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"nivolumab" and "ipilimumab"

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https://www.readbyqxmd.com/read/28926356/development-of-bell-s-palsy-after-treatment-with-ipilimumab-and-nivolumab-for-metastatic-melanoma-a-case-report
#1
Julia M Zecchini, Sara Kim, Kendra Yum, Philip Friedlander
Ipilimumab is a human monoclonal antibody that targets cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), and it is FDA approved for the treatment of unresectable or metastatic melanoma. Immune-related adverse events (irAEs) of gastrointestinal, dermatologic, and endocrine origin are commonly seen, ranging between 18% and 44%, with immune checkpoint inhibitors (anti-CTLA-4 and anti-PD-1/PD-L1). Rare irAEs include neurological, renal, and hematologic toxicities. Bell's palsy is a form of neurological toxicity that presents as an idiopathic paralysis of the muscles on one side of the face...
September 18, 2017: Journal of Immunotherapy
https://www.readbyqxmd.com/read/28923537/metagenomic-shotgun-sequencing-and-unbiased-metabolomic-profiling-identify-specific-human-gut-microbiota-and-metabolites-associated-with-immune-checkpoint-therapy-efficacy-in-melanoma-patients
#2
Arthur E Frankel, Laura A Coughlin, Jiwoong Kim, Thomas W Froehlich, Yang Xie, Eugene P Frenkel, Andrew Y Koh
This is the first prospective study of the effects of human gut microbiota and metabolites on immune checkpoint inhibitor (ICT) response in metastatic melanoma patients. Whereas many melanoma patients exhibit profound response to ICT, there are fewer options for patients failing ICT-particularly with BRAF-wild-type disease. In preclinical studies, specific gut microbiota promotes regression of melanoma in mice. We therefore conducted a study of the effects of pretreatment gut microbiota and metabolites on ICT Response Evaluation Criteria in Solid Tumors response in 39 metastatic melanoma patients treated with ipilimumab, nivolumab, ipilimumab plus nivolumab (IN), or pembrolizumab (P)...
September 14, 2017: Neoplasia: An International Journal for Oncology Research
https://www.readbyqxmd.com/read/28921644/clinical-pharmacology-considerations-for-the-development-of-immune-checkpoint-inhibitors
#3
Jennifer Sheng, Shivani Srivastava, Kinjal Sanghavi, Zheng Lu, Brian J Schmidt, Akintunde Bello, Manish Gupta
Immuno-oncology works through activation of the patient's immune system against cancer, with several advantages over other treatment approaches, including cytotoxic agents and molecular-targeted therapies. The most notable feature of immuno-oncology treatments is the nature of the patient responses achieved, which can be more durable and sustained than with other modalities. Increased understanding of immune system complexity has provided a number of opportunities to advance several strategies for the development of immuno-oncology therapies...
October 2017: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28915085/pooled-analysis-safety-profile-of-nivolumab-and-ipilimumab-combination-therapy-in-patients-with-advanced-melanoma
#4
Mario Sznol, Pier Francesco Ferrucci, David Hogg, Michael B Atkins, Pascal Wolter, Massimo Guidoboni, Celeste Lebbé, John M Kirkwood, Jacob Schachter, Gregory A Daniels, Jessica Hassel, Jonathan Cebon, Winald Gerritsen, Victoria Atkinson, Luc Thomas, John McCaffrey, Derek Power, Dana Walker, Rafia Bhore, Joel Jiang, F Stephen Hodi, Jedd D Wolchok
Purpose The addition of nivolumab (anti-programmed death-1 antibody) to ipilimumab (anti-cytotoxic T-cell lymphocyte-associated 4 antibody) in patients with advanced melanoma improves antitumor response and progression-free survival but with a higher frequency of adverse events (AEs). This cross-melanoma study describes the safety profile of the approved nivolumab plus ipilimumab regimen. Methods This retrospective safety review on data from three trials (phase I, II, and III) included patients with advanced melanoma who received at least one dose of nivolumab 1 mg/kg plus ipilimumab 3 mg/kg every 3 weeks × 4 and then nivolumab 3 mg/kg every 2 weeks until disease progression or unacceptable toxicity while following established guidelines for AE management...
