IMMUNOSCORE® Scoring Immune Response in Colon Cancer

for unmatched clinical performance in routine settings

Why Immunoscore®?

Immunoscore®* is an in vitro diagnostic test predicting the risk of relapse in early stage colon cancer patients, by measuring the host immune response at the tumor site.

It is a risk-assessment tool that provides independent and superior prognostic value than the usual tumor risk parameters, and should be used as an adjunct to the TNM classification (Pagès F et al. The Lancet 2018, Sinicrope F et al. J Clin Oncol 2018). Immunoscore® can thus improve individual patient treatment strategies, particularly the modulation of adjuvant chemotherapy in stage II and stage III.

a) SITC International study results, The Lancet May 2018
b) N0147 study results, ASCO 17 & ASCO GI 18

* CE-IVD for European Community countries, performed in CLIA certified laboratory for the US.

Immunoscore®
Material: FFPE block or FFPE slides from tumor resection
Target: CD3+ & CD8+ T cells 
Location: Center and periphery of the tumor
Technology: Image Analysis

The Immunoscore® scoring has been defined in a large international SITC-led retrospective validation study conducted on more than 2500 St I-III CC patients (Pagès et al, The Lancet May 2018).

Immunