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https://www.readbyqxmd.com/read/29790143/-managing-the-adverse-effects-related-to-immune-checkpoint-inhibitors
#1
Hsiao-Hsuan Kuo, Wei-Wu Chen
Immune checkpoint inhibitors (ICIs) have become the new posterchild of cancer treatment in recent years largely due to their impressive clinical efficacy. Drugs targeting cytotoxic T- lymphocyte-associated antigen 4 (CTLA-4) and programmed cell death-1 (PD-1) antibodies, e.g., ipilimumab (Yervoy®), pembrolizumab (Keytruda®), and nivolumab (Opdivo®), reinvigorate cytotoxic T cells to kill cancer cells in patients. Despite the impressive clinical benefits, ICIs may induce immune-related adverse events (irAE) of the skin, gastrointestinal tract, liver, endocrine, and lung with a wide spectrum of severity...
June 2018: Hu Li za Zhi the Journal of Nursing
https://www.readbyqxmd.com/read/29764494/precision-medicine-becomes-reality-tumor-type-agnostic-therapy
#2
REVIEW
Li Yan, Wei Zhang
Precision medicine just witnessed two breakthroughs in oncology in 2017. Pembrolizumab (Keytruda), Merck's anti-programmed cell death-1 (PD-1) monoclonal antibody (mAb), received accelerated approval in May 2017 by the US Food and Drug Administration for the treatment of adult and pediatric patients with unresectable or metastatic solid tumors that have been identified as having microsatellite instability-high (MSI-H) or deficient DNA mismatch repair (dMMR). Shortly after, nivolumab (Opdivo), Bristol-Myers Squibb's anti-PD-1 mAb, gained an accelerated approval in August 2017 for adult and pediatric patients with MSI-H or dMMR metastatic colorectal cancer that has progressed after standard chemotherapy...
March 31, 2018: Cancer communications
https://www.readbyqxmd.com/read/29763344/from-the-valley-of-death-to-the-crossroads-of-opportunity-a-discussion-of-evolving-benefit-risk-evaluation-standards
#3
Peter J Pitts, Patrick Brady
A series of recent US Food and Drug Administration (FDA) approvals (such as Sarepta's Exondys 51, Merck's Keytruda, and Portola's Bevyxxa) has generated significant interest within the drug development ecosystem. Facilitated regulatory pathways aimed toward expediting medicines to patients suffering from serious and life-threatening conditions are a good thing, even if it raises curiosity and introduces some degree of uncertainty. Over the last 20 years, two key words in drug development have been speed and innovation...
January 1, 2018: Therapeutic Innovation & Regulatory Science
https://www.readbyqxmd.com/read/29758342/next-generation-sequencing-in-drug-development-target-identification-and-genetically-stratified-clinical-trials
#4
REVIEW
Abolfazl Doostparast Torshizi, Kai Wang
Next-generation sequencing (NGS) enabled high-throughput analysis of genotype-phenotype relationships on human populations, ushering in a new era of genetics-informed drug development. The year 2017 was remarkable, with the first FDA-approved gene therapy for cancer (Kymriah™) and for inherited diseases (LUXTURNA™), the first multiplex NGS panel for companion diagnostics (MSK-IMPACT™) and the first drug targeting a genetic signature rather than a disease (Keytruda® ). We envision that population-scale NGS with paired electronic health records (EHRs) will become a routine measure in the drug development process for the identification of novel drug targets, and that genetically stratified clinical trials could be widely adopted to improve power in precision-medicine-guided drug development...
May 24, 2018: Drug Discovery Today
https://www.readbyqxmd.com/read/29626663/a-case-of-graves-ophthalmopathy-associated-with-pembrolizumab-keytruda-therapy
#5
Ella S Y Park, Guilherme Rabinowits, Ole-Petter R Hamnvik, Linda R Dagi
We present the first reported case of Graves' orbitopathy induced by pembrolizumab, a new FDA-approved drug used for the treatment of multiple refractory solid tumors and classic Hodgkin lymphoma. Pembrolizumab elicits T-lymphocyte proliferation; we suspect that thyroid eye disease may result in some cases.
