메뉴 건너뛰기




Volumn 28, Issue 6, 2017, Pages 1388-1398

Pembrolizumab KEYNOTE-001: An adaptive study leading to accelerated approval for two indications and a companion diagnostic
[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

IPILIMUMAB; PEMBROLIZUMAB; PROGRAMMED DEATH 1 LIGAND 1; PROGRAMMED DEATH 1 RECEPTOR; T LYMPHOCYTE RECEPTOR; IMMUNOLOGICAL ANTINEOPLASTIC AGENT; MONOCLONAL ANTIBODY; PDCD1 PROTEIN, HUMAN;

EID: 85021068496     PISSN: 09237534     EISSN: 15698041     Source Type: Journal    
DOI: 10.1093/annonc/mdx076     Document Type: Article
Times cited : (73)

References (78)
  • 2
    • 38849152398 scopus 로고    scopus 로고
    • Targeted therapies: a new generation of cancer treatments
    • Gerber DE. Targeted therapies: a new generation of cancer treatments. Am Fam Physician. 2008; 77: 311-319.
    • (2008) Am Fam Physician. , vol.77 , pp. 311-319
    • Gerber, D.E.1
  • 3
    • 84886315269 scopus 로고    scopus 로고
    • Cancer immunotherapy: present status, future perspective, and a new paradigm of peptide immunotherapeutics
    • Miller MJ, Foy KC, Kaumaya PT. Cancer immunotherapy: present status, future perspective, and a new paradigm of peptide immunotherapeutics. Discov Med 2013; 15: 166-176.
    • (2013) Discov Med , vol.15 , pp. 166-176
    • Miller, M.J.1    Foy, K.C.2    Kaumaya, P.T.3
  • 4
    • 84875884456 scopus 로고    scopus 로고
    • Cellular heterogeneity and molecular evolution in cancer
    • Almendro V, Marusyk A, Polyak K. Cellular heterogeneity and molecular evolution in cancer. Annu Rev Pathol 2013; 8: 277-302.
    • (2013) Annu Rev Pathol , vol.8 , pp. 277-302
    • Almendro, V.1    Marusyk, A.2    Polyak, K.3
  • 6
    • 84858766182 scopus 로고    scopus 로고
    • The blockade of immune checkpoints in cancer immunotherapy
    • Pardoll DM. The blockade of immune checkpoints in cancer immunotherapy. Nat Rev Cancer 2012; 12: 252-264.
    • (2012) Nat Rev Cancer , vol.12 , pp. 252-264
    • Pardoll, D.M.1
  • 7
    • 79952284127 scopus 로고    scopus 로고
    • Hallmarks of cancer: the next generation
    • Hanahan D, Weinberg RA. Hallmarks of cancer: the next generation. Cell 2011; 144: 646-674.
    • (2011) Cell , vol.144 , pp. 646-674
    • Hanahan, D.1    Weinberg, R.A.2
  • 9
    • 0029947568 scopus 로고    scopus 로고
    • Enhancement of antitumor immunity by CTLA-4 blockade
    • Leach DR, Krummel MF, Allison JP. Enhancement of antitumor immunity by CTLA-4 blockade. Science 1996; 271: 1734-1736.
    • (1996) Science , vol.271 , pp. 1734-1736
    • Leach, D.R.1    Krummel, M.F.2    Allison, J.P.3
  • 10
    • 77955256254 scopus 로고    scopus 로고
    • Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study
    • O'Day SJ, Maio M, Chiarion-Sileni V, et al. Efficacy and safety of ipilimumab monotherapy in patients with pretreated advanced melanoma: a multicenter single-arm phase II study. Ann Oncol 2010; 21: 1712-1717.
    • (2010) Ann Oncol , vol.21 , pp. 1712-1717
    • O'Day, S.J.1    Maio, M.2    Chiarion-Sileni, V.3
  • 11
    • 69949095926 scopus 로고    scopus 로고
    • A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma
    • Weber J, Thompson JA, Hamid O, et al. A randomized, double-blind, placebo-controlled, phase II study comparing the tolerability and efficacy of ipilimumab administered with or without prophylactic budesonide in patients with unresectable stage III or IV melanoma. Clin Cancer Res 2009; 15: 5591-5598.
    • (2009) Clin Cancer Res , vol.15 , pp. 5591-5598
    • Weber, J.1    Thompson, J.A.2    Hamid, O.3
  • 12
    • 77954801079 scopus 로고    scopus 로고
    • Improved survival with ipilimumab in patients with metastatic melanoma
    • Hodi FS, O'Day SJ, McDermott DF, et al. Improved survival with ipilimumab in patients with metastatic melanoma. N Engl J Med 2010; 363: 711-723.
