SITC Announces Validation of Global Immune Biomarker Study


June 5, 2016

Results of SITC-led, international collaboration validate the prognostic value of Immunoscore in colon cancer and further highlight the importance of collaboration in the fight against cancer

CHICAGO, IL - 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 today’s oral abstract session at the 2016 American Society for Clinical Oncology (ASCO) Annual Meeting. The findings ultimately validate the prognostic value of Immunoscore in an international cohort of colon cancer patients. Furthermore, the success of this study emphasizes the importance and the promise that collaboration holds for the fight against cancer.

“The SITC-led Immunoscore project was formed as a result of a manuscript outlining the key hurdles in the field of cancer immunotherapy. This collaborative effort among experts in medical centers worldwide has not only resulted in the validation of a standardized test that has the potential to be transformative for the field of oncology, but also leads the way for future collaborations and information exchange critical to advancing the field,” said Dr. Bernard Fox, past SITC President and SITC Immunoscore Steering Committee Chair.

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.

In this morning’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.

"The Immunoscore validation data confirms the importance of the interaction between the immune system and cancer," said Dr. Howard Kaufman, SITC President. “SITC is proud to have contributed to this important work," he added, "since the findings will help improve cancer prognosis and may also help guide patient selection for treatment and be an important predictive biomarker of response to immunotherapy."

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. This type of interdisciplinary collaboration is vital in the pursuit of a cure for cancer, as stated earlier this year by Vice President Joe Biden. SITC is extremely proud to have played a role in such an important initiative.

Established in 1984, the Society for Immunotherapy of Cancer (SITC) is a non-profit organization of medical professionals dedicated to improving cancer patient outcomes by advancing the development, science and application of cancer immunotherapy and tumor immunology. SITC is comprised of influential basic and translational scientists, practitioners, healthcare professionals, government leaders and industry professionals around the globe. Through educational initiatives that foster scientific exchange and collaboration among leaders in the field, SITC aims to one day make the word “cure” a reality for cancer patients everywhere. Learn more about SITC, our educational offerings and other resources at


Media Contact

Erin Irelan, SITC Communications Manager