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https://www.readbyqxmd.com/read/27932067/nivolumab-plus-ipilimumab-as-first-line-treatment-for-advanced-non-small-cell-lung-cancer-checkmate-012-results-of-an-open-label-phase-1-multicohort-study
#1
Matthew D Hellmann, Naiyer A Rizvi, Jonathan W Goldman, Scott N Gettinger, Hossein Borghaei, Julie R Brahmer, Neal E Ready, David E Gerber, Laura Q Chow, Rosalyn A Juergens, Frances A Shepherd, Scott A Laurie, William J Geese, Shruti Agrawal, Tina C Young, Xuemei Li, Scott J Antonia
BACKGROUND: Nivolumab has shown improved survival in the treatment of advanced non-small-cell lung cancer (NSCLC) previously treated with chemotherapy. We assessed the safety and activity of combination nivolumab plus ipilimumab as first-line therapy for NSCLC. METHODS: The open-label, phase 1, multicohort study (CheckMate 012) cohorts reported here were enrolled at eight US academic centres. Eligible patients were aged 18 years or older with histologically or cytologically confirmed recurrent stage IIIb or stage IV, chemotherapy-naive NSCLC...
December 2, 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27686971/phase-2-study-of-erlotinib-in-combination-with%C3%A2-linsitinib-osi-906-or-placebo-in-chemotherapy-naive-patients-with-non-small-cell-lung-cancer-and-activating-epidermal-growth-factor-receptor-mutations
#2
Natasha B Leighl, Naiyer A Rizvi, Lopes Gilberto de Lima, Wichit Arpornwirat, Charles M Rudin, Alberto A Chiappori, Myung-Ju Ahn, Laura Q M Chow, Lyudmila Bazhenova, Arunee Dechaphunkul, Patrapim Sunpaweravong, Keith Eaton, Jihong Chen, Sonja Medley, Srinivasu Poondru, Margaret Singh, Joyce Steinberg, Rosalyn A Juergens, Shirish M Gadgeel
INTRODUCTION: First-line epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor treatment of advanced non-small-cell lung cancer with EGFR-activating mutations improves outcomes compared with chemotherapy, but resistance develops in most patients. Compensatory signaling through type 1 insulin-like growth factor 1 receptor (IGF-1R) may contribute to resistance; dual blockade of IGF-1R and EGFR may improve outcomes. PATIENTS AND METHODS: We performed a randomized, double-blind, placebo-controlled phase II study of linsitinib, a dual IGF-1R and insulin receptor tyrosine kinase inhibitor, plus erlotinib versus placebo plus erlotinib in chemotherapy-naive patients with EGFR-mutation positive, advanced non-small-cell lung cancer...
August 8, 2016: Clinical Lung Cancer
https://www.readbyqxmd.com/read/27676569/p2-35-nivolumab-vs-docetaxel-in-advanced%C3%A2-nsclc-checkmate-017-057%C3%A2-2-y-update-and-exploratory-cytokine-profile-analysis-track-immunotherapy
#3
Hossein Borghaei, Julie Brahmer, Leora Horn, Neal Ready, Martin Steins, Enriqueta Felip, Luis Paz-Ares, Xx Xx, Fabrice Barlesi, Scott Antonia, Jérome Fayette, Naiyer Rizvi, Lucio Crino, Martin Reck, Wilfried Ernst Erich Eberhardt, Matthew Hellmann, Kaushal Desai, Ang Li, Diane Healey, David Spigel, Clarissa Mathias
No abstract text is available yet for this article.
October 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27645803/defining-a-radiomic-response-phenotype-a-pilot-study-using-targeted-therapy-in-nsclc
#4
Hugo J W L Aerts, Patrick Grossmann, Yongqiang Tan, Geoffrey G Oxnard, Naiyer Rizvi, Lawrence H Schwartz, Binsheng Zhao
Medical imaging plays a fundamental role in oncology and drug development, by providing a non-invasive method to visualize tumor phenotype. Radiomics can quantify this phenotype comprehensively by applying image-characterization algorithms, and may provide important information beyond tumor size or burden. In this study, we investigated if radiomics can identify a gefitinib response-phenotype, studying high-resolution computed-tomography (CT) imaging of forty-seven patients with early-stage non-small cell lung cancer before and after three weeks of therapy...