    • (2010) N Engl J Med , vol.363 , pp. 711-723
    • Hodi, F.S.1    O'Day, S.J.2    McDermott, D.F.3
  • 13
    • 84893489025 scopus 로고    scopus 로고
    • PD-1 as a potential target in cancer therapy
    • McDermott DF, Atkins MB. PD-1 as a potential target in cancer therapy. Cancer Med 2013; 2: 662-673.
    • (2013) Cancer Med , vol.2 , pp. 662-673
    • McDermott, D.F.1    Atkins, M.B.2
  • 16
    • 0030005099 scopus 로고    scopus 로고
    • Expression of the PD-1 antigen on the surface of stimulated mouse T and B lymphocytes
    • Agata Y, Kawasaki A, Nishimura H, et al. Expression of the PD-1 antigen on the surface of stimulated mouse T and B lymphocytes. Int Immunol 1996; 8: 765-772.
    • (1996) Int Immunol , vol.8 , pp. 765-772
    • Agata, Y.1    Kawasaki, A.2    Nishimura, H.3
  • 17
    • 84957839638 scopus 로고    scopus 로고
    • CTLA-4 and PD-1 pathways: similarities, differences, and implications of their inhibition
    • Buchbinder EI, Desai A. CTLA-4 and PD-1 pathways: similarities, differences, and implications of their inhibition. AmJ Clin Oncol 2016; 39: 98-106.
    • (2016) AmJ Clin Oncol , vol.39 , pp. 98-106
    • Buchbinder, E.I.1    Desai, A.2
  • 18
    • 77953747963 scopus 로고    scopus 로고
    • The PD-1 pathway in tolerance and autoimmunity
    • Francisco LM, Sage PT, Sharpe AH. The PD-1 pathway in tolerance and autoimmunity. Immunol Rev 2010; 236: 219-242.
    • (2010) Immunol Rev , vol.236 , pp. 219-242
    • Francisco, L.M.1    Sage, P.T.2    Sharpe, A.H.3
  • 19
    • 84939456588 scopus 로고    scopus 로고
    • Development of PD-1/PD-L1 pathway in tumor immune microenvironment and treatment for non-small cell lung cancer
    • He J, Hu Y, Hu M, Li B. Development of PD-1/PD-L1 pathway in tumor immune microenvironment and treatment for non-small cell lung cancer. Sci Rep 2015; 5: 13110.
    • (2015) Sci Rep , vol.5 , pp. 13110
    • He, J.1    Hu, Y.2    Hu, M.3    Li, B.4
  • 20
    • 84859158384 scopus 로고    scopus 로고
    • Targeting the PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity
    • Topalian SL, Drake CG, Pardoll DM. Targeting the PD-1/B7-H1(PD-L1) pathway to activate anti-tumor immunity. Curr Opin Immunol 2012; 24: 207-212.
    • (2012) Curr Opin Immunol , vol.24 , pp. 207-212
    • Topalian, S.L.1    Drake, C.G.2    Pardoll, D.M.3
  • 21
    • 84964023144 scopus 로고    scopus 로고
    • PD-L2 expression in human tumors: relevance to anti-PD-1 therapy in cancer
    • Yearley J, Gibson G, Yu N, et al. PD-L2 expression in human tumors: relevance to anti-PD-1 therapy in cancer. Eur J Biochem FEBS 2016; 51(suppl 3): S718.
    • (2016) Eur J Biochem FEBS , vol.51 , pp. S718
    • Yearley, J.1    Gibson, G.2    Yu, N.3
  • 22
    • 85021147839 scopus 로고    scopus 로고
    • Whitehouse Station, NJ, Merck Sharp & Dohme Corp
    • Keytruda [package insert]. Whitehouse Station, NJ, Merck Sharp & Dohme Corp.; 2015.
    • (2015)
  • 23
    • 85021091843 scopus 로고    scopus 로고
    • 28 February 2017, date last accessed).
    • US Food and Drug Administration. FDA approves Keytruda for advanced melanoma [press release]. 2014. http://www.fiercebiotech.com/biotech/fda-approves-keytruda-for-advanced-melanoma (28 February 2017, date last accessed).
    • (2014) FDA approves Keytruda for advanced melanoma [press release]
  • 24
    • 33646858444 scopus 로고    scopus 로고
    • FDA orphan drug designations and approvals. Pembrolizumab. (28 February 2017, date last accessed).
