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      The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)

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          Head and neck cancers, including those of the lip and oral cavity, nasal cavity, paranasal sinuses, oropharynx, larynx and nasopharynx represent nearly 700,000 new cases and 380,000 deaths worldwide per annum, and account for over 10,000 annual deaths in the United States alone. Improvement in outcomes are needed for patients with recurrent and or metastatic squamous cell carcinoma of the head and neck (HNSCC). In 2016, the US Food and Drug Administration (FDA) granted the first immunotherapeutic approvals – the anti-PD-1 immune checkpoint inhibitors nivolumab and pembrolizumab – for the treatment of patients with recurrent squamous cell carcinoma of the head and neck (HNSCC) that is refractory to platinum-based regimens. The European Commission followed in 2017 with approval of nivolumab for treatment of the same patient population, and shortly thereafter with approval of pembrolizumab monotherapy for the treatment of recurrent or metastatic HNSCC in adults whose tumors express PD-L1 with a ≥ 50% tumor proportion score and have progressed on or after platinum-containing chemotherapy. Then in 2019, the FDA granted approval for PD-1 inhibition as first-line treatment for patients with metastatic or unresectable, recurrent HNSCC, approving pembrolizumab in combination with platinum and fluorouracil for all patients with HNSCC and pembrolizumab as a single agent for patients with HNSCC whose tumors express a PD-L1 combined positive score ≥ 1. These approvals marked the first new therapies for these patients since 2006, as well as the first immunotherapeutic approvals in this disease. In light of the introduction of these novel therapies for the treatment of patients with head and neck cancer, The Society for Immunotherapy of Cancer (SITC) formed an expert committee tasked with generating consensus recommendations for emerging immunotherapies, including appropriate patient selection, therapy sequence, response monitoring, adverse event management, and biomarker testing. These consensus guidelines serve as a foundation to assist clinicians’ understanding of the role of immunotherapies in this disease setting, and to standardize utilization across the field for patient benefit. Due to country-specific variances in approvals, availability and regulations regarding the discussed agents, this panel focused solely on FDA-approved drugs for the treatment of patients in the U.S.

          Electronic supplementary material

          The online version of this article (10.1186/s40425-019-0662-5) contains supplementary material, which is available to authorized users.

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          Most cited references 102

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          Cancer immunotherapy: the beginning of the end of cancer?

          These are exciting times for cancer immunotherapy. After many years of disappointing results, the tide has finally changed and immunotherapy has become a clinically validated treatment for many cancers. Immunotherapeutic strategies include cancer vaccines, oncolytic viruses, adoptive transfer of ex vivo activated T and natural killer cells, and administration of antibodies or recombinant proteins that either costimulate cells or block the so-called immune checkpoint pathways. The recent success of several immunotherapeutic regimes, such as monoclonal antibody blocking of cytotoxic T lymphocyte-associated protein 4 (CTLA-4) and programmed cell death protein 1 (PD1), has boosted the development of this treatment modality, with the consequence that new therapeutic targets and schemes which combine various immunological agents are now being described at a breathtaking pace. In this review, we outline some of the main strategies in cancer immunotherapy (cancer vaccines, adoptive cellular immunotherapy, immune checkpoint blockade, and oncolytic viruses) and discuss the progress in the synergistic design of immune-targeting combination therapies.
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            Anti-NKG2A mAb Is a Checkpoint Inhibitor that Promotes Anti-tumor Immunity by Unleashing Both T and NK Cells

            Summary Checkpoint inhibitors have revolutionized cancer treatment. However, only a minority of patients respond to these immunotherapies. Here, we report that blocking the inhibitory NKG2A receptor enhances tumor immunity by promoting both natural killer (NK) and CD8+ T cell effector functions in mice and humans. Monalizumab, a humanized anti-NKG2A antibody, enhanced NK cell activity against various tumor cells and rescued CD8+ T cell function in combination with PD-x axis blockade. Monalizumab also stimulated NK cell activity against antibody-coated target cells. Interim results of a phase II trial of monalizumab plus cetuximab in previously treated squamous cell carcinoma of the head and neck showed a 31% objective response rate. Most common adverse events were fatigue (17%), pyrexia (13%), and headache (10%). NKG2A targeting with monalizumab is thus a novel checkpoint inhibitory mechanism promoting anti-tumor immunity by enhancing the activity of both T and NK cells, which may complement first-generation immunotherapies against cancer.
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              PD-1 Blockade with Cemiplimab in Advanced Cutaneous Squamous-Cell Carcinoma

              No systemic therapies have been approved for the treatment of advanced cutaneous squamous-cell carcinoma. This cancer may be responsive to immune therapy, because the mutation burden of the tumor is high and the disease risk is strongly associated with immunosuppression. In the dose-escalation portion of the phase 1 study of cemiplimab, a deep and durable response was observed in a patient with metastatic cutaneous squamous-cell carcinoma.

                Author and article information

                J Immunother Cancer
                J Immunother Cancer
                Journal for Immunotherapy of Cancer
                BioMed Central (London )
                15 July 2019
                15 July 2019
                : 7
                [1 ]ISNI 0000 0001 2107 4242, GRID grid.266100.3, Moores Cancer Center, , University of California San Diego, ; San Diego, CA USA
                [2 ]ISNI 0000 0004 0465 4685, GRID grid.415290.b, Earle A. Chiles Research Institute at the Robert W. Franz Cancer Center, , Providence Cancer Institute, ; Portland, OR USA
                [3 ]ISNI 0000000419368710, GRID grid.47100.32, Yale School of Medicine and Yale Cancer Center, ; New Haven, CT USA
                [4 ]ISNI 0000 0001 2291 4776, GRID grid.240145.6, The University of Texas MD Anderson Cancer Center, ; Houston, TX USA
                [5 ]ISNI 0000 0001 1271 4623, GRID grid.18886.3f, The Institute of Cancer Research, ; London, UK
                [6 ]ISNI 0000000419368956, GRID grid.168010.e, Stanford University, ; Stanford, CA USA
                [7 ]ISNI 0000 0001 2171 9952, GRID grid.51462.34, Memorial Sloan Kettering Cancer Center, ; New York, NY USA
                [8 ]ISNI 0000 0004 0456 9819, GRID grid.478063.e, UPMC Hillman Cancer Center, ; Pittsburgh, PA USA
                [9 ]ISNI 0000 0001 0807 2568, GRID grid.417893.0, Fondazione IRCCS Istituto Nazionale dei Tumori Milan and University of Milan, ; Milan, Italy
                [10 ]ISNI 0000 0004 1936 7486, GRID grid.6572.6, Institute of Head and Neck Studies and Education, , University of Birmingham, ; Birmingham, UK
                [11 ]ISNI 0000 0004 0444 1241, GRID grid.414316.5, Helen F. Graham Cancer Center, ; Newark, DE USA
                [12 ]ISNI 0000 0001 2160 926X, GRID grid.39382.33, Baylor College of Medicine, ; Houston, TX USA
                [13 ]ISNI 0000 0004 0378 8294, GRID grid.62560.37, Brigham and Women’s Hospital and Dana-Farber Cancer Institute, ; Boston, MA USA
                [14 ]The Immunotherapy Foundation, San Diego, CA USA
                © The Author(s). 2019

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

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