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https://www.readbyqxmd.com/read/29754585/significance-and-implications-of-fda-approval-of-pembrolizumab-for-biomarker-defined-disease
#1
Michael M Boyiadzis, John M Kirkwood, John L Marshall, Colin C Pritchard, Nilofer S Azad, James L Gulley
The U.S. Food and Drug Administration (FDA) recently approved pembrolizumab, an anti- programmed cell death protein 1 cancer immunotherapeutic, for use in advanced solid tumors in patients with the microsatellite-high/DNA mismatch repair-deficient biomarker. This is the first example of a tissue-agnostic FDA approval of a treatment based on a patient's tumor biomarker status, rather than on tumor histology. Here we discuss key issues and implications arising from the biomarker-based disease classification implied by this historic approval...
May 14, 2018: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/29715538/age-and-sex-dependent-effects-of-methamphetamine-on-cognitive-flexibility-and-5-ht-2c-receptor-localization-in-the-orbitofrontal-cortex-of-sprague-dawley-rats
#2
Emily R Hankosky, Sara R Westbrook, Rachel M Haake, Jari Willing, Lori T Raetzman, Janice M Juraska, Joshua M Gulley
Adolescents and females experience worse outcomes of drug use compared to adults and males. This could result from age- and sex-specific consequences of drug exposure on brain function and cognitive behavior. In the current study, we examined whether a history of intravenous methamphetamine (METH) self-administration impacted cognitive flexibility and 5-HT2C R localization in the orbitofrontal cortex (OFC) in an age- and sex-dependent manner. Strategy shifting was assessed in male and female Sprague-Dawley rats that had self-administered METH (0...
April 28, 2018: Behavioural Brain Research
https://www.readbyqxmd.com/read/29709495/morphological-changes-induced-by-intraprostatic-psa-based-vaccine-in-prostate-cancer-biopsies-phase-i-clinical-trial
#3
Maria J Merino, A Peter, Vanessa Moreno, Sara Gil, Jeffrey Schlom, James L Gulley
Immunotherapy is a novel treatment for many tumors including prostate cancer. Little is known about the histological changes in prostate biopsies caused by the prostatic-specific antigen (PSA)-based vaccine. This study evaluated the histopathological effects in prostate biopsies of recombinant fowlpox (rF) virus-based vaccine engineered to present the PSA and three costimulatory molecules (collectively labeled as PSA-TRICOM). This vaccine has shown that it can break tolerance of the PSA, and its administration directly into a tumor enables the affected tumor cells to act as antigen-presenting cells activating new T-cells, and broadening the immune response to recognize and kill tumor...
April 27, 2018: Human Pathology
https://www.readbyqxmd.com/read/29610301/china-the-united-states-and-competition-for-resources-that-enable-emerging-technologies
#4
Andrew L Gulley, Nedal T Nassar, Sean Xun
Historically, resource conflicts have often centered on fuel minerals (particularly oil). Future resource conflicts may, however, focus more on competition for nonfuel minerals that enable emerging technologies. Whether it is rhenium in jet engines, indium in flat panel displays, or gallium in smart phones, obscure elements empower smarter, smaller, and faster technologies, and nations seek stable supplies of these and other nonfuel minerals for their industries. No nation has all of the resources it needs domestically...
April 2, 2018: Proceedings of the National Academy of Sciences of the United States of America
https://www.readbyqxmd.com/read/29602821/a-prospective-comparison-of-18-f-sodium-fluoride-pet-ct-and-psma-targeted-18-f-dcfbc-pet-ct-in-metastatic-prostate-cancer
#5
Stephanie A Harmon, Ethan Bergvall, Esther Mena, Joanna H Shih, Stephen Adler, Yolanda McKinney, Sherif Mehralivand, Deborah E Citrin, Anna Couvillon, Ravi Madan, James Gulley, Ronnie C Mease, Paula M Jacobs, Martin G Pomper, Baris Turkbey, Peter L Choyke, M Liza Lindenberg
Purpose: The purpose of this study was to compare the diagnostic performance of 18 F-DCFBC positron emission tomography/computed tomography (PET/CT), a first generation 18 F-labelled prostate-specific membrane antigen (PSMA)-targeted agent, and 18 F-NaF PET/CT, a sensitive marker of osteoblastic activity, in a prospective cohort of patients with metastatic prostate cancer. Methods: Twenty-eight prostate cancer patients with metastatic disease on conventional imaging prospectively received up to four PET/CT scans...
