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https://www.readbyqxmd.com/read/28807351/cost-effectiveness-of-nivolumab-in-advanced-renal-cell-carcinoma
#1
Michal Sarfaty, Moshe Leshno, Noa Gordon, Assaf Moore, Victoria Neiman, Eli Rosenbaum, Daniel A Goldstein
BACKGROUND: In recent years, new drugs have been introduced for second-line treatment of advanced renal cell carcinoma (RCC). Nivolumab increases overall survival and is associated with less toxicity compared to everolimus in this setting according to the CheckMate 025 study. However, because of the high cost of nivolumab, there is a need to define its value by considering both efficacy and cost. OBJECTIVE: To estimate the cost effectiveness of nivolumab for second-line treatment of advanced RCC from the US payer perspective...
August 11, 2017: European Urology
https://www.readbyqxmd.com/read/28769573/emerging-role-of-nivolumab-in-the-management-of-patients-with-non-small-cell-lung-cancer-current-data-and-future-perspectives
#2
REVIEW
Emily Feld, Leora Horn
Immune-checkpoint inhibitors have become valuable therapies in the treatment of patients with non-small-cell lung cancer (NSCLC). Recent clinical trials have shown promising results with regard to efficacy and toxicity profiles of these agents compared to cytotoxic chemotherapy. Nivolumab was one of the first immune-checkpoint inhibitors to demonstrate clinical activity in patients with NSCLC, and is currently approved in the US for treatment of patients with advanced squamous and nonsquamous NSCLC who have progressed on or after platinum-based chemotherapy...
2017: OncoTargets and Therapy
https://www.readbyqxmd.com/read/28734759/nivolumab-in-patients-with-metastatic-dna-mismatch-repair-deficient-or-microsatellite-instability-high-colorectal-cancer-checkmate-142-an-open-label-multicentre-phase-2-study
#3
Michael J Overman, Ray McDermott, Joseph L Leach, Sara Lonardi, Heinz-Josef Lenz, Michael A Morse, Jayesh Desai, Andrew Hill, Michael Axelson, Rebecca A Moss, Monica V Goldberg, Z Alexander Cao, Jean-Marie Ledeine, Gregory A Maglinte, Scott Kopetz, Thierry André
BACKGROUND: Metastatic DNA mismatch repair-deficient (dMMR)/microsatellite instability-high (MSI-H) colorectal cancer has a poor prognosis after treatment with conventional chemotherapy and exhibits high levels of tumour neoantigens, tumour-infiltrating lymphocytes, and checkpoint regulators. All of these features are associated with the response to PD-1 blockade in other tumour types. Therefore, we aimed to study nivolumab, a PD-1 immune checkpoint inhibitor, in patients with dMMR/MSI-H metastatic colorectal cancer...
July 19, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28726813/lung-cancer-frontline-nivolumab-checkmate-026-ends-in-stalemate
#4
David Killock
No abstract text is available yet for this article.
July 20, 2017: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/28715649/excellent-response-to-anti-pd-1-therapy-in-a-patient-with-hepatocellular-carcinoma-case-report-and-review-of-literature
#5
Hirva Mamdani, Howard Wu, Bert H O'Neil, Amikar Sehdev
Hepatocellular carcinoma (HCC) is an aggressive cancer associated with high mortality worldwide. HCC develops in the setting of underlying cirrhosis due to chronic liver disease. Surgery is usually considered the treatment of choice for early disease; however, most patients have locally advanced or metastatic HCC at diagnosis in which case treatments are limited. Immune checkpoint blockade of programmed death receptor-1 (PD-1) pathway offers a potential treatment strategy based on the encouraging results of the phase I/II trial of nivolumab (Checkmate 040 trial)...
May 2017: Discovery Medicine
https://www.readbyqxmd.com/read/28680957/health-related-quality-of-life-as-a-prognostic-measure-of-clinical-outcomes-in-renal-cell-carcinoma-a-review-of-the-checkmate-025-trial
#6
EDITORIAL
Marc-Oliver Grimm, Viktor Grünwald
The phase III, randomized, open-label CheckMate 025 study showed an overall survival benefit in patients with advanced renal cell carcinoma treated with nivolumab versus everolimus. Here, we review the health-related quality of life (HRQoL) results of this trial, in which nivolumab was associated with significant improvements in HRQoL, with more patients having a clinically meaningful HRQoL improvement and a shorter time to onset of improvement compared with everolimus. Further exploratory analysis suggests a positive correlation between baseline HRQoL scores and overall survival...