April 4, 2018: Journal of AAPOS: the Official Publication of the American Association for Pediatric Ophthalmology and Strabismus
https://www.readbyqxmd.com/read/29571563/-pd-l1-testing-in-non-small-cell-lung-carcinoma-guidelines-from-the-pattern-group-of-thoracic-pathologists
#6
Sylvie Lantuejoul, Julien Adam, Nicolas Girard, Mickael Duruisseaux, Audrey Mansuet-Lupo, Aurélie Cazes, Isabelle Rouquette, Laure Gibault, Stéphane Garcia, Martine Antoine, Jean Michael Vignaud, Françoise Galateau-Sallé, Christine Sagan, Cécile Badoual, Frédérique Penault-Llorca, Diane Damotte
Lung cancer is the leading cause of cancer death in France with low response rates to conventional chemotherapy. Nevertheless, new therapies have emerged recently, among which PD1 immune checkpoint inhibitors (ICI), such as nivolumab (OPDIVO® , Bristol-Myers Squibb) and pembrolizumab (KEYTRUDA® , Merck & Co), or PD-L1 ICI, such as atezolizumab (TECENTRIQ® , Genentech), durvalumab (IMFINZI® , Astra-Zeneca), and avelumab (BAVENCIO® , EMD Serono). The prescription of pembrolizumab for advanced stage non-small cell lung carcinoma (NSCLC) patients requires the demonstration of PD-L1 expression by tumor cells by immunohistochemistry (IHC) (minimum of 50% of positive tumor cells is required for first-line setting, and of 1% for second-line and beyond) and PD-L1 assay is now considered as a companion diagnostic tool for this drug...
April 2018: Annales de Pathologie
https://www.readbyqxmd.com/read/29523645/implementing-keytruda-pembrolizumab-testing-in-clinical-practice
#7
Dmitry Ratner, Jochen K Lennerz
No abstract text is available yet for this article.
March 9, 2018: Oncologist
https://www.readbyqxmd.com/read/29390572/acute-liver-failure-caused-by-pembrolizumab-in-a-patient-with-pulmonary-metastatic-liver-cancer-a-case-report
#8
Zhenping Wu, Lingling Lai, Ming Li, Lunli Zhang, Wenfeng Zhang
RATIONALE: Keytruda (pembrolizumab) is an inhibitor of programmed cell death receptor-1 (PD-1), which was approved to treat advanced melanoma and nonsmall cell lung cancer patients who do not respond to other treatment. However, its efficacy and security in the treatment of advanced liver cancer is still under investigation. PATIENT CONCERNS: A 60-year-old man was diagnosed with pulmonary metastatic liver cancer who accepted pembrolizumab treatment after the failure of sorafenib...
December 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/29275461/tumor-immuno-environment-in-cancer-progression-and-therapy
#9
Pawel Kalinski, James E Talmadge
The approvals of Provenge (Sipuleucel-T), Ipilimumab (Yervoy/anti-CTLA-4) and blockers of the PD-1 - PD-L1/PD-L2 pathway, such as nivolumab (Opdivo), pembrolizumab (Keytruda), or atezolizumab (Tecentriq), have established immunotherapy as a key component of comprehensive cancer care. Further, murine mechanistic studies and studies in immunocompromised patients have documented the critical role of immunity in effectiveness of radio- and chemotherapy. However, in addition to the ability of the immune system to control cancer progression, it can also promote tumor growth, via regulatory T cells (Tregs), myeloid-derived dendritic cells (MDSCs) and tumor associated macrophages (TAM), which can enhance survival of cancer cells directly or via the regulation of the tumor stroma...
2017: Advances in Experimental Medicine and Biology
https://www.readbyqxmd.com/read/29209918/molecular-classification-and-precision-therapy-of-cancer-immune-checkpoint-inhibitors
#10
Yingyan Yu
On May 23, 2017, the US Food and Drug Administration (FDA) approved a treatment for cancer patients with positive microsatellite instability-high (MSI-H) markers or mismatch repair deficient (dMMR) markers. This approach is the first approved tumor treatment using a common biomarker rather than specified tumor locations in the body. FDA previously approved Keytruda for treatment of several types of malignancies, such as metastatic melanoma, metastatic non-small-cell lung cancer, recurrent or metastatic head and neck cancer, refractory Hodgkin lymphoma, and urothelial carcinoma, all of which carry positive programmed death-1/programmed death-ligand 1 biomarkers...