    • US Food and Drug Administration. US Department of Health and Human Services. FDA orphan drug designations and approvals. Pembrolizumab. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm? cfgridkey=381012 (28 February 2017, date last accessed).
    • US Department of Health and Human Services
  • 25
    • 85021183333 scopus 로고    scopus 로고
    • [press release].4-24-2013. (28 February 2017, date last accessed).
    • Merck announces breakthrough therapy designation for lambrolizumab an investigational antibody therapy for advancedmelanoma [press release].4-24-2013. http://www.mercknewsroom.com/press-release/research-anddevelopment- news/merck-announces-breakthrough-therapy-designationlambrol (28 February 2017, date last accessed).
  • 27
    • 84963991419 scopus 로고    scopus 로고
    • Belgium: Schering- Plough Lab NV
    • Keytruda [summary of product characteristics]. Belgium: Schering- Plough Lab NV; 2015.
    • (2015) summary of product characteristics
  • 28
    • 85021150435 scopus 로고    scopus 로고
    • Merck receives FDA breakthrough therapy designation for Keytruda (pembrolizumab) in advanced non-small cell lung cancer
    • [press release]. 10-27-2014. (28 February 2017, date last accessed).
    • Merck receives FDA breakthrough therapy designation for Keytruda (pembrolizumab) in advanced non-small cell lung cancer [press release]. 10-27-2014. http://www.mercknewsroom.com/news-release/oncologynewsroom/merck-receives-fda-breakthrough-therapy-designation-key truda-pembroli (28 February 2017, date last accessed).
  • 29
    • 85021126664 scopus 로고    scopus 로고
    • FDA approves Keytruda (pembrolizumab) for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 with disease progression on or after platinum-containing chemotherapy
    • [press release]. 10-2-2015. (28 February 2017, date last accessed).
    • FDA approves Keytruda (pembrolizumab) for the treatment of patients with metastatic non-small cell lung cancer whose tumors express PD-L1 with disease progression on or after platinum-containing chemotherapy [press release]. 10-2-2015. http://www.mercknewsroom.com/news-re lease/prescription-medicine-news/fda-approves-keytruda-pembrolizu mab-treatment-patients-metas (28 February 2017, date last accessed).
  • 30
    • 85021073987 scopus 로고    scopus 로고
    • (28 February 2017, date last accessed).
    • US Food and Drug Administration. Premarket approval (PMA) PD-L1 IHC 22C3 pharmDX. 2016. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMA/pma.cfm?id=P150013 (28 February 2017, date last accessed).
    • (2016) Premarket approval (PMA) PD-L1 IHC 22C3 pharmDX
  • 31
    • 85021093290 scopus 로고    scopus 로고
    • [press release]. (28 February 2017, date last accessed).
    • Dako. Dako, an Agilent Technologies company, announces FDA approval of new companion diagnostic for lung cancer [press release]. http://www.agilent.com/about/newsroom/presrel/2015/02oct-dk 15004.html (28 February 2017, date last accessed).
  • 32
    • 39149104690 scopus 로고    scopus 로고
    • Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials
    • Korn EL, Liu PY, Lee SJ, et al. Meta-analysis of phase II cooperative group trials in metastatic stage IV melanoma to determine progression-free and overall survival benchmarks for future phase II trials. J Clin Oncol 2008; 26: 527-534.
    • (2008) J Clin Oncol , vol.26 , pp. 527-534
    • Korn, E.L.1    Liu, P.Y.2    Lee, S.J.3
  • 33
    • 77955877759 scopus 로고    scopus 로고
    • Early palliative care for patients with metastatic non-small-cell lung cancer
    • Temel JS, Greer JA, Muzikansky A, et al. Early palliative care for patients with metastatic non-small-cell lung cancer. N Engl JMed 2010; 363: 733-742.
    • (2010) N Engl JMed , vol.363 , pp. 733-742
    • Temel, J.S.1    Greer, J.A.2    Muzikansky, A.3
  • 34
    • 80052476869 scopus 로고    scopus 로고
    • High expression of PD-L1 in lung cancer may contribute to poor prognosis and tumor cells immune escape through suppressing tumor infiltrating dendritic cells maturation
    • Mu CY, Huang JA, Chen Y, et al. High expression of PD-L1 in lung cancer may contribute to poor prognosis and tumor cells immune escape through suppressing tumor infiltrating dendritic cells maturation. Med Oncol 2011; 28: 682-688.
