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Separate studies presented at the 2021 Genitourinary Cancers Symposium provide supportive evidence for belzutifan (formerly MK-6482) as an active treatment for metastatic clear cell renal cell carcinoma (RCC). One study showed single-agent activity for this novel approach in an early-phase trial,...
Xin Gao, MD, a medical oncologist at Mass General Hospital and Instructor at Harvard Medical School, said these were important findings. “Analyses of patient-reported outcomes pertaining to health-related quality-of-life measures from CheckMate 9ER showed significantly improved quality-of-life...
Results of the CheckMate 9ER phase III trial showed significantly improved patient-reported outcomes in quality of life for first-line treatment with nivolumab plus cabozantinib compared with sunitinib for patients with advanced renal cell carcinoma.1 These findings are in line with the previously...
The treatment paradigm for patients with metastatic renal cell carcinoma has undergone a dramatic shift over the past few years, improving outcomes for many patients but leaving many unanswered questions as to how to optimally choose the best treatment for an individual patient. The changes are...
As reported in two articles in the Journal of Clinical Oncology by David F. McDermott, MD, of Beth Israel Deaconess Medical Center, and colleagues, the phase II KEYNOTE-427 study showed that pembrolizumab monotherapy produced durable responses as first-line treatment in cohorts of patients with...
Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center, discusses the several hereditary renal cell cancer syndromes, the importance of surveillance for both renal and nonrenal manifestations, and the treatment options available.
On January 22, 2021, the U.S. Food and Drug Administration approved the combination of nivolumab and cabozantinib as first-line treatment for patients with advanced renal cell carcinoma.1-3 Supporting Efficacy Data Approval was based on the findings of the phase III, open-label CheckMate 9ER trial...
Cabozantinib achieved a statistically significant and clinically meaningful extension in progression-free survival compared with sunitinib in patients with metastatic papillary renal cell carcinoma, a relatively uncommon type of renal cell carcinoma, according to the randomized phase II SWOG 1500...
The combination of lenvatinib plus pembrolizumab was superior to sunitinib for progression-free and overall survival as well as other key endpoints in patients with advanced clear cell renal cell carcinoma (RCC), according to results of the phase III CLEAR trial presented at the 2021 Genitourinary ...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to the HIF-2α inhibitor belzutifan for the treatment of patients with von Hippel-Lindau (VHL) disease–associated renal cell carcinoma. The agency also granted Fast Track designation to poziotinib for the treatment of...
As reported in The New England Journal of Medicine by Toni K. Choueiri, MD, and colleagues, the phase III CheckMate 9ER trial has shown that the combination of nivolumab and cabozantinib improved progression-free survival and overall survival vs sunitinib in first-line treatment of patients with...
In a study reported in a research letter in JAMA Oncology, Lalani et al found that higher body mass index (BMI) was associated with better overall survival among patients with metastatic renal cell carcinoma receiving anti–PD-1/PD-L1–based immune checkpoint inhibitor treatment. No association of...
On March 10, the U.S. Food and Drug Administration (FDA) approved tivozanib (Fotivda), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma following two or more prior systemic therapies. TIVO-3 Efficacy was evaluated in TIVO-3 (ClinicalTrials.gov...
In the phase II SWOG 1500 study reported in The Lancet, Pal et al found that among three comparator MET kinase inhibitors, cabozantinib prolonged progression-free survival vs sunitinib in metastatic papillary renal cell carcinoma. Study Details In the open-label trial, 147 eligible patients from...
At the 2021 Genitourinary Cancers Symposium, Motzer et al presented the clinical results of the CLEAR trial, adding a novel regimen, lenvatinib plus pembrolizu-mab, to the growing armamentarium of first-line treatments for patients with metastatic clear cell renal cell carcinoma (RCC). The...
As reported in the Journal of Clinical Oncology by McDermott et al, findings in a cohort of the phase II KEYNOTE-427 study showed that pembrolizumab monotherapy produced durable responses as first-line treatment for advanced non–clear cell renal cell carcinoma. In a separate cohort of the study,...
Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, discusses key abstracts discussed at this year’s meeting on renal cell carcinoma and offers her views on the latest trends and findings (Abstracts 269, 308, 270, 313).
Elizabeth R. Plimack, MD, of Fox Chase Cancer Center, discusses phase III results from the KEYNOTE-426 study—specifically, an exploratory subgroup analysis of patients with advanced renal cell carcinoma who were randomly assigned to receive pembrolizumab plus axitinib and completed 2 years of treatment (Abstract 327).
Sumanta K. Pal, MD, of City of Hope, discusses findings of the TIVO-3 study, which showed that the tyrosine kinase inhibitor tivozanib improved progression-free survival vs sorafenib in patients whose advanced renal cell carcinoma progressed after multiple lines of therapy (Abstract 278).
Sumanta K. Pal, MD, of City of Hope, discusses phase II results from the SWOG 1500 study, which showed that compared with crizotinib and savolitinib, cabozantinib was the only agent that prolonged progression-free survival vs sunitinib in patients with metastatic papillary renal cell carcinoma (Abstract 270).
A spirited discussion ensued when we asked Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, and Thomas Powles, MD, PhD, of Cancer Research UK Barts Centre, to compare notes on how they treat bladder, prostate, and kidney cancers.
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discuses a preliminary phase II analysis of the HIF-2a inhibitor belzutifan in combination with cabozantinib, which showed antitumor activity in previously treated patients with metastatic clear cell renal cell carcinoma (Abstract 272).
As reported in the Journal of Clinical Oncology by McDermott et al, findings in a cohort of the phase II KEYNOTE-427 study showed that pembrolizumab monotherapy produced durable responses as first-line treatment for advanced clear cell renal cell carcinoma. In a separate cohort of the study,...
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses phase III results of the CLEAR study, which showed that for first-line treatment of advanced renal cell carcinoma, lenvatinib plus pembrolizumab improved outcomes vs sunitinib. Lenvatinib plus everolimus also improved progression-free survival and overall survival rates vs sunitinib (Abstract 269).
The combination of lenvatinib plus pembrolizumab showed superiority over sunitinib in terms of overall survival, progression-free survival, and objective response rate in patients with advanced clear cell renal cell carcinoma (RCC), according to results of the phase III CLEAR trial. The CLEAR study ...
During the peak of the COVID-19 pandemic, several elective surgeries for renal cell carcinoma were delayed, with an unknown impact on outcomes for patients. In a retrospective study, researchers from Rutgers Cancer Institute of New Jersey explored the impact of surgical delays for these patients...
New analyses from the phase III CheckMate 9ER trial are being presented at the 2021 Genitourinary Cancers Symposium. These new findings demonstrate clinically meaningful, sustained efficacy benefits as well as quality-of-life improvements with the combination of nivolumab and cabozantinib compared...
On January 22, the U.S. Food and Drug Administration (FDA) approved the combination of nivolumab (Opdivo) and cabozantinib (Cabometyx) as first-line treatment for patients with advanced renal cell carcinoma. CheckMate 9ER Efficacy was evaluated in CheckMate 9ER, a randomized, open-label trial in...
In the past 3 years, we have seen a dramatic shift in the treatment paradigm for first-line therapy for metastatic clear cell renal cell carcinoma. Multiple phase III clinical trials have demonstrated improved efficacy with combinations compared with sunitinib, leading to the regulatory approval of ...
In a phase III trial (SORCE) reported in the Journal of Clinical Oncology, Tim Eisen, FMedSci, FRCP, PhD, of Cambridge University Hospitals NHS Foundation Trust, and colleagues found no disease-free survival benefit with 3 years of sorafenib vs placebo as adjuvant therapy in patients with renal...
As reported in The Lancet Oncology by Thomas Powles, MD, PhD, and colleagues, extended follow-up of the phase III KEYNOTE-426 trial shows continued progression-free and overall survival superiority with pembrolizumab/axitinib vs sunitinib in the first-line treatment of advanced renal cell...
In the phase II OMNIVORE study reported in the Journal of Clinical Oncology, Rana R. McKay, MD, and colleagues did not find evidence supporting a strategy of discontinuing nivolumab monotherapy in responders and adding ipilimumab in nivolumab nonresponders among patients with metastatic renal cell...
Recently, the U.S. Food and Drug Administration (FDA) granted Priority Review to treatments for EGFR-mutant lung cancer and advanced renal cell carcinoma; granted Fast Track designation to agents in chronic lymphocytic leukemia (CLL) and locally advanced or metastatic solid tumors; and more....
