Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers

Lisa H. Butterfield, A. Karolina Palucka, Cedrik M. Britten, Madhav V. Dhodapkar, Leif Håkansson, Sylvia Janetzki, Yutaka Kawakami, Thomas Oliver Kleen, Peter P. Lee, Cristina Maccalli, Holden T. Maecker, Vernon C. Maino, Michele Maio, Anatoli Malyguine, Giuseppe Masucci, Graham Pawelec, Douglas M. Potter, Licia Rivoltini, Lupe G. Salazar, Dolores J. Schendel & 13 others Craig L. Slingluff, Wenru Song, David F. Stroncek, Hideaki Tahara, Magdalena Thurin, Giorgio Trinchieri, Sjoerd H. Van Der Burg, Theresa L. Whiteside, Jon M. Wigginton, Francesco Marincola, Samir N. Khleif, Bernard A. Fox, Mary L. Disis

Research output: Contribution to journalReview article

79 Citations (Scopus)

Abstract

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.

Original languageEnglish (US)
Pages (from-to)3064-3076
Number of pages13
JournalClinical Cancer Research
Volume17
Issue number10
DOIs
StatePublished - May 15 2011

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Biological Therapy
National Cancer Institute (U.S.)
United States Food and Drug Administration
Immunotherapy
Biomarkers
Education
Immunity
Neoplasms
Immunologic Monitoring
Quality Control
Research Design
RNA
DNA
Therapeutics
Serum

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

Cite this

Butterfield, L. H., Palucka, A. K., Britten, C. M., Dhodapkar, M. V., Håkansson, L., Janetzki, S., ... Disis, M. L. (2011). Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers. Clinical Cancer Research, 17(10), 3064-3076. https://doi.org/10.1158/1078-0432.CCR-10-2234

Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers. / Butterfield, Lisa H.; Palucka, A. Karolina; Britten, Cedrik M.; Dhodapkar, Madhav V.; Håkansson, Leif; Janetzki, Sylvia; Kawakami, Yutaka; Kleen, Thomas Oliver; Lee, Peter P.; Maccalli, Cristina; Maecker, Holden T.; Maino, Vernon C.; Maio, Michele; Malyguine, Anatoli; Masucci, Giuseppe; Pawelec, Graham; Potter, Douglas M.; Rivoltini, Licia; Salazar, Lupe G.; Schendel, Dolores J.; Slingluff, Craig L.; Song, Wenru; Stroncek, David F.; Tahara, Hideaki; Thurin, Magdalena; Trinchieri, Giorgio; Van Der Burg, Sjoerd H.; Whiteside, Theresa L.; Wigginton, Jon M.; Marincola, Francesco; Khleif, Samir N.; Fox, Bernard A.; Disis, Mary L.

In: Clinical Cancer Research, Vol. 17, No. 10, 15.05.2011, p. 3064-3076.

Research output: Contribution to journalReview article

Butterfield, LH, Palucka, AK, Britten, CM, Dhodapkar, MV, Håkansson, L, Janetzki, S, Kawakami, Y, Kleen, TO, Lee, PP, Maccalli, C, Maecker, HT, Maino, VC, Maio, M, Malyguine, A, Masucci, G, Pawelec, G, Potter, DM, Rivoltini, L, Salazar, LG, Schendel, DJ, Slingluff, CL, Song, W, Stroncek, DF, Tahara, H, Thurin, M, Trinchieri, G, Van Der Burg, SH, Whiteside, TL, Wigginton, JM, Marincola, F, Khleif, SN, Fox, BA & Disis, ML 2011, 'Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers', Clinical Cancer Research, vol. 17, no. 10, pp. 3064-3076. https://doi.org/10.1158/1078-0432.CCR-10-2234
Butterfield LH, Palucka AK, Britten CM, Dhodapkar MV, Håkansson L, Janetzki S et al. Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers. Clinical Cancer Research. 2011 May 15;17(10):3064-3076. https://doi.org/10.1158/1078-0432.CCR-10-2234
Butterfield, Lisa H. ; Palucka, A. Karolina ; Britten, Cedrik M. ; Dhodapkar, Madhav V. ; Håkansson, Leif ; Janetzki, Sylvia ; Kawakami, Yutaka ; Kleen, Thomas Oliver ; Lee, Peter P. ; Maccalli, Cristina ; Maecker, Holden T. ; Maino, Vernon C. ; Maio, Michele ; Malyguine, Anatoli ; Masucci, Giuseppe ; Pawelec, Graham ; Potter, Douglas M. ; Rivoltini, Licia ; Salazar, Lupe G. ; Schendel, Dolores J. ; Slingluff, Craig L. ; Song, Wenru ; Stroncek, David F. ; Tahara, Hideaki ; Thurin, Magdalena ; Trinchieri, Giorgio ; Van Der Burg, Sjoerd H. ; Whiteside, Theresa L. ; Wigginton, Jon M. ; Marincola, Francesco ; Khleif, Samir N. ; Fox, Bernard A. ; Disis, Mary L. / Recommendations from the iSBTc-SITC/FDA/NCI workshop on immunotherapy biomarkers. In: Clinical Cancer Research. 2011 ; Vol. 17, No. 10. pp. 3064-3076.
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abstract = "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.",
author = "Butterfield, {Lisa H.} and Palucka, {A. Karolina} and Britten, {Cedrik M.} and Dhodapkar, {Madhav V.} and Leif H{\aa}kansson and Sylvia Janetzki and Yutaka Kawakami and Kleen, {Thomas Oliver} and Lee, {Peter P.} and Cristina Maccalli and Maecker, {Holden T.} and Maino, {Vernon C.} and Michele Maio and Anatoli Malyguine and Giuseppe Masucci and Graham Pawelec and Potter, {Douglas M.} and Licia Rivoltini and Salazar, {Lupe G.} and Schendel, {Dolores J.} and Slingluff, {Craig L.} and Wenru Song and Stroncek, {David F.} and Hideaki Tahara and Magdalena Thurin and Giorgio Trinchieri and {Van Der Burg}, {Sjoerd H.} and Whiteside, {Theresa L.} and Wigginton, {Jon M.} and Francesco Marincola and Khleif, {Samir N.} and Fox, {Bernard A.} and Disis, {Mary L.}",
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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

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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.

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