April 2018: Frontiers of Medicine
https://www.readbyqxmd.com/read/29120224/is-there-a-role-for-programmed-death-ligand-1-testing-and-immunotherapy-in-colorectal-cancer-with-microsatellite-instability-part-ii-the-challenge-of-programmed-death-ligand-1-testing-and-its-role-in-microsatellite-instability-high-colorectal-cancer
#11
REVIEW
Esmeralda Celia Marginean, Barbara Melosky
CONTEXT: - The world of oncology has changed dramatically in the past few years with the introduction of checkpoint inhibitors and immunotherapy. The promising findings of a small, phase 2 clinical trial that led to the US Food and Drug Administration breakthrough designation and approval of the anti-programmed death receptor-1 (PD-1) drug pembrolizumab (Keytruda, Merck, Kenilworth, New Jersey) to treat metastatic/refractory microsatellite instability-high colorectal cancer (CRC) has significantly boosted interest in immunomodulatory therapies in microsatellite instability-high CRC...
January 2018: Archives of Pathology & Laboratory Medicine
https://www.readbyqxmd.com/read/28958385/engineering-tumor-hypersusceptibility-to-checkpoint-immunotherapy
#12
Ariel Fernández
The immune checkpoint blocker pembrolizumab (Keytruda) has proven successful in treating solid tumors harboring a DNA mismatch repair (MMR) deficiency. We show that it is possible to generate a drug-promoted phenotype mimicking the MMR deficiency in solid tumors, and thereby to engineer a generic hypersusceptibility to Keytruda through drug-induced metabolic stress on DNA synthesis. The potential of such drug-Keytruda combinations as universal treatments for solid tumors deserves clinical evaluation.
October 2017: Trends in Cancer
https://www.readbyqxmd.com/read/28923211/nivolumab-and-pembrolizumab-monoclonal-antibodies-against-programmed-cell-death-1-pd-1-that-are-interchangeable
#13
REVIEW
Vinay Prasad, Victoria Kaestner
Nivolumab (Opdivo, Bristol Meyer Squibb, New York, NY) and pembrolizumab (Keytruda, Merck, Kenilworth, NJ) are the first two US Food and Drug Administration (FDA)-approved monoclonal antibodies targeting programmed death-1 (PD-1). Nivolumab and pembrolizumab work by interfering with the interaction between PD-1 and programmed death ligand-1 (PD-L1), whose unimpeded interaction downregulates T cells allowing cancer cells to evade immune surveillance. These drugs have earned a series of FDA approvals for melanoma, non-small cell lung cancer (NSCLC), head and neck squamous cell cancer (HNSCC), urothelial cancer, classical Hodgkin lymphoma, and renal cell cancer...
April 2017: Seminars in Oncology
https://www.readbyqxmd.com/read/28846956/hypermutated-tumours-in-the-era-of-immunotherapy-the-paradigm-of-personalised-medicine
#14
REVIEW
Laetitia Nebot-Bral, David Brandao, Loic Verlingue, Etienne Rouleau, Olivier Caron, Emmanuelle Despras, Yolla El-Dakdouki, Stéphane Champiat, Said Aoufouchi, Alexandra Leary, Aurélien Marabelle, David Malka, Nathalie Chaput, Patricia L Kannouche
Immune checkpoint inhibitors have demonstrated unprecedented clinical activity in a wide range of cancers. Significant therapeutic responses have recently been observed in patients presenting mismatch repair-deficient (MMRD) tumours. MMRD cancers exhibit a remarkably high rate of mutations, which can result in the formation of neoantigens, hypothesised to enhance the antitumour immune response. In addition to MMRD tumours, cancers mutated in the exonuclease domain of the catalytic subunit of the DNA polymerase epsilon (POLE) also exhibit an ultramutated genome and are thus likely to benefit from immunotherapy...
October 2017: European Journal of Cancer
https://www.readbyqxmd.com/read/28837184/checkpoint-inhibitors-a-cutting-edge-in-oncology
#15
REVIEW
C Jago
The checkpoint inhibitor field, and indeed the whole of immuno-oncology, is fast-paced and fascinating, with huge clinical and commercial potential. The challenge in the coming years will be to define the best type and combination of immunotherapy, and the best target population to receive it. Keytruda's ground-breaking approval for a biomarker-based rather than location-based indication is a solid step in this direction, and is likely to be followed by other such approvals. As the field develops, it is to be hoped that immuno-oncology therapeutics will continue to deliver the significant improvements in patient outcome that have been seen so far...
