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Nivolumab renal cell carcinoma

Jacopo Giuliani, Andrea Bonetti
INTRODUCTION: The introduction of active new agents, such as small molecules and checkpoint inhibitors, for the treatment of metastatic renal-cell cancer (mRCC) is associated with a relevant increase in costs, and it is therefore important to strike a balance between the costs of treatment and the added value represented by the improvement of the clinical parameters of interest such as progression-free survival (PFS) and overall survival (OS). METHODS: This analysis was conducted to assess the pharmacologic costs of second-line treatments for mRCC and was restricted to pivotal phase 3 randomized controlled trials (RCTs) used as second-line therapy...
February 22, 2018: Clinical Genitourinary Cancer
Andreas Seeber, Gerald Klinglmair, Josef Fritz, Fabian Steinkohl, Kai-Christian Zimmer, Friedrich Aigner, Wolfgang Horninger, Günther Gastl, Bettina Zelger, Andrea Brunner, Renate Pichler
Nivolumab belongs to the standard therapy in the second-line setting of metastatic renal cell carcinoma (mRCC). Although deep and long-lasting responses are seen in some patients, the majority of patients will further progress. PD-L1 as predictive biomarker is still under critical evaluation. Thus, more accurate biomarkers are clearly warranted. Here, we investigated for the first time the predictive role of IDO-1, a negative immune-regulatory molecule, on clear cell RCC tissues of 15 patients undergoing nivolumab therapy...
March 2, 2018: Cancer Science
Nizar M Tannir, Sumanta K Pal, Michael B Atkins
The management of advanced clear-cell renal cell carcinoma has steadily improved over the past decade with the introduction of antiangiogenic and targeted therapies. Recently, three new therapies have been approved for use as second-line options that further advance the treatment armamentarium: nivolumab, a monoclonal antibody targeting the programmed cell death receptor; cabozantinib, a small-molecule tyrosine kinase inhibitor (TKI) of vascular endothelial growth factor receptor (VEGFR), MET, and AXL; and lenvatinib, a small-molecule TKI of VEGF and fibroblast growth factor receptors that is used in combination with everolimus, an inhibitor of the mechanistic target of rapamycin...
February 27, 2018: Oncologist
Linda Chen, Jacqueline Douglass, Lawrence Kleinberg, Xiaobu Ye, Ariel E Marciscano, Patrick M Forde, Julie Brahmer, Evan Lipson, William Sharfman, Hans Hammers, Jarushka Naidoo, Chetan Bettegowda, Michael Lim, Kristin J Redmond
PURPOSE: To characterize the effect of concurrent stereotactic radiosurgery-stereotactic radiation therapy (SRS-SRT) and immune checkpoint inhibitors on patient outcomes and safety in patients with brain metastases (BMs). METHODS AND MATERIALS: We retrospectively identified metastatic non-small cell lung cancer, melanoma, and renal cell carcinoma patients who had BMs treated with SRS-SRT from 2010 to 2016 without prior whole-brain radiation therapy. We included SRS-SRT patients who were treated with anti-cytotoxic T-lymphocyte-associated protein 4 (ipilimumab) and anti-programmed cell death protein 1 receptor (nivolumab, pembrolizumab)...
March 15, 2018: International Journal of Radiation Oncology, Biology, Physics
Amir Mehrvarz Sarshekeh, Michael J Overman, Scott Kopetz
Nivolumab is a PD-1 inhibitor approved for the use in treatment of multiple tumor types (such as melanoma, non-small-cell lung cancer, renal cell carcinoma, urothelial cancer and Hodgkin's lymphoma). In July 2017, the US FDA granted accelerated approval of this agent for the treatment of metastatic colorectal cancer patients whose tumor harbors deficient mismatch repair, or microsatellite-instability high and have progressed on conventional chemotherapy. In this review, we will discuss the use, efficacy, and safety of this agent in microsatellite-instability high metastatic colorectal cancer...
February 23, 2018: Future Oncology
Cesar E Ochoa, Richard W Joseph
Targeted agents form the backbone of most therapeutic strategies in advanced renal cell carcinoma (aRCC) but ultimately resistance develops and toxicity often leads to discontinuation of treatment, limiting the clinical benefits of these treatments. Nivolumab, a fully human IgG4 anti-PD-1 antibody, selectively blocks the interaction between PD-1 and its ligands PD-L1 and PD-L2 and provides a novel therapy option for patients with aRCC. In 2015, the pivotal phase III study CheckMate 025 led to the Food and Drug Administration approval of nivolumab in patients with aRCC who had received prior anti-angiogenic therapy, and in 2017, the phase III study CheckMate 214 showed that combined immunotherapy with nivolumab plus ipilimumab resulted in greater objective response rate and prolonged progression-free survival when compared with sunitinib in intermediate- and poor-risk patients with previously untreated aRCC...
