IMMUNOSCORE® COLON Scoring Immune Response to Cancers

for unmatched clinical performance in routine settings

Why Immunoscore® Colon?

Immunoscore® Colon is an in vitro diagnostic assay for risk of relapse assessment in colon cancer patients.

By measuring the density of CD3+ and CD8+ T lymphocyte populations in the center and at the periphery of the tumor, Immunoscore® Colon is a key risk factor to guide treatment strategies for stages II and III colon cancer patients.

Immunoscore® Colon
Material: two FFPE slides from tumor resection
Assay: CD3+ & CD8+ T cells detection by immunohistochemistry
Digital pathology: determination of  cell densities in two zones of the sample
Score & report: software computation of cell densities in relation with patient outcome

Clinical Utility

Immunoscore® Colon is a test predicting the risk of relapse of patients with localized CC to help guiding treatment strategies. By evaluating the immune reaction at the tumor site, it provides independent and superior prognostic value to usual risk factors.

A high Immunoscore predicts a low risk of relapse while a low Immunoscore indicates a weak anti-tumor immune response and a high risk of relapse. This information supports decision about adjuvant chemotherapy need (stage II) and duration of treatment (stage III). 

In the large Immunoscore® SITC study (more than 3,000 stage I-III patients), Immunoscore® was strongly predictive of the patient outcome and surpassed the TNM classification prognostic performance.

Focusing on stage II (n = 1,433 patients), Immunoscore® identified a subgroup of high-risk stage II patients (25%) who may benefit from chemotherapy.

TTR in Stage II Patients  

Galon et al. demonstrated that Immunoscore® was stronger than the MSI (Microsatellite Instability) status to predict relapse.

HalioDx intends to further document Immunoscore® clinical utility in stage II CC as a key risk factor for guiding chemotherapy prescription.

Results from the Immunoscore® validation N0147 study presented by Frank Sinicrope, at ASCO 2017 and ESMO-GI 2017 (manuscript in preparation)

Immunoscore & DFSSince 2004, a 6 months oxaliplatin-based treatment is the standard of care as adjuvant therapy for stage III CC but 25% of treated patients still relapse in this population. 
HalioDx collaborated with the Mayo Clinic on the N0147 cohort to confirm the prognostic value of Immunoscore® Colon.

The prognostic value of Immunoscore® was confirmed in stage III CC patients treated with FOLFOX alone (n=600) from the randomized Phase III adjuvant trial NCCTG N0147.

Immunoscore® High was associated with significantly better prognosis than Immunoscore® Low (81.6% vs. 66.1% 3-yr DFS; p<0.003). Results were similar regardless of the MSI status. The results were presented at the ASCO 2017 meeting.

The IDEA international collaboration results also presented @the ASCO 2017 meeting showed that for stage III colon cancer patients, a 3-month course of chemotherapy was almost as effective as a standard 6-month course while reducing the risk of neurotoxicity. A subgroup analysis further showed that the 3-month course was most appropriated for low-risk patients (T1-3, N1). Thus, a risk-based approach is now recommended by the IDEA collaboration to guide adjuvant chemotherapy prescription.

HalioDx announces clinical collaboration with PRODIGE to evaluate Immunoscore® in IDEA stage III colon cancer study (1400 patients). Results are expected to be revealed during year 2018.

A comprehensive body of clinical evidence - as of September 2017

Immunoscore® surpasses TNM for prediction of tumor recurrence and survival in CRC patients

Galon J et al. - Science 2006

Pages F et al. - JCO 2009

Mlecnik B et al. - JCO 2011

Galon J et al. - ASCO 2016

Immunoscore® is a stronger predictor of survival than MSI in CC

Mlecnik B et al. - Immunity 2016

Stage II CC patients with a Immunoscore Low have a higher risk of recurrence

Galon J et al. - ASCO 2016 - Oral presentation of the SITC Immunoscore® study  (manuscript submitted)

Stage III CC patients with a Immunoscore High have a lower risk of recurrence regardless of the MSI status

Sinicrope FA et al. - ASCO 2017 - Poster (manuscript in preparation)

HalioDx is conducting multiple studies to reach a higher level of clinical evidence. This will further support the Immunoscore®-based risk assessment for CC patients management.

 

 

What is Immunoscore® Colon ?

Immunoscore® Colon measures the density of two T lymphocyte populations in the center and at the periphery of the tumor: CD3+ and CD8+ T cells.

The best performing algorithm to compute the Immunoscore® for colon cancer (CC) has been defined in the large international SITC -led retrospective validation study conducted on more than 3800 St I-III CC patients (J Galon et al. J Clin Oncol 2016;34 (Suppl abstr 3500)).

Based on this study, the software Immunoscore® from HalioDx was developed to perform the tissue segmentation and lymphocytes quantification and provides Immunoscore® results that can be integrated in the decision making process for colon cancer patient management.

Immunoscore® Colon under its CE-IVD version is the first immune scoring diagnostic tests used in routine by pathology labs leveraging advanced image analysis. The accuracy and robustness of the test relies on precise counting of positive immune cells in predefined regions and automatic calculation of Immunoscore® for each patient based on specific algorithm.

How to Order

Immunoscore® Colon workflow

Interested in ordering Immunoscore® Colon? contact us

Scientific Data

Selected publications

Selected videos of Jerome Galon & Fabienne Hermitte presenting Immunoscore® principle, prognostic value & analytical performances


Posters

Mlecnik B et al.

Comprehensive Intrametastatic Immune Quantification and Major Impact of Immunoscore on Survival.

J Natl Cancer Inst. 2018 ;

Jan 1;110(1). doi: 10.1093

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Berghoff AS et al.

Density of tumor-infiltrating lymphocytes correlates with extent of brain edema and overall survival time in patients with brain metastases.

Oncoimmunology 2016 ;

Jun 9;5(1):e1057388

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Kirilovsky A et al.

Rational bases for the use of the Immunoscore in routine clinical settings as a prognostic and predictive biomarker in cancer patients

Int Immunol. 2016

doi: 10.1093/intimm/dxw021

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Hermitte F

Biomarkers immune monitoring technology primer: Immunoscore® Colon

Journal for ImmunoTherapy of Cancer 2016

DOI: 10.1186/s40425-016-0161-x

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Galon J et al

Validation of the Immunoscore (IM) as a prognostic marker in stage I/II/III colon cancer: Results of a worldwide consortium-based analysis of 1,336 patients.

2016 ASCO Annual Meeting

J Clin Oncol 34, 2016 (suppl; abstr 3500)

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Mlecnik B et al.

Integrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability.

Immunity. 2016 ;

Mar 15;44(3):698-711.

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Mlecnik B et al.

The tumor microenvironment and Immunoscore are critical determinants of dissemination to distant metastasis.

Sci Transl Med. 2016 ;

24 Feb 2016, Vol. 8, Issue 327, pp. 327ra26.

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Galon J et al.

Towards the introduction of the 'Immunoscore' in the classification of malignant tumours

J Pathol. 2014

Jan;232(2):199-209.

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Galon J et al.

Cancer classification using the Immunoscore: a worldwide task force.

J Transl Med 2012 ;

10 : 205.

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Mlecnik B et al.

Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction.

J Clin Oncol 2011 ;

29 : 610-8.

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Pagès F al.

In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer.

J Clin Oncol 2009 ;

27 : 5944-51.

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Galon J et al.

Type, density, and location of immune cells within human colorectal tumors predict clinical outcome.

Science 2006 ;

313 : 1960-4.

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