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Kidney Cancer

Adjuvant Nivolumab vs Placebo in Localized Renal Cell Carcinoma at High Risk of Recurrence After Nephrectomy

As reported in the Journal of Clinical Oncology by Motzer et al, part B of the phase III CheckMate 914 trial showed no disease-free survival benefit with the adjuvant use of nivolumab vs placebo in patients with localized renal cell carcinoma at high risk of recurrence after nephrectomy. These...

Kidney Cancer

Addition of Nivolumab to Tivozanib Following Immune Checkpoint Inhibitor Treatment in Metastatic Renal Cell Carcinoma

As reported in The Lancet by Choueiri et al, the phase III TiNivo-2 trial has shown that immune checkpoint inhibitor rechallenge with nivolumab plus tivozanib did not improve progression-free survival vs tivozanib alone in patients with metastatic renal cell carcinoma following immune checkpoint...

Kidney Cancer

Detecting Clear Cell Renal Cell Carcinoma: Use of Zr-89 Girentuximab PET-CT Imaging

In a phase III trial reported in The Lancet Oncology, Shuch et al found that zirconium Zr-89–labeled girentuximab (Zr-89 girentuximab) positron-emission tomography/computed tomography (PET-CT) imaging was accurate in detecting clear cell renal cell carcinoma (RCC) in patients with renal masses....

Kidney Cancer

Overall Survival With Cabozantinib vs Sunitinib in Advanced Papillary Renal Cell Carcinoma

As reported in the Journal of Clinical Oncology by Barata et al, the final overall survival results of the phase II SWOG 1500 trial indicated no significant benefit with cabozantinib vs sunitinib in patients with advanced papillary renal cell carcinoma. Study Details In the open-label multicenter...

Kidney Cancer

Belzutifan vs Everolimus in Previously Treated Advanced Renal Cell Carcinoma

As reported in The New England Journal of Medicine by Choueiri and colleagues, the phase III LITESPARK-005 trial has shown improved progression-free survival with the hypoxia-inducible factor–2α inhibitor belzutifan vs everolimus in previously treated patients with advanced clear-cell renal cell...

Kidney Cancer

Adjuvant Everolimus in Localized Papillary and Chromophobe Non–Clear Cell Renal Cell Carcinoma

In a subgroup analysis of the EVEREST trial reported in JAMA Network Open, Gulati et al found that adjuvant everolimus did not improve recurrence-free survival vs placebo in patients with localized papillary or chromophobe non–clear cell renal cell carcinoma (RCC). Study Details In the trial,...

Bladder Cancer
Kidney Cancer

Advanced/Metastatic Genitourinary Tumors: Cabozantinib/Nivolumab With or Without Ipilimumab

As reported in the Journal of Clinical Oncology by Andrea B. Apolo, MD, and colleagues, findings in expansion cohorts of a phase I study showed the activity of cabozantinib/nivolumab alone or with the addition of ipilimumab in patients with advanced/metastatic genitourinary (GU) tumors. Study...

Kidney Cancer

Perioperative Nivolumab in Renal Cell Carcinoma

As reported in The Lancet Oncology by Allaf et al, a planned interim analysis of the phase III PROSPER ECOG-ACRIN EA8143 trial showed no recurrence-free survival benefit with perioperative nivolumab vs observation in patients undergoing nephrectomy for high-risk renal cell carcinoma.  Study ...

Kidney Cancer
Issues in Oncology

Novel Biomarker May Be Predictive of Clear Cell Renal Cell Carcinoma Recurrence

Researchers have discovered a biomarker that could help identify which patients with clear cell renal cell carcinoma may be at greater risk of cancer recurrence, according to a recent study published by Mehra et al in JCO Precision Oncology. Background Approximately 3% to 5% of all cancer diagnoses ...