2018: Journal of Kidney Cancer and VHL
Malmaruha Arasaratnam, Howard Gurney
Renal cell carcinoma (RCC) has typically been considered an immunogenic malignancy with responses seen to IL-2 and IFN-α. Response rates, however, were low and at the cost of considerable toxicity and as such, agents targeting angiogenesis have become the mainstay of treatment. Nivolumab is an immune checkpoint inhibitor targeting PD-1 thereby upregulating the host immune response against tumor cells. Nivolumab has emerged as a promising new therapy in advanced malignancies, and the first agent to show survival advantage in patients failing prior VEGFR-targeted therapy in metastatic RCC...
February 20, 2018: Future Oncology
Charles McCrea, Sukhvinder Johal, Shuo Yang, Justin Doan
Background: We evaluated the cost-effectiveness of nivolumab versus everolimus in patients with advanced renal cell carcinoma (RCC) from a US payer perspective. Methods: A partitioned survival model consisting of three health states, progression-free survival (PFS), progressive disease, and death, was developed to evaluate the cost-effectiveness of intravenous nivolumab versus oral everolimus over a lifetime. The proportion of patients in each state was calculated based on parametric distributions fitted to PFS and overall survival (OS) data from CheckMate 025 (N = 821), a large randomized phase 3 trial of nivolumab versus everolimus for advanced RCC...
2018: Experimental Hematology & Oncology
Tasnime Akbaraly, Magali Saguintaah, Delphine Topart, Nicolas Sirvent
No abstract text is available yet for this article.
February 7, 2018: Journal of Pediatric Hematology/oncology
Mehmet Asim Bilen, Giselle Marie Almeida Dutcher, Yuan Liu, Deepak Ravindranathan, Haydn T Kissick, Bradley C Carthon, Omer Kucuk, Wayne B Harris, Viraj A Master
BACKGROUND: Biomarkers to guide treatment in metastatic renal-cell carcinoma (mRCC) are lacking. We aimed to investigate the association between pretreatment neutrophil-to-lymphocyte ratio (NLR) and outcome of patients with mRCC receiving nivolumab. PATIENTS AND METHODS: Through retrospective chart review, we identified 38 patients with mRCC treated with standard-of-care nivolumab between 2015 and 2016 at Winship Cancer Institute of Emory University. NLR was determined from complete blood count collected before starting treatment, and imaging was performed to assess progression...
January 4, 2018: Clinical Genitourinary Cancer
Steve J Edwards, Victoria Wakefield, Peter Cain, Charlotta Karner, Kayleigh Kew, Mariana Bacelar, Natalie Masento, Fatima Salih
BACKGROUND: Several therapies have recently been approved for use in the NHS for pretreated advanced or metastatic renal cell carcinoma (amRCC), but there is a lack of comparative evidence to guide decisions between them. OBJECTIVE: To evaluate the clinical effectiveness and cost-effectiveness of axitinib (Inlyta®, Pfizer Inc., NY, USA), cabozantinib (Cabometyx®, Ipsen, Slough, UK), everolimus (Afinitor®, Novartis, Basel, Switzerland), nivolumab (Opdivo®, Bristol-Myers Squibb, NY, USA), sunitinib (Sutent®, Pfizer, Inc...
January 2018: Health Technology Assessment: HTA
Vadim S Koshkin, Pedro C Barata, Tian Zhang, Daniel J George, Michael B Atkins, William J Kelly, Nicholas J Vogelzang, Sumanta K Pal, JoAnn Hsu, Leonard J Appleman, Moshe C Ornstein, Timothy Gilligan, Petros Grivas, Jorge A Garcia, Brian I Rini
BACKGROUND: Nivolumab is approved for patients with metastatic renal cell carcinoma (mRCC) refractory to prior antiangiogenic therapy. The clinical activity of nivolumab in patients with non-clear cell RCC subtypes remains unknown as these patients were excluded from the original nivolumab trials. METHODS: Patients from 6 centers in the United States who received at least one dose of nivolumab for non-clear cell mRCC between 12/2015 and 06/2017 were identified. A retrospective analysis including patient characteristics, objective response rate according to RECIST v1...