September 20, 2016: Scientific Reports
https://www.readbyqxmd.com/read/27532023/pd-l1-biomarker-testing-for-non-small-cell-lung-cancer-truth-or-fiction
#5
REVIEW
Claud Grigg, Naiyer A Rizvi
Research in cancer immunology is currently accelerating following a series of cancer immunotherapy breakthroughs during the last 5 years. Various monoclonal antibodies which block the interaction between checkpoint molecules PD-1 on immune cells and PD-L1 on cancer cells have been used to successfully treat non-small cell lung cancer (NSCLC), including some durable responses lasting years. Two drugs, nivolumab and pembrolizumab, are now FDA approved for use in certain patients who have failed or progressed on platinum-based or targeted therapies while agents targeting PD-L1, atezolizumab and durvalumab, are approaching the final stages of clinical testing...
2016: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/27354485/nivolumab-monotherapy-for-first-line-treatment-of-advanced-non-small-cell-lung-cancer
#6
Scott Gettinger, Naiyer A Rizvi, Laura Q Chow, Hossein Borghaei, Julie Brahmer, Neal Ready, David E Gerber, Frances A Shepherd, Scott Antonia, Jonathan W Goldman, Rosalyn A Juergens, Scott A Laurie, Faith E Nathan, Yun Shen, Christopher T Harbison, Matthew D Hellmann
PURPOSE: Nivolumab, a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, has demonstrated improved survival over docetaxel in previously treated advanced non-small-cell lung cancer (NSCLC). First-line monotherapy with nivolumab for advanced NSCLC was evaluated in the phase I, multicohort, Checkmate 012 trial. METHODS: Fifty-two patients received nivolumab 3 mg/kg intravenously every 2 weeks until progression or unacceptable toxicity; postprogression treatment was permitted per protocol...
September 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27354481/nivolumab-in-combination-with-platinum-based-doublet-chemotherapy-for-first-line-treatment-of-advanced-non-small-cell-lung-cancer
#7
Naiyer A Rizvi, Matthew D Hellmann, Julie R Brahmer, Rosalyn A Juergens, Hossein Borghaei, Scott Gettinger, Laura Q Chow, David E Gerber, Scott A Laurie, Jonathan W Goldman, Frances A Shepherd, Allen C Chen, Yun Shen, Faith E Nathan, Christopher T Harbison, Scott Antonia
PURPOSE: Nivolumab, a fully human immunoglobulin G4 programmed death-1 immune checkpoint inhibitor antibody, has demonstrated improved survival in previously treated patients with advanced non-small-cell lung cancer (NSCLC). CheckMate 012, a phase I, multicohort study, was conducted to explore the safety and efficacy of nivolumab as monotherapy or combined with current standard therapies in first-line advanced NSCLC. Here, we report results for nivolumab plus platinum-based doublet chemotherapy (PT-DC)...
September 1, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27308563/genomic-profile-smoking-and-response-to-anti-pd-1-therapy-in-non-small-cell-lung-carcinoma
#8
Matthew Hellmann, Naiyer Rizvi, Jedd D Wolchok, Timothy A Chan
The recent successes of immune checkpoint therapies have established a new era for the treatment of patients with cancer, yet the predictors of response remain largely undetermined. We recently demonstrated that the genomic landscape of lung cancers substantially influences the response to programmed cell death 1 receptor (PD-1) blockade, providing new insights into the molecular determinants of the response to immunotherapy.
