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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).
Nizar M. Tannir, MD, of The University of Texas MD Anderson Cancer Center, discusses overall survival and an independent review of response in CheckMate 214 with 42-month follow-up, using first-line nivolumab plus ipilimumab vs sunitinib in patients with advanced renal cell carcinoma (Abstract 609).
Thomas Powles, MD, PhD, of Queen Mary University of London, summarizes two papers on metastatic renal cell carcinoma for which he was the discussant: nivolumab in combination with stereotactic body radiotherapy in pretreated patients, and combining dual immune checkpoint inhibition with stereotactic radiation (Abstracts 613 & 614).
Toni K. Choueiri, MD, of Dana-Farber Cancer Institute, discusses findings from a phase I/II trial that found MK-6482 was well tolerated and demonstrated activity in heavily pretreated patients with clear cell renal cell carcinoma (Abstract 611).
Ziad Bakouny, MD, of Dana-Farber Cancer Institute, discusses the controversial and ill-defined role of cytoreductive nephrectomy in treating patients with metastatic renal cell carcinoma who have received targeted therapies or immune checkpoint inhibitors (Abstract 608).
In studies to be presented at the 2020 Genitourinary Cancers Symposium (Abstracts 649 and 665), researchers examined the prevalence of fear of cancer recurrence in patients with renal cell carcinoma and evaluated the prognostic understanding patients with genitourinary cancer possess of their...
A novel, first-in-class, small molecule, hypoxia-inducible factor 2 alpha (HIF2A) inhibitor showed single-agent activity in heavily pretreated patients with metastatic clear cell renal cell carcinoma. These results from a phase I/II study will be presented by Toni Choueiri, MD, and colleagues at...
In a study presented by Lindskog et al at the 2020 ASCO-SITC Clinical Immuno-Oncology Symposium (Abstract 11), researchers found ilixadencel, a cell-based allogeneic off-the-shelf product, in combination with sunitinib produced a higher objective response rate than sunitinib alone in patients with...
The likelihood of a patient responding to immune checkpoint blockade may depend on B cells in the tumor, located within specialized immune-cell clusters known as tertiary lymphoid structures, according to three studies all recently published in Nature. The studies showed that enrichment of B cells...
As reported in The Lancet Oncology by Brian I. Rini, MD, and colleagues, the phase III TIVO-3 trial has shown a statistically significant increase in progression-free survival with tivozanib vs sorafenib as a third- or fourth-line treatment for advanced renal cell carcinoma. Study Details The...
On April 19, 2019, pembrolizumab was approved for use in combination with the small-molecule tyrosine kinase inhibitor axitinib for the first-line treatment of patients with advanced renal cell carcinoma.1,2 Supporting Efficacy Data Approval was based on findings in the open-label phase III...
Immunotherapy with checkpoint inhibitors is now considered a standard of care for the front-line treatment of advanced renal cell carcinoma. Despite better outcomes with these agents, there is still room for improvement. At the 2019 Chemotherapy Foundation Symposium, Robert J. Motzer, MD, of...
In a phase II trial reported in the Journal of Clinical Oncology, Toni K. Choueiri, MD, and colleagues found that the combination of atezolizumab and bevacizumab was active in metastatic renal cell carcinoma with variant histology and clear cell renal cell carcinoma with ≥ 20% sarcomatoid...
The ESMO Congress continues to grow as a pivotal platform for research in clinical oncology. At the ESMO Congress 2019, important findings were showcased in more than 2,200 studies, including 93 late-breaking abstracts. The ASCO Post summarized much of that news in separate articles over several...
The treatment landscape for patients with advanced renal cell carcinoma has changed drastically over the past several years with the introduction of many new therapeutic options for patients. The revolution began with the U.S. Food and Drug Administration (FDA) approval of nivolumab and ipilimumab...
As reported in The Lancet Oncology by Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, New York, and colleagues, extended follow-up of the phase III CheckMate 214 trial has shown maintained survival benefit of first-line nivolumab/ipilimumab vs sunitinib among patients with...
In a phase II study reported in The Lancet Oncology, Ornstein et al found that individualized axitinib regimens showed activity in patients with locally recurrent or metastatic renal cell carcinoma who had previously received immune checkpoint inhibitor therapy, although the progression-free...
As reported in The Lancet Oncology by Robert J. Motzer, MD, and colleagues, extended follow-up of the phase III CheckMate 214 trial has shown a maintained survival benefit for first-line nivolumab/ipilimumab vs sunitinib in patients with previously untreated intermediate- or poor-risk advanced...
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
There were numerous notable presentations at the 2019 Genitourinary Cancers Symposium, many of which were covered in The ASCO Post over the past few months. To add to our continued coverage of this meeting, here are some highlights from studies focusing on novel therapeutics in renal cell carcinoma ...
As reported by Suzanne L. Topalian, MD, and colleagues in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell...
The 2019 ASCO Annual Meeting featured a wealth of presentations on important topics. In addition to our regular news coverage of the meeting, we present below some highlights of other studies that add to our knowledge base for treatment of various cancers. Olaratumab in Soft-Tissue Sarcoma...