September 15, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28911080/rituximab-for-nivolumab-plus-ipilimumab-induced-encephalitis-in-a-small-cell-lung-cancer-patient
#5
M Ito, S Fujiwara, D Fujimoto, R Mori, H Yoshimura, A Hata, N Kohara, K Tomii
No abstract text is available yet for this article.
September 1, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28901560/erythema-nodosum-like-panniculitis-mimicking-disease-recurrence-a-novel-toxicity-from-immune-checkpoint-blockade-therapy-report-of-two-patients
#6
Michael T Tetzlaff, Amir A Jazaeri, Carlos A Torres-Cabala, Brinda Rao Korivi, Genie A Landon, Priyadharsini Nagarajan, Adrienne Choksi, Leon Chen, Marc Uemura, Phyu P Aung, Adi Diab, Padmanee Sharma, Michael A Davies, Rodabe Amaria, Victor G Prieto, Jonathan L Curry
Immunotherapies targeting cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) and the programmed cell death 1 (PD-1) receptor and its ligand (PD-L1) have demonstrated substantial clinical benefit in patients with clinically advanced solid malignancies. However, autoimmune toxicities are common and often significant adverse events with these agents. While rash and pruritus remain the most common cutaneous complications in treated patients, novel dermatologic toxicities related to immune checkpoint blockade continue to emerge as the number of patients exposed to immunotherapy increases...
September 13, 2017: Journal of Cutaneous Pathology
https://www.readbyqxmd.com/read/28891423/adjuvant-nivolumab-versus-ipilimumab-in-resected-stage-iii-or-iv-melanoma
#7
Jeffrey Weber, Mario Mandala, Michele Del Vecchio, Helen J Gogas, Ana M Arance, C Lance Cowey, Stéphane Dalle, Michael Schenker, Vanna Chiarion-Sileni, Ivan Marquez-Rodas, Jean-Jacques Grob, Marcus O Butler, Mark R Middleton, Michele Maio, Victoria Atkinson, Paola Queirolo, Rene Gonzalez, Ragini R Kudchadkar, Michael Smylie, Nicolas Meyer, Laurent Mortier, Michael B Atkins, Georgina V Long, Shailender Bhatia, Celeste Lebbé, Piotr Rutkowski, Kenji Yokota, Naoya Yamazaki, Tae M Kim, Veerle de Pril, Javier Sabater, Anila Qureshi, James Larkin, Paolo A Ascierto
Background Nivolumab and ipilimumab are immune checkpoint inhibitors that have been approved for the treatment of advanced melanoma. In the United States, ipilimumab has also been approved as adjuvant therapy for melanoma on the basis of recurrence-free and overall survival rates that were higher than those with placebo in a phase 3 trial. We wanted to determine the efficacy of nivolumab versus ipilimumab for adjuvant therapy in patients with resected advanced melanoma. Methods In this randomized, double-blind, phase 3 trial, we randomly assigned 906 patients (≥15 years of age) who were undergoing complete resection of stage IIIB, IIIC, or IV melanoma to receive an intravenous infusion of either nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks (453 patients) or ipilimumab at a dose of 10 mg per kilogram every 3 weeks for four doses and then every 12 weeks (453 patients)...
September 10, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28889792/overall-survival-with-combined-nivolumab-and-ipilimumab-in-advanced-melanoma
#8
Jedd D Wolchok, Vanna Chiarion-Sileni, Rene Gonzalez, Piotr Rutkowski, Jean-Jacques Grob, C Lance Cowey, Christopher D Lao, John Wagstaff, Dirk Schadendorf, Pier F Ferrucci, Michael Smylie, Reinhard Dummer, Andrew Hill, David Hogg, John Haanen, Matteo S Carlino, Oliver Bechter, Michele Maio, Ivan Marquez-Rodas, Massimo Guidoboni, Grant McArthur, Celeste Lebbé, Paolo A Ascierto, Georgina V Long, Jonathan Cebon, Jeffrey Sosman, Michael A Postow, Margaret K Callahan, Dana Walker, Linda Rollin, Rafia Bhore, F Stephen Hodi, James Larkin
Background Nivolumab combined with ipilimumab resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone in a phase 3 trial involving patients with advanced melanoma. We now report 3-year overall survival outcomes in this trial. Methods We randomly assigned, in a 1:1:1 ratio, patients with previously untreated advanced melanoma to receive nivolumab at a dose of 1 mg per kilogram of body weight plus ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of 3 mg per kilogram every 2 weeks; nivolumab at a dose of 3 mg per kilogram every 2 weeks plus placebo; or ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses plus placebo, until progression, the occurrence of unacceptable toxic effects, or withdrawal of consent...
