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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,...
In a study reported in the Journal of Clinical Oncology, Gul et al found that salvage therapy with nivolumab/ipilimumab was capable of producing a response after prior programmed cell death 1 (PD-1) pathway inhibitor therapy in some patients with metastatic renal cell carcinoma. Study Details The...
Over the past month, the U.S. Food and Drug Administration has granted Fast Track designation to agents designed to treat colorectal and pancreatic cancers, in addition to lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia; accepted a new drug application for a treatment for relapsed or...
A minimally invasive procedure that destroys cancer cells by freezing them may be an option other than surgery for treating early-stage kidney cancer. The two methods showed similar 10-year survival rates, with cryoablation showing a lower rate of complications, according to a study published by...
By analyzing tumors from patients treated with immunotherapy for advanced kidney cancer in three clinical trials, scientists have identified several features of the tumors that influence their response to immune checkpoint inhibitors. The research was presented during the ASCO20 Virtual Scientific...
In a study presented at the ASCO20 Virtual Scientific Program (Abstract 5077) and published as a brief report in JAMA Oncology, Ravi et al found that rechallenge with immune checkpoint inhibitor therapy was capable of producing responses in patients with metastatic renal cell carcinoma, including...
Eric Jonasch, MD, of The University of Texas MD Anderson Cancer Center, discusses phase II study findings on the oral HIF-2α inhibitor known as MK-6482, which showed efficacy and tolerability in patients with Von Hippel-Lindau (VHL)–associated clear cell renal cell carcinoma as well as responses in other VHL-related lesions (Abstract 5003).
In 2019, at the ASCO Annual Meeting, Ian Tannock, MD, PhD, DSc, FASCO, was honored with the Allen S. Lichter Visionary Award for his contributions to the fields of genitourinary and breast cancers as well as his efforts to optimize clinical trial design. The title of his lecture was “Clinical...
In an international trial, treatment with MK-6482, a small-molecule inhibitor of hypoxia-inducible factor (HIF)-2a, was well tolerated and resulted in clinical responses for patients with von Hippel-Lindau disease–associated renal cell carcinoma (RCC). The results of the phase II trial were shared ...
The use of opioids continues to be major issue facing patients with cancer in the United States. Most patients undergoing prostate and kidney removal may be managed effectively without opioids during the postoperative period, according to new data from researchers in Pittsburgh highlighted during a ...
Over the past few weeks, the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designations for an antibody-drug conjugate in the treatment of gastric and lung cancers. The Agency has also issued Orphan Drug designations for agents being investigated in chronic myeloid...
Although the live 2020 National Comprehensive Cancer Network (NCCN) Annual Conference was canceled, more than 100 posters scheduled for presentation are now available online, as part of the NCCN 2020 Virtual Annual Conference. The ASCO Post has summarized some of the clinical trial updates we found ...
Attendees gathered at the 2020 Genitourinary Cancers Symposium in San Francisco to hear the latest news about treating patients with cancers of the prostate, bladder, kidneys, and testicles. In addition to the comprehensive coverage of the meeting in The ASCO Post, here are some brief highlights...
Despite recent enthusiasm for combining stereotactic body radiation therapy with immunotherapy in renal cell carcinoma, two preliminary studies presented at the 2020 Genitourinary Cancers Symposium suggest that it may not be the best path forward. In one study, the combination of nivolumab plus...
In a Children’s Oncology Group study (AREN0321) reported in the Journal of Clinical Oncology, Daw et al found that the addition of vincristine/irinotecan to a regimen used in the National Wilms Tumor Study 5 (NWTS-5; vincristine, doxorubicin, cyclophosphamide, carboplatin, and etoposide plus...
Ilixadencel is essentially a dendritic cell vaccine without preloaded antigens. In the MERECA study, ilixadencel produced “a great signal,” though this approach is still very experimental, said the study’s invited discussant, Navid Hafez, MD, MPH, of Yale Cancer Center. Dr. Hafez is a member of the ...
Ilixadencel is a cell-based, allogeneic, off-the-shelf product aimed at priming the anticancer immune response when injected intratumorally. The phase II MERECA study evaluated this allogeneic dendritic cell product given with sunitinib in 88 patients with metastatic renal cell carcinoma. The study ...
Formal discussant of this trial of MK-6482, Daniel Geynisman, MD, of Fox Chase Cancer Center, Philadelphia, was enthusiastic about this presentation. “The response rates were fabulous in this group of heavily pretreated patients,” he stated. “A total of 69% had some tumor shrinkage, 24% had an...
A novel approach using a drug called MK-6482 showed activity in a phase I/II study in patients with metastatic clear cell renal cell carcinoma, according to a presentation at the 2020 Genitourinary Cancers Symposium.1 MK-6482 is an oral, first-in-class selective small-molecule inhibitor that...
In a phase Ib/II trial (BTRC-GU14-003) reported in the Journal of Clinical Oncology, Dudek et al found that the combination of pembrolizumab and bevacizumab showed activity in patients with metastatic clear cell renal cell carcinoma. As stated by the investigators, “Anti-angiogenic treatment has...
Ziad Bakouny, MD, of Dana-Farber Cancer Institute, discusses two types of renal cell cancer that are associated with poor prognosis. Because recent early data suggest these tumors respond well to immune checkpoint inhibitors, the authors characterized the tumors in an integrative molecular and clinical study (Abstract 715).
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, describes a currently recruiting phase III study (COSMIC-313) of cabozantinib in combination with nivolumab and ipilimumab vs nivolumab/ipilimumab for patients with previously untreated advanced renal cell carcinoma of intermediate or poor risk (Abstract TPS767).