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On April 19, 2019, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda) plus axitinib for the first-line treatment of patients with advanced renal cell carcinoma (RCC). KEYNOTE-426 Approval was based on KEYNOTE-426, a randomized, multicenter, open-label trial conducted in ...
THE FORMAL DISCUSSANT of the KEYNOTE-427 trial, Tracy Rose, MD, MPH, of the University of North Carolina, Chapel Hill, told listeners: “I think pembrolizumab should now be considered an option for non–clear cell kidney cancer. Response rates, however, remain inferior to those seen in clear cell...
IMMUNOTHERAPY WITH the checkpoint inhibitor pembrolizumab may prove to be an effective option for patients with advanced non–clear cell renal cell carcinoma, according to results in cohort B of the KEYNOTE-427 trial, presented at the 2019 Genitourinary Cancers Symposium.1 Response rates were...
THE COMBINATION of savolitinib and durvalumab achieved durable responses in approximately one-fourth of patients with metastatic papillary renal cell carcinoma in the phase II CALYPSO study.1 Treatment options are limited for papillary renal cell carcinoma. Clinical guidelines recommend enrollment...
THE COMBINATION of pembrolizumab and cabozantinib demonstrated antitumor activity in patients with previously treated metastatic renal cell carcinoma and both drugs were tolerable at their approved doses, according to data from a dose-escalation cohort of a phase I study.1 Among eight patients with ...
NIVOLUMAB PLUS low-dose ipilimumab continued to demonstrate strong responses as well as a survival benefit with a median of 32.4 months of follow-up as front-line treatment for patients with intermediate- and poor-risk advanced renal cell carcinoma, according to an update of the phase II CheckMate...
IN A RETROSPECTIVE analysis of median overall survival from the phase III METEOR trial,1 Ignacio Duran, MD, PhD, and colleagues sought to determine whether early tumor shrinkage following therapy with cabozantinib or everolimus could be an early indicator of prognosis for patients with metastatic...
THE PROGRAMMED cell death-ligand 1 (PD-L1) inhibitor, avelumab, was combined with the multitargeted vascular growth endothelial factor (VEGF) agent, axitinib, and compared to monotherapy with sunitinib in the first-line treatment of patients with metastatic renal cell carcinoma. Toni K. Choueiri,...
LORI WOOD, MD, of Dalhousie University in Halifax, Nova Scotia, Canada was the formal discussant for the KEYNOTE 426 study presented at the 2019 Genitourinary Cancers Symposium.1,2 Dr. Wood called the KEYNOTE 426 phase III trial “practice-changing,” and added, “The majority of patients with...
AS REPORTED at the 2019 Genitourinary Cancers Symposium by Thomas Powles, MD, and as published in The New England Journal of Medicine by Brian Rini, MD, and colleagues, significant benefits in overall and progression-free survival were achieved with the combination of pembrolizumab plus axitinib...
THIS YEAR saw a huge turnout and a large number of scientific abstracts presented at both the 2019 Gastrointestinal (GI) Cancers Symposium, held on January 17–19, and the 2019 Genitourinary (GU) Cancers Symposium, held on February 14–16, both in San Francisco. The GU Cancers Symposium attracted...
Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center, discusses major findings over the past 12 months in kidney cancer, including combination immunotherapies and trends in surgical oncology.
The information contained in this Clinical Trials Resource Guide includes actively recruiting clinical studies that are focused on several different kinds of treatments for kidney cancer. These trials are evaluating gene therapy, immunotherapy, chemotherapy, radiotherapy, and combinations thereof....
Sumanta K. Pal, MD, of City of Hope, talks about the need for investigators across the country to enroll their patients with rare tumors in clinical trials. He describes a trial he is leading for papillary kidney cancer and how others can join his efforts.
In a retrospective cohort study reported in The Lancet Oncology, Chanzá et al found evidence of activity of cabozantinib in advanced non–clear cell renal carcinoma. Cabozantinib is approved in metastatic renal cell carcinoma on the basis of studies in clear cell histology. As noted by ...
Toni K. Choueiri, MD, and Ziad Bakouny, MD, both of Dana-Farber Cancer Institute, talk about novel cytokines, checkpoint inhibitors, and vaccines in the treatment pipeline for renal cell carcinoma.
