title: De-Risking Immunotherapy: Report of a Consensus Workshop of the Cancer Immunotherapy Consortium of the Cancer Research Institute.
abstract: With the recent FDA approvals of pembrolizumab and nivolumab, and a host of additional immunomodulatory agents entering clinical development each year, the field of cancer immunotherapy is changing rapidly. Strategies that can assist researchers in choosing the most promising drugs and drug combinations to move forward through clinical development are badly needed in order to reduce the likelihood of late-stage clinical trial failures. On October 5, 2014, the Cancer Immunotherapy Consortium of the Cancer Research Institute, a collaborative think tank composed of stakeholders from academia, industry, regulatory agencies, and patient interest groups, met to discuss strategies for de-risking immunotherapy development, with a focus on integrating preclinical and clinical studies, and conducting smarter early-phase trials, particularly for combination therapies. Several recommendations were made, including making better use of clinical data to inform preclinical research, obtaining adequate tissues for biomarker studies, and choosing appropriate clinical trial endpoints to identify promising drug candidates and combinations in nonrandomized early-phase trials.
authors.affiliation: Genentech, San Francisco, California.
authors.forename: Ira
authors.initials: I
authors.lastname: Mellman
authors.affiliation: Cancer Research Institute, New York, New York.
authors.forename: Vanessa M
authors.initials: VM
authors.lastname: Hubbard-Lucey
authors.affiliation: Cancer Research Institute, New York, New York.
authors.forename: Matthew J
authors.initials: MJ
authors.lastname: Tontonoz
authors.affiliation: Eli Lilly & Company, New York, New York.
authors.forename: Michael D
authors.initials: MD
authors.lastname: Kalos
authors.affiliation: Genentech, San Francisco, California.
authors.forename: Daniel S
authors.initials: DS
authors.lastname: Chen
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, Texas.
authors.forename: James P
authors.initials: JP
authors.lastname: Allison
authors.affiliation: Johns Hopkins School of Medicine, Baltimore, Maryland.
authors.forename: Charles G
authors.initials: CG
authors.lastname: Drake
authors.affiliation: Roche Innovation Center, Zurich, Switzerland.
authors.forename: Hy
authors.initials: H
authors.lastname: Levitsky
authors.affiliation: Bristol-Myers Squibb, New York, New York.
authors.forename: Nils
authors.initials: N
authors.lastname: Lonberg
authors.affiliation: Leiden University Medical Center, Leiden, the Netherlands.
authors.forename: Sjoerd H
authors.initials: SH
authors.lastname: van der Burg
authors.affiliation: Cold Spring Harbor Laboratory, Cold Spring Harbor, New York.
authors.forename: Douglas T
authors.initials: DT
authors.lastname: Fearon
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: E John
authors.initials: EJ
authors.lastname: Wherry
authors.affiliation: Regeneron Pharmaceuticals, Tarrytown, New York.
authors.forename: Israel
authors.initials: I
authors.lastname: Lowy
authors.affiliation: Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Vonderheide
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, Texas. phwu@mdanderson.org.
authors.forename: Patrick
authors.initials: P
authors.lastname: Hwu
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000494:pharmacology / Q000627:therapeutic use; D019496:Cancer Vaccines / Q000276:immunology / Q000627:therapeutic use; D017321:Clinical Trials, Phase I as Topic; D003131:Combined Modality Therapy; D004195:Disease Models, Animal; D055808:Drug Discovery; D004353:Drug Evaluation, Preclinical; D006801:Humans; D007167:Immunotherapy / Q000009:adverse effects / Q000379:methods; D051379:Mice; D058990:Molecular Targeted Therapy; D009369:Neoplasms / Q000276:immunology* / Q000628:therapy*
chemical_list: D000911:Antibodies, Monoclonal; D019496:Cancer Vaccines