    • (2011) Med Oncol , vol.28 , pp. 682-688
    • Mu, C.Y.1    Huang, J.A.2    Chen, Y.3
  • 35
    • 84929713513 scopus 로고    scopus 로고
    • PD-L1 expression and survival in patients with non-small cell lung cancer (NSCLC) in Korea
    • Sun JM, Zhou W, Choi SJ, et al. PD-L1 expression and survival in patients with non-small cell lung cancer (NSCLC) in Korea. J Clin Oncol 2014; 32(suppl 5): Abstr 8066.
    • (2014) J Clin Oncol , vol.32
    • Sun, J.M.1    Zhou, W.2    Choi, S.J.3
  • 36
    • 61549122071 scopus 로고    scopus 로고
    • Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma
    • Gao Q, Wang XY, Qiu SJ, et al. Overexpression of PD-L1 significantly associates with tumor aggressiveness and postoperative recurrence in human hepatocellular carcinoma. Clin Cancer Res 2009; 15: 971-979.
    • (2009) Clin Cancer Res , vol.15 , pp. 971-979
    • Gao, Q.1    Wang, X.Y.2    Qiu, S.J.3
  • 37
    • 84938329177 scopus 로고    scopus 로고
    • PD-L1 and survival in solid tumors: a meta-analysis
    • Wu P, Wu D, Li L, et al. PD-L1 and survival in solid tumors: a meta-analysis. PLoS ONE 2015; 10: e0131403.
    • (2015) PLoS ONE , vol.10
    • Wu, P.1    Wu, D.2    Li, L.3
  • 38
    • 84958758515 scopus 로고    scopus 로고
    • Pembrolizumab: a review in advanced melanoma
    • Deeks ED. Pembrolizumab: a review in advanced melanoma. Drugs 2016; 76: 375-386.
    • (2016) Drugs , vol.76 , pp. 375-386
    • Deeks, E.D.1
  • 39
    • 84922339585 scopus 로고    scopus 로고
    • Pembrolizumab: PD-1 inhibition as a therapeutic strategy in cancer
    • McDermott J, Jimeno A. Pembrolizumab: PD-1 inhibition as a therapeutic strategy in cancer. Drugs Today 2015; 51: 7-20.
    • (2015) Drugs Today , vol.51 , pp. 7-20
    • McDermott, J.1    Jimeno, A.2
  • 41
    • 84945554100 scopus 로고    scopus 로고
    • Phase I study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in patients with advanced solid tumors
    • Patnaik A, Kang SP, Rasco D, et al. Phase I study of pembrolizumab (MK-3475; anti-PD-1 monoclonal antibody) in patients with advanced solid tumors. Clin Cancer Res 2015; 21: 4286-4293.
    • (2015) Clin Cancer Res , vol.21 , pp. 4286-4293
    • Patnaik, A.1    Kang, S.P.2    Rasco, D.3
  • 42
    • 84879759020 scopus 로고    scopus 로고
    • Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma
    • Hamid O, Robert C, Daud A, et al. Safety and tumor responses with lambrolizumab (anti-PD-1) in melanoma. N Engl J Med 2013; 369: 134-144.
    • (2013) N Engl J Med , vol.369 , pp. 134-144
    • Hamid, O.1    Robert, C.2    Daud, A.3
  • 43
    • 84908354848 scopus 로고    scopus 로고
    • Anti-programmed-death-receptor- treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial
    • Robert C, Ribas A, Wolchok JD, et al. Anti-programmed-death-receptor- treatment with pembrolizumab in ipilimumab-refractory advanced melanoma: a randomised dose-comparison cohort of a phase 1 trial. Lancet 2014; 384: 1109-1117.
    • (2014) Lancet , vol.384 , pp. 1109-1117
    • Robert, C.1    Ribas, A.2    Wolchok, J.D.3
  • 44
    • 84907498839 scopus 로고    scopus 로고
    • Randomized comparison of two doses of the anti-PD-1 monoclonal antibody MK-3475 for ipilimumabrefractory (IPI-R) and IPI-naive (IPI-N) melanoma (MEL)
    • Hamid O, Robert C, Ribas A, et al. Randomized comparison of two doses of the anti-PD-1 monoclonal antibody MK-3475 for ipilimumabrefractory (IPI-R) and IPI-naive (IPI-N) melanoma (MEL). J Clin Oncol 2014; 32(suppl 15): Abstr 3000.