Kidney Cancer

Previously Untreated Advanced Clear Cell RCC: Bempegaldesleukin/Nivolumab vs TKI Therapy

As reported in the Journal of Clinical Oncology by Nizar M. Tannir, MD, FACP, and colleagues, the phase III PIVOT-09 trial has shown no objective response or overall survival benefit with bempegaldesleukin plus nivolumab vs tyrosine kinase inhibitor (TKI) treatment with sunitinib or cabozantinib in ...

kidney cancer

Laurence Albiges, MD, PhD, on Renal Cell Carcinoma: Biomarker Analysis of the IMmotion010 Study

Laurence Albiges, MD, PhD, of Gustave Roussy, Université Paris-Saclay, discusses phase III findings showing that high baseline serum KIM-1 levels were associated with poorer prognosis but improved clinical outcomes with atezolizumab vs placebo in patients with renal cell carcinoma at increased risk of recurrence after resection. Increased post-treatment KIM-1 levels were found to be associated with worse disease-free survival (Abstract 4506).

kidney cancer

Brian I. Rini, MD, on Renal Cell Carcinoma: Exploratory Biomarker Results

Brian I. Rini, MD, of Vanderbilt Ingram Cancer Center, discusses phase III findings of the KEYNOTE-426 study of pembrolizumab plus axitinib vs sunitinib for patients with advanced renal cell carcinoma. He details the exploratory biomarker results, including RNA sequencing, whole-exome sequencing, and PD-L1 (Abstract 4505).

kidney cancer

Toni K. Choueiri, MD, FASCO, on RCC: Biomarker Analysis From the CLEAR Trial

Toni K. Choueiri, MD, FASCO, of the Dana-Farber Cancer Institute, discusses phase III findings showing that, in patients with advanced renal cell carcinoma (RCC), the benefit of lenvatinib plus pembrolizumab vs sunitinib in overall response rate does not appear to be affected by such factors as gene‐expression signatures for tumor‐induced proliferation, PD‐L1 status, or the mutation status of RCC driver genes.

Kidney Cancer

KEYNOTE-564: Adjuvant Pembrolizumab Improves Overall Survival vs Placebo in Renal Cell Carcinoma

As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, FASCO, of Dana-Farber Cancer Institute and Harvard Medical School, and colleagues, the third prespecified interim analysis of overall survival in the phase III KEYNOTE-564 trial has shown significant benefit with adjuvant...

Kidney Cancer
Immunotherapy

CRISPR-Edited, Off-the-Shelf CAR T-Cell Therapy Shows Proof of Concept in Renal Cell Carcinoma

Evidence from a small early trial called COBALT-RCC provides proof of concept for use of an allogeneic off-the-shelf CD70-targeted chimeric antigen receptor (CAR) T-cell therapy called CTX130 in patients with advanced clear cell renal cell carcinoma (RCC). CTX130 is engineered using gene-editing...

Kidney Cancer

Marker for Distinguishing Renal Cell Carcinoma From Benign Renal Masses

In a study reported in the Journal of Clinical Oncology, Xu et al found that higher levels of preoperative plasma kidney injury molecule-1 (pKIM-1) distinguished renal cell carcinoma from benign renal masses. As stated by the investigators, “Both clear cell and papillary renal cell carcinoma...

Kidney Cancer

Belzutifan in Previously Treated Advanced Renal Cell Carcinoma

On December 14, 2023, the hypoxia-inducible factor inhibitor belzutifan (Welireg) was approved for patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma with disease progression on previous treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial...

Kidney Cancer
Issues in Oncology

Novel PET Agent May Accelerate Imaging in Patients With Clear Cell Renal Cell Carcinoma

The novel investigational positron-emission tomography (PET) imaging agent gallium (Ga)-68–DPI-4452 may offer rapid and accurate visualization of lesions in patients with clear cell renal cell carcinoma, according to a recent study published by Hofman et al in The Journal of Nuclear Medicine. The...