The checkpoint inhibitor pembrolizumab plus the vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor axitinib significantly improved overall survival, progression-free survival, and objective response rates vs sunitinib as first-line therapy for clear cell metastatic renal cell...
As reported at the 2019 Genitourinary Cancers Symposium (Abstract 543) and in The New England Journal of Medicine, Rini et al found significant benefits in overall and progression-free survival with the combination of pembrolizumab plus axitinib vs sunitinib in the first-line treatment of advanced...
Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, discusses current models used to estimate the risk of recurrence as well as genomic data that could help pinpoint individual tumor biology.
Rana R. McKay, MD, of the University of California, San Diego, discusses phase II study findings on atezolizumab and bevacizumab in non–clear cell renal cell carcinoma and clear cell renal cell carcinoma with sarcomatoid differentiation (Abstract 548).
Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, discusses phase III findings on a comparison of tivozanib and sorafenib in patients with refractory advanced renal cell carcinoma (Abstract 541).
Ignacio Duran, MD, PhD, of the Hospital Universitario Marqués de Valdecilla, discusses an overall survival analysis of the phase III METEOR trial of cabozantinib vs everolimus in advanced renal cell carcinoma (Abstract 550).
Laurence Albiges, MD, PhD, of Gustave Roussy, discusses findings on the safety and efficacy of nivolumab used in a “real world” prospective study on metastatic renal cell carcinoma (mRCC). This research was conducted after nivolumab was approved for the treatment of mRCC following failure of one or two tyrosine kinase inhibitors (Abstract 542).
The TIVO-3 trial was conducted to confirm progression-free survival results from the TIVO-1 trial, which found an improvement in median progression-free survival in patients with metastatic renal cell carcinoma treated with tivozanib vs sorafenib. Findings from TIVO-3 were presented by...
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses a subgroup analysis from the JAVELIN Renal 101 study on outcomes for avelumab plus axitinib vs sunitinib in advanced renal cell carcinoma (Abstract 544).
Brian I. Rini, MD, of the Cleveland Clinic Taussig Cancer Institute, and Thomas Powles, MD, PhD, of Queen Mary University of London, discuss their study findings on pembrolizumab plus axitinib vs sunitinib as first-line therapy for locally advanced or metastatic renal cell carcinoma (Abstract 543).
A combination of two drugs could become a new standard first-line treatment for patients with metastatic kidney cancer, according to results from the JAVELIN Renal 101 trial presented at the 2019 Genitourinary Cancers Symposium (Abstract 544) and simultaneously published in The New England...
Over the past week, the U.S. Food and Drug Administration (FDA) granted multiple Priority Reviews: Pembrolizumab in Combination With Axitinib as First-Line Treatment for Advanced Renal Cell Carcinoma Today, the FDA accepted and granted Priority Review for a new supplemental biologics license...
Results from the randomized, phase III KEYNOTE-426 clinical trial show that first-line therapy with a combination of pembrolizumab and axitinib extended both overall survival (OS) and progression-free survival (PFS) for patients with clear cell metastatic renal cell carcinoma compared with the...
Personalized treatment plans may extend life expectancy for patients with early-stage kidney cancer who also have risk factors for worsening kidney disease, according to a new study published by Kang et al in Radiology. Kidney tumors are often discovered at an early stage and are frequently...
As reported in The Lancet Oncology by Cella et al, patient-reported outcomes were better with nivolumab plus ipilimumab vs sunitinib in the phase III CheckMate 214 trial among patients with intermediate- or poor-risk advanced renal cell carcinoma. The ongoing trial showed significantly improved...
Researchers at the Dana-Farber Cancer Institute in Boston are testing a first-of-its-kind personalized cancer vaccine combined with an immunotherapy drug, with the aim of improving outcomes for patients with kidney cancer who are at high risk of recurrence after surgery. A two-pronged approach to...
In a trial with a modified primary endpoint due to slow accrual reported in JAMA Oncology, Bex et al found that deferred cytoreductive nephrectomy after sunitinib did not improve 28-week progression-free rate (PFR) vs immediate nephrectomy followed by sunitinib in patients with metastatic renal...
“TARGETED AGENTS were a breakthrough in the treatment of renal cell carcinoma, and immunotherapy also works well, improving survival. In the past 2 years, combining a checkpoint inhibitor with targeted agents appears to work even better, and multiple combination trials are underway. The outcomes...