As reported by Topalian et al in JAMA Oncology, long-term follow up of patients from a phase I expansion cohort study indicated 5-year overall survival rates of 34.2%, 27.7%, and 15.6% among patients who received nivolumab monotherapy for advanced melanoma, renal cell carcinoma (RCC), and...
ON JUNE 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell lung...
Many elderly and medically complex patients with metastatic renal cell carcinoma (RCC)—who are often underrepresented in clinical trials—saw overall survival benefits from treatment with targeted therapies, according to a study that analyzed 13 years of data on Medicare patients...
On June 28, the U.S. Food and Drug Administration (FDA) approved bevacizumab-bvzr (Zirabev), a biosimilar to bevacizumab (Avastin), for the treatment of five types of cancer: metastatic colorectal cancer; unresectable, locally advanced, recurrent, or metastatic nonsquamous non–small cell ...
In an analysis of the phase II GETUG-AFU 26 NIVOREN study reported in the Journal of Clinical Oncology, Flippot et al found that nivolumab had limited activity in patients with previously untreated brain metastases from clear cell renal cell carcinoma. The study assessed nivolumab in patients with ...
The E2810 trial was conducted to determine whether treatment with the oral drug pazopanib following surgery to remove further metastases in patients with advanced renal cell carcinoma would improve their disease-free survival. Results from the study—which showed that primary endpoint of...
Leonard J. Appleman, MD, PhD, of UPMC Hillman Cancer Center, discusses phase III trial findings that showed a trend toward worse survival with pazopanib in patients with metastatic kidney cancer who exhibited no evidence of disease following metastasectomy (Abstract 4502).
Christopher Sweeney, MBBS, of Dana-Farber Cancer Institute, and Ian D. Davis, MBBS, PhD, of Monash University and Eastern Health, discuss the Australian and New Zealand Urogenital and Prostate Cancer Trials Group, working globally to speed clinical research in and treatment of urogenital cancers.
Toni K. Choueiri, MD, and Ziad Bakouny, MD, both of Dana-Farber Cancer Institute, discuss a retrospective review of genomically profiled patients with sarcomatoid/rhabdoid renal cell cancer who were found to have better outcomes with immune checkpoint inhibitors and to harbor mutations associated with poor prognosis (Abstract 4514).
Neeraj Agarwal, MD, of the Huntsman Cancer Institute, and Arnaud Méjean, MD, PhD, of the Hôpital Européen Georges-Pompidou, Paris Descartes University, discuss an update to the CARMENA trial with new phase III study results on the benefit of cytoreductive nephrectomy followed by sunitinib vs sunitinib alone in metastatic renal cell carcinoma (Abstract 4508).
Neeraj Agarwal, MD, of Huntsman Cancer Institute, University of Utah Health Care, and Thomas Powles, MD, PhD, of Queen Mary University of London, discuss phase III study findings on outcomes with combination therapy for intermediate/poor-risk and sarcomatoid subgroups of renal cell carcinoma (Abstract 4500).
In the phase III IMmotion151 trial reported in The Lancet, Rini et al found that atezolizumab plus bevacizumab prolonged progression-free survival vs sunitinib in patients with previously untreated, programmed cell death ligand 1 (PD-L1)-positive, metastatic renal cell carcinoma. Study Details...
On May 14, the U.S. Food and Drug Administration (FDA) approved avelumab (Bavencio) in combination with axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This is the first FDA approval for an anti–programmed cell death ligand 1 (PD-L1) therapy as...
The 24th Annual Conference of the National Comprehensive Cancer Network® (NCCN®) was held this past March in Orlando, Florida. Updates to a number of Clinical Practice Guidelines (NCCN Guidelines®) were reported, including three relevant to the field of genitourinary oncology: kidney cancer,...
May 14, 2019: Avelumab (Bavencio) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). April 19, 2019: Pembrolizumab (Keytruda) plus axitinib (Inlyta) for the first-line treatment of patients with advanced renal cell carcinoma (RCC). April 12,...
The CARMENA trial presented at the 2018 ASCO Annual Meeting, published simultaneously in The New England Journal of Medicine,1,2 and reported in this supplement to The ASCO Post, evaluated the role of nephrectomy in patients with metastatic renal cell carcinoma. Formal discussant of the trial,...
In a trial with a modified primary endpoint due to slow accrual reported in JAMA Oncology,1 Axel Bex, MD, PhD, and colleagues found that deferred cytoreductive nephrectomy after sunitinib did not improve the 28-week progression-free rate vs immediate nephrectomy followed by sunitinib in patients...
Cabozantinib, a kinase inhibitor, is approved in metastatic renal cell carcinoma on the basis of studies in clear cell histology. Its activity in non–clear cell renal cell carcinoma is poorly defined. In a retrospective cohort study, Nieves Martinez Chanzá, MD, and colleagues reported that...
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 Rini et al...
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...
THE FRONT-LINE systemic treatment landscape for metastatic renal cell carcinoma has undergone tremendous movement over the past several years. A better understanding of the current management paradigm for therapy-naive patients warrants a reflection of historic landmark clinical trials that have...