Kidney Cancer
Issues in Oncology

Newly Identified Biomarkers May Improve Diagnosis and Treatment of RCC Subtypes

Researchers have identified novel biomarkers in renal cell carcinoma subtypes, according to a new study published by Li et al in Cell Reports Medicine. The findings may help identify therapeutic targets in non–clear cell renal cell carcinomas. Background Renal cell carcinoma is a diverse cancer...

Kidney Cancer

Adjuvant Pembrolizumab in Renal Cell Carcinoma: Overall Survival in KEYNOTE-564

As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, FASCO, and colleagues, the third prespecified interim analysis of overall survival in the phase III KEYNOTE-564 trial has shown a significant benefit with adjuvant pembrolizumab vs placebo in patients with clear cell renal...

kidney cancer

Metastatic RCC After Disease Progression on VEGF/IO Therapy

This is Part 3 of Later-Line Considerations in Relapsed/Refractory Renal Cell Carcinoma, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable.   In this video, Drs. Rana McKay, Bradley McGregor, and Sumanta K. Pal discuss the management of metastatic renal cell carcinoma (RCC) after disease progression on VEGF-targeted therapy and immunotherapy (IO). The patient is a 56-year-old woman who presented in 2015 with sharp abdominal pain. Imaging revealed a large renal mass, and CT of the chest and brain MRI were negative. She underwent a left nephrectomy, which revealed a 10.9-cm grade 3 renal cell carcinoma with renal vein invasion. After 4 years of surveillance, a CT of the chest, abdomen, and pelvis revealed pulmonary nodules and a right adrenal nodule. She started treatment with nivolumab plus ipilimumab, continuing to receive maintenance nivolumab after completion of therapy. One year later, she developed a retinal detachment related to immune infiltrates, which led to the permanent discontinuation of nivolumab. She continued to be monitored, and her disease was found to be stable with the exception of growing right adrenal nodule, for which she received stereotactic ablative body radiotherapy. The following year, she experienced disease progression in her lungs with multiple new pulmonary nodules.   In the conversation that follows, the faculty discuss how to approach the management of a patient presenting with newly diagnosed metastatic RCC, the role of radiation therapy for patients with oligoprogressive disease, and treatment options in the later-line setting for patients whose disease progresses on VEGF-targeted therapy and IO.

kidney cancer

Refractory RCC After Disease Progression on Adjuvant IO Therapy

This is Part 2 of Later-Line Considerations in Relapsed/Refractory Renal Cell Carcinoma, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable.   In this video, Drs. Rana McKay, Bradley McGregor, and Sumanta K. Pal discuss the management of refractory renal cell carcinoma (RCC) after disease progression on adjuvant immunotherapy (IO). The patient is a 50-year-old man who underwent an early cancer detection test in 2022 and received a positive test result. A CT of the chest, abdomen, and pelvis revealed a 5.1-cm right upper pole mass in the kidney. He underwent a right partial nephrectomy and was found to have grade 3 clear cell RCC with perinephric fat invasion and renal vein invasion. The patient received pembrolizumab for 1 year, followed by a 3-month surveillance schedule. On his first subsequent scan, he was found to have new small pulmonary nodules and underwent a video-assisted thoracoscopic surgery, which confirmed clear cell RCC.   In the conversation that follows, the faculty discuss their preferred methods of risk stratification, how to address small changes revealed on surveillance scans after IO therapy, and whether IO or VEGF-targeted therapy would be appropriate following disease progression on adjuvant IO.

