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Highlights from the 2023 American Society of Clinical Oncology Annual Meeting
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Poster Session: Genitourinary Cancer--Kidney and Bladder
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| Determinants of Resistance to Nivolumab Monotherapy Investigated Through Genomic and Transcriptomic Analysis of Renal Cell Carcinoma Tumors from the HCRN GU16-260 Study
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| David A. Braun, MD, Ph.D.
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| David Braun presents the results of genomic and transcriptomic analysis from the HCRN GU16-260 study evaluating determinants of resistance to nivolumab monotherapy. Bulk genomic and single-cell transcriptomic analyses of patients with treatment-naïve, advanced RCC from the HCRN GU16-260 phase II trial revealed somatic alterations and infiltrating T cell populations associated with resistance to frontline nivolumab monotherapy. Additional independent and functional validation studies are currently in progress.
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| Biomarker-Driven Prospective Clinical Trial in Renal Cell Carcinoma: Developing Machine Learning Models to Allocate Patients to Treatment Arms Using RNA Sequencing
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| Anupama Reddy, Ph.D. |
| Anupama Reddy presents the results of a study evaluating machine learning models allocating renal cell carcinoma (RCC) patients to treatment arms using biomarker-driven RNA sequencing. Randomized clinical trials of systemic treatment in the metastatic RCC setting currently randomize patients to treatment arms without considering underlying genomic classifiers of disease biology. RNA sequencing has shown promise in defining the biology of individual RCC tumors. |
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| A Phase I/II Study to Evaluate the Safety, Pharmacodynamics, and Efficacy of Entinostat in Combination with Atezolizumab and Bevacizumab in Patients with Renal Cell Carcinoma |
| Roberto Pili, MD
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| Roberto Pili presents the results of a phase I/II study evaluating the safety, pharmacodynamics, and efficacy of entinostat in combination with atezolizumab and bevacizumab in patients with renal cell carcinoma (RCC). The preliminary results from this study suggest that the combination of entinostat and atezolizumab plus bevacizumab is relatively well-tolerated and may be active in patients with ccRCC. |
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| Health-Related Quality of Life (HRQoL) of Risk-Based Patient Subgroups with Advanced Renal Cell Cancer (aRCC) Treated with Nivolumab plus Cabozantinib vs Sunitinib in the CheckMate 9ER Trial |
| David Cella, Ph.D. |
| David Cella presents the patient reported outcomes (PROs) from the CheckMate 9ER trial evaluating health-related quality of life (HRQoL) of IMDC risk-based patient subgroups with advanced renal cell cancer (RCC) treated with nivolumab plus cabozantinib versus sunitinib. Compared to sunitinib, combination nivolumab + cabozantinib improved or maintained HRQoL in intermediate/poor risk patients and was associated with less side effect bother in all subgroups. |
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| CASSIOPE: A Prospective Noninterventional Study of Cabozantinib Treatment Following Prior Vascular Endothelial Growth Factor - Targeted Therapy in Patients with Advanced Renal Cell Carcinoma |
| Michael D. Staehler, MD, Ph.D. |
| The real-world CASSIOPE study demonstrates that the tolerability of cabozantinib in the ≥2nd line setting is consistent with that observed in the METEOR trial. Cabozantinib dose modifications due to AEs were common, but discontinuation rates due to AEs were substantially less frequent. Cabozantinib activity was maintained across lines. |
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| Head-to-Head Effectiveness and Safety of Pembrolizumab plus Axitinib vs. Nivolumab plus Ipilimumab in Metastatic Renal Cell Carcinoma in the United States
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| Dvir Aran, Ph.D., BSc, MSc
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| Dvir Aran presents the results of an analysis comparing the effectiveness and safety of pembrolizumab plus axitinib versus nivolumab plus ipilimumab in metastatic renal cell carcinoma (RCC) in the United States.
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| Phase 2 Study of Batiraxcept as Monotherapy, in Combination with Cabozantinib, and in Combination with Cabozantinib and Nivolumab in Patients with Advanced Clear Cell Renal Cell Carcinoma |
| Katy Beckermann, MD, Ph.D. |
| Batiraxcept monotherapy is well-tolerated but has limited clinical activity in heavily pre-treated patients with relapsing disease and no other curative options. Batiraxcept-based combinations demonstrated efficacy and tolerability in both treatment-naïve patients and those with at least 1 prior therapy. Given the encouraging safety and efficacy signals, batiraxcept + cabozantinib will be further studied in a phase 3 trial of ccRCC patients in the ≥2nd line setting, whose disease has progressed on prior immunotherapy and VEGF-TKI treatment. |
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| Nivolumab plus Cabozantinib in Patients with Non-Clear Cell Renal Cell Carcinoma: Updated Results from a Phase 2 Trial
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| Chung-Han Lee, MD, PhD |
| Chung-Han Lee presents updated results of CaboNivo, a phase 2 trial evaluating combination of nivolumab plus cabozantinib in patients with non-clear cell renal cell carcinoma (RCC). These updated results with extended follow-up highlight the efficacy and safety of combination of cabozantinib plus nivolumab in metastatic non-clear cell RCC patients with papillary, unclassified, or translocation associated histologies. |
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| Characterizing Progression to Subsequent Lines of Therapy in Metastatic Renal Cell Carcinoma After Nivolumab plus Ipilimumab (Nivo+Ipi): Results from the IMDC |
| Audreylie Lemelin, MD |
| Audreylie Lemelin presents an analysis from the International mRCC Database Consortium (IMDC) characterizing subsequent treatment patterns in metastatic renal cell carcinoma (mRCC) patients progressing following nivolumab plus ipilimumab. |
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| Core Biopsy Accuracy and Safety of Biopsy and Preoperative Immunotherapy in Predicting Histological Subtype and Nuclear Grade in ECOG-ACRIN EA8143 Perioperative Nivolumab Versus Observation in Patients with Kidney Cancer Undergoing Nephrectomy
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| Naomi Haas, MD |
| Naomi Haas presents the results of a post-hoc analysis from PROSPER (ECOG-ACRIN EA8143), which evaluated perioperative nivolumab versus observation in renal cell carcinoma (RCC) patients undergoing a radical or partial nephrectomy. |
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| Adjuvant Everolimus in Patients with Localized Non-Clear Cell Renal Cell Carcinoma: Subgroup Analysis from the EVEREST Trial |
| Shuchi Gulati, MD, MS |
| Shuchi Gulati presents the results of a subgroup analysis from the EVEREST trial (SWOG S0931) evaluating adjuvant everolimus in patients with localized non-clear cell renal cell carcinoma. These results are in contrast to prior reports of mTOR inhibitor activity in this subtype. Although inferences are limited by sample size and wide confidence intervals, this is the largest experience in chromophobe or papillary RCC subgroups among any adjuvant trials presented to date. |
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| Biomarkers of Response to First-Line Nivolumab Therapy in Patients with Advanced Renal Cell Carcinoma Enrolled in the HCRN GU16-260 Trial |
| Nourhan El Ahmar, MD |
The HCRN GU16-260 study showed that nivolumab (nivo) monotherapy is active in treatment-naïve patients with renal cell carcinoma. Although efficacy correlated with tumor PD-L1 expression, more clinically relevant biomarkers are needed. High levels of CD8+ PD1+ TIM-3-LAG-3- TILs were associated with response to first-line nivo in pts with advanced RCC, and the combination with TC PD-L1 status further separated the outcomes of pts with ccRCC, validating their previous findings.
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