2017: Oncology and Therapy
https://www.readbyqxmd.com/read/28678668/safety-and-efficacy-of-nivolumab-in-combination-with-ipilimumab-in-metastatic-renal-cell-carcinoma-the-checkmate-016-study
#7
Hans J Hammers, Elizabeth R Plimack, Jeffrey R Infante, Brian I Rini, David F McDermott, Lionel D Lewis, Martin H Voss, Padmanee Sharma, Sumanta K Pal, Albiruni R Abdul Razak, Christian Kollmannsberger, Daniel Y C Heng, Jennifer Spratlin, M Brent McHenry, Asim Amin
Purpose Combination treatment with immune checkpoint inhibitors has shown enhanced antitumor activity compared with monotherapy in tumor types such as melanoma. The open-label, parallel-cohort, dose-escalation, phase I CheckMate 016 study evaluated the efficacy and safety of nivolumab plus ipilimumab in combination, and nivolumab plus a tyrosine kinase inhibitor in metastatic renal cell carcinoma (mRCC). Safety and efficacy results from the nivolumab plus ipilimumab arms of the study are presented. Patients and Methods Patients with mRCC received intravenous nivolumab 3 mg/kg plus ipilimumab 1 mg/kg (N3I1), nivolumab 1 mg/kg plus ipilimumab 3 mg/kg (N1I3), or nivolumab 3 mg/kg plus ipilimumab 3 mg/kg (N3I3) every 3 weeks for four doses followed by nivolumab monotherapy 3 mg/kg every 2 weeks until progression or toxicity...
July 5, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28671856/overall-survival-in-patients-with-advanced-melanoma-who-received-nivolumab-versus-investigator-s-choice-chemotherapy-in-checkmate-037-a-randomized-controlled-open-label-phase-iii-trial
#8
James Larkin, David Minor, Sandra D'Angelo, Bart Neyns, Michael Smylie, Wilson H Miller, Ralf Gutzmer, Gerald Linette, Bartosz Chmielowski, Christopher D Lao, Paul Lorigan, Kenneth Grossmann, Jessica C Hassel, Mario Sznol, Adil Daud, Jeffrey Sosman, Nikhil Khushalani, Dirk Schadendorf, Christoph Hoeller, Dana Walker, George Kong, Christine Horak, Jeffrey Weber
Purpose Until recently, limited options existed for patients with advanced melanoma who experienced disease progression while receiving treatment with ipilimumab. Here, we report the coprimary overall survival (OS) end point of CheckMate 037, which has previously shown that nivolumab resulted in more patients achieving an objective response compared with chemotherapy regimens in ipilimumab-refractory patients with advanced melanoma. Patients and Methods Patients were stratified by programmed death-ligand 1 expression, BRAF status, and best prior cytotoxic T-lymphocyte antigen-4 therapy response, then randomly assigned 2:1 to nivolumab 3 mg/kg intravenously every 2 weeks or investigator's choice chemotherapy (ICC; dacarbazine 1,000 mg/m(2) every 3 weeks or carboplatin area under the curve 6 plus paclitaxel 175 mg/m(2) every 3 weeks)...
July 3, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28662232/nivolumab-for-patients-with-advanced-melanoma-treated-beyond-progression-analysis-of-2-phase-3-clinical-trials
#9
Georgina V Long, Jeffrey S Weber, James Larkin, Victoria Atkinson, Jean-Jacques Grob, Dirk Schadendorf, Reinhard Dummer, Caroline Robert, Ivan Márquez-Rodas, Catriona McNeil, Henrik Schmidt, Karen Briscoe, Jean-François Baurain, F Stephen Hodi, Jedd D Wolchok
Importance: Immune checkpoint inhibitors have demonstrated atypical response patterns, which may not be fully captured by conventional response criteria. There is a need to better understand the potential benefit of continued immune checkpoint inhibition beyond progression. Objective: To evaluate the safety and potential benefit of nivolumab (anti-programmed cell death receptor 1) monotherapy beyond Response Evaluation Criteria in Solid Tumors (RECIST) v1.1-defined progression...
June 29, 2017: JAMA Oncology
https://www.readbyqxmd.com/read/28651929/nivolumab-versus-standard-single-agent-therapy-of-investigator-s-choice-in-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck-checkmate-141-health-related-quality-of-life-results-from-a-randomised-phase-3-trial
#10
Kevin J Harrington, Robert L Ferris, George Blumenschein, A Dimitrios Colevas, Jérôme Fayette, Lisa Licitra, Stefan Kasper, Caroline Even, Everett E Vokes, Francis Worden, Nabil F Saba, Naomi Kiyota, Robert Haddad, Makoto Tahara, Viktor Grünwald, James W Shaw, Manish Monga, Mark Lynch, Fiona Taylor, Michael DeRosa, Laura Morrissey, Kim Cocks, Maura L Gillison, Joël Guigay
BACKGROUND: Patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options and poor prognosis. Nivolumab significantly improved survival of this patient population when compared with standard single-agent therapy of investigator's choice in Checkmate 141; here we report the effect of nivolumab on patient-reported outcomes (PROs). METHODS: CheckMate 141 was a randomised, open-label, phase 3 trial in patients with recurrent or metastatic squamous cell carcinoma of the head and neck who progressed within 6 months after platinum-based chemotherapy...