kidney cancer

Metastatic Favorable-Risk RCC After Progression on VEGF/IO Therapy

This is Part 1 of Later-Line Considerations in Relapsed/Refractory Renal Cell Carcinoma, a three-part video roundtable series. Scroll down to watch the other videos from this roundtable.   In this video, Drs. Rana McKay, Bradley McGregor, and Sumanta K. Pal discuss the management of metastatic favorable-risk renal cell carcinoma (RCC) in a patient whose disease has progressed after receiving treatment with VEGF inhibitors and immunotherapy (IO). The patient is a 67-year-old woman who was diagnosed with localized clear cell RCC in 2007 and monitored with active surveillance. Almost 10 years after her original diagnosis, she developed progressive disease with a stable pulmonary nodule, a small but growing adrenal nodule, and a new pancreatic mass. Over the next 2 years, she received pazopanib, which was discontinued due to intolerance, and nivolumab, which was discontinued after growth of her adrenal nodules and pancreatic metastasis.   In the conversation that follows, the faculty discuss when active surveillance may be appropriate for patients with renal cell carcinoma, how to approach patients who present with metastatic disease after a long latency period, the impact that sites of metastasis have on treatment options, and what options are available after disease progression on multiple lines of therapy.

Kidney Cancer
Immunotherapy

Novel CAR T-Cell Therapy May Show Benefit in Patients With Advanced Clear Cell Renal Cell Carcinoma

The CD70-targeted allogeneic chimeric antigen receptor (CAR) T-cell therapy CTX130 may be effective in patients with advanced clear cell renal cell carcinoma, according to findings presented by Srour et al at the American Association for Cancer Research (AACR) Annual Meeting 2024 (Abstract CT002)...

Kidney Cancer

Pazopanib in Patients With Metastatic Renal Cell Carcinoma and No Evidence of Disease After Metastasectomy

As reported in the Journal of Clinical Oncology by Leonard J. Appleman, MD, PhD, and colleagues, the phase II ECOG-ACRIN E2810 trial showed no significant improvement in disease-free survival with pazopanib vs placebo in patients with metastatic renal cell carcinoma with no evidence of disease...

Kidney Cancer

Belzutifan in Previously Treated Advanced Renal Cell Carcinoma

On December 14, 2023, the hypoxia-inducible factor inhibitor belzutifan (Welireg) was approved for patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma with disease progression on previous treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial...

Kidney Cancer

SABR for Patients With Primary Kidney Cancer Not Undergoing Resection

In a phase II study (FASTRACK II) reported in The Lancet Oncology, Shankar Siva, MBBS, PhD, and colleagues found that stereotactic ablative body radiotherapy (SABR) was effective in patients with primary kidney cancer who did not undergo resection. Study Details Seventy patients were enrolled in...

Kidney Cancer

Expert Point of View: Pedro Barata, MD, MSc, FACP

Invited discussant of KEYNOTE-564, Pedro Barata, MD, MSc, FACP, of the University Hospital Seidman Cancer Center, Cleveland, said the reasons for the disparate results in these two adjuvant trials of checkpoint inhibitors were likely the result of many factors. “Factors such as histology, different ...

Kidney Cancer

Two Adjuvant Therapy Studies Show Divergent Outcomes With PD-1 Inhibitors in Renal Cell Carcinoma

In the third prespecified interim analysis of the phase III KEYNOTE-564 trial,1 adjuvant treatment with the PD-1 inhibitor pembrolizu­mab significantly improved overall survival compared with placebo in patients with intermediate- or high-risk clear cell renal cell carcinoma (RCC). However, a...

Kidney Cancer

Expert Point of View: Lisa Pickering, PhD, FRCP

Invited discussant Lisa Pickering, PhD, FRCP, Consultant Medical Oncologist at The Royal Marsden NHS Foundation Trust, London, considered belzutifan to be a major advance in renal cell carcinoma (RCC). “LITESPARK-005 met both its primary endpoints of progression-free survival and overall response...

Kidney Cancer

Belzutifan: New Standard in Previously Treated Renal Cell Carcinoma

Belzutifan is a first-in-class, oral hypoxia-inducible factor (HIF)-2α inhibitor, and active HIF-2α is a key oncogenic driver in clear cell renal cancer. The manufacturer has filed a new drug application for the treatment of adults with RCC who experienced disease progression after PD-1/PD-L1– and...