January 2016: Molecular & Cellular Oncology
https://www.readbyqxmd.com/read/27092830/association-of-pembrolizumab-with-tumor-response-and-survival-among-patients-with-advanced-melanoma
#9
MULTICENTER STUDY
Antoni Ribas, Omid Hamid, Adil Daud, F Stephen Hodi, Jedd D Wolchok, Richard Kefford, Anthony M Joshua, Amita Patnaik, Wen-Jen Hwu, Jeffrey S Weber, Tara C Gangadhar, Peter Hersey, Roxana Dronca, Richard W Joseph, Hassane Zarour, Bartosz Chmielowski, Donald P Lawrence, Alain Algazi, Naiyer A Rizvi, Brianna Hoffner, Christine Mateus, Kevin Gergich, Jill A Lindia, Maxine Giannotti, Xiaoyun Nicole Li, Scot Ebbinghaus, S Peter Kang, Caroline Robert
IMPORTANCE: The programmed death 1 (PD-1) pathway limits immune responses to melanoma and can be blocked with the humanized anti-PD-1 monoclonal antibody pembrolizumab. OBJECTIVE: To characterize the association of pembrolizumab with tumor response and overall survival among patients with advanced melanoma. DESIGN, SETTINGS, AND PARTICIPANTS: Open-label, multicohort, phase 1b clinical trials (enrollment, December 2011-September 2013). Median duration of follow-up was 21 months...
April 19, 2016: JAMA: the Journal of the American Medical Association
https://www.readbyqxmd.com/read/27026678/into-the-clinic-with-nivolumab-and-pembrolizumab
#10
Catherine A Shu, Naiyer A Rizvi
No abstract text is available yet for this article.
May 2016: Oncologist
https://www.readbyqxmd.com/read/26940869/clonal-neoantigens-elicit-t-cell-immunoreactivity-and-sensitivity-to-immune-checkpoint-blockade
#11
Nicholas McGranahan, Andrew J S Furness, Rachel Rosenthal, Sofie Ramskov, Rikke Lyngaa, Sunil Kumar Saini, Mariam Jamal-Hanjani, Gareth A Wilson, Nicolai J Birkbak, Crispin T Hiley, Thomas B K Watkins, Seema Shafi, Nirupa Murugaesu, Richard Mitter, Ayse U Akarca, Joseph Linares, Teresa Marafioti, Jake Y Henry, Eliezer M Van Allen, Diana Miao, Bastian Schilling, Dirk Schadendorf, Levi A Garraway, Vladimir Makarov, Naiyer A Rizvi, Alexandra Snyder, Matthew D Hellmann, Taha Merghoub, Jedd D Wolchok, Sachet A Shukla, Catherine J Wu, Karl S Peggs, Timothy A Chan, Sine R Hadrup, Sergio A Quezada, Charles Swanton
As tumors grow, they acquire mutations, some of which create neoantigens that influence the response of patients to immune checkpoint inhibitors. We explored the impact of neoantigen intratumor heterogeneity (ITH) on antitumor immunity. Through integrated analysis of ITH and neoantigen burden, we demonstrate a relationship between clonal neoantigen burden and overall survival in primary lung adenocarcinomas. CD8(+)tumor-infiltrating lymphocytes reactive to clonal neoantigens were identified in early-stage non-small cell lung cancer and expressed high levels of PD-1...
March 25, 2016: Science
https://www.readbyqxmd.com/read/26858122/safety-and-antitumour-activity-of-durvalumab-plus-tremelimumab-in-non-small-cell-lung-cancer-a-multicentre-phase-1b-study
#12
RANDOMIZED CONTROLLED TRIAL
Scott Antonia, Sarah B Goldberg, Ani Balmanoukian, Jamie E Chaft, Rachel E Sanborn, Ashok Gupta, Rajesh Narwal, Keith Steele, Yu Gu, Joyson J Karakunnel, Naiyer A Rizvi
BACKGROUND: PD-L1 and CTLA-4 immune checkpoints inhibit antitumour T-cell activity. Combination treatment with the anti-PD-L1 antibody durvalumab and the anti-CTLA-4 antibody tremelimumab might provide greater antitumour activity than either drug alone. We aimed to assess durvalumab plus tremelimumab in patients with advanced squamous or non-squamous non-small cell lung cancer (NSCLC). METHODS: We did a multicentre, non-randomised, open-label, phase 1b study at five cancer centres in the USA...
March 2016: Lancet Oncology
https://www.readbyqxmd.com/read/26851183/immunotherapy-and-oncogenic-pathways-the-pten-connection
#13
Naiyer A Rizvi, Timothy A Chan
Peng and colleagues describe the effects of PTEN inactivation on antitumor immunity and response to immune checkpoint blockade in melanoma. These results shed light on the intricate interplay between oncogenic pathways and antitumor immune response.