March 30, 2018: Journal of Nuclear Medicine: Official Publication, Society of Nuclear Medicine
https://www.readbyqxmd.com/read/29582792/perspectives-on-the-clinical-development-of-immunotherapy-in-prostate-cancer
#6
Lisa M Cordes, James L Gulley, Ravi A Madan
Despite impressive survival benefits with immunotherapy in patients with various solid tumors, the full potential of these agents in prostate cancer has yet to be realized. Sipuleucel-T demonstrated a survival benefit in this population, indicating that prostate cancer is an immunoresponsive disease; however, these results have not been matched by other agents. A large trial with ipilimumab in prostate cancer failed to meet its primary objective, and small trials with PD-1/PD-L1 inhibitors did not yield a significant improvement in overall response...
March 27, 2018: Asian Journal of Andrology
https://www.readbyqxmd.com/read/29481101/age-and-sex-differences-in-behavioral-flexibility-sensitivity-to-reward-value-and-risky-decision-making
#7
Sara R Westbrook, Emily R Hankosky, Megan R Dwyer, Joshua M Gulley
Compared with adults, adolescent behavior is often characterized by reduced behavioral flexibility, increased sensitivity to reward, and increased likelihood to take risks. These traits, which have been hypothesized to confer heightened vulnerability to psychopathologies such as substance use disorders (SUDs), have been the focus of studies in laboratory animal models that seek to understand their neural underpinnings. However, rodent studies to date have typically used only males and have adopted standard methodological practices (e...
April 2018: Behavioral Neuroscience
https://www.readbyqxmd.com/read/29469949/safety-profile-of-avelumab-in-patients-with-advanced-solid-tumors-a-pooled-analysis-of-data-from-the-phase-1-javelin-solid-tumor-and-phase-2-javelin-merkel-200-clinical-trials
#8
Karen Kelly, Jeffrey R Infante, Matthew H Taylor, Manish R Patel, Deborah J Wong, Nicholas Iannotti, Janice M Mehnert, Anja H Loos, Helga Koch, Isabell Speit, James L Gulley
BACKGROUND: Antibodies targeting the programmed death-ligand 1 (PD-L1)/programmed cell death protein 1 (PD-1) checkpoint may cause adverse events (AEs) that are linked to the mechanism of action of this therapeutic class and unique from those observed with conventional chemotherapy. METHODS: Patients with advanced solid tumors who were enrolled in the phase 1 JAVELIN Solid Tumor (1650 patients) and phase 2 JAVELIN Merkel 200 (88 patients) trials received avelumab, a human anti-PD-L1 IgG1 antibody at a dose of 10 mg/kg every 2 weeks...
May 1, 2018: Cancer
https://www.readbyqxmd.com/read/29396271/at-the-intersection-of-chronic-disease-disability-and-health-services-research-a-scoping-literature-review
#9
REVIEW
Stephen P Gulley, Elizabeth K Rasch, Christina D Bethell, Adam C Carle, Benjamin G Druss, Amy J Houtrow, Amanda Reichard, Leighton Chan
BACKGROUND: There is a concerted effort underway to evaluate and reform our nation's approach to the health of people with ongoing or elevated needs for care, particularly persons with chronic conditions and/or disabilities. OBJECTIVE: This literature review characterizes the current state of knowledge on the measurement of chronic disease and disability in population-based health services research on working age adults (age 18-64). METHODS: Scoping review methods were used to scan the health services research literature published since the year 2000, including medline, psycINFO and manual searches...
April 2018: Disability and Health Journal
https://www.readbyqxmd.com/read/29298798/phase-i-trial-of-m7824-msb0011359c-a-bifunctional-fusion-protein-targeting-pd-l1-and-tgf%C3%AE-in-advanced-solid-tumors
#10
Julius Strauss, Christopher R Heery, Jeffrey Schlom, Ravi A Madan, Liang Cao, Zhigang Kang, Elizabeth Lamping, Jennifer L Marté, Renee N Donahue, Italia Grenga, Lisa Cordes, Olaf Christensen, Lisa Mahnke, Christoph Helwig, James L Gulley
Purpose: M7824 (MSB0011359C) is an innovative first-in-class bifunctional fusion protein composed of a mAb against programmed death ligand 1 (PD-L1) fused to a TGFβ "trap." Experimental Design: In the 3+3 dose-escalation component of this phase I study (NCT02517398), eligible patients with advanced solid tumors received M7824 at 1, 3, 10, or 20 mg/kg once every 2 weeks until confirmed progression, unacceptable toxicity, or trial withdrawal; in addition, a cohort received an initial 0.3 mg/kg dose to evaluate pharmacokinetics/pharmacodynamics, followed by 10 mg/kg dosing...
