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Open Access Highly Accessed Commentary

Defining the critical hurdles in cancer immunotherapy

Bernard A Fox12*, Dolores J Schendel3, Lisa H Butterfield456, Steinar Aamdal7, James P Allison89, Paolo Antonio Ascierto10, Michael B Atkins1112, Jirina Bartunkova13, Lothar Bergmann14, Neil Berinstein15, Cristina C Bonorino16, Ernest Borden1718, Jonathan L Bramson19, Cedrik M Britten2021, Xuetao Cao2223, William E Carson24, Alfred E Chang25, Dainius Characiejus26, A Raja Choudhury27, George Coukos28, Tanja de Gruijl29, Robert O Dillman30, Harry Dolstra31, Glenn Dranoff323334, Lindy G Durrant35, James H Finke36, Jerome Galon37, Jared A Gollob38, Cécile Gouttefangeas39, Fabio Grizzi40, Michele Guida41, Leif Håkansson4243, Kristen Hege44, Ronald B Herberman45, F Stephen Hodi4647, Axel Hoos48, Christoph Huber49, Patrick Hwu50, Kohzoh Imai51, Elizabeth M Jaffee52, Sylvia Janetzki53, Carl H June54, Pawel Kalinski5, Howard L Kaufman55, Koji Kawakami56, Yutaka Kawakami57, Ulrich Keilholtz58, Samir N Khleif59, Rolf Kiessling60, Beatrix Kotlan61, Guido Kroemer62, Rejean Lapointe6364, Hyam I Levitsky65, Michael T Lotze456, Cristina Maccalli66, Michele Maio67, Jens-Peter Marschner68, Michael J Mastrangelo69, Giuseppe Masucci70, Ignacio Melero71, Cornelius Melief72, William J Murphy73, Brad Nelson74, Andrea Nicolini75, Michael I Nishimura76, Kunle Odunsi77, Pamela S Ohashi78, Jill O'Donnell-Tormey79, Lloyd J Old80, Christian Ottensmeier81, Michael Papamichail82, Giorgio Parmiani83, Graham Pawelec84, Enrico Proietti85, Shukui Qin86, Robert Rees87, Antoni Ribas88, Ruggero Ridolfi89, Gerd Ritter880, Licia Rivoltini90, Pedro J Romero91, Mohamed L Salem92, Rik J Scheper93, Barbara Seliger94, Padmanee Sharma95, Hiroshi Shiku9697, Harpreet Singh-Jasuja98, Wenru Song99, Per Thor Straten100, Hideaki Tahara101, Zhigang Tian102103, Sjoerd H van Der Burg104, Paul von Hoegen105, Ena Wang106107, Marij JP Welters108, Hauke Winter109, Tara Withington110, Jedd D Wolchok8, Weihua Xiao111, Laurence Zitvogel112, Heinz Zwierzina113, Francesco M Marincola106107, Thomas F Gajewski114, Jon M Wigginton115 and Mary L Disis116

Author Affiliations

1 Earle A. Chiles Research Institute, Robert W. Franz Research Center, Providence Cancer Center, Providence Portland Medical Center, Portland, OR, USA

2 Department of Molecular Microbiology and Immunology and Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA

3 Institute of Molecular Immunology and Clinical Cooperation Group "Immune Monitoring", Helmholtz Centre Munich, German Research Center for Environmental Health, Munich, Germany

4 Departments of Medicine, Division of Hematology Oncology, University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA

