TY - JOUR
T1 - Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers
AU - Butterfield, Lisa H.
AU - Palucka, A. Karolina
AU - Britten, Cedrik M.
AU - Dhodapkar, Madhav V.
AU - Håkansson, Leif
AU - Janetzki, Sylvia
AU - Kawakami, Yutaka
AU - Kleen, Thomas Oliver
AU - Lee, Peter P.
AU - Maccalli, Cristina
AU - Maecker, Holden T.
AU - Maino, Vernon C.
AU - Maio, Michele
AU - Malyguine, Anatoli
AU - Masucci, Giuseppe
AU - Pawelec, Graham
AU - Potter, Douglas M.
AU - Rivoltini, Licia
AU - Salazar, Lupe G.
AU - Schendel, Dolores J.
AU - Slingluff, Craig L.
AU - Song, Wenru
AU - Stroncek, David F.
AU - Tahara, Hideaki
AU - Thurin, Magdalena
AU - Trinchieri, Giorgio
AU - Van Der Burg, Sjoerd H.
AU - Whiteside, Theresa L.
AU - Wigginton, Jon M.
AU - Marincola, Francesco
AU - Khleif, Samir N.
AU - Fox, Bernard A.
AU - Disis, Mary L.
PY - 2011/5/15
Y1 - 2011/5/15
N2 - Purpose: To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of antitumor immunity to measure and which assays are optimal for those measurements. Experimental Design: The iSBTc-SITC (International Society for Biological Therapy of Cancer-Society for Immunotherapy of Cancer), FDA (Food and Drug Administration), and NCI (National Cancer Institute) partnered to address these issues for immunotherapy of cancer. Here, we review the major challenges, give examples of approaches and solutions, and present our recommendations. Results and Conclusions: Although specific immune parameters and assays are not yet validated, we recommend following standardized (accurate, precise, and reproducible) protocols and use of functional assays for the primary immunologic readouts of a trial; consideration of central laboratories for immune monitoring of large, multi-institutional trials; and standardized testing of several phenotypic and functional potential potency assays specific to any cellular product. When reporting results, the full QA (quality assessment)/QC (quality control) should be conducted and selected examples of truly representative raw data and assay performance characteristics should be included. Finally, to promote broader analysis of multiple aspects of immunity, and gather data on variability, we recommend that in addition to cells and serum, RNA and DNA samples be banked (under standardized conditions) for later testing. We also recommend that sufficient blood be drawn to allow for planned testing of the primary hypothesis being addressed in the trial, and that additional baseline and posttreatment blood is banked for testing novel hypotheses (or generating new hypotheses) that arise in the field.
AB - Purpose: To facilitate development of innovative immunotherapy approaches, especially for treatment concepts exploiting the potential benefits of personalized therapy, there is a need to develop and validate tools to identify patients who can benefit from immunotherapy. Despite substantial effort, we do not yet know which parameters of antitumor immunity to measure and which assays are optimal for those measurements. Experimental Design: The iSBTc-SITC (International Society for Biological Therapy of Cancer-Society for Immunotherapy of Cancer), FDA (Food and Drug Administration), and NCI (National Cancer Institute) partnered to address these issues for immunotherapy of cancer. Here, we review the major challenges, give examples of approaches and solutions, and present our recommendations. Results and Conclusions: Although specific immune parameters and assays are not yet validated, we recommend following standardized (accurate, precise, and reproducible) protocols and use of functional assays for the primary immunologic readouts of a trial; consideration of central laboratories for immune monitoring of large, multi-institutional trials; and standardized testing of several phenotypic and functional potential potency assays specific to any cellular product. When reporting results, the full QA (quality assessment)/QC (quality control) should be conducted and selected examples of truly representative raw data and assay performance characteristics should be included. Finally, to promote broader analysis of multiple aspects of immunity, and gather data on variability, we recommend that in addition to cells and serum, RNA and DNA samples be banked (under standardized conditions) for later testing. We also recommend that sufficient blood be drawn to allow for planned testing of the primary hypothesis being addressed in the trial, and that additional baseline and posttreatment blood is banked for testing novel hypotheses (or generating new hypotheses) that arise in the field.
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U2 - 10.1158/1078-0432.CCR-10-2234
DO - 10.1158/1078-0432.CCR-10-2234
M3 - Review article
C2 - 21558394
AN - SCOPUS:79956000143
SN - 1078-0432
VL - 17
SP - 3064
EP - 3076
JO - Clinical Cancer Research
JF - Clinical Cancer Research
IS - 10
ER -
