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Pembrolizumab and head and neck

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https://www.readbyqxmd.com/read/28533473/u-s-food-and-drug-administration-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
#1
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...
May 22, 2017: Oncologist
https://www.readbyqxmd.com/read/28515943/evaluation-of-dosing-strategy-for-pembrolizumab-for-oncology-indications
#2
Tomoko Freshwater, Anna Kondic, Malidi Ahamadi, Claire H Li, Rik de Greef, Dinesh de Alwis, Julie A Stone
BACKGROUND: Traditionally, most monoclonal antibodies (mAbs) have been dosed based on body weight because of perceived contribution of body size in pharmacokinetic variability. The same approach was used in the initial pembrolizumab studies; however, following availability of PK data, the need for weight-based dosing for pembrolizumab was reassessed. METHODS: A previously established population PK (popPK) model as well as exposure-response results from patients with advanced melanoma or non-small cell lung cancer (NSCLC) were used to evaluate the potential application of a fixed dosing regimen with the aim of maintaining pembrolizumab exposures within the range demonstrated to provide near maximal efficacy and acceptable safety...
2017: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/28487385/immune-related-gene-expression-profiling-after-pd-1-blockade-in-non-small-cell-lung-carcinoma-head-and-neck-squamous-cell-carcinoma-and-melanoma
#3
Aleix Prat, Alejandro Navarro, Laia Paré, Noemí Reguart, Patricia Galvan, Tomás Pascual, Alex Martínez, Paolo Nuciforo, Laura Comerma, Llucia Alos, Nuria Pardo, Susana Cedrés, Cheng Fan, Joel S Parker, Lydia Gaba, Ivan Victoria, Nuria Viñolas, Ana Vivancos, Ana Arance, Enriqueta Felip
Antibody targeting of the immune checkpoint receptor PD1 produces therapeutic activity in a variety of solid tumors, but most patients exhibit partial or complete resistance to treatment for reasons that are unclear. In this study, we evaluated tumor speciments from 65 patients with melanoma, lung non-squamous, squamous cell lung or head and neck cancers who were treated with the approved PD1 targeting antibodies pembrolizumab or nivolumab. Tumor RNA before anti-PD1 therapy was analyzed on the nCounter system using the PanCancer 730-Immune Panel, and we identified 23 immune-related genes or signatures linked to response and progression-free survival (PFS)...
May 9, 2017: Cancer Research
https://www.readbyqxmd.com/read/28485332/current-status-of-systemic-therapy-for-recurrent-and-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck
#4
REVIEW
L A Jacob, T Chaudhuri, K C Lakshmaiah, K G Babu, L Dasappa, McS Babu, A H Rudresha, K N Lokesh, L K Rajeev
Head and neck squamous cell carcinoma (HNSCC) is now the seventh most common cancer worldwide. The median overall survival for patients with recurrent and/or metastatic (R/M) HNSCC remains <1 year despite modern systemic chemotherapy and targeted agents. Palliative systemic therapy for patients with R/M HNSCC typically includes a platinum-based doublet, with an understanding that the increase in efficacy compared with single agents is primarily related to improved response rate, and not survival. Till date, the only systemic therapy regimen to demonstrate survival superiority over platinum-5-fluorouracil (5-FU) doublet is platinum, FU, and cetuximab...
October 2016: Indian Journal of Cancer
https://www.readbyqxmd.com/read/28467522/eruptive-keratoacanthomas-associated-with-pembrolizumab-therapy
#5
Azael Freites-Martinez, Bernice Y Kwong, Kerri E Rieger, Daniel G Coit, A Dimitrios Colevas, Mario E Lacouture
Importance: To our knowledge, there have been no previous reports of eruptive keratoacanthomas (KAs) in patients receiving pembrolizumab. Objective: To report the cases of 3 consecutive patients with pembrolizumab-induced eruptive KAs and their management. Design, Setting, and Participants: Case report study of 3 patients from 2 centers with pembrolizumab-treated cancer who all developed eruptive KAs. Interventions: All 3 patients had AK treatment with clobetasol ointment and intralesional triamcinolone; 2 patients also underwent open superficial cryosurgery...