February 2016: Cancer Discovery
https://www.readbyqxmd.com/read/26451299/genetics-and-immunology-reinvigorated
#14
Alexandra Snyder, Vladimir Makarov, Matthew Hellmann, Naiyer Rizvi, Taha Merghoub, Jedd D Wolchok, Timothy A Chan
Immune checkpoint blockade therapy is changing oncology by improving the outcome of patients with advanced malignancies. Our research has revealed the genetic features of tumors present in patients who initiate a successful antitumor immune response and derive clinical benefit from immune checkpoint blockade therapy versus non-responders.
October 2015: Oncoimmunology
https://www.readbyqxmd.com/read/26412456/nivolumab-versus-docetaxel-in-advanced-nonsquamous-non-small-cell-lung-cancer
#15
RANDOMIZED CONTROLLED TRIAL
Hossein Borghaei, Luis Paz-Ares, Leora Horn, David R Spigel, Martin Steins, Neal E Ready, Laura Q Chow, Everett E Vokes, Enriqueta Felip, Esther Holgado, Fabrice Barlesi, Martin Kohlhäufl, Oscar Arrieta, Marco Angelo Burgio, Jérôme Fayette, Hervé Lena, Elena Poddubskaya, David E Gerber, Scott N Gettinger, Charles M Rudin, Naiyer Rizvi, Lucio Crinò, George R Blumenschein, Scott J Antonia, Cécile Dorange, Christopher T Harbison, Friedrich Graf Finckenstein, Julie R Brahmer
BACKGROUND: Nivolumab, a fully human IgG4 programmed death 1 (PD-1) immune-checkpoint-inhibitor antibody, disrupts PD-1-mediated signaling and may restore antitumor immunity. METHODS: In this randomized, open-label, international phase 3 study, we assigned patients with nonsquamous non-small-cell lung cancer (NSCLC) that had progressed during or after platinum-based doublet chemotherapy to receive nivolumab at a dose of 3 mg per kilogram of body weight every 2 weeks or docetaxel at a dose of 75 mg per square meter of body-surface area every 3 weeks...
October 22, 2015: New England Journal of Medicine
https://www.readbyqxmd.com/read/26389763/immunotherapy-for-advanced-lung-cancer
#16
REVIEW
Ramsey Asmar, Naiyer A Rizvi
Lung cancers are immunogenic tumors that manage to evade the immune system by exploiting checkpoint pathways that render effector T cells anergic. Inhibition of these checkpoints can restore and invigorate endogenous antitumor T-cell responses. The immunotherapeutic approach of checkpoint inhibition has become an important treatment option for patients with advanced non-small cell lung cancer, playing a role that will continue to evolve over the coming years. The programmed death 1 inhibitors nivolumab and pembrolizumab have both been shown to induce durable responses and improve survival in a subset of patients with platinum-refractory metastatic non-small cell lung cancer...
September 2015: Cancer Journal
https://www.readbyqxmd.com/read/26003007/preliminary-safety-pharmacokinetics-and-efficacy-of-regorafenib-cisplatin-and-pemetrexed-in-patients-with-advanced-nonsquamous-non-small-cell-lung-cancers
#17
MULTICENTER STUDY
Matthew D Hellmann, Isrid Sturm, Zuzana Jirakova Trnkova, John Lettieri, Konstanze Diefenbach, Naiyer A Rizvi, Scott N Gettinger
UNLABELLED: Regorafenib is an oral multitargeted kinase inhibitor with potent antiangiogenic activity. In this phase I trial we evaluated the safety, pharmacokinetics, and efficacy of regorafenib with cisplatin and pemetrexed for patients with advanced nonsquamous non-small-cell lung cancers (nsNSCLCs). Nine patients enrolled before premature termination of the study. Five of 9 (56%) patients had a partial response and the median progression-free survival was 7 months (range, 1.5-15.1 months)...
