title: Defining the critical hurdles in cancer immunotherapy.
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.
authors.affiliation: Earle A, Chiles Research Institute, Robert W, Franz Research Center, Providence Cancer Center, Providence Portland Medical Center, Portland, OR, USA. foxb@foxlab.org
authors.forename: Bernard A
authors.initials: BA
authors.lastname: Fox
authors.forename: Dolores J
authors.initials: DJ
authors.lastname: Schendel
authors.forename: Lisa H
authors.initials: LH
authors.lastname: Butterfield
authors.forename: Steinar
authors.initials: S
authors.lastname: Aamdal
authors.forename: James P
authors.initials: JP
authors.lastname: Allison
authors.forename: Paolo Antonio
authors.initials: PA
authors.lastname: Ascierto
authors.forename: Michael B
authors.initials: MB
authors.lastname: Atkins
authors.forename: Jirina
authors.initials: J
authors.lastname: Bartunkova
authors.forename: Lothar
authors.initials: L
authors.lastname: Bergmann
authors.forename: Neil
authors.initials: N
authors.lastname: Berinstein
authors.forename: Cristina C
authors.initials: CC
authors.lastname: Bonorino
authors.forename: Ernest
authors.initials: E
authors.lastname: Borden
authors.forename: Jonathan L
authors.initials: JL
authors.lastname: Bramson
authors.forename: Cedrik M
authors.initials: CM
authors.lastname: Britten
authors.forename: Xuetao
authors.initials: X
authors.lastname: Cao
authors.forename: William E
authors.initials: WE
authors.lastname: Carson
authors.forename: Alfred E
authors.initials: AE
authors.lastname: Chang
authors.forename: Dainius
authors.initials: D
authors.lastname: Characiejus
authors.forename: A Raja
authors.initials: AR
authors.lastname: Choudhury
authors.forename: George
authors.initials: G
authors.lastname: Coukos
authors.forename: Tanja
authors.initials: T
authors.lastname: de Gruijl
authors.forename: Robert O
authors.initials: RO
authors.lastname: Dillman
authors.forename: Harry
authors.initials: H
authors.lastname: Dolstra
authors.forename: Glenn
authors.initials: G
authors.lastname: Dranoff
authors.forename: Lindy G
authors.initials: LG
authors.lastname: Durrant
authors.forename: James H
authors.initials: JH
authors.lastname: Finke
authors.forename: Jerome
authors.initials: J
authors.lastname: Galon
authors.forename: Jared A
authors.initials: JA
authors.lastname: Gollob
authors.forename: Cécile
authors.initials: C
authors.lastname: Gouttefangeas
authors.forename: Fabio
authors.initials: F
authors.lastname: Grizzi
authors.forename: Michele
authors.initials: M
authors.lastname: Guida
authors.forename: Leif
authors.initials: L
authors.lastname: Håkansson
authors.forename: Kristen
authors.initials: K
authors.lastname: Hege
authors.forename: Ronald B
authors.initials: RB
authors.lastname: Herberman
authors.forename: F Stephen
authors.initials: FS
authors.lastname: Hodi
authors.forename: Axel
authors.initials: A
authors.lastname: Hoos
authors.forename: Christoph
authors.initials: C
authors.lastname: Huber
authors.forename: Patrick
authors.initials: P
authors.lastname: Hwu
authors.forename: Kohzoh
authors.initials: K
authors.lastname: Imai
authors.forename: Elizabeth M
authors.initials: EM
authors.lastname: Jaffee
authors.forename: Sylvia
authors.initials: S
authors.lastname: Janetzki
authors.forename: Carl H
authors.initials: CH
authors.lastname: June
authors.forename: Pawel
authors.initials: P
authors.lastname: Kalinski
authors.forename: Howard L
authors.initials: HL
authors.lastname: Kaufman
authors.forename: Koji
authors.initials: K
authors.lastname: Kawakami
authors.forename: Yutaka
authors.initials: Y
authors.lastname: Kawakami
authors.forename: Ulrich
authors.initials: U
authors.lastname: Keilholtz
authors.forename: Samir N
authors.initials: SN
authors.lastname: Khleif
authors.forename: Rolf
authors.initials: R
authors.lastname: Kiessling
authors.forename: Beatrix
authors.initials: B
authors.lastname: Kotlan
authors.forename: Guido
authors.initials: G
authors.lastname: Kroemer
authors.forename: Rejean