August 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28651159/health-related-quality-of-life-results-from-the-phase-iii-checkmate-067-study
#11
Dirk Schadendorf, James Larkin, Jedd Wolchok, F Stephen Hodi, Vanna Chiarion-Sileni, Rene Gonzalez, Piotr Rutkowski, Jean-Jacques Grob, C Lance Cowey, Christopher Lao, John Wagstaff, Margaret K Callahan, Michael A Postow, Michael Smylie, Pier Francesco Ferrucci, Reinhard Dummer, Andrew Hill, Fiona Taylor, Javier Sabater, Dana Walker, Srividya Kotapati, Amy Abernethy, Georgina V Long
BACKGROUND: Nivolumab, a monoclonal antibody of immune checkpoint programmed death 1 on T cells (PD-1), combined with ipilimumab, an immune checkpoint cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) inhibitor, as combination therapy on the one hand and nivolumab as monotherapy on the other, have both demonstrated improved efficacy compared with ipilimumab alone in the CheckMate 067 study. However, the combination resulted in a higher frequency of grade 3/4 adverse events (AEs), which could result in diminished health-related quality of life (HRQoL)...
June 22, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28636851/first-line-nivolumab-in-stage-iv-or-recurrent-non-small-cell-lung-cancer
#12
COMMENT
David P Carbone, Martin Reck, Luis Paz-Ares, Benjamin Creelan, Leora Horn, Martin Steins, Enriqueta Felip, Michel M van den Heuvel, Tudor-Eliade Ciuleanu, Firas Badin, Neal Ready, T Jeroen N Hiltermann, Suresh Nair, Rosalyn Juergens, Solange Peters, Elisa Minenza, John M Wrangle, Delvys Rodriguez-Abreu, Hossein Borghaei, George R Blumenschein, Liza C Villaruz, Libor Havel, Jana Krejci, Jesus Corral Jaime, Han Chang, William J Geese, Prabhu Bhagavatheeswaran, Allen C Chen, Mark A Socinski
BACKGROUND: Nivolumab has been associated with longer overall survival than docetaxel among patients with previously treated non-small-cell lung cancer (NSCLC). In an open-label phase 3 trial, we compared first-line nivolumab with chemotherapy in patients with programmed death ligand 1 (PD-L1)-positive NSCLC. METHODS: We randomly assigned, in a 1:1 ratio, patients with untreated stage IV or recurrent NSCLC and a PD-L1 tumor-expression level of 1% or more to receive nivolumab (administered intravenously at a dose of 3 mg per kilogram of body weight once every 2 weeks) or platinum-based chemotherapy (administered once every 3 weeks for up to six cycles)...
June 22, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28595514/the-incidence-and-relative-risk-of-pulmonary-toxicity-in-patients-treated-with-anti-pd1-pd-l1-therapy-for-solid-tumors-a-meta-analysis-of-current-studies
#13
Chiara Ciccarese, Roberto Iacovelli, Emilio Bria, Alessandra Modena, Francesco Massari, Matteo Brunelli, Emanuela Fantinel, Davide Bimbatti, Giulia A Zamboni, Walter Artibani, Giampaolo Tortora
AIM: Monoclonal antibodies (mAbs) directed against PD-1/PD-L1 have recently entered the therapeutic algorithm of several solid tumors. Among treatment-related adverse events pulmonary toxicity (PT) is of particular interest. We assess the incidence and relative risk (RR) of PT in patients treated with anti-PD1/PD-L1 mAbs. RESULTS: 11 articles were selected. The incidence of any- and high-grade PT was low (2.9 and 1.0%, respectively). Compared with standard therapies, anti-PD-1 mAbs do not significantly increase the risk of both any-grade (RR: 2...
June 2017: Immunotherapy
https://www.readbyqxmd.com/read/28585613/-immunotherapy-of-renal-cell-cancer
#14
Lajos Géczi, Krisztián Nagyiványi, Anikó Maráz
The authors briefly highlight the results of targeted therapy and present new solutions in kidney cancer immunotherapy. The important checkpoint inhibitors (anti-CTLA-4, -PD-1 and -PD-L1/2) and their combinations, together with the combinations of targeted drugs and immunotherapy are discussed. The newest checkpoint agents, vaccination and pegylated interleukin-2 are also presented. The most promising clinical trials (CheckMate-025, AGS-003, IMA 901) and the on-going first line phase III trials are shown in metastatic clear cell renal carcinoma...