    • (2014) J Clin Oncol , vol.32
    • Hamid, O.1    Robert, C.2    Ribas, A.3
  • 45
    • 84941024351 scopus 로고    scopus 로고
    • Pembrolizumab (pembro; MK- 3475) for advanced melanoma (MEL): randomized comparison of two dosing schedules
    • Robert C, Joshua AM, Weber JS, et al. Pembrolizumab (pembro; MK- 3475) for advanced melanoma (MEL): randomized comparison of two dosing schedules. Ann Oncol 2014; 25: 1-41.
    • (2014) Ann Oncol , vol.25 , pp. 1-41
    • Robert, C.1    Joshua, A.M.2    Weber, J.S.3
  • 46
    • 84940545027 scopus 로고    scopus 로고
    • Pembrolizumab (MK-3475) for advanced melanoma: randomized comparison of two dosing schedules
    • Congress, 26-30 September 2014; Madrid, Spain.
    • Robert C, Joshua AM, Weber JS, et al. Pembrolizumab (MK-3475) for advanced melanoma: randomized comparison of two dosing schedules. Poster presented at: European Society for Medical Oncology 2014 Congress, 26-30 September 2014; Madrid, Spain.
    • (2014) Poster presented at: European Society for Medical Oncology
    • Robert, C.1    Joshua, A.M.2    Weber, J.S.3
  • 47
    • 84964341647 scopus 로고    scopus 로고
    • Association of pembrolizumab with tumor response and survival among patients with advanced melanoma
    • Ribas A, Hamid O, Daud A, et al. Association of pembrolizumab with tumor response and survival among patients with advanced melanoma. JAMA 2016; 315: 1600-1609.
    • (2016) JAMA , vol.315 , pp. 1600-1609
    • Ribas, A.1    Hamid, O.2    Daud, A.3
  • 48
    • 84904856935 scopus 로고    scopus 로고
    • Preliminary clinical safety and activity of MK-3475 monotherapy for the treatment of previously treated patients with non-small cell lung cancer (NSCLC)
    • 27-30 October 2013, Sydney, Australia.
    • Garon E, Balmanoukian A, Hamid O, et al. Preliminary clinical safety and activity of MK-3475 monotherapy for the treatment of previously treated patients with non-small cell lung cancer (NSCLC). Presented at: IASLC15th World Conference on Lung Cancer, 27-30 October 2013, Sydney, Australia.
    • Presented at: IASLC15th World Conference on Lung Cancer
    • Garon, E.1    Balmanoukian, A.2    Hamid, O.3
  • 49
    • 85031507158 scopus 로고    scopus 로고
    • Safety and clinical activity of MK-3475 in previously treated patients (pts) with non-small cell lung cancer (NSCLC)
    • Poster presented at the ASCO Annual Meeting, 30May- June 2014; Chicago, IL, USA.
    • Garon EB, Leighl NA, Rizvi NA, Safety and clinical activity of MK-3475 in previously treated patients (pts) with non-small cell lung cancer (NSCLC). Poster presented at the ASCO Annual Meeting, 30May- June 2014; Chicago, IL, USA.
    • Garon, E.B.1    Leighl, N.A.2    Rizvi, N.A.3
  • 50
    • 84947473096 scopus 로고    scopus 로고
    • Optimizing PD-L1 as a biomarker of response with pembrolizumab (pembro; MK-3475) as first-line therapy for PD-L1-positive metastatic non-small cell lung cancer (NSCLC)
    • Updated data from KEYNOTE-001. Poster presented at the ASCO Annual Meeting, 25 May-3 June 2015, Chicago, IL, USA.
    • Rizvi NA, Garon EB, Leighl N, et al. Optimizing PD-L1 as a biomarker of response with pembrolizumab (pembro; MK-3475) as first-line therapy for PD-L1-positive metastatic non-small cell lung cancer (NSCLC): Updated data from KEYNOTE-001. Poster presented at the ASCO Annual Meeting, 25 May-3 June 2015, Chicago, IL, USA.
    • Rizvi, N.A.1    Garon, E.B.2    Leighl, N.3
  • 51
    • 84929481480 scopus 로고    scopus 로고
    • Pembrolizumab for the treatment of non-small-cell lung cancer
    • Garon EB, Rizvi NA, Hui R, et al. Pembrolizumab for the treatment of non-small-cell lung cancer. N Engl J Med 2015; 372: 2018-2028.