September 11, 2017: New England Journal of Medicine
https://www.readbyqxmd.com/read/28883738/checkpoint-inhibitors-for-malignant-melanoma-a-systematic-review-and-meta-analysis
#9
REVIEW
Adam K Karlsson, Sohag N Saleh
BACKGROUND AND OBJECTIVES: Rates of malignant melanoma are continuing to increase, and until recently effective treatments were lacking. However, since 2011 three immunotherapeutic agents, known as checkpoint inhibitors, have been approved. This review aims to establish whether these three drugs - ipilimumab, nivolumab, and pembrolizumab - offer greater efficacy and tolerability compared to control interventions (placebo, immunotherapy, or chemotherapy) in patients with stage III or IV unresectable cutaneous melanoma...
2017: Clinical, Cosmetic and Investigational Dermatology
https://www.readbyqxmd.com/read/28883282/development-of-immune-checkpoint-inhibitors
#10
Shigehisa Kitano
Immune checkpoint inhibitors are the most striking innovation in the clinical development of immunotherapy. Monoclonal antibodies (mAbs) restore and augment the antitumor immune activities of cytotoxic T cells by mainly blocking immune checkpoint molecules on T cells or their ligands on antigen-presenting and tumor cells. Based on preclinical data, many clinical trials have demonstrated the acceptable safety profiles and efficacies of mAb in various cancers. The A first-in-class approved immune checkpoint inhibitor is ipilimumab, which is a fully humanized mAb that blocks the immunosuppressive signal by cytotoxic T-lymphocyte antigen 4...
2017: [Rinshō Ketsueki] the Japanese Journal of Clinical Hematology
https://www.readbyqxmd.com/read/28881222/immune-checkpoint-blockade-for-unresectable-or-metastatic-uveal-melanoma-a-systematic-review
#11
REVIEW
Markus V Heppt, Theresa Steeb, Justin Gabriel Schlager, Stefanie Rosumeck, Corinna Dressler, Thomas Ruzicka, Alexander Nast, Carola Berking
BACKGROUND: The use of immune checkpoint blockade (ICB) for uveal melanoma (UM) is little established. The aim of this review was to provide a comprehensive overview on the efficacy, safety, and tolerability of ICB in patients with UM. METHODS: We performed a systematic literature research covering MEDLINE, Embase and CENTRAL. Abstracts of pertinent conferences and trial registers were handsearched for relevant studies. RESULTS: Out of 1327 records initially identified, 12 eligible studies were included in the qualitative synthesis...
August 24, 2017: Cancer Treatment Reviews
https://www.readbyqxmd.com/read/28866758/modelling-the-survival-outcomes-of-immuno-oncology-drugs-in-economic-evaluations-a-systematic-approach-to-data-analysis-and-extrapolation
#12
Eddie Gibson, Ian Koblbauer, Najida Begum, George Dranitsaris, Danny Liew, Phil McEwan, Amir Abbas Tahami Monfared, Yong Yuan, Ariadna Juarez-Garcia, David Tyas, Michael Lees
BACKGROUND: New immuno-oncology (I-O) therapies that harness the immune system to fight cancer call for a re-examination of the traditional parametric techniques used to model survival from clinical trial data. More flexible approaches are needed to capture the characteristic I-O pattern of delayed treatment effects and, for a subset of patients, the plateau of long-term survival. OBJECTIVES: Using a systematic approach to data management and analysis, the study assessed the applicability of traditional and flexible approaches and, as a test case of flexible methods, investigated the suitability of restricted cubic splines (RCS) to model progression-free survival (PFS) in I-O therapy...