March 15, 2018: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/29221108/checkpoint-and-parp-inhibitors-for-whom-and-when
#11
EDITORIAL
Jung-Min Lee, James L Gulley
No abstract text is available yet for this article.
November 10, 2017: Oncotarget
https://www.readbyqxmd.com/read/29220526/anti-pd-l1-treatment-induced-central-diabetes-insipidus
#12
Chen Zhao, Sri Harsha Tella, Jaydira Del Rivero, Anuhya Kommalapati, Ifechukwude Ebenuwa, James Gulley, Julius Strauss, Isaac Brownell
Context: Immune checkpoint inhibitors, including anti-programmed cell death protein 1 (PD-1), anti-programmed cell death protein ligand 1 (PD-L1), and anti-cytotoxic T-lymphocyte antigen 4 (anti-CTLA4) monoclonal antibodies, have been widely used in cancer treatment. They are known to cause immune-related adverse events (irAEs), which resemble autoimmune diseases. Anterior pituitary hypophysitis with secondary hypopituitarism is a frequently reported irAE, especially in patients receiving anti-CTLA4 treatment...
February 1, 2018: Journal of Clinical Endocrinology and Metabolism
https://www.readbyqxmd.com/read/29217288/avelumab-in-metastatic-urothelial-carcinoma-after-platinum-failure-javelin-solid-tumor-pooled-results-from-two-expansion-cohorts-of-an-open-label-phase-1-trial
#13
Manish R Patel, John Ellerton, Jeffrey R Infante, Manish Agrawal, Michael Gordon, Raid Aljumaily, Carolyn D Britten, Luc Dirix, Keun-Wook Lee, Mathew Taylor, Patrick Schöffski, Ding Wang, Alain Ravaud, Arnold B Gelb, Junyuan Xiong, Galit Rosen, James L Gulley, Andrea B Apolo
BACKGROUND: The approval of anti-programmed death ligand 1 (PD-L1) and anti-programmed death 1 agents has expanded treatment options for patients with locally advanced or metastatic urothelial carcinoma. Avelumab, a human monoclonal anti-PD-L1 antibody, has shown promising antitumour activity and safety in this disease. We aimed to assess the safety profile in patients (both post-platinum therapy and cisplatin-naive) treated with avelumab and to assess antitumour activity of this drug in post-platinum patients...
January 2018: Lancet Oncology
https://www.readbyqxmd.com/read/29210144/adolescent-impulsivity-as-a-sex-dependent-and-subtype-dependent-predictor-of-impulsivity-alcohol-drinking-and-dopamine-d-2-receptor-expression-in-adult-rats
#14
Lindsey R Hammerslag, Amogh P Belagodu, Olubankole A Aladesuyi Arogundade, Angela G Karountzos, Qingrou Guo, Roberto Galvez, Brent W Roberts, Joshua M Gulley
Impulsivity is a personality trait associated with a heightened risk for drug use and other psychiatric conditions. Because impulsivity-related disorders typically emerge during adolescence, there has been interest in exploring methods for identifying adolescents that will be at risk to develop substance use disorders in adulthood. Here, we used a rodent model to assess inhibitory control (impulsive action) and impulsive decision making (impulsive choice) during adolescence (43-50 days old) or adulthood (93-100 days old) and then examined the impact of development on these impulsivity traits by re-testing rats 50 days later...
December 5, 2017: Addiction Biology
https://www.readbyqxmd.com/read/29197983/reduced-sensitivity-to-reinforcement-in-adolescent-compared-to-adult-sprague-dawley-rats-of-both-sexes
#15
Emily R Hankosky, Sara R Westbrook, Rachel M Haake, Michela Marinelli, Joshua M Gulley
RATIONALE: Adolescence is a period of considerable development of brain and behavior and is the time during which most drug use is initiated. OBJECTIVE: Age-dependent differences in motivated behaviors may be one of the factors that contribute to heightened vulnerability to developing substance use disorders, so we sought to compare age differences in methamphetamine (METH) and saccharin seeking. METHODS: Beginning during adolescence or adulthood, male and female Sprague-Dawley rats were trained to self-administer 0...
