Defining the critical hurdles in cancer immunotherapy

Bernard A Fox, Dolores J Schendel, Lisa H Butterfield, Steinar Aamdal, James P Allison, Paolo Antonio Ascierto, Michael B Atkins, Jirina Bartunkova, Lothar Bergmann, Neil Berinstein, Cristina C Bonorino, Ernest Borden, Jonathan L Bramson, Cedrik M Britten, Xuetao Cao, William E Carson, Alfred E Chang, Dainius Characiejus, A Raja Choudhury, George Coukos, Tanja de Gruijl, Robert O Dillman, Harry Dolstra, Glenn Dranoff, Lindy G Durrant, James H Finke, Jerome Galon, Jared A Gollob, Cécile Gouttefangeas, Fabio Grizzi, Michele Guida, Leif Håkansson, Kristen Hege, Ronald B Herberman, F Stephen Hodi, Axel Hoos, Christoph Huber, Patrick Hwu, Kohzoh Imai, Elizabeth M Jaffee, Sylvia Janetzki, Carl H June, Pawel Kalinski, Howard L Kaufman, Koji Kawakami, Yutaka Kawakami, Ulrich Keilholtz, Samir N Khleif, Rolf Kiessling, Beatrix Kotlan, Guido Kroemer, Rejean Lapointe, Hyam I Levitsky, Michael T Lotze, Cristina Maccalli, Michele Maio, Jens-Peter Marschner, Michael J Mastrangelo, Giuseppe Masucci, Ignacio Melero, Cornelius Melief, William J Murphy, Brad Nelson, Andrea Nicolini, Michael I Nishimura, Kunle Odunsi, Pamela S Ohashi, Jill O'Donnell-Tormey, Lloyd J Old, Christian Ottensmeier, Michael Papamichail, Giorgio Parmiani, Graham Pawelec, Enrico Proietti, Shukui Qin, Robert Rees, Antoni Ribas, Ruggero Ridolfi, Gerd Ritter, Licia Rivoltini, Pedro J Romero, Mohamed L Salem, Rik J Scheper, Barbara Seliger, Padmanee Sharma, Hiroshi Shiku, Harpreet Singh-Jasuja, Wenru Song, Per Thor Straten, Hideaki Tahara, Zhigang Tian, Sjoerd H van Der Burg, Paul von Hoegen, Ena Wang, Marij JP Welters, Hauke Winter, Tara Withington, Jedd D Wolchok, Weihua Xiao, Laurence Zitvogel, Heinz Zwierzina, Francesco M Marincola, Thomas F Gajewski, Jon M Wigginton, Mary L Disis

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.