May 3, 2017: JAMA Dermatology
https://www.readbyqxmd.com/read/28464441/current-studies-of-immunotherapy-in-head-and-neck-cancer
#6
Volkan Dogan, Thorsten Rieckmann, Adrian Münscher, Chia-Jung Busch
BACKGROUND: Recently enormous progress in cancer therapy has been achieved by the use of immune checkpoint inhibitors. Activating the body's own immune system has added a novel and powerful therapeutic option for the treatment of melanoma and lung cancer. Furthermore, the potential use of immunotherapy is being extensively explored also in other malignancies. OBJECTIVE OF REVIEW: This review summarizes current clinical studies using immune checkpoint modulators for the treatment of head and neck cancer (HNSCC)...
May 2, 2017: Clinical Otolaryngology
https://www.readbyqxmd.com/read/28419181/hyperprogression-during-anti-pd-1-pd-l1-therapy-in-patients-with-recurrent-and-or-metastatic-head-and-neck-squamous-cell-carcinoma
#7
E Saâda-Bouzid, C Defaucheux, A Karabajakian, V Palomar Coloma, V Servois, X Paoletti, C Even, J Fayette, J Guigay, D Loirat, F Peyrade, M Alt, J Gal, C Le Tourneau
Background: HASH(0x3d2da00) Pembrolizumab and nivolumab are immune checkpoint inhibitors targeting PD-1 that have recently been approved in pretreated recurrent and/or metastatic head and neck squamous cell carcinoma (R/M HNSCC) patients. In the clinic, some patients seem not only not to benefit from anti-PD-L1/PD-1 agents but rather to experience an acceleration of tumor growth kinetics (TGK). Patients and Methods: HASH(0x2f96a98) We retrospectively compared TGK on immunotherapy and TGK on last treatment in patients with R/M HNSCC treated with PD-1/PD-L1 inhibitors in four French centers...
April 13, 2017: Annals of Oncology: Official Journal of the European Society for Medical Oncology
https://www.readbyqxmd.com/read/28382569/targeted-therapy-in-head-and-neck-cancer-an-update-on-current-clinical-developments-in-epidermal-growth-factor-receptor-targeted-therapy-and-immunotherapies
#8
REVIEW
Jonathan Moreira, Alexander Tobias, Michael P O'Brien, Mark Agulnik
Most patients diagnosed with head and neck squamous cell carcinoma (HNSCC) will present with locally advanced disease, requiring multimodality therapy. Despite this curative approach, a significant subset of these patients will develop locoregional failure and/or distant metastases. Despite significant progress in the treatment and subsequent prognosis of locally advanced HNSCC, the prognosis of those patients with recurrent and/or metastatic (R/M) HNSCC is poor, with short-lived responses to palliative chemotherapy and few therapeutic agents available...
May 2017: Drugs
https://www.readbyqxmd.com/read/28366274/pembrolizumab-in-advanced-head-and-neck-cancer
#9
Vicki Brower
No abstract text is available yet for this article.
March 30, 2017: Lancet Oncology
https://www.readbyqxmd.com/read/28328302/pembrolizumab-for-platinum-and-cetuximab-refractory-head-and-neck-cancer-results-from-a-single-arm-phase-ii-study
#10
Joshua Bauml, Tanguy Y Seiwert, David G Pfister, Francis Worden, Stephen V Liu, Jill Gilbert, Nabil F Saba, Jared Weiss, Lori Wirth, Ammar Sukari, Hyunseok Kang, Michael K Gibson, Erminia Massarelli, Steven Powell, Amy Meister, Xinxin Shu, Jonathan D Cheng, Robert Haddad
Purpose There are no approved treatments for recurrent/metastatic head and neck squamous cell carcinoma refractory to platinum and cetuximab. In the single-arm, phase II KEYNOTE-055 study, we evaluated pembrolizumab, an anti-programmed death 1 receptor antibody, in this platinum- and cetuximab-pretreated population with poor prognosis. Methods Eligibility stipulated disease progression within 6 months of platinum and cetuximab treatment. Patients received pembrolizumab 200 mg every 3 weeks. Imaging was performed every 6 to 9 weeks...