March 2018: Psychopharmacology
https://www.readbyqxmd.com/read/29146441/combining-immunotherapies-for-the-treatment-of-prostate-cancer
#16
REVIEW
Jason M Redman, James L Gulley, Ravi A Madan
Sipuleucel-T, a therapeutic dendritic-cell vaccine, was Food and Drug Administration-approved for prostate cancer in 2010. No new immunotherapies for prostate cancer have been approved since. However, novel agents and combination approaches offer great promise for improving outcomes for prostate cancer patients. Here we review the latest developments in immunotherapy for prostate cancer. Sipuleucel-T has demonstrated a survival advantage of 4.1 months in metastatic castration-resistant prostate cancer. PSA-TRICOM (PROSTVAC), a prostate-specific antigen-targeted vaccine platform, showed evidence of clinical and immunologic efficacy in early-phase clinical trials, and results from a phase III trial in advanced disease are pending...
December 2017: Urologic Oncology
https://www.readbyqxmd.com/read/29123964/a-novel-bifunctional-anti-pd-l1-tgf-%C3%AE-trap-fusion-protein-m7824-efficiently-reverts-mesenchymalization-of-human-lung-cancer-cells
#17
Justin M David, Charli Dominguez, Kristen K McCampbell, James L Gulley, Jeffrey Schlom, Claudia Palena
Mesenchymalization is a cellular and molecular program in which epithelial cells progressively lose their well-differentiated phenotype and adopt mesenchymal characteristics. Tumor mesenchymalization occurs during the progression of cancer to metastatic disease, and is also associated with resistance to multiple therapeutics, including killing by cytotoxic immune cells. Furthermore, tumor cells can evade immune destruction by upregulating the checkpoint molecule PD-L1, and emerging research has found higher PD-L1 expression in mesenchymalized tumors...
2017: Oncoimmunology
https://www.readbyqxmd.com/read/29118215/adolescence-and-reward-making-sense-of-neural-and-behavioral-changes-amid-the-chaos
#18
REVIEW
Deena M Walker, Margaret R Bell, Cecilia Flores, Joshua M Gulley, Jari Willing, Matthew J Paul
Adolescence is a time of significant neural and behavioral change with remarkable development in social, emotional, and cognitive skills. It is also a time of increased exploration and risk-taking (e.g., drug use). Many of these changes are thought to be the result of increased reward-value coupled with an underdeveloped inhibitory control, and thus a hypersensitivity to reward. Perturbations during adolescence can alter the developmental trajectory of the brain, resulting in long-term alterations in reward-associated behaviors...
November 8, 2017: Journal of Neuroscience: the Official Journal of the Society for Neuroscience
https://www.readbyqxmd.com/read/28855356/phase-i-study-of-a-poxviral-tricom-based-vaccine-directed-against-the-transcription-factor-brachyury
#19
Christopher R Heery, Claudia Palena, Sheri McMahon, Renee N Donahue, Lauren M Lepone, Italia Grenga, Ulrike Dirmeier, Lisa Cordes, Jenn Marté, William Dahut, Harpreet Singh, Ravi A Madan, Romaine I Fernando, Duane H Hamilton, Jeffrey Schlom, James L Gulley
Purpose: The transcription factor brachyury has been shown in preclinical studies to be a driver of the epithelial-to-mesenchymal transition (EMT) and resistance to therapy of human tumor cells. This study describes the characterization of a Modified Vaccinia Ankara (MVA) vector-based vaccine expressing the transgenes for brachyury and three human costimulatory molecules (B7.1, ICAM-1, and LFA-3, designated TRICOM) and a phase I study with this vaccine. Experimental Design: Human dendritic cells (DC) were infected with MVA-brachyury-TRICOM to define their ability to activate brachyury-specific T cells...
November 15, 2017: Clinical Cancer Research: An Official Journal of the American Association for Cancer Research
https://www.readbyqxmd.com/read/28837181/avelumab-for-the-treatment-of-metastatic-merkel-cell-carcinoma
#20
REVIEW
L M Cordes, J L Gulley
Avelumab is a promising new therapeutic agent for patients with metastatic Merkel cell carcinoma, a rare and aggressive type of neuroendocrine tumor of the skin. Until the recent approval of avelumab (Bavencio), no therapies were approved by the U.S. Food and Drug Administration for the treatment of metastatic Merkel cell carcinoma. In a recent trial, avelumab, an anti-programmed death ligand-1 antibody, demonstrated an objective response in 28 of 88 patients (31.8% [95.9% CI, 21.9-43.1]) with advanced, chemotherapy-refractory Merkel cell carcinoma...
July 2017: Drugs of Today
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