between January 2021 and April 2023 with various IO-based regimens: nivolumab + cabozantinib, nivolumab + ipilimumab, pembrolizumab + axitinib, and pembrolizumab + lenvatinib. |
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| Real-World Effectiveness and Safety of First-Line Avelumab + Axitinib in Patients with Advanced Renal Cell Carcinoma: Primary Analysis of the AVION Study. |
| Axel S. Merseburger, MD, PhD |
| Axel Merseburger presented the primary analysis of the AVION study at ASCO GU 2025, which examined the effectiveness and safety of first-line avelumab + axitinib in patients with advanced renal cell carcinoma (aRCC) in real-world clinical practice. This prospective, non-interventional study involved patients from Belgium, Germany, Greece, and Russia, and evaluated outcomes such as overall survival (OS), progression-free survival (PFS), and treatment-related adverse events (TRAEs). |
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| Real-World Analysis of Pembrolizumab Utilization and Characteristics of Patients Being Prescribed Treatment in Early Stage RCC |
| Robert G. Uzzo, MD, MBA, FACS |
| Robert Uzzo presented a real-world analysis of pembrolizumab utilization in early-stage RCC at ASCO GU 2025. The study, conducted within The US Oncology Network, examined 178 post-nephrectomy RCC patients, finding that 66.3% received adjuvant pembrolizumab. Most patients had stage III disease (79%) and clear cell RCC histology (83%). The median real-world time on treatment (11.5 months) aligned with the Keynote-564 trial’s findings. Factors influencing pembrolizumab use included histology (non-ccRCC patients had 93% lower odds of treatment) and timing of the first oncology visit post-surgery. |
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| Development of a FKSI-23: A New Bespoke Health-Related Quality of Life Questionnaire for the Advanced and Adjuvant Setting in RCC
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| Cristiane D. Bergerot, MD
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| Cristiane Bergerot presented the development of FKSI-23, a new health-related quality of life (HRQoL) questionnaire for patients with advanced and adjuvant renal cell carcinoma (RCC) at ASCO GU 2025. The questionnaire was created through a four-phase process, incorporating feedback from patients, advocates, and experts, with a focus on addressing the unique HRQoL needs of both localized and metastatic RCC patients. FKSI-23 aims to improve symptom management, patient-provider communication, and patient-centered care, and is being validated in ongoing trials like PRISM and CARE-1.
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| Updated Results of the TIDE-A Study Evaluating Avelumab plus Intermittent Axitinib in Previously Untreated Patients with Metastatic Renal Cell Carcinoma (mRCC) |
| Daniela Arduini, MD, MSc |
| Daniela Arduini presented updated results from the TIDE-A study at ASCO GU 2025, which evaluated the combination of avelumab and intermittent axitinib in previously untreated metastatic renal cell carcinoma (mRCC) patients. The study demonstrated that VEGFR-TKI interruption followed by avelumab maintenance is feasible and effective, with a median progression-free survival (PFS) of 27.9 months and a 24-month overall survival (OS) rate of 85%. |
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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 |
| Toni K. Choueiri, MD |
| The updated results from the phase II LITESPARK-003 study, presented by Dr. Toni Choueiri at ASCO GU 2025, reinforce the potential of belzutifan plus cabozantinib in advanced clear cell renal cell carcinoma (ccRCC). With longer follow-up, the combination demonstrated a 70% ORR in treatment-naïve patients and a 31% ORR in previously treated patients. Median PFS was 30.3 months in cohort 1 and 13.8 months in cohort 2. Safety findings remained consistent with prior data. These results highlight the ongoing clinical benefit of combining a HIF-2α inhibitor with a VEGFR TKI in both first-line and subsequent-line settings. |
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| First-in-Human Phase 0 Safety, Imaging, Pharmacokinetics, and Dosimetry Study of 64Cu-PD-32766, a CAIX-Targeting Peptide, in Patients with Clear Cell RCC |
| Toshihiro Horii, PhD |
| A phase 0 study of 64Cu-PD-32766, a CAIX-targeting peptide, in clear cell RCC demonstrated good tolerability and strong PET uptake (96.2% lesion-level positivity). Tumor accumulation was sustained, while systemic clearance was rapid, suggesting its potential as both a diagnostic and therapeutic radioligand. These findings highlight 64Cu-PD-32766 as a promising tool for improved RCC imaging and management. |
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| INTerpath-004: A Phase 2, Randomized, Double-Blind Study of Adjuvant Pembrolizumab (Pembro) With V940 (mRNA-4157) or Placebo for Renal Cell Carcinoma (RCC)
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| Robert Motzer, MD
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| The INTerpath-004 trial is a phase 2, randomized, double-blind study evaluating adjuvant pembrolizumab with V940 (mRNA-4157), an individualized neoantigen therapy, versus placebo in patients with RCC following nephrectomy. The study aims to assess disease-free survival as the primary endpoint, with secondary endpoints including metastasis-free survival, overall survival, and safety. A total of 272 patients will be enrolled, with imaging assessments conducted regularly to monitor recurrence, and the trial is currently active.
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| STARLITE 2: Phase 2 Study of Nivolumab Plus 177lutetium-Labeled Anti–Carbonic Anhydrase IX (CAIX) Monoclonal Antibody Girentuximab (177Lu-Girentuximab) in Patients With Advanced Clear Cell Renal Cell Carcinoma (ccRCC) |
| Darren Feldman, MD |
| The STARLITE 2 trial is a phase 2 study evaluating the combination of ¹⁷⁷Lu-girentuximab, a CAIX-targeting radiolabeled monoclonal antibody, with nivolumab in patients with previously treated advanced ccRCC. The trial includes a safety lead-in phase to establish the maximum tolerated dose, followed by an efficacy assessment using a Simon two-stage design. Key endpoints include objective response rate, progression-free survival, overall survival, and safety, aiming to determine the potential of this combination as a novel therapeutic strategy. |
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| Phase 1b/2 Study of Combination 177Lu Girentuximab + Cabozantinib and Nivolumab in Treatment Naive Patients With Advanced Clear Cell RCC |
| Eric Jonasch, MD |
| This phase 1b/2 trial, presented by Dr. Eric Jonasch investigates the addition of ¹⁷⁷Lu-girentuximab to cabozantinib and nivolumab in treatment-naïve advanced clear cell RCC patients. The study aims to enhance complete response rates by leveraging radiation-induced DNA damage to potentiate immune checkpoint inhibition. The trial will enroll up to 100 patients, with primary endpoints focused on safety and complete response rate, while secondary endpoints include objective response rate, progression-free survival, and overall survival. |
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| A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) |
| Tian Zhang, MD, MHS |
| Tian Zhang presented the ongoing BOOST-RCC phase II trial at ASCO GU 2025, which evaluates the combination of evolocumab (a PCSK9 inhibitor) and nivolumab in patients with metastatic renal cell carcinoma (mRCC) who have progressed after prior immune checkpoint inhibitor (ICI) therapy. The study hypothesizes that PCSK9 inhibition may overcome ICI resistance by enhancing tumor antigen presentation and improving immune responses. |
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