A NEW ANALYSIS of the phase III IMmotion151 trial identified gene signatures in renal cell carcinoma that correlate with improved progression-free survival in patients treated with atezolizumab (Tecentriq) plus bevacizumab (Avastin) vs sunitinib (Sutent). These findings were presented at the...
In a study reported in The Lancet Oncology, Voss et al found that adding the mutation status of prognostic genes to the Memorial Sloan Kettering Cancer Center (MSKCC) risk model improved the prognostic performance of the model in patients with advanced renal cell carcinoma. The study involved...
In the JAVELIN Renal 101 phase III study, the combination of the immune checkpoint inhibitor avelumab (Bavencio), a programmed death ligand-1 (PD-L1) blocking antibody, plus the tyrosine kinase inhibitor axitinib (Inlyta) significantly improved progression-free survival in previously untreated...
Findings in a study reported by Mullen and colleagues for the Children’s Oncology Group in the Journal of Clinical Oncology suggest that routine computed tomography (CT) surveillance may not be necessary for recurrence detection in favorable-histology Wilms tumor. The study was a...
Treatment of renal cell carcinoma with stereotactic radiation therapy is as safe and effective for patients with one kidney as it is for those with two, according to an analysis of an international data set presented by Correa et al at the 60th Annual Meeting of the American Society for...
Laurence Albiges, MD, PhD, of Gustave Roussy, discusses data from the global, phase III JAVELIN trial that compared axitinib plus avelumab vs sunitinib, which could lead to a new standard of care in renal cell carcinoma (Abstract LBA6_PR).
A combination of the immune checkpoint blocker avelumab (Bavencio) plus the tyrosine kinase inhibitor axitinib (Inlyta) improved progression-free survival (PFS) in previously untreated patients with advanced renal cell carcinoma (RCC) in the phase III JAVELIN Renal 101 study, according to results...
In the Clinic provides overviews of novel oncology agents, addressing indications, mechanisms of action, administration recommendations, safety profiles, and other essential information needed for the appropriate clinical use of these drugs. On April 16, 2018, nivolumab (Opdivo) and ipilimumab...
Cora N. Sternberg, MD, of San Camillo-Forlanini Hospital and the Israel Englander Institute of Precision Medicine at Weill Cornell, discusses results from the phase III CheckMate-025 study on nivolumab vs everolimus for mRCC; the CheckMate-214 study on nivolumab, ipilimumab, and sunitinib for treatment-naive advanced or metastatic clear-cell RCC; and immunotherapy for urothelial cancer for both first- line cisplatin-ineligible and second-line therapy after cisplatin chemotherapy.
The results of the pivotal phase III JAVELIN Renal 101 study—which evaluated avelumab (Bavencio) in combination with axitinib (Inlyta) compared with sunitinib (Sutent) as initial therapy for patients with advanced renal cell carcinoma—were recently announced. As part of a planned...
Recently, the National Comprehensive Cancer Network® (NCCN®) updated its Clinical Practice Guidelines to include new recommendations for cabozantinib (Cabometyx) tablets. With the updates, cabozantinib is recommended by the NCCN for the treatment of advanced renal cell carcinoma regardless...
A research team from Roswell Park Comprehensive Cancer Center has discovered a way to use computed tomography (CT) imaging to assess kidney tumors that test positive for the biomarker CD117 and accurately determine—before surgery—whether the tumor is benign or malignant. Their findings...
In an interim analysis of the French phase III noninferiority Carmena trial reported in The New England Journal of Medicine, Méjean et al found that sunitinib alone was not inferior in overall survival vs nephrectomy followed by sunitinib in patients with intermediate- or poor-risk...
For patients with early kidney cancer, surgically removing a portion of the kidney instead of the whole organ is often a preferred treatment, because the procedure can effectively remove tumors while preserving kidney function. But when it comes to the best surgical approach—robotic,...
According to the American Cancer Society, cancer is the leading cause of death for Hispanics and Asian/Pacific Islanders in the United States. However, their cancer burden is less than that of non-Hispanic whites and especially non-Hispanic blacks, who bear the most disproportionate share of the...
In a study reported in JAMA Oncology, Carlo et al found a high prevalence of germline mutations in cancer susceptibility genes in patients with advanced renal cell carcinoma (RCC). Study Details In this cohort study, conducted between October 2015 and July 2017, 254 of 267 patients with advanced...