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June 6, 2016

SITC Announces Validation of Global Immune Biomarker Study and Release of Key Information

Latest Results

Results from the Society for Immunotherapy of Cancer (SITC)-led Immunoscore worldwide consortium were presented by Dr. Jérôme Galon, principal investigator and SITC Board member, in yesterday’s oral abstract session at the 2016 American Society for Clinical Oncology (ASCO) Annual Meeting.

In yesterday’s presentation, Dr. Jérôme Galon reported that the prespecified primary endpoint of the Immunoscore study had been reached. Among stage I-III colon cancer patients (n=2667), time-to-recurrence was significantly longer in patients classified as Immunoscore-High versus Immunoscore-Low in the training subset of patients (HR (95% CI), .41 (.28-.61), p<.0001) as well as two independent validation cohorts of patients – the internal validation set (HR (95% CI), .41 (.27-.65), p<.0001) and the external validation set (HR (95% CI), .51 (.38-.68), p<.0001)). Moreover, the Immunoscore classification identified a subgroup of high-risk stage II patients, as time-to-recurrence was also significantly longer in Immunoscore-High compared with Immunoscore-Low stage II colon cancer patients (n=1433) (HR (95% CI), .36 (.23-.56), p<.0001). Further analyses were also presented from this study that demonstrated the predictive value of the Immunoscore classification in secondary objectives including disease-free and overall survival among stage I-III colon cancer patients as well as multivariate statistical analyses.

Overall, the findings reported illustrate the importance of predictive immune biomarkers in cancer and may result in the implementation of the Immunoscore into current cancer staging systems. Additionally, the success of the Immunoscore worldwide consortium demonstrates the value of collaboration in the fight against cancer. SITC is extremely proud to have played a role in such an important initiative.

Key Information Release

In order to help move the Immunoscore assay into the clinic and ultimately to benefit cancer patients, SITC is pleased to announce a key information release from the SITC Immunoscore Validation Project. Under this release, detailed methodology used to calculate the Immunoscore will be distributed to qualified entities upon request including:

  • Values of validated cut-points used to calculate the individual scores for each marker
  • Method and values for grouping patients into Immunoscore classes
  • Density distributions for the hotspots and regions of interest for the entire cohort as well as each center
  • Inter-laboratory precision for density measures and Immunoscore assessment
  • Quality criteria used to qualify laboratories

For application instructions and review criteria, please visit here.

About

Mounting evidence has illustrated the powerful predictive value of characterizing immune cell infiltrates within the tumor microenvironment. Therefore, the Immunoscore was developed as a standardized assay to evaluate the immune contexture by measuring the density of immune cells (CD3+ lymphocytes/CD8+ cytotoxic T cells) in the tumor core as well as in the invasive tumor margin. Initiated by SITC in 2012 with 23 pathology centers from 17 countries worldwide, more than 3,500 patient samples were evaluated for this study. To learn more about the SITC Immunoscore Validation Project, visit here. For questions regarding the key information release, please email scientificresources@sitcancer.org or call (414) 271-2456

Disclaimers

The SITC Immunoscore Validation Project is a collaborative effort comprised of international experts and data from medical centers worldwide. SITC has acted solely as a facilitator in this project and is furnishing this information "as is".

1. No Warranties or Representations
The data and information designated for release will be furnished “as is.” SITC makes no warranties or representations, expressed, implied or otherwise, regarding the accuracy, completeness or performance of the information provided in this release, or of the data and information referred to herein.

2. Release from Liability
SITC accepts no responsibility or liability for any use of the data and information released. All recipients will be required to release SITC from any and all liability related to or arising from use of the data and information.

3. No Licenses Granted
The Immunoscore® is a trademark of INSERM (2012-08-10). Various patent applications and patents have been filed and/or granted in jurisdictions throughout the world covering methods and materials related to prognosis and/or response to cancer therapeutics, including the clinical use of immune-oncology biomarkers, the Immunoscore concept and method, and gene expression signatures. NO LICENSE or other right to use under any copyright, trademark right, patent right, or any other property right, is granted or otherwise transferred or conveyed by the release of this data and information referred to herein.
 

Society for Immunotherapy of Cancer (SITC)
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Phone: +1 414 271 2456 | Email: info@sitcancer.org

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