    • (2015) N Engl J Med , vol.372 , pp. 2018-2028
    • Garon, E.B.1    Rizvi, N.A.2    Hui, R.3
  • 52
    • 84966341112 scopus 로고    scopus 로고
    • FDA approval summary: pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer whose tumors express programmed death-ligand 1
    • Sul J, Blumenthal GM, Jiang X, et al. FDA approval summary: pembrolizumab for the treatment of patients with metastatic non-small cell lung cancer whose tumors express programmed death-ligand 1. Oncologist 2016; 21: 643-650.
    • (2016) Oncologist , vol.21 , pp. 643-650
    • Sul, J.1    Blumenthal, G.M.2    Jiang, X.3
  • 53
    • 84897455604 scopus 로고    scopus 로고
    • The Pathway from idea to regulatory approval: examples for drug development
    • In B Lo, MJ Field (eds), Washington, DC: National Academies Press
    • Corr P, Williams DE, The Pathway from idea to regulatory approval: examples for drug development. In B Lo, MJ Field (eds), Conflict of Interest in Medical Research, Education and Practice. Washington, DC: National Academies Press 2009.
    • (2009) Conflict of Interest in Medical Research, Education and Practice
    • Corr, P.1    Williams, D.E.2
  • 54
    • 84856144549 scopus 로고    scopus 로고
    • FDAReview.org website. (28 February 2017, date last accessed).
    • Independent Institute. The drug development and approval process. FDAReview.org website. http://www.fdareview.org/03_drug_develop ment.php (28 February 2017, date last accessed).
    • The drug development and approval process
  • 56
    • 85021107978 scopus 로고    scopus 로고
    • press release]. 12-18-2015. (28 February 2017, date last accessed).
    • FDA approves expanded indication for Merck's Keytruda (pembrolizumab) for the treatment of patients with advanced melanoma [press release]. 12-18-2015. http://www.businesswire.com/news/home/20151218005982/en (28 February 2017, date last accessed).
  • 57
    • 84938205998 scopus 로고    scopus 로고
    • Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial
    • Ribas A, Puzanov I, Dummer R, et al. Pembrolizumab versus investigator-choice chemotherapy for ipilimumab-refractory melanoma (KEYNOTE-002): a randomised, controlled, phase 2 trial. Lancet Oncol 2015; 16: 908-918.
    • (2015) Lancet Oncol , vol.16 , pp. 908-918
    • Ribas, A.1    Puzanov, I.2    Dummer, R.3
  • 58
    • 84929481481 scopus 로고    scopus 로고
    • Pembrolizumab versus ipilimumab in advanced melanoma
    • Robert C, Schachter J, Long GV, et al. Pembrolizumab versus ipilimumab in advanced melanoma. N Engl J Med 2015; 372: 2521-2532.
    • (2015) N Engl J Med , vol.372 , pp. 2521-2532
    • Robert, C.1    Schachter, J.2    Long, G.V.3
  • 59
    • 84947704341 scopus 로고    scopus 로고
    • Long-term efficacy of pembrolizumab (pembro; MK-3475) in a pooled analysis of 655 patients (pts) with advanced melanoma (MEL) enrolled in KEYNOTE-001
    • Daud A, Ribas A, Robert C, et al. Long-term efficacy of pembrolizumab (pembro; MK-3475) in a pooled analysis of 655 patients (pts) with advanced melanoma (MEL) enrolled in KEYNOTE-001. J Clin Oncol 2015; 33(suppl 15): Abstr 9005.
    • (2015) J Clin Oncol , vol.33
    • Daud, A.1    Ribas, A.2    Robert, C.3
  • 60
    • 85021139088 scopus 로고    scopus 로고
    • Three year overall survival for patients with advanced melanoma treated with pembrolizumab in KEYNOTE001
    • Presented at 2016 ASCO AnnualMeeting, June 3-7, Chicago, IL.
    • Robert C, Ribas A, Hamid O, et al. Three year overall survival for patients with advanced melanoma treated with pembrolizumab in KEYNOTE001. Presented at 2016 ASCO AnnualMeeting, June 3-7, Chicago, IL.
    • Robert, C.1    Ribas, A.2    Hamid, O.3
  • 61
    • 85021051852 scopus 로고    scopus 로고
    • FDA approves Merck's Keytruda (pembrolizumab) for patients with recurrent ormetastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy
    • press release]. 8-5-2016. (28 February 2017, date last accessed).
    • FDA approves Merck's Keytruda (pembrolizumab) for patients with recurrent ormetastatic head and neck squamous cell carcinoma with disease progression on or after platinum-containing chemotherapy [press release]. 8-5-2016. http://www.businesswire.com/news/home/2016080500 5807/en (28 February 2017, date last accessed).