May 10, 2017: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/28174141/checkpoint-inhibition-for-advanced-mucosal-melanoma
#11
Julia Thierauf, Johannes A Veit, Jochen Hess, Nicolai Treiber, Catharina Lisson, Stephanie E Weissinger, Martin Bommer, Thomas K Hoffmann
BACKGROUND: Whereas anti-PD-1 therapy has demonstrated a significant and durable response against advanced cutaneous melanoma, conventional chemotherapies have shown only minor benefit against advanced mucosal melanoma. OBJECTIVES: To investigate the efficacy of anti-PD-1 therapy in a small cohort of patients with mucosal melanoma of the head and neck. MATERIAL & METHODS: We analysed five patients with mucosal melanoma of the head and neck who received nivolumab or pembrolizumab, at an advanced stage...
February 3, 2017: European Journal of Dermatology: EJD
https://www.readbyqxmd.com/read/28166090/chemotherapy-for-recurrent-metastatic-head-and-neck-cancers
#12
Andy Karabajakian, Philippe Toussaint, Eve-Marie Neidhardt, Valérie Paulus, Pierre Saintigny, Jérôme Fayette
Chemotherapy is the only option of treatment for most patients presenting with a recurrent and/or metastatic head and neck squamous cell carcinoma. The triple association of cisplatin, 5-fluorouracile, and cetuximab is still the current standard for fit patients. Other schemes are currently being compared with this protocol in ongoing trials and the association of cisplatin, docetaxel, and cetuximab appears to be the most efficient. The human papilloma virus is very likely a favorable prognostic factor. Immunotherapy with nivolumab or pembrolizumab is now a new standard of treatment in second line after yielding an improvement in overall survival, but predictive markers of efficacy are needed to refine the selection of patients...
April 2017: Anti-cancer Drugs
https://www.readbyqxmd.com/read/27895920/pd1-pd-l1-inhibition-as-a-potential-radiosensitizer-in-head-and-neck-squamous-cell-carcinoma-a-case-report
#13
Misako Nagasaka, Mark Zaki, Harold Kim, S Naweed Raza, George Yoo, Ho-Sheng Lin, Ammar Sukari
BACKGROUND: Immunotherapy targeting the checkpoint PD1 (programmed cell death protein 1) or PDL1 (programmed death ligand 1) has led to advances in the treatment of melanoma and non-small cell lung cancer (NSCLC). The use of such therapies has also been introduced into the treatment of other malignancies, including head and neck cancer. The combined effects of checkpoint inhibitors and anti-PD1(L1) antibodies and radiation therapy have not yet been sufficiently investigated. CASE PRESENTATION: We report a case of locally relapsed non-resectable oral cavity squamous cell carcinoma, with excellent local control after pembrolizumab (MK3475) followed by radiotherapy...
2016: Journal for Immunotherapy of Cancer
https://www.readbyqxmd.com/read/27797438/putting-t-cells-to-work-outsourcing-neoantigen-detection-in-head-and-neck-cancers
#14
R Xiao, C Van Waes, N C Schmitt
No abstract text is available yet for this article.
October 31, 2016: Oral Diseases
https://www.readbyqxmd.com/read/27663515/immune-biomarkers-of-treatment-failure-for-a-patient-on-a-phase-i-clinical-trial-of-pembrolizumab-plus-radiotherapy
#15
Gregory S Alexander, Joshua D Palmer, Madalina Tuluc, Jianqing Lin, Adam P Dicker, Voichita Bar-Ad, Larry A Harshyne, Jennifer Louie, Colette M Shaw, D Craig Hooper, Bo Lu
BACKGROUND: Pembrolizumab is a monoclonal antibody that is designed against programmed cell death protein 1 (PD-1). Pembrolizumab and other immunocheckpoint-blocking monoclonal antibodies work by modulating a patient's own immune system to increase anti-tumor activity. While immunocheckpoint blockade has shown promising results, only 20-40 % of patients experience objective clinical benefit. Differences in individual tumor biology and the presence multiple immune checkpoints present a challenge for treatment...
