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      The Value of Cancer Immunotherapy Summit at the 2016 Society for Immunotherapy of Cancer 31 st anniversary annual meeting

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          Abstract

          As healthcare costs continue to rise, there has been great interest in understanding and defining the value of current therapeutic strategies for the treatment of cancer. Cancer immunotherapy has emerged as a clinically beneficial alternative to conventional therapies for a variety of malignancies. Characterized by broad clinical activity, durable response rates, distinct side effects, and unique response kinetics, immune-based agents are vastly different compared with traditional cytotoxic or targeted therapies. To date, however, value assessments in oncology have not focused on the unique aspects of cancer immunotherapy, which has resulted in a lack of understanding of the true value of these therapies. Therefore, the Society for Immunotherapy of Cancer (SITC) convened key stakeholders to address the critical issues that define the value of cancer immunotherapy in National Harbor, Maryland on November 13, 2016. Organized in collaboration with the American Society for Clinical Oncology (ASCO) and with over 1500 registrants, this Value of Cancer Immunotherapy Summit united research scientists, academic physicians, industry professionals, health economists, third-party payers, and patients to discuss critical issues surrounding the value framework for cancer immunotherapy. This half-day summit addressed the current landscape of cancer therapy value models, economic outcomes, the current status of predictive biomarkers, as well as presentations from third-party payers, industry representatives, patient outcome experts, and patient advocacy groups to gain their perspectives on the value of cancer immunotherapy. Here, we summarize the presentations and the dominant themes from this symposium, with the intention of providing insight on future directions and to develop recommendations to better define the value of cancer immunotherapy for patients with cancer.

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          Most cited references8

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          Combined nivolumab and ipilimumab versus ipilimumab alone in patients with advanced melanoma: 2-year overall survival outcomes in a multicentre, randomised, controlled, phase 2 trial.

          Results from phase 2 and 3 trials in patients with advanced melanoma have shown significant improvements in the proportion of patients achieving an objective response and prolonged progression-free survival with the combination of nivolumab (an anti-PD-1 antibody) plus ipilimumab (an anti-CTLA-4 antibody) compared with ipilimumab alone. We report 2-year overall survival data from a randomised controlled trial assessing this treatment in previously untreated advanced melanoma.
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            Programmed death ligand-1 expression in non-small cell lung cancer.

            Recent strategies targeting the interaction of the programmed cell death ligand-1 (PD-L1, B7-H1, CD274) with its receptor, PD-1, resulted in promising activity in early phase clinical trials. In this study, we used various antibodies and in situ mRNA hybridization to measure PD-L1 in non-small cell lung cancer (NSCLC) using a quantitative fluorescence (QIF) approach to determine the frequency of expression and prognostic value in two independent populations. A control tissue microarray (TMA) was constructed using PD-L1-transfected cells, normal human placenta and known PD-L1-positive NSCLC cases. Only one of four antibodies against PD-L1 (5H1) validated for specificity on this TMA. In situ PD-L1 mRNA using the RNAscope method was similarly validated. Two cohorts of NSCLC cases in TMAs including 340 cases from hospitals in Greece and 204 cases from Yale University were assessed. Tumors showed PD-L1 protein expression in 36% (Greek) and 25% (Yale) of the cases. PD-L1 expression was significantly associated with tumor-infiltrating lymphocytes in both cohorts. Patients with PD-L1 (both protein and mRNA) expression above the detection threshold showed statistically significant better outcome in both series (log-rank P=0.036 and P=0.027). Multivariate analysis showed that PD-L1 expression was significantly associated with better outcome independent of histology. Measurement of PD-L1 requires specific conditions and some commercial antibodies show lack of specificity. Expression of PD-L1 protein or mRNA is associated with better outcome. Further studies are required to determine the value of this marker in prognosis and prediction of response to treatments targeting this pathway.
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              High-dose recombinant interleukin 2 therapy for patients with metastatic melanoma: analysis of 270 patients treated between 1985 and 1993.

