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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...
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 ...
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 ...
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 ...
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).
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).
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.
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...
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...
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...
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...
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...
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...
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...
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.
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.
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.
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)...
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...
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...
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...
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 ...
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...
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...
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...
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...
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).
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).
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).
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).
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...
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 ...
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...
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...
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...
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,...
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 ...
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...
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...
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...
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...
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...
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...
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...
Older adults diagnosed with kidney tumors that are not suitable for surgery may benefit from targeted, high-dose radiation, a new study from Australian and Dutch researchers suggests. A multi-institutional phase II study—TransTasman Radiation Oncology Group (TROG) FASTRACK II—found 100% local...
The addition of the monoclonal antibody atezolizumab to the tyrosine kinase inhibitor cabozantinib failed to improve progression-free survival and overall survival vs cabozantinib alone in patients with advanced renal cell carcinoma (previously treated with an immune checkpoint inhibitor) in the...
In a phase II trial (KEYNOTE-B61) reported in The Lancet Oncology, Laurence Albiges, MD, PhD, of Gustave Roussy, Paris–Saclay University, Villejuif, France, and colleagues found that first-line pembrolizumab plus lenvatinib produced durable responses in patients with advanced non–clear cell renal...
A new report published by Knudsen et al in PLOS ONE focused on the clinical validation of a drug response predictor (DRP) biomarker algorithm for dovitinib, a receptor tyrosine kinase inhibitor of VEGFR1–3, PDGFR, FGFR1/3, c-KIT, FLT3, and topoisomerase 1 and 2. Data showed that the DRP-dovitinib...
The addition of cabozantinib to nivolumab plus ipilimumab prolonged progression-free survival in untreated intermediate-risk patients with advanced renal cell carcinoma (RCC), according to the first results of the phase III COSMIC-313 trial. These findings were presented as a Presidential Symposium ...
The 3-year follow-up of the phase III CheckMate 9ER trial demonstrates superior outcomes with the combination of nivolumab plus cabozantinib vs the former standard-of-care sunitinib as first-line treatment of advanced or metastatic renal cell carcinoma.1 These benefits were achieved with the...