September 23, 2016: Journal of Hematology & Oncology
https://www.readbyqxmd.com/read/27646946/antitumor-activity-of-pembrolizumab-in-biomarker-unselected-patients-with-recurrent-and-or-metastatic-head-and-neck-squamous-cell-carcinoma-results-from-the-phase-ib-keynote-012-expansion-cohort
#16
Laura Q M Chow, Robert Haddad, Shilpa Gupta, Amit Mahipal, Ranee Mehra, Makoto Tahara, Raanan Berger, Joseph Paul Eder, Barbara Burtness, Se-Hoon Lee, Bhumsuk Keam, Hyunseok Kang, Kei Muro, Jared Weiss, Ravit Geva, Chia-Chi Lin, Hyun Cheol Chung, Amy Meister, Marisa Dolled-Filhart, Kumudu Pathiraja, Jonathan D Cheng, Tanguy Y Seiwert
PURPOSE: Treatment with pembrolizumab, an anti-programmed death-1 antibody, at 10 mg/kg administered once every 2 weeks, displayed durable antitumor activity in programmed death-ligand 1 (PD-L1) -positive recurrent and/or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) in the KEYNOTE-012 trial. Results from the expansion cohort, in which patients with HNSCC, irrespective of biomarker status, received a fixed dose of pembrolizumab at a less frequent dosing schedule, are reported...
September 19, 2016: Journal of Clinical Oncology: Official Journal of the American Society of Clinical Oncology
https://www.readbyqxmd.com/read/27429658/immunotherapy-for-head-and-neck-squamous-cell-carcinoma
#17
REVIEW
Thorsten Fuereder
Over the past years immuno-oncology has evolved and become a novel promising strategy for cancer therapy. Immune checkpoint inhibitors such as pembrolizumab or nivolumab, which target the interaction between programmed death receptor 1/programmed death ligand 1 (PD-1/PDL-1) and PDL-2, have been recently approved for the treatment of various malignancies and are currently being investigated in clinical phase III trials for head and neck squamous cell carcinoma (HNSCC). Data available from these trials indicate substantial activity accompanied by a favorable safety and toxicity profile in this patient population...
2016: Memo
https://www.readbyqxmd.com/read/27408990/pembrolizumab-the-value-of-pdl1-biomarker-in-head-and-neck-cancer
#18
Raffaele Addeo, Michele Caraglia, Giada Iuliano
No abstract text is available yet for this article.
September 2016: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/27287289/pembrolizumab-has-antitumor-activity-in-advanced-head-and-neck-cancer
#19
(no author information available yet)
Pembrolizumab is well tolerated and active in advanced squamous cell carcinoma of the head and neck.
July 2016: Cancer Discovery
https://www.readbyqxmd.com/read/27247226/safety-and-clinical-activity-of-pembrolizumab-for-treatment-of-recurrent-or-metastatic-squamous-cell-carcinoma-of-the-head-and-neck-keynote-012-an-open-label-multicentre-phase-1b-trial
#20
Tanguy Y Seiwert, Barbara Burtness, Ranee Mehra, Jared Weiss, Raanan Berger, Joseph Paul Eder, Karl Heath, Terrill McClanahan, Jared Lunceford, Christine Gause, Jonathan D Cheng, Laura Q Chow
BACKGROUND: Patients with recurrent or metastatic squamous cell carcinoma of the head and neck have few treatment options. We aimed to assess the safety, tolerability, and antitumour activity of pembrolizumab, a humanised anti-programmed death receptor 1 (PD-1) antibody, in patients with PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck. METHODS: This study was an open-label, multicentre, phase 1b trial of patients with recurrent or metastatic squamous cell carcinoma of the head and neck...
July 2016: Lancet Oncology
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