5 Department of Surgery University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA

6 Department of Immunology, University of Pittsburgh Cancer Institute, Pittsburgh, PA, USA

7 Department of Clinical Cancer Research, The Norwegian Radium Hospital, Oslo University Hospital, Oslo, Norway

8 Memorial Sloan-Kettering Cancer Center, New York, NY, USA

9 Howard Hughes Medical Institute, New York, NY, USA

10 Medical Oncology and Innovative Therapy, Instituto Nazionale Tumori-Fondazione 'G. Pascale', Naples, Italy

11 Beth Israel Deaconess Medical Center, Boston, MA, USA

12 Harvard Medical School, Boston, MA, USA

13 Institute of Immunology, FOCIS Center of Excellence, 2nd Medical School, Charles University, Prague, Czech Republic

14 Goethe Universität Frankfurt Am Main,Medizinische Klinik II, Frankfurt Am Main, Germany

15 IRX Therapeutics, New York, NY, USA

16 Instituto Nacional para o Controle do Câncer, Instituto de Pesquisas Biomédicas, PUCRS Faculdade de Biociências, PUCRS, Porto Alegre RS Brazil

17 Department of Translational Hematology and Oncology Research, Cleveland Clinic, Cleveland, OH, USA

18 Department of Solid Tumor Oncology, Cleveland Clinic, Cleveland, OH, USA

19 Department of Pathology, McMaster University, Hamilton, ON, Canada

20 University Medical Center Mainz, III. Medical Department, Mainz, Germany

21 Ribological GmbH, Mainz, Germany

22 Chinese Academy of Medical Sciences, Beijing, China

23 Institute of Immunology, National Key Laboratory of Medical Immunology, Second Military Medical University, Shanghai, China

24 Department of Surgery, Ohio State University, Columbus, OH, USA

25 Department of Surgery, University of Michigan Medical Center, Ann Arbor, MI

26 Faculty of Medicine, Vilnius University, Vilnius, Lithuania

27 University of Queensland, Brisbane, Australia

28 Ovarian Cancer Research Center, University of Pennsylvania Medical Center, Philadelphia, A, USA

29 Department of Medical Oncology, VU Medical Center, Cancer Center Amsterdam Amsterdam, The Netherlands

30 Hoag Institute for Research and Education, Hoag Cancer Institute, Newport Beach, CA, USA

31 Department of Laboratory Medicine, Nijmegen Centre for Molecular Life Sciences, Radboud University, Nijmegen Medical Centre, Nijmegen, The Netherlands

32 Department of Medical Oncology, Dana-Farber Cancer Institute, Boston, MA, USA

33 Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA

34 Harvard Medical School, Boston, MA, USA

35 Academic Department of Clinical Oncology, University of Nottingham, Nottingham, UK

36 Department of Immunology, Cleveland Clinic Foundation, Cleveland, OH, USA

37 INSERM U872, Cordeliers Research Center, Paris, France

38 Alnylam Pharmaceuticals, Inc., Cambridge, MA, USA

39 Institute for Cell Biology, Department of Immunology, University of Tuebingen, Tuebingen, Germany

40 Istituto Clinico Humanitas, IRCCS, Milan, Italy

41 Oncology Department, Oncology Institute Bari, Italy

42 University of Lund, Lund, Sweden

43 CanImGuide Therapeutics AB, Hoellviken, Sweden

44 University of California, San Francisco, CA and Celgene Corporation, San Francisco, CA, USA

45 Intrexon Corporation, Germantown,MD, USA

46 Department of Medicine, Harvard Medical School, Boston, MA, USA

47 Dana-Farber Cancer Institute, Boston, MA, USA

48 Bristol-Myers Squibb Company, Wallingford, Connecticut, USA

49 Translational Oncology & Immunology Centre TRON at the Mainz University Medical Center, Mainz, Germany

50 Department of Melanoma Medical Oncology, MD Anderson Cancer Center, Houston, TX, USA

51 The Institute of Medical Science, The University of Tokyo, Tokyo, Japan

52 Department of Oncology, the Sidney Kimmel Cancer Center at Johns Hopkins, Baltimore, MD, USA

53 ZellNet Consulting, Inc., Fort Lee, NJ, USA

54 Pathology and Laboratory Medicine, University of Pennsylvania, Philadelphia, PA, USA

55 Rush University Cancer Center, Rush University Medical Center, Chicago, IL, USA

56 School of Medicine and Public Health, Kyoto University, Kyoto, Japan

57 Division of Cellular Signaling, Institute for Advanced Medical Research, Keio University School of Medicine, Tokyo, Japan