July 2017: Drugs of Today
https://www.readbyqxmd.com/read/28835513/fda-approval-summary-pembrolizumab-for-treatment-of-metastatic-non-small-cell-lung-cancer-first-line-therapy-and-beyond
#16
Lee Pai-Scherf, Gideon M Blumenthal, Hongshan Li, Sriram Subramaniam, Pallavi S Mishra-Kalyani, Kun He, Hong Zhao, Jingyu Yu, Mark Paciga, Kirsten B Goldberg, Amy E McKee, Patricia Keegan, Richard Pazdur
On October 24, 2016, the U.S. Food and Drug Administration (FDA) approved pembrolizumab (Keytruda; Merck & Co., Inc., https://www.merck.com) for treatment of patients with metastatic non-small cell lung cancer (mNSCLC) whose tumors express programmed death-ligand 1 (PD-L1) as determined by an FDA-approved test, as follows: (a) first-line treatment of patients with mNSCLC whose tumors have high PD-L1 expression (tumor proportion score [TPS] ≥50%), with no epidermal growth factor receptor ( EGFR ) or anaplastic lymphoma kinase ( ALK ) genomic tumor aberrations, and (b) treatment of patients with mNSCLC whose tumors express PD-L1 (TPS ≥1%), with disease progression on or after platinum-containing chemotherapy...
November 2017: Oncologist
https://www.readbyqxmd.com/read/28661847/keytruda-crosses-first-line-finish-line-first
#17
Thomas Reinke
Approval of Merck's checkpoint inhibitor is further evidence that cancer treatment decisions are increasingly dependent on the PD-L1 biomarker and other molecular-level differences in tumor cells. But testing for PD-L1 is tricky, and variations in the concentration of PD-L1 cells in different regions of the sample can produce different test results.
May 2017: Managed Care
https://www.readbyqxmd.com/read/28533473/fda-approval-summary-pembrolizumab-for-the-treatment-of-recurrent-or-metastatic-head-and-neck-squamous-cell-carcinoma-with-disease-progression-on-or-after-platinum-containing-chemotherapy
#18
MULTICENTER STUDY
Erin Larkins, Gideon M Blumenthal, Weishi Yuan, Kun He, Rajeshwari Sridhara, Sriram Subramaniam, Hong Zhao, Chao Liu, Jingyu Yu, Kirsten B Goldberg, Amy E McKee, Patricia Keegan, Richard Pazdur
On August 5, 2016, the U.S. Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA injection, Merck Sharp & Dohme Corp., Kenilworth, NJ) for treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy. Approval was based on the objective response rate (ORR) and duration of response (DoR) in a cohort of patients in a nonrandomized multi-cohort trial (KEYNOTE-012) that included 174 patients with recurrent or metastatic HNSCC who had disease progression on or after platinum-containing chemotherapy...
July 2017: Oncologist
https://www.readbyqxmd.com/read/28528510/immunogenomics-using-genomics-to-personalize-cancer-immunotherapy
#19
REVIEW
Rance C Siniard, Shuko Harada
While the use of genomic data has the potential to revolutionize patient care, there is still much work to be done with regard to the transformation of host-tumor interactions into favorable clinical outcomes for our patients. High-throughput technologies, such as next-generation sequencing (NGS), have rapidly advanced our understanding of oncology, and we are learning that most tumors do not simply possess consistently mutated genes that are responsible for tumorigenesis, facilitating the need for personalized cancer therapy...
August 2017: Virchows Archiv: An International Journal of Pathology
https://www.readbyqxmd.com/read/28247187/development-of-novel-immunopet-tracers-to-image-human-pd-1-checkpoint-expression-on-tumor-infiltrating-lymphocytes-in-a-humanized-mouse-model
#20
Arutselvan Natarajan, Aaron T Mayer, Robert E Reeves, Claude M Nagamine, Sanjiv Sam Gambhir
PURPOSE: It is well known that cancers exploit immune checkpoints (programmed death 1 receptor (PD-1) and its ligand (PD-L1)) to evade anti-tumor immune responses. Although immune checkpoint (IC) blockade is a promising approach, not all patients respond. Hence, imaging of tumor-infiltrating lymphocytes (TILs) is of high specific interest, as they are known to express PD-1 during activation and subsequent exhaustion in the tumor microenvironment and are thought to be potentially predictive of therapeutic responses to IC blockade...
December 2017: Molecular Imaging and Biology: MIB: the Official Publication of the Academy of Molecular Imaging
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