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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
#1
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...
April 20, 2017: Lancet
https://www.readbyqxmd.com/read/28419248/nivolumab-versus-everolimus-in-advanced-renal-cell-carcinoma-japanese-subgroup-analysis-from-the-checkmate-025-study
#2
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
https://www.readbyqxmd.com/read/28417343/adjuvant-therapy-for-melanoma
#3
REVIEW
Aya Agha, Ahmad A Tarhini
Systemic adjuvant therapy for surgically resected cutaneous melanoma that is at high risk for disease recurrence and death targets residual micrometastatic disease which is the source of future local or distant relapse. Interferon-alfa (IFNα) has been the most extensively studied in regimens that varied by dosage, route of administration, formulation, and duration of therapy. Most regimens have demonstrated improvements in relapse-free survival (RFS), while the regimen administered at high dosage (HDI) showed improvements in overall survival (OS) in two out of three RCTs...
May 2017: Current Oncology Reports
https://www.readbyqxmd.com/read/28410865/treatment-beyond-progression-in-patients-with-advanced-renal-cell-carcinoma-treated-with-nivolumab-in-checkmate-025
#4
Bernard Escudier, Robert J Motzer, Padmanee Sharma, John Wagstaff, Elizabeth R Plimack, Hans J Hammers, Frede Donskov, Howard Gurney, Jeffrey A Sosman, Pawel G Zalewski, Ulrika Harmenberg, David F McDermott, Toni K Choueiri, Martin Richardet, Yoshihiko Tomita, Alain Ravaud, Justin Doan, Huanyu Zhao, Helene Hardy, Saby George
BACKGROUND: Response patterns to nivolumab differ from those seen with other approved targeted therapies. OBJECTIVE: To investigate the efficacy of nivolumab in previously treated patients with advanced renal cell carcinoma who were treated beyond (Response Evaluation Criteria In Solid Tumors) RECIST progression. DESIGN, SETTING, AND PARTICIPANTS: This was a subgroup analysis of patients treated with nivolumab in the phase 3 CheckMate 025 study...
April 12, 2017: European Urology
https://www.readbyqxmd.com/read/28407528/immunotherapy-revolutionises-non-small-cell-lung-cancer-therapy-results-perspectives-and-new-challenges
#5
REVIEW
Etienne Giroux Leprieur, Coraline Dumenil, Catherine Julie, Violaine Giraud, Jennifer Dumoulin, Sylvie Labrune, Thierry Chinet
Immune checkpoint inhibitors (ICIs) are antibodies that target key signalling pathways such as programmed death 1 (PD1)/programmed death-ligands 1 and 2 (PDL1 and PDL2) to improve anti-tumour immune responses. Until recently, nivolumab was the only ICI validated for advanced non-small-cell lung cancer (NSCLC) in a second-line treatment setting. Results from recent phase II and phase III randomised trials testing other ICIs have been presented. In Keynote-024, pembrolizumab, an anti-PD1 antibody, was reported to have great efficacy in the first-line treatment of PDL1 ≥ 50% tumours (30% of screened tumours), with a progression-free survival (PFS, median) of 10...
April 10, 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28382562/biomarkers-to-predict-prognosis-and-response-to-checkpoint-inhibitors
#6
REVIEW
Takeshi Yuasa, Hitoshi Masuda, Shinya Yamamoto, Noboru Numao, Junji Yonese
Nivolumab is a fully human immunoglobulin (Ig) G4 antibody that selectively inhibits the programmed death 1 (PD-1) immune checkpoint molecule, and has recently been launched for the treatment of renal cell cancer (RCC) in Japan. Based on its promising anti-tumor efficacy and manageable safety profile demonstrated in the phase III Checkmate 025 trial, nivolumab therapy is rapidly being introduced in metastatic RCC clinical practice. The phase Ia study of atezolizumab, which is a humanized anti-PD-ligand 1 (PD-L1) monoclonal IgG1 antibody, also demonstrated excellent treatment results...
April 5, 2017: International Journal of Clinical Oncology
https://www.readbyqxmd.com/read/28377499/immunotherapy-combo-offers-slight-survival-benefit-in-melanoma
#7
(no author information available yet)
Data on 2-year survival in the phase III CheckMate 067 trial testing nivolumab plus ipilimumab showed a slight survival benefit for the combination over nivolumab monotherapy-but the difference may not be dramatic enough to justify using the combination given the added side effects.