September 2, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28864844/checkpoint-inhibitors-the-new-treatment-paradigm-for-urothelial-bladder-cancer
#13
REVIEW
Heather Katz, Emnet Wassie, Mohamed Alsharedi
Bladder cancer is the most common malignancy involving the genitourinary system (Siegel et al. in CA Cancer J Clin, 66:7-30, 2016). In the USA, it is the fifth most common cancer and approximately 79,000 new cases will be diagnosed in 2017 (Siegel et al. in CA Cancer J Clin, 66:7-30, 2016). The mortality from bladder cancer is approximately 17,000 deaths each year (Siegel et al. in CA Cancer J Clin, 66:7-30, 2016). The incidence rate for bladder cancer is higher in men compared to women. Risk factors are predominantly related to tobacco smoking, although infection with Schistosoma haematobium is another risk factor in selected populations (Antoni et al...
September 1, 2017: Medical Oncology
https://www.readbyqxmd.com/read/28854831/autoimmune-diseases-induced-by-biological-agents-a-review-of-12731-cases-biogeas-registry
#14
Marta Pérez-De-Lis, Soledad Retamozo, Alejandra Flores-Chávez, Belchin Kostov, Roberto Perez-Alvarez, Pilar Brito-Zerón, Manuel Ramos-Casals
Biological drugs are therapies designed to target a specific molecule of the immune system. Paradoxically, their use has been linked with the development or exacerbation of autoimmune disorders. Areas covered. The BIOGEAS Registry currently collects information about nearly 13,000 reported cases of autoimmune diseases developed in patients exposed to biologics, including more than 50 different systemic and organ-specific autoimmune disorders, of which psoriasis (n=6375), inflammatory bowel disease (n=845), demyelinating CNS disease (n=803), interstitial lung disease (n=519), lupus (n=369), peripheral neuropathy (n=328), vasculitis (n=291) and hypophysitis (n=221) were the most frequently reported...
August 31, 2017: Expert Opinion on Drug Safety
https://www.readbyqxmd.com/read/28854067/phase-iii-trial-of-ipilimumab-combined-with-paclitaxel-and-carboplatin-in-advanced-squamous-non-small-cell-lung-cancer
#15
Ramaswamy Govindan, Aleksandra Szczesna, Myung-Ju Ahn, Claus-Peter Schneider, Pablo Fernando Gonzalez Mella, Fabrice Barlesi, Baohui Han, Doina Elena Ganea, Joachim Von Pawel, Vladimir Vladimirov, Natalia Fadeeva, Ki Hyeong Lee, Takayasu Kurata, Li Zhang, Tomohide Tamura, Pieter E Postmus, Jacek Jassem, Kenneth O'Byrne, Justin Kopit, Mingshun Li, Marina Tschaika, Martin Reck
Purpose Patients with squamous non-small-cell lung cancer (NSCLC) have poor prognosis and limited treatment options. This randomized, double-blind, phase III study investigated the efficacy and safety of first-line ipilimumab or placebo plus paclitaxel and carboplatin in advanced squamous NSCLC. Patients and Methods Patients with stage IV or recurrent chemotherapy-naïve squamous NSCLC were randomly assigned (1:1) to receive paclitaxel and carboplatin plus blinded ipilimumab 10 mg/kg or placebo every 3 weeks on a phased induction schedule comprising six chemotherapy cycles, with ipilimumab or placebo from cycles 3 to 6 and then, after induction treatment, ipilimumab or placebo maintenance every 12 weeks for patients with stable disease or better...
August 30, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28841387/efficacy-and-safety-outcomes-in-patients-with-advanced-melanoma-who-discontinued-treatment-with-nivolumab-and-ipilimumab-because-of-adverse-events-a-pooled-analysis-of-randomized-phase-ii-and-iii-trials
#16
Dirk Schadendorf, Jedd D Wolchok, F Stephen Hodi, Vanna Chiarion-Sileni, Rene Gonzalez, Piotr Rutkowski, Jean-Jacques Grob, C Lance Cowey, Christopher D Lao, Jason Chesney, Caroline Robert, Kenneth Grossmann, David McDermott, Dana Walker, Rafia Bhore, James Larkin, Michael A Postow
Purpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409)...