authors.initials: R
authors.lastname: Lapointe
authors.forename: Hyam I
authors.initials: HI
authors.lastname: Levitsky
authors.forename: Michael T
authors.initials: MT
authors.lastname: Lotze
authors.forename: Cristina
authors.initials: C
authors.lastname: Maccalli
authors.forename: Michele
authors.initials: M
authors.lastname: Maio
authors.forename: Jens-Peter
authors.initials: JP
authors.lastname: Marschner
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Mastrangelo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Masucci
authors.forename: Ignacio
authors.initials: I
authors.lastname: Melero
authors.forename: Cornelius
authors.initials: C
authors.lastname: Melief
authors.forename: William J
authors.initials: WJ
authors.lastname: Murphy
authors.forename: Brad
authors.initials: B
authors.lastname: Nelson
authors.forename: Andrea
authors.initials: A
authors.lastname: Nicolini
authors.forename: Michael I
authors.initials: MI
authors.lastname: Nishimura
authors.forename: Kunle
authors.initials: K
authors.lastname: Odunsi
authors.forename: Pamela S
authors.initials: PS
authors.lastname: Ohashi
authors.forename: Jill
authors.initials: J
authors.lastname: O'Donnell-Tormey
authors.forename: Lloyd J
authors.initials: LJ
authors.lastname: Old
authors.forename: Christian
authors.initials: C
authors.lastname: Ottensmeier
authors.forename: Michael
authors.initials: M
authors.lastname: Papamichail
authors.forename: Giorgio
authors.initials: G
authors.lastname: Parmiani
authors.forename: Graham
authors.initials: G
authors.lastname: Pawelec
authors.forename: Enrico
authors.initials: E
authors.lastname: Proietti
authors.forename: Shukui
authors.initials: S
authors.lastname: Qin
authors.forename: Robert
authors.initials: R
authors.lastname: Rees
authors.forename: Antoni
authors.initials: A
authors.lastname: Ribas
authors.forename: Ruggero
authors.initials: R
authors.lastname: Ridolfi
authors.forename: Gerd
authors.initials: G
authors.lastname: Ritter
authors.forename: Licia
authors.initials: L
authors.lastname: Rivoltini
authors.forename: Pedro J
authors.initials: PJ
authors.lastname: Romero
authors.forename: Mohamed L
authors.initials: ML
authors.lastname: Salem
authors.forename: Rik J
authors.initials: RJ
authors.lastname: Scheper
authors.forename: Barbara
authors.initials: B
authors.lastname: Seliger
authors.forename: Padmanee
authors.initials: P
authors.lastname: Sharma
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Shiku
authors.forename: Harpreet
authors.initials: H
authors.lastname: Singh-Jasuja
authors.forename: Wenru
authors.initials: W
authors.lastname: Song
authors.forename: Per Thor
authors.initials: PT
authors.lastname: Straten
authors.forename: Hideaki
authors.initials: H
authors.lastname: Tahara
authors.forename: Zhigang
authors.initials: Z
authors.lastname: Tian
authors.forename: Sjoerd H
authors.initials: SH
authors.lastname: van Der Burg
authors.forename: Paul
authors.initials: P
authors.lastname: von Hoegen
authors.forename: Ena
authors.initials: E
authors.lastname: Wang
authors.forename: Marij Jp
authors.initials: MJ
authors.lastname: Welters
authors.forename: Hauke
authors.initials: H
authors.lastname: Winter
authors.forename: Tara
authors.initials: T
authors.lastname: Withington
authors.forename: Jedd D
authors.initials: JD
authors.lastname: Wolchok
authors.forename: Weihua
authors.initials: W
authors.lastname: Xiao
authors.forename: Laurence
authors.initials: L
authors.lastname: Zitvogel
authors.forename: Heinz
authors.initials: H
authors.lastname: Zwierzina
authors.forename: Francesco M
authors.initials: FM
authors.lastname: Marincola
authors.forename: Thomas F
authors.initials: TF
authors.lastname: Gajewski
authors.forename: Jon M
authors.initials: JM
authors.lastname: Wigginton
authors.forename: Mary L
authors.initials: ML
authors.lastname: Disis
mesh_terms: D006801:Humans; D007167:Immunotherapy; D007391:International Cooperation; D009369:Neoplasms / Q000628:therapy*; D057170:Translational Research, Biomedical