58 Dept. of Hematology and Medical Oncology, Charité Comprehensive Cancer Center, Berlin, Germany

59 Cancer Vaccine Section, NCI, NIH, Bethesda, MD, USA

60 Department of Oncology - Pathology, Cancer Center Karolinska, Karolinska Institute, Karolinska University Hospital, Stockholm, Sweden

61 Department of Molecular Immunology and Toxicology, Center of Surgical and Molecular Tumor pathology, National Institute of Oncology, Budapest, Hungary

62 INSERM, U848, Institut Gustave Roussy, Villejuif, France

63 Research Center, University Hospital, Université de Montréal (CRCHUM), Montréal, Québec, Canada

64 Institut du Cancer de, Montréal, Montréal, Québec, Canada

65 School of Medicine, Oncology Center, Johns Hopkins University, Baltimore, MD, USA

66 Department of Molecular Oncology, Foundation San Raffaele Scientific Institute, Milan, Italy

67 Medical Oncology and Immunotherapy, Department of Oncology, University, Hospital of Siena, Istituto Toscano Tumori, Siena, Italy

68 Merck KGaA, Darmstadt, Germany

69 Department of Medical Oncology, Thomas Jefferson University, Philadelphia, PA, USA

70 Department of Oncology-Pathology, Karolinska Institute, Stockholm, Sweden

71 Department of Immunology, CIMA, CUN and Medical School University of Navarra, Pamplona, Spain

72 Deptartment of Immunohematology and Blood Transfusion, Leiden University Medical Centre, Leiden, the Netherlands

73 University of California-Davis Medical Center, Sacramento, CA, USA

74 Deeley Research Centre, BC Cancer Agency, Victoria, BC, Canada

75 Department of Internal Medicine, University of Pisa, Santa Chiara Hospital, Pisa, Italy

76 Oncology Institute, Loyola University Medical Center, Cardinal Bernardin Cancer Center, Maywood, IL, USA

77 Department of Gynecologic Oncology, Tumor Immunology and Immunotherapy Program, Roswell Park Cancer Institute, Buffalo, NY, USA

78 Ontario Cancer Institute/University Health Network, Toronto, ON, Canada

79 Cancer Research Institute, New York, NY, USA

80 Ludwig Institute for Cancer Research, New York, NY, USA

81 Experimental Cancer Medicine Centre, University of Southampton Faculty of Medicine, Southampton, UK

82 Cancer Immunology and Immunotherapy Center, Saint Savas Cancer Hospital, Athens, Greece

83 Unit of Immuno-Biotherapy of Melanoma and Solid Tumors, San Raffaele Scientific Institute, Milan, Italy

84 Center for Medical Research, University of Tuebingen, Tuebingen, Germany

85 Istituto Superiore di Sanita', Rome, Italy

86 Chinese PLA Cancer Center, Nanjing, China

87 The John van Geest Cancer Research Centre, School of Science and Technology, Nottingham Trent University, Nottingham, UK

88 Department of Medicine, Jonsson Comprehensive Cancer Center, UCLA, Los Angeles, California, USA

89 Immunoterapia e Terapia Cellulare Somatica, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.), Meldola (FC), Italy

90 Unit of Immunotherapy of Human Tumors, IRCCS Foundation, Istituto Nazionale Tumori, Milan, Italy

91 Division of Clinical Onco-Immunology, Ludwig Center for Cancer Research of the University of Lausanne, Epalinges, Switzerland