August 25, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28833119/the-clinical-value-of-combination-of-immune-checkpoint-inhibitors-in-cancer-patients-a-meta-analysis-of-efficacy-and-safety
#17
Yingcheng Wu, Hui Shi, Maorong Jiang, Mingyan Qiu, Keren Jia, Tianyue Cao, Yujuan Shang, Lili Shi, Kui Jiang, Huiqun Wu
The use of immune checkpoint inhibitors (ICIs) in combination therapy is an emerging trend in tumor immunology. However, the value of combination immunotherapy remains controversial, because of the toxic effects induced by combination. The added benefit of each additional drug has not been assessed against the added toxicity. We searched for clinical trials that evaluated ICI monotherapies and combination therapies in lung cancer and melanoma patients. The overall response rate (ORR), grade 3/4 treatment-related adverse event rate, overall survival (OS), and progression-free survival (PFS) were extracted from the most recently published studies to determine the relative risk (RR), hazard ratios (HRs), and 95% confidence intervals (CIs)...
August 22, 2017: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/28827234/multiple-treatment-comparison-of-seven-new-drugs-for-patients-with-advanced-malignant-melanoma-a-systematic-review-and-health-economic-decision-model-in-a-norwegian-setting
#18
Eva Pike, Vida Hamidi, Ingvil Saeterdal, Jan Odgaard-Jensen, Marianne Klemp
OBJECTIVE: To assess the relative effectiveness and cost-effectiveness of seven new drugs (cobimetinib, dabrafenib, ipilimumab, nivolumab, pembrolizumab, trametinib and vemurafenib) used for treatment of patients with advanced malignant melanoma in the Norwegian setting. DESIGN: A multiple technology assessment. PATIENTS: Patients with advanced malignant melanoma aged 18 or older. DATA SOURCES: A systematic search for randomised controlled trials in relevant bibliographic databases...
August 21, 2017: BMJ Open
https://www.readbyqxmd.com/read/28821685/nivolumab-related-myasthenia-gravis-with-myositis-and-myocarditis-in-japan
#19
Shigeaki Suzuki, Nobuhisa Ishikawa, Fumie Konoeda, Nobuhiko Seki, Satoshi Fukushima, Kikuko Takahashi, Hisashi Uhara, Yoshikazu Hasegawa, Shinichiro Inomata, Yasushi Otani, Kenji Yokota, Takashi Hirose, Ryo Tanaka, Norihiro Suzuki, Makoto Matsui
OBJECTIVE: To report the clinical features of myasthenia gravis (MG) induced by treatment with immune checkpoint inhibitors using 2-year safety databases based on postmarketing surveys in Japan. METHODS: We studied 10,277 patients with cancer who had received monotherapy with either nivolumab or ipilimumab between September 2014 and August 2016. As the control group, 105 patients with idiopathic MG were used. RESULTS: There were 12 MG cases (0...
September 12, 2017: Neurology
https://www.readbyqxmd.com/read/28817755/measuring-toxic-effects-and-time-to-treatment-failure-for-nivolumab-plus-ipilimumab-in-melanoma
#20
Alexander N Shoushtari, Claire F Friedman, Pedram Navid-Azarbaijani, Michael A Postow, Margaret K Callahan, Parisa Momtaz, Katherine S Panageas, Jedd D Wolchok, Paul B Chapman
Importance: Nivolumab plus ipilimumab (nivo + ipi) is a standard treatment of advanced melanoma. Two randomized trials describe high objective response rates by Response Evaluation Criteria in Solid Tumors. The trials assessed toxic effects using the Common Terminology Criteria for Adverse Events (CTCAE), which may underestimate incidence of clinically significant immune-related adverse events (AEs). Objective: To describe detailed toxic effects and time to treatment failure of patients with melanoma treated with nivo + ipi in a prospective cohort...
August 17, 2017: JAMA Oncology
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