  • 62
    • 84969988424 scopus 로고    scopus 로고
    • 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
    • Seiwert TY, Burtness B, Mehra R, et al. 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. Lancet Oncol 2016; 17: 956-965.
    • (2016) Lancet Oncol , vol.17 , pp. 956-965
    • Seiwert, T.Y.1    Burtness, B.2    Mehra, R.3
  • 63
    • 85021074156 scopus 로고    scopus 로고
    • Whitehouse Station, NJ, USA: Merck, Sharp & Dohme Corp.; August
    • Keytruda [package insert]. Whitehouse Station, NJ, USA: Merck, Sharp & Dohme Corp.; August 2016.
    • (2016)
  • 64
    • 84950117835 scopus 로고    scopus 로고
    • Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial
    • Herbst RS, Baas P, Kim DW, et al. Pembrolizumab versus docetaxel for previously treated, PD-L1-positive, advanced non-small-cell lung cancer (KEYNOTE-010): a randomised controlled trial. Lancet 2016; 387: 1540-1550.
    • (2016) Lancet , vol.387 , pp. 1540-1550
    • Herbst, R.S.1    Baas, P.2    Kim, D.W.3
  • 65
    • 85021110844 scopus 로고    scopus 로고
    • Whitehouse Station, NJ, USA; Merck, Sharp & Dohme Corp.; October
    • Keytruda [package insert]. Whitehouse Station, NJ, USA; Merck, Sharp & Dohme Corp.; October 2016.
    • (2016)
  • 67
    • 85021138577 scopus 로고    scopus 로고
    • [press release] 3-14-2017. (16May 2017, date last accessed).
    • FDA approves Merck's Keytruda (pembrolizumab) for adult and pediatric patients with classical hodgkin lymphoma (cHL) refractory to treatment, or who have relapsed after three or more prior lines of therapy. [press release] 3-14-2017. http://investors.merck.com/news/press-releasedetails/2017/FDA-Approves-Mercks-KEYTRUDA-pembrolizumab-for- Adult-and-Pediatric-Patients-with-Classical-Hodgkin-Lymphoma-cHLRefractory- to-Treatment-or-Who-Have-Relapsed-After-Three-or-More- Prior-Lines-of-Therapy/default.aspx (16May 2017, date last accessed).
  • 68
    • 85021163316 scopus 로고    scopus 로고
    • FDA approves Merck's Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC)
    • irrespective of PD-L1 expression. [press release] 5-10-2017. (16May 2017, date last accessed).
    • FDA approves Merck's Keytruda (pembrolizumab) as first-line combination therapy with pemetrexed and carboplatin for patients with metastatic nonsquamous non-small cell lung cancer (NSCLC), irrespective of PD-L1 expression. [press release] 5-10-2017. http://www.mercknewsroom.com/news-release/prescription-medicine-news/fda-approves-mercks-keytrudapembrolizumab- first-line-combin (16May 2017, date last accessed).
  • 69
    • 84993993467 scopus 로고    scopus 로고
    • Programmed death-1 blockade with pembrolizumab in patients with classical Hodgkin lymphoma after brentuximab vedotin failure
    • Armand P, Shipp MA, Ribrag V, et al. Programmed death-1 blockade with pembrolizumab in patients with classical Hodgkin lymphoma after brentuximab vedotin failure. J Clin Oncol 2016; 34: 3733-3739.
    • (2016) J Clin Oncol , vol.34 , pp. 3733-3739
    • Armand, P.1    Shipp, M.A.2    Ribrag, V.3
  • 70
    • 84930960194 scopus 로고    scopus 로고
    • Immune checkpoint blockade in hematologic malignancies
    • Armand P. Immune checkpoint blockade in hematologic malignancies. Blood 2015; 125: 3393-3400.
    • (2015) Blood , vol.125 , pp. 3393-3400
    • Armand, P.1
  • 71
    • 84980349168 scopus 로고    scopus 로고
    • PD-1 blockade with the monoclonal antibody pembrolizumab (MK-3475) in patients with classical hodgkin lymphoma after brentuximab vedotin failure: preliminary results from a phase 1b study (KEYNOTE-013)
    • Moskowitz CH, Ribrag V, Michot JM, et al. PD-1 blockade with the monoclonal antibody pembrolizumab (MK-3475) in patients with classical hodgkin lymphoma after brentuximab vedotin failure: preliminary results from a phase 1b study (KEYNOTE-013). 56th Annual Meeting of the American Society of Hematology. Blood 2014; 124: 290.