              To determine the short- and long-term efficacy and toxicity of the high-dose intravenous bolus interleukin 2 (IL-2) regimen in patients with metastatic melanoma. Two hundred seventy assessable patients were entered onto eight clinical trials conducted between 1985 and 1993. IL-2 (Proleukin [aldesleukin]; Chiron Corp, Emeryville, CA) 600,000 or 720,000 IU/kg was administered by 15-minute intravenous infusion every 8 hours for up to 14 consecutive doses over 5 days as clinically tolerated with maximum support, including pressors. A second identical treatment cycle was scheduled after 6 to 9 days of rest, and courses could be repeated every 6 to 12 weeks in stable or responding patients. Data were analyzed through fall 1996. The overall objective response rate was 16% (95% confidence interval, 12% to 21%); there were 17 complete responses (CRs) (6%) and 26 partial responses (PRs) (10%). Responses occurred with all sites of disease and in patients with large tumor burdens. The median response duration for patients who achieved a CR has not been reached and was 5.9 months for those who achieved a PR. Twelve (28%) of the responding patients, including 10 (59%) of the patients who achieved a CR, remain progression-free. Disease did not progress in any patient responding for more than 30 months. Baseline performance status and whether patients had received prior systemic therapy were the only predictive prognostic factors for response to IL-2 therapy. Toxicities, although severe, generally reversed rapidly after therapy was completed. Six patients (2%) died from adverse events, all related to sepsis. High-dose IL-2 treatment seems to benefit some patients with metastatic melanoma by producing durable CRs or PRs and should be considered for appropriately selected melanoma patients.
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                Author and article information

                Contributors
                howard.kaufman@rutgers.edu
                mba41@Georgetown.edu
                adam.dicker@jefferson.edu
                Heather.Jim@moffitt.org
                lgarrisn@u.washington.edu
                roy.herbst@yale.edu
                mcgivney.wt@gmail.com
                sttaran@aol.com
                wiggintonj@macrogenics.com
                peter.yu@hhchealth.org
                Journal
                J Immunother Cancer
                J Immunother Cancer
                Journal for Immunotherapy of Cancer
                BioMed Central (London )
                2051-1426
                18 April 2017
                18 April 2017
                2017
                : 5
                : 38
                Affiliations
                [1 ]ISNI 0000 0004 1936 8796, GRID grid.430387.b, , Rutgers Cancer Institute of New Jersey, ; New Brunswick, NJ 08901 USA
                [2 ]ISNI 0000 0001 1955 1644, GRID grid.213910.8, , Georgetown-Lombardi Comprehensive Cancer Center, ; Washington, DC 20016 USA
                [3 ]ISNI 0000 0001 2166 5843, GRID grid.265008.9, , Thomas Jefferson University, ; Philadelphia, PA 19107 USA
                [4 ]ISNI 0000 0000 9891 5233, GRID grid.468198.a, , H. Lee Moffitt Cancer Center & Research Institute, ; Tampa, FL 33612 USA
                [5 ]ISNI 0000000122986657, GRID grid.34477.33, , University of Washington School of Pharmacy, ; Seattle, WA 98195 USA
                [6 ]ISNI 0000000419368710, GRID grid.47100.32, , Yale School of Medicine, ; New Haven, CT 06510 USA
                [7 ]McGivney Global Advisors, 130 W Lancaster Ave, Suite 301, Wayne, PA 19087 USA
                [8 ]GRID grid.453449.b, , Melanoma Research Foundation, ; Woodcliff Lake, NJ 07077 USA
                [9 ]ISNI 0000 0004 0432 6278, GRID grid.421076.6, , MacroGenics, Inc., ; Rockville, MD 20850 USA
                [10 ]Hartford HealthCare, Memorial Sloan Kettering Cancer Alliance, Hartford, CT 06102 USA
                Article
                241
                10.1186/s40425-017-0241-6
                5394621
                958d133c-9e16-4102-9abb-33655e0af50e
                © The Author(s). 2017

                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.

                History
                : 7 February 2017
                : 7 April 2017
                Categories
                Meeting Report
                Custom metadata
                © The Author(s) 2017

                cancer immunotherapy,value,cost,summit,biomarkers,patient-reported outcomes

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