November 2015: Clinical Lung Cancer
https://www.readbyqxmd.com/read/25897158/overall-survival-and-long-term-safety-of-nivolumab-anti-programmed-death-1-antibody-bms-936558-ono-4538-in-patients-with-previously-treated-advanced-non-small-cell-lung-cancer
#18
Scott N Gettinger, Leora Horn, Leena Gandhi, David R Spigel, Scott J Antonia, Naiyer A Rizvi, John D Powderly, Rebecca S Heist, Richard D Carvajal, David M Jackman, Lecia V Sequist, David C Smith, Philip Leming, David P Carbone, Mary C Pinder-Schenck, Suzanne L Topalian, F Stephen Hodi, Jeffrey A Sosman, Mario Sznol, David F McDermott, Drew M Pardoll, Vindira Sankar, Christoph M Ahlers, Mark Salvati, Jon M Wigginton, Matthew D Hellmann, Georgia D Kollia, Ashok K Gupta, Julie R Brahmer
PURPOSE: Programmed death 1 is an immune checkpoint that suppresses antitumor immunity. Nivolumab, a fully human immunoglobulin G4 programmed death 1 immune checkpoint inhibitor antibody, was active and generally well tolerated in patients with advanced solid tumors treated in a phase I trial with expansion cohorts. We report overall survival (OS), response durability, and long-term safety in patients with non-small-cell lung cancer (NSCLC) receiving nivolumab in this trial. PATIENTS AND METHODS: Patients (N = 129) with heavily pretreated advanced NSCLC received nivolumab 1, 3, or 10 mg/kg intravenously once every 2 weeks in 8-week cycles for up to 96 weeks...
June 20, 2015: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/25891174/pembrolizumab-for-the-treatment-of-non-small-cell-lung-cancer
#19
Edward B Garon, Naiyer A Rizvi, Rina Hui, Natasha Leighl, Ani S Balmanoukian, Joseph Paul Eder, Amita Patnaik, Charu Aggarwal, Matthew Gubens, Leora Horn, Enric Carcereny, Myung-Ju Ahn, Enriqueta Felip, Jong-Seok Lee, Matthew D Hellmann, Omid Hamid, Jonathan W Goldman, Jean-Charles Soria, Marisa Dolled-Filhart, Ruth Z Rutledge, Jin Zhang, Jared K Lunceford, Reshma Rangwala, Gregory M Lubiniecki, Charlotte Roach, Kenneth Emancipator, Leena Gandhi
BACKGROUND: We assessed the efficacy and safety of programmed cell death 1 (PD-1) inhibition with pembrolizumab in patients with advanced non-small-cell lung cancer enrolled in a phase 1 study. We also sought to define and validate an expression level of the PD-1 ligand 1 (PD-L1) that is associated with the likelihood of clinical benefit. METHODS: We assigned 495 patients receiving pembrolizumab (at a dose of either 2 mg or 10 mg per kilogram of body weight every 3 weeks or 10 mg per kilogram every 2 weeks) to either a training group (182 patients) or a validation group (313 patients)...
May 21, 2015: New England Journal of Medicine
https://www.readbyqxmd.com/read/25765070/cancer-immunology-mutational-landscape-determines-sensitivity-to-pd-1-blockade-in-non-small-cell-lung-cancer
#20
Naiyer A Rizvi, Matthew D Hellmann, Alexandra Snyder, Pia Kvistborg, Vladimir Makarov, Jonathan J Havel, William Lee, Jianda Yuan, Phillip Wong, Teresa S Ho, Martin L Miller, Natasha Rekhtman, Andre L Moreira, Fawzia Ibrahim, Cameron Bruggeman, Billel Gasmi, Roberta Zappasodi, Yuka Maeda, Chris Sander, Edward B Garon, Taha Merghoub, Jedd D Wolchok, Ton N Schumacher, Timothy A Chan
Immune checkpoint inhibitors, which unleash a patient's own T cells to kill tumors, are revolutionizing cancer treatment. To unravel the genomic determinants of response to this therapy, we used whole-exome sequencing of non-small cell lung cancers treated with pembrolizumab, an antibody targeting programmed cell death-1 (PD-1). In two independent cohorts, higher nonsynonymous mutation burden in tumors was associated with improved objective response, durable clinical benefit, and progression-free survival. Efficacy also correlated with the molecular smoking signature, higher neoantigen burden, and DNA repair pathway mutations; each factor was also associated with mutation burden...
April 3, 2015: Science
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