June 6, 2017: Magyar Onkologia
https://www.readbyqxmd.com/read/28571578/immunotherapy-in-head-and-neck-cancer-aiming-at-extreme-precision
#15
Petr Szturz, Jan B Vermorken
BACKGROUND: Locoregionally advanced, recurrent, and metastatic squamous cell carcinomas of the head and neck (SCCHN) remain difficult to treat disease entities, in which systemic treatment often forms an integral part of their management. Immunotherapy is based on functional restoration of the host immune system, helping to counteract various tumour evasion strategies. Broadly, immunotherapeutic approaches encompass tumour-specific antibodies, cancer vaccines, cytokines, adoptive T-cell transfer, and immune-modulating agents...
June 2, 2017: BMC Medicine
https://www.readbyqxmd.com/read/28530525/cost-effectiveness-of-nivolumab-ipilimumab-combination-therapy-compared-with-monotherapy-for-first-line-treatment-of-metastatic-melanoma-in-the-united-states
#16
Anna Oh, Dang M Tran, Leann C McDowell, Dor Keyvani, Jay Andrew Barcelon, Oscar Merino, Leslie Wilson
BACKGROUND: The approval of new immunotherapies has dramatically changed the treatment landscape of metastatic melanoma. These survival gains come with trade-offs in side effects and costs, as well as important considerations for third-party payer systems, physicians, and patients. OBJECTIVE: To develop a Markov model to determine the cost-effectiveness of nivolumab, ipilimumab, and nivolumab-ipilimumab combination as firstline therapy in metastatic melanoma, while accounting for differential effectiveness in programmed death-ligand 1 (PD-L1) positive and negative patients...
June 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/28487550/liver-cancer-nivolumab-checkmate-for-hepatocellular-carcinoma
#17
Katrina Ray
No abstract text is available yet for this article.
June 2017: Nature Reviews. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28485409/immunotherapy-nivolumab-keeps-hcc-in-check-and-opens-avenues-for-checkmate
#18
David Killock
No abstract text is available yet for this article.
July 2017: Nature Reviews. Clinical Oncology
https://www.readbyqxmd.com/read/28434648/nivolumab-in-patients-with-advanced-hepatocellular-carcinoma-checkmate-040-an-open-label-non-comparative-phase-1-2-dose-escalation-and-expansion-trial
#19
Anthony B El-Khoueiry, Bruno Sangro, Thomas Yau, Todd S Crocenzi, Masatoshi Kudo, Chiun Hsu, Tae-You Kim, Su-Pin Choo, Jörg Trojan, Theodore H Welling, Tim Meyer, Yoon-Koo Kang, Winnie Yeo, Akhil Chopra, Jeffrey Anderson, Christine Dela Cruz, Lixin Lang, Jaclyn Neely, Hao Tang, Homa B Dastani, Ignacio Melero
BACKGROUND: For patients with advanced hepatocellular carcinoma, sorafenib is the only approved drug worldwide, and outcomes remain poor. We aimed to assess the safety and efficacy of nivolumab, a programmed cell death protein-1 (PD-1) immune checkpoint inhibitor, in patients with advanced hepatocellular carcinoma with or without chronic viral hepatitis. METHODS: We did a phase 1/2, open-label, non-comparative, dose escalation and expansion trial (CheckMate 040) of nivolumab in adults (≥18 years) with histologically confirmed advanced hepatocellular carcinoma with or without hepatitis C or B (HCV or HBV) infection...
June 24, 2017: Lancet
https://www.readbyqxmd.com/read/28419248/nivolumab-versus-everolimus-in-advanced-renal-cell-carcinoma-japanese-subgroup-analysis-from-the-checkmate-025-study
#20
Yoshihiko Tomita, Satoshi Fukasawa, Nobuo Shinohara, Hiroshi Kitamura, Mototsugu Oya, Masatoshi Eto, Kazunari Tanabe, Go Kimura, Junji Yonese, Masahiro Yao, Robert J Motzer, Hirotsugu Uemura, M Brent McHenry, Elmer Berghorn, Seiichiro Ozono
Background: Nivolumab improved overall survival (OS) and objective response rate (ORR) versus everolimus in previously treated patients with advanced renal cell carcinoma in the phase III CheckMate 025 study (minimum follow-up: 14 months). We report efficacy and safety in the global and Japanese populations (minimum follow-up: 26 months). Methods: Patients were randomized 1:1 to receive nivolumab 3 mg/kg intravenously every 2 weeks or everolimus 10-mg tablet orally once daily...
April 13, 2017: Japanese Journal of Clinical Oncology
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