Issues in Oncology
Prostate Cancer
Bladder Cancer
Kidney Cancer

Insufficiencies Discovered in Patient-Reported Outcomes Data From Genitourinary Cancer Clinical Trials

Investigators may have found a significant unmet need for improved analyses and reporting of patient-reported outcomes in genitourinary cancer clinical trials, according to a recent study published by Paravathaneni et al in eClinicalMedicine. Background Genitourinary cancers affect over 444,000...

kidney cancer

Thomas Powles, MD, on Clear Cell Kidney Cancer: Overall Survival Update With Adjuvant Pembrolizumab

Thomas Powles, MD, of Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, and Queen Mary University of London, discusses overall survival results from the phase III KEYNOTE-564 study of adjuvant pembrolizumab vs placebo in patients with clear cell renal cell carcinoma (Abstract LBA359).

kidney cancer

Andrew Johns, MD, on Clear Cell Renal Cell Carcinoma: Data on Tivozanib in Pretreated Patients

Andrew Johns, MD, of The University of Texas MD Anderson Cancer Center, discusses efficacy, safety, and tolerability data on tivozanib. The agent yielded a modest clinical benefit in a minority of patients with advanced clear cell renal cell carcinoma who received prior immune checkpoint–based therapies, cabozantinib, and lenvatinib with or without everolimus (Abstract 419).

kidney cancer
immunotherapy

Saby George, MD, on Clear Cell Kidney Cancer: Subcutaneous vs Intravenous Nivolumab

Saby George, MD, of Roswell Park Comprehensive Cancer Center, discusses pharmacokinetics, efficacy, and safety results from CheckMate 67T, a phase III trial comparing the use of subcutaneous vs intravenous nivolumab in patients with advanced or metastatic clear cell renal cell carcinoma who have received prior systemic therapy (Abstract LBA360).

kidney cancer

Thomas Powles, MD, on RCC: Patient-Reported Outcomes With Belzutifan vs Everolimus

Thomas Powles, MD, of Barts Cancer Institute, Cancer Research UK Experimental Cancer Medicine Centre, and Queen Mary University of London, discusses outcomes reported by patients with previously treated renal cell carcinoma (RCC), taking part in the phase III LITESPARK-005 study. Belzutifan was associated with a prolonged time to deterioration, fewer disease-specific symptoms, and better quality of life compared with everolimus (Abstract 361).

Kidney Cancer
Immunotherapy

Subcutaneous vs Intravenous Nivolumab in Advanced Clear Cell RCC

In previously treated patients with advanced or metastatic clear cell renal cell carcinoma, a subcutaneous formulation of nivolumab was found to be noninferior to the intravenous formulation, which is standard of care for nivolumab in renal cell carcinoma and other cancers. Compared with...

Kidney Cancer
Immunotherapy
Issues in Oncology

Immune Checkpoint Inhibitor–Based Therapy May Have Comparative Efficacy in Black and White Patients With Metastatic Renal Cell Carcinoma

Immune checkpoint inhibitor–based therapy may be an equally effective front-line treatment in both Black and White patients with metastatic renal cell carcinoma, according to recent findings presented by Kaur et al at the 2024 ASCO Genitourinary Cancers Symposium (Abstract 369). Background Race may ...

Kidney Cancer

Survival Benefit With Adjuvant Immunotherapy in Patients With Clear Cell RCC

The phase III KEYNOTE-564 study has reported that adjuvant pembrolizumab provides a significant improvement in overall survival for patients with clear cell renal cell carcinoma at high risk of recurrence after surgery. This study is significant, as it represents the first phase III study to show...

Kidney Cancer

Final Overall Survival Analysis of CLEAR/KEYNOTE-581: Lenvatinib/Pembrolizumab vs Sunitinib in First-Line Treatment of Advanced RCC

As reported in the Journal of Clinical Oncology by Robert J. Motzer, MD, and colleagues, the prespecified final overall analysis of the phase III CLEAR/KEYNOTE-581 trial supported a benefit of lenvatinib/pembrolizumab vs sunitinib in the first-line treatment of advanced renal cell carcinoma. The...