January 29, 2018: Journal for Immunotherapy of Cancer
David M Gill, Andrew W Hahn, Peter Hale, Benjamin L Maughan
Treatment of metastatic clear cell renal cancer (mccRCC) has seen substantial progress over the last 20 years, with many regulatory approvals since 2006 culminating in a substantial increase to overall survival (OS). Six therapies are currently available for first-line use, with additional treatments currently being tested in this setting, some of which are expected to be approved soon based on new data from the CABOSUN and CheckMate-214 trials. Based on the available evidence, we strongly believe that vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI) therapy over mechanistic target or rapamycin (mTOR; formerly known as mammalian target of rapamycin) inhibitor therapy is the most effective first-line option regardless of risk category assignment...
January 24, 2018: Current Treatment Options in Oncology
Kanako Sakurai, Satsuki Niitsuma, Ryota Sato, Kazuhiro Takahashi, Zenei Arihara
The programmed cell death-1 (PD-1) pathway is a novel therapeutic target in immune checkpoint therapy for cancer. Nivolumab, an anti-PD-1 monoclonal antibody, blocks PD-1 and can restore anti-cancer immune responses by disrupting the signal that inhibits T-cell activation. Nivolumab may induce endocrine-related adverse events, including hypophysitis, autoimmune thyroiditis, and type 1 diabetes mellitus. Here we report a 68-year-old female patient with advanced renal cell carcinoma who was treated with nivolumab...
January 2018: Tohoku Journal of Experimental Medicine
N Baize, P Bigot
CONTEXT: Nivolumab, an anti-PD1 immune control point inhibitor, is the first treatment that has improved the overall survival of patients after first-line metastatic renal cell carcinoma in 2015. Over the past two years, a large number of trials on these treatments and the interest of associations are being evaluated. OBJECTIVE: In this article, we propose to summarize the clinical development of checkpoint inhibitors to assess the direction of clinical research in this area...
January 12, 2018: Progrès en Urologie
Harvey Yu-Li Su
No abstract text is available yet for this article.
December 21, 2017: Clinical Genitourinary Cancer
Jens Bedke, Marc-Oliver Grimm, Viktor Grünwald
Renal cell carcinoma (RCC) represents the seventh (men) respectively tenth (women) most frequent cancer in western countries. After one or more lines of VEGF-targeted therapy, immunotherapy with nivolumab is strongly recommended in patients with metastatic RCC. Nivolumab is the first, and so far, only approved programmed death 1 (PD-1) immune checkpoint inhibitor to demonstrate a gain in overall survival in RCC. We describe herein design and rationale of trial CA209653 ('NIS NORA'), a prospective, noninterventional cohort study investigating the effectiveness of nivolumab...
January 12, 2018: Future Oncology
Bernard Escudier, Padmanee Sharma, David F McDermott, Saby George, Hans J Hammers, Sandhya Srinivas, Scott S Tykodi, Jeffrey A Sosman, Giuseppe Procopio, Elizabeth R Plimack, Daniel Castellano, Howard Gurney, Frede Donskov, Katriina Peltola, John Wagstaff, Thomas C Gauler, Takeshi Ueda, Huanyu Zhao, Ian M Waxman, Robert J Motzer
No abstract text is available yet for this article.
January 3, 2018: European Urology
Seiji Kishi, Masanori Minato, Atsuro Saijo, Naoka Murakami, Masanori Tamaki, Motokazu Matsuura, Taichi Murakami, Kojiro Nagai, Hideharu Abe, Yasuhiko Nishioka, Toshio Doi
Immune checkpoint inhibitors (ICIs) are becoming a common and important cancer therapy. ICIs are associated with a unique category of side effects, termed immune-related adverse events (irAEs). We herein report the case of a 72-year-old man with postoperative recurrence of lung squamous cell carcinoma who was treated with nivolumab and who developed proteinuria and a worsening kidney function. A kidney biopsy revealed IgA nephropathy. After drug withdrawal, the proteinuria improved and the deterioration of the patient's renal function was halted...
December 27, 2017: Internal Medicine
A Poprach, R Lakomý, T Büchler
Treatment of renal cell carcinoma is still palliative. Targeted therapy increases response rates and prolongs overall survival and progression-free survival compared with cytokines and chemotherapy. Checkpoint inhibitors constitute the up-date of therapeutic approaches, and anti-PD-1 antibody, one checkpoint inhibitor, is now well established as a second and/or third palliative treatment for patients with renal cell carcinoma. In this study, we present the latest data from current studies on cytokines, cancer vaccines, ipilimumab, and nivolumab...
2017: Klinická Onkologie: Casopis Ceské a Slovenské Onkologické Spolecnosti
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