In the phase III SORCE trial reported in the Journal of Clinical Oncology, Eisen et al found no benefit of sorafenib vs placebo as adjuvant therapy in patients with renal cell carcinoma at intermediate or high risk of disease recurrence. Study Details The double-blind trial included 1,711 patients...
Acknowledging there are now expanded therapeutic choices in the first-line setting for advanced renal cell carcinoma, formal study discussant Camillo Porta, MD, of the University of Bari Aldo Moro, Italy, said that studies of the immunotherapy combinations could not be compared directly. “We should ...
The combination of nivolumab plus cabozantinib was found to be superior to the former standard, sunitinib, in the first-line treatment of advanced or metastatic renal cell carcinoma, according to the results of the phase III CheckMate 9ER trial reported at the European Society for Medical Oncology...
Circulating tumor DNA (ctDNA) analysis is a minimally invasive genomic assessment tool utilizing targeted next-generation sequencing of peripheral blood. At the ESMO Virtual Congress 2020, Zengin et al reported genomic results from a large cohort of patients with metastatic renal cell carcinoma...
Sumanta K. Pal, MD, of the City of Hope National Medical Center, discusses results from the COSMIC-021 study, which tested two different doses of cabozantinib, each with a standard dose of atezolizumab, administered to patients with metastatic advanced clear cell renal cell carcinoma. Dr. Pal reports on response rates and progression-free survival, as well as biologic correlates that may have influenced response (Abstract 702O).
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses the first results from the phase III CheckMate 9ER trial, which suggested the combination of nivolumab and cabozantinib is safe. It showed activity in progression-free and overall survival, as well as in overall response rates and may have a place in treating patients with metastatic renal cell carcinoma (Abstract 696O_PR).
The combination of nivolumab plus cabozantinib was superior to the former standard, sunitinib, as first-line treatment for advanced/metastatic renal cell carcinoma, according to results of the phase III CheckMate 9ER trial reported by Toni K. Choueiri, MD, and colleagues at the ESMO Virtual...
Researchers have found that greater gut microbial diversity in patients with metastatic kidney cancer is associated with better treatment outcomes in those receiving immunotherapy. These findings were published by Salgia et al in European Urology. “We also reported the changes over time in the gut...
Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented during the ASCO20 Virtual Scientific Program by Elizabeth R....
In a study reported in the Journal of Clinical Oncology,1 Anita Gul, MD, of the Cleveland Clinic Taussig Cancer Institute, and colleagues found that salvage therapy with nivolumab/ipilimumab was capable of producing a response after prior PD-1 pathway inhibitor therapy in some patients with...
Two recently reported phase III trials have shown the benefits of combination therapy vs sunitinib in the first-line treatment of advanced renal cell carcinoma. As reported in The New England Journal of Medicine by Brian I. Rini, MD, of Cleveland Clinic Taussig Cancer Institute, and colleagues, the ...
Pembrolizumab Plus Axitinib: On April 19, 2019, pembrolizumab (Keytruda) was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma. Approval was based on findings in the phase...
In a study presented during the ASCO20 Virtual Scientific Program1 and published as a brief report in JAMA Oncology,2 Praful Ravi, MB, BChir, of the Dana-Farber Cancer Institute, Boston, and colleagues found that rechallenge with immune checkpoint inhibitor therapy was capable of producing...
Over the past year, we have seen significant advances in the treatment of prostate, kidney, and urothelial cancers that will benefit patients now and in the future. We have learned about the final results of important clinical trials across multiple genitourinary cancers disease states leading to...
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has issued designations and accepted applications for novel agents, as well as approved companion diagnostics. We summarize these regulatory movements below. Breakthrough Therapy Designation for MK-6482 in von Hippel-Lindau...
Targeting MET alterations with savolitinib appears to be a better strategy than sunitinib for patients with MET-driven papillary renal cell carcinoma, according to results of the open-label, randomized, phase III SAVOIR trial.1 Patients with MET-driven metastatic papillary renal cell carcinoma...
Extended analysis of the phase III KEYNOTE-426 study upholds pembrolizumab plus axitinib as a preferred front-line regimen over sunitinib in patients with advanced sporadic renal cell carcinoma.1 These updated results were presented at the ASCO20 Virtual Scientific Program by Elizabeth R. Plimack,...