Kidney Cancer

FDA Approves Belzutifan for Advanced Renal Cell Carcinoma

On December 14, the U.S. Food and Drug Administration (FDA) approved belzutifan (Welireg) for patients with advanced renal cell carcinoma following treatment with a PD-1 or PD-L1 inhibitor and a vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor. LITESPARK-005 Efficacy was...

Kidney Cancer

ASCO Rapid Recommendation Update Cautions Against Triplet Therapy for Metastatic Clear Cell RCC

An ASCO Rapid Recommendation Update advises oncologists to avoid the use of triple combination therapy for the management of metastatic clear cell renal cell carcinoma (RCC).1 The new guidance, which updates recommendations from the original 2022 guideline, reflects findings from a phase III,...

Kidney Cancer

Adjuvant Everolimus Improves Recurrence-Free Survival in Very High–Risk Renal Cell Carcinoma

A secondary analysis from the phase III SWOG S0931 EVEREST trial found that adjuvant everolimus given to patients with clear cell renal cell carcinoma at very high risk of recurrence after nephrectomy produced a statistically significant improvement in recurrence-free survival compared with placebo ...

Kidney Cancer

Modified vs Standard Ipilimumab Plus Nivolumab in Advanced Renal Cell Carcinoma

In a UK phase II trial (PRISM) reported in the Journal of Clinical Oncology, Vasudev and colleagues found that ipilimumab given every 12 weeks vs every 3 weeks in combination with nivolumab resulted in a significantly reduced rate of treatment-related grade ≥ 3 adverse events in treatment-naive...

Kidney Cancer
Immunotherapy

Nivolumab With or Without Nivolumab/Ipilimumab Boost in Metastatic Renal Cell Carcinoma

In the phase II TITAN-RCC trial reported in The Lancet Oncology, Grimm et al found that a strategy of nivolumab monotherapy with or without nivolumab/ipilimumab as an immunotherapeutic boost was associated with activity in patients with metastatic clear cell renal cell carcinoma. Study Details In...

Kidney Cancer

Stereotactic Body Radiation Therapy Demonstrates ‘Exceptional Control’ in Primary Renal Cell Carcinoma

Although surgery remains the standard of care for primary renal cell carcinoma, a novel, noninvasive approach has yielded positive results that could pave the way for future treatment strategies, according to data presented at the 2023 American Society for Radiation Oncology (ASTRO) Annual...

Genomics/Genetics
Kidney Cancer
Immunotherapy

Two New Studies Using CancerLinQ Data

Two new studies—presented by Drumheller et al and Vento et al at the 2023 ASCO Quality Care Symposium—utilized data from ASCO’s CancerLinQ® database (Abstracts 418 and 532). One study revealed deficiencies in biomarker testing and tracking in electronic health records, and the other analyzed...

Kidney Cancer

Belzutifan Improves Outcomes for Pretreated Patients With Clear Cell Renal Cell Carcinoma Compared to Everolimus

The hypoxia-inducible factor (HIF)-2α inhibitor belzutifan significantly reduced the risk of progression of clear cell renal cell carcinoma in patients previously treated with immune checkpoint inhibitors and antiangiogenic therapies compared with everolimus. The phase III LITESPARK-005 trial, led...

Kidney Cancer

EVEREST Trial: Adjuvant Everolimus for High-Risk Clear Cell Renal Cell Carcinoma

A secondary analysis from the phase III SWOG S0931 EVEREST trial found patients with clear cell renal cell carcinoma at very high risk of recurrence after nephrectomy who received adjuvant everolimus had a statistically significant improvement in recurrence-free survival compared to patients who...

Kidney Cancer
Immunotherapy

Can AI Help Identify Kidney Tumors That May Respond to Immunotherapy?

Clear cell renal cell carcinoma is the most common type of kidney cancer, comprising 80% of all malignant tumors found within the kidney. Although some clear cell renal cell carcinoma tumors are sensitive to immune checkpoint inhibitors, currently, there are no measures to predict whether a tumor...

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