    • (2014) 56th Annual Meeting of the American Society of Hematology. Blood , vol.124 , pp. 290
    • Moskowitz, C.H.1    Ribrag, V.2    Michot, J.M.3
  • 72
    • 84929342219 scopus 로고    scopus 로고
    • A phase Ib study of pembrolizumab (MK-3475) in patients with advanced triple-negative breast cancer
    • Presented at: 37th Annual CTRC-AACR San Antonio Breast Cancer Symposium, 9-13 December 2014, San Antonio, TX.
    • Nanda R, Chow LQ, Dees EC, et al. A phase Ib study of pembrolizumab (MK-3475) in patients with advanced triple-negative breast cancer. Presented at: 37th Annual CTRC-AACR San Antonio Breast Cancer Symposium, 9-13 December 2014, San Antonio, TX.
    • Nanda, R.1    Chow, L.Q.2    Dees, E.C.3
  • 73
    • 84931278393 scopus 로고    scopus 로고
    • Pembrolizumab (Pembro; MK-3475) for advanced urothelial cancer: results of a phase IB study
    • O'Donnell PH, Plimack ER, Bellmunt J, et al. Pembrolizumab (Pembro; MK-3475) for advanced urothelial cancer: results of a phase IB study. J Clin Oncol 2015; 33(suppl 7): Abstr 296.
    • (2015) J Clin Oncol , vol.33
    • O'Donnell, P.H.1    Plimack, E.R.2    Bellmunt, J.3
  • 74
    • 84937041504 scopus 로고    scopus 로고
    • Relationship between PD-L1 expression and clinical outcomes in patients with advanced gastric cancer treated with the anti-PD1 monoclonal antibody pembrolizumab (MK-3475) in KEYNOTE-012
    • Muro K, Bang YJ, Shankaran V, et al. Relationship between PD-L1 expression and clinical outcomes in patients with advanced gastric cancer treated with the anti-PD1 monoclonal antibody pembrolizumab (MK-3475) in KEYNOTE-012. J Clin Oncol 2015; 33(suppl 3): Abstr 03.
    • (2015) J Clin Oncol , vol.33
    • Muro, K.1    Bang, Y.J.2    Shankaran, V.3
  • 75
    • 85021067603 scopus 로고    scopus 로고
    • New Keytruda (pembrolizumab) data at 2016 ASCO annual meeting includes three-year overall survival data in melanoma and updated overall survival data in non-small cell lung cancer as well as updated findings in head and neck cancer
    • [press release]. 5-16-2016. (28 February 2017, date last accessed).
    • New Keytruda (pembrolizumab) data at 2016 ASCO annual meeting includes three-year overall survival data in melanoma and updated overall survival data in non-small cell lung cancer as well as updated findings in head and neck cancer [press release]. 5-16-2016. http://www.business wire.com/news/home/20160516005363/en (28 February 2017, date last accessed).
  • 76
    • 85021109167 scopus 로고    scopus 로고
    • [press release]. 11-2-2015. (28 February 2017, date last accessed).
    • Merck receives breakthrough therapy designation from US Food and Drug Administration for Keytruda (pembrolizumab) in advanced colorectal cancer [press release]. 11-2-2015. http://www.businesswire. com/news/home/20151102005577/en/(28 February 2017, date last accessed).
  • 77
    • 85021176144 scopus 로고    scopus 로고
    • [press release]. 4-18-2016. (28 February 2017, date last accessed).
    • Merck receives breakthrough therapy designation from US food and drug administration for Keytruda (pembrolizumab) in classical Hodgkin lymphoma (cHL) [press release]. 4-18-2016. http://www.busi nesswire.com/news/home/20160418005495/en/(28 February 2017, date last accessed).
  • 78
    • 85021146424 scopus 로고    scopus 로고
    • FDA grants priority review to Merck's supplemental biologics license application (sBLA) seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high cancer
    • [press release]. 11-28-2016. (28 February 2017, date last accessed
    • FDA grants priority review to Merck's supplemental biologics license application (sBLA) seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high cancer [press release]. 11-28-2016. http://investors.merck.com/news/press-release-details/2016/FDA-Grants-Priority-Review-to-Mercks-Supplemental-Biologics- License-Application-sBLA-Seeking-Approval-for-KEYTRUDA-pembroli zumab-for-New-Indication-in-Microsatellite-Instability-High-Cancer/default.aspx (28 February 2017, date last accessed).


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.