April 4, 2017: Cancer Discovery
https://www.readbyqxmd.com/read/28314610/subset-analyses-from-checkmate-025-a-challenge-to-current-clinical-dogma
#8
EDITORIAL
Sumanta K Pal, Manuel C Maia, Nazli Dizman, Neeraj Agarwal
No abstract text is available yet for this article.
March 14, 2017: European Urology
https://www.readbyqxmd.com/read/28286925/cabozantinib-for-renal-cell-carcinoma-current-and-future-paradigms
#9
REVIEW
Ahmed Abdelaziz, Ulka Vaishampayan
Cabozantinib was approved by the FDA in April 2016 for the treatment of advanced renal cancer, pretreated with at least one prior antiangiogenic therapy. This is the first agent in the therapy of kidney cancer to show a statistically significant improvement in all three endpoints of clinical efficacy, response rate, progression free survival, and overall survival (OS), in a phase III randomized trial. The reporting of METEOR coincided with that of the Checkmate 025 study which randomized similarly eligible patients to receive nivolumab or everolimus 10 mg daily...
March 2017: Current Treatment Options in Oncology
https://www.readbyqxmd.com/read/28262413/checkmate-025-randomized-phase-3-study-outcomes-by-key-baseline-factors-and-prior-therapy-for-nivolumab-versus-everolimus-in-advanced-renal-cell-carcinoma
#10
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
BACKGROUND: The randomized, phase 3 CheckMate 025 study of nivolumab (n=410) versus everolimus (n=411) in previously treated adults (75% male; 88% white) with advanced renal cell carcinoma (aRCC) demonstrated significantly improved overall survival (OS) and objective response rate (ORR). OBJECTIVE: To investigate which baseline factors were associated with OS and ORR benefit with nivolumab versus everolimus. DESIGN, SETTING, AND PARTICIPANTS: Subgroup OS analyses were performed using Kaplan-Meier methodology...
March 2, 2017: European Urology
https://www.readbyqxmd.com/read/28251908/turning-skin-check-into-checkmate
#11
Hadar Lev-Tov
Artificial intelligence algorithm performs on par with dermatologists to distinguish malignant from benign skin tumors.
March 1, 2017: Science Translational Medicine
https://www.readbyqxmd.com/read/28131785/nivolumab-in-metastatic-urothelial-carcinoma-after-platinum-therapy-checkmate-275-a-multicentre-single-arm-phase-2-trial
#12
Padmanee Sharma, Margitta Retz, Arlene Siefker-Radtke, Ari Baron, Andrea Necchi, Jens Bedke, Elizabeth R Plimack, Daniel Vaena, Marc-Oliver Grimm, Sergio Bracarda, José Ángel Arranz, Sumanta Pal, Chikara Ohyama, Abdel Saci, Xiaotao Qu, Alexandre Lambert, Suba Krishnan, Alex Azrilevich, Matthew D Galsky
BACKGROUND: Patients with metastatic urothelial carcinoma have a dismal prognosis and few treatment options after first-line chemotherapy. Responses to second-line treatment are uncommon. We assessed nivolumab, a fully human IgG4 PD-1 immune checkpoint inhibitor antibody, for safety and activity in patients with metastatic or surgically unresectable urothelial carcinoma whose disease progressed or recurred despite previous treatment with at least one platinum-based chemotherapy regimen...
March 2017: Lancet Oncology
https://www.readbyqxmd.com/read/27997007/-new-perspectives-in-second-line-treatment-in-non-squamous-non-small-cell-lung-cancer
#13
Francesco Grossi
The treatment options for patients with non-squamous non-small cell lung cancer (NSCLC) in second-line have been limited for a long time. Docetaxel, pemetrexed and erlotinib are the standard second-line treatment. Docetaxel is frequently used although it is associated with an unfavorable safety profile. Recently, the results from the trial CheckMate 057 with nivolumab, an anti-PD-1 inhibitor, has increased the therapeutic options for patients with non-squamous NSCLC in the second-line setting. The results of this randomized phase III trial comparing nivolumab vs docetaxel have deeply changed our current clinical practice...
