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Cancer Immunol Res. 2016 Apr;4(4):279-88. doi: 10.1158/2326-6066.CIR-16-0045.

De-Risking Immunotherapy: Report of a Consensus Workshop of the Cancer Immunotherapy Consortium of the Cancer Research Institute.

Author information

1
Genentech, San Francisco, California.
2
Cancer Research Institute, New York, New York.
3
Eli Lilly & Company, New York, New York.
4
The University of Texas MD Anderson Cancer Center, Houston, Texas.
5
Johns Hopkins School of Medicine, Baltimore, Maryland.
6
Roche Innovation Center, Zurich, Switzerland.
7
Bristol-Myers Squibb, New York, New York.
8
Leiden University Medical Center, Leiden, the Netherlands.
9
Cold Spring Harbor Laboratory, Cold Spring Harbor, New York.
10
Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania.
11
Regeneron Pharmaceuticals, Tarrytown, New York.
12
The University of Texas MD Anderson Cancer Center, Houston, Texas. phwu@mdanderson.org.

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.

PMID:
27036972
DOI:
10.1158/2326-6066.CIR-16-0045
[Indexed for MEDLINE]
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