92 Immunology and Biotechnology Unit, Department of Zoology, Faculty of Science, Tanta University, Egypt

93 Dept. of Pathology, VU University Medical Center, Amsterdam, The Netherlands

94 Institute of Medical Immunology, Halle, Germany

95 MD Anderson Cancer Center, Houston, TX, USA

96 Department of Cancer Vaccine, Mie University Graduate School of Medicine, Mie, Japan

97 Department of Immuno-gene Therapy, Mie University Graduate School of Medicine, Mie, Japan

98 Immatics Biotechnologies GmbH, Tübingen, Germany

99 Millennium: The Takeda Oncology Company, Cambridge, MA, USA

100 Center for Cancer Immune Therapy (CCIT), Department of Hematology, Herlev Hospital, Herlev, Denmark

101 Department of Surgery and Bioengineering, Advanced Clinical Research Center, Institute of Medical Science, The University of Tokyo, Tokyo, Japan

102 Institute of Immunology, School of Life Sciences, University of Science & Technology of China, Hefei, China

103 Institute of Immunopharmacology & Immunotherapy, School of Pharmaceutical Sciences, Shandong University, Jinan, China

104 Experimental Cancer Immunology and Therapy, Department of Clinical Oncology, Leiden University Medical Center, Leiden, Netherlands

105 Euraccine Consulting Group, Brussels, Belgium

106 Infectious Disease and Immunogenetics Section (IDIS), Department of Transfusion Medicine, Clinical Center, NIH, Bethesda, MD, USA

107 Center for Human Immunology (CHI), NIH, Bethesda, MD, USA

108 Experimental Cancer Immunology and Therapy, Department of Clinical Oncology (K1-P), Leiden University Medical Center, Leiden, The Netherlands

109 Department of Surgery, Klinikum Grosshadern, Ludwig Maximilians University, Munich, Germany

110 Society for Immunotherapy of Cancer, Milwaukee, WI, USA

111 Institute of Immunology, School of Life Science, University of Science and Technology of China, Hefei, China

112 Institut Gustave Roussy, Center of Clinical Investigations CICBT507, Villejuif, France

113 Department Haematology and Oncology Innsbruck Medical University, Innsbruck, Austria

114 University of Chicago Medical Center, Chicago, IL, USA

115 Discovery Medicine-Oncology, Bristol-Myers Squibb Company, Princeton, New Jersey, USA

116 Tumor Vaccine Group, Center for Translational Medicine in Women's Health, University of Washington, Seattle, WA, USA

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Journal of Translational Medicine 2011, 9:214  doi:10.1186/1479-5876-9-214

Published: 14 December 2011

Abstract

Scientific discoveries that provide strong evidence of antitumor effects in preclinical models often encounter significant delays before being tested in patients with cancer. While some of these delays have a scientific basis, others do not. We need to do better. Innovative strategies need to move into early stage clinical trials as quickly as it is safe, and if successful, these therapies should efficiently obtain regulatory approval and widespread clinical application. In late 2009 and 2010 the Society for Immunotherapy of Cancer (SITC), convened an "Immunotherapy Summit" with representatives from immunotherapy organizations representing Europe, Japan, China and North America to discuss collaborations to improve development and delivery of cancer immunotherapy. One of the concepts raised by SITC and defined as critical by all parties was the need to identify hurdles that impede effective translation of cancer immunotherapy. With consensus on these hurdles, international working groups could be developed to make recommendations vetted by the participating organizations. These recommendations could then be considered by regulatory bodies, governmental and private funding agencies, pharmaceutical companies and academic institutions to facilitate changes necessary to accelerate clinical translation of novel immune-based cancer therapies. The critical hurdles identified by representatives of the collaborating organizations, now organized as the World Immunotherapy Council, are presented and discussed in this report. Some of the identified hurdles impede all investigators; others hinder investigators only in certain regions or institutions or are more relevant to specific types of immunotherapy or first-in-humans studies. Each of these hurdles can significantly delay clinical translation of promising advances in immunotherapy yet if overcome, have the potential to improve outcomes of patients with cancer.