December 2016: Recenti Progressi in Medicina
https://www.readbyqxmd.com/read/27969526/ps01-59-checkmate-370-a-master-protocol-of-phase-1-2-studies-of-nivolumab-as-maintenance-or-first-line-%C3%A2-standard-of-care-therapies-in-advanced-nsclc-topic-medical-oncology
#14
George Blumenschein, Jason Chandler, Edward B Garon, David Waterhouse, Jonathan W Goldman, Vijay K Gunuganti, Ralph Boccia, David Spigel, John Glaspy, Donald A Berry, Beata Korytowsky, Jin Zhu, Wen Hong Lin, Kelly Bennett, Craig Reynolds
No abstract text is available yet for this article.
November 2016: Journal of Thoracic Oncology
https://www.readbyqxmd.com/read/27969442/oral01-03-checkmate-012-safety-and-efficacy-of-first-line-nivolumab-and-ipilimumab-in-advanced-nsclc-topic-medical-oncology
#15
Scott J Antonia, Scott N Gettinger, Jonathan Goldman, Julie Brahmer, Hossein Borghaei, Laura Q Chow, Neal E Ready, David E Gerber, Rosalyn Juergens, Frances Shepherd, Scott A Laurie, Tina Young, William J Geese, Shruti Agrawal, Xuemei Li, Matthew D Hellmann
No abstract text is available yet for this article.
November 2016: Journal of Thoracic Oncology
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
#16
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...
January 2017: Lancet Oncology
https://www.readbyqxmd.com/read/27826379/checkmate-and-devil-s-tower
#17
(no author information available yet)
No abstract text is available yet for this article.
September 2016: Methodist DeBakey Cardiovascular Journal
https://www.readbyqxmd.com/read/27782862/acquired-resistance-to-anti-pd1-therapy-checkmate-to-checkpoint-blockade
#18
Jake S O'Donnell, Mark J Smyth, Michele W L Teng
Anti-programmed cell death 1 (PD1) immunotherapies are among the most effective anti-cancer immunotherapies available; however, a large number of patients present with or develop resistance to them. Unfortunately, very little is known regarding the mechanisms of resistance to such therapies. A recent study sought to identify mutations associated with resistance to anti-PD1 therapy. Results from this study demonstrated that mutations which affected the sensitivity of tumor cells to T-cell-derived interferons, and mutations limiting tumor-cell antigen presentation, could cause acquired resistance...
October 25, 2016: Genome Medicine
https://www.readbyqxmd.com/read/27733243/nivolumab-monotherapy-in-recurrent-metastatic-urothelial-carcinoma-checkmate-032-a-multicentre-open-label-two-stage-multi-arm-phase-1-2-trial
#19
Padmanee Sharma, Margaret K Callahan, Petri Bono, Joseph Kim, Pavlina Spiliopoulou, Emiliano Calvo, Rathi N Pillai, Patrick A Ott, Filippo de Braud, Michael Morse, Dung T Le, Dirk Jaeger, Emily Chan, Chris Harbison, Chen-Sheng Lin, Marina Tschaika, Alex Azrilevich, Jonathan E Rosenberg
BACKGROUND: Few effective treatments exist for patients with advanced urothelial carcinoma that has progressed after platinum-based chemotherapy. We assessed the activity and safety of nivolumab in patients with locally advanced or metastatic urothelial carcinoma whose disease progressed after previous platinum-based chemotherapy. METHODS: In this phase 1/2, multicentre, open-label study, we enrolled patients (age ≥18 years) with urothelial carcinoma of the renal pelvis, ureter, bladder, or urethra at 16 sites in Finland, Germany, Spain, the UK, and the USA...
November 2016: Lancet Oncology
https://www.readbyqxmd.com/read/27718784/nivolumab-for-recurrent-squamous-cell-carcinoma-of-the-head-and-neck
#20
RANDOMIZED CONTROLLED TRIAL
Robert L Ferris, George Blumenschein, Jerome Fayette, Joel Guigay, A Dimitrios Colevas, Lisa Licitra, Kevin Harrington, Stefan Kasper, Everett E Vokes, Caroline Even, Francis Worden, Nabil F Saba, Lara C Iglesias Docampo, Robert Haddad, Tamara Rordorf, Naomi Kiyota, Makoto Tahara, Manish Monga, Mark Lynch, William J Geese, Justin Kopit, James W Shaw, Maura L Gillison
BACKGROUND: Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition. METHODS: In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab)...
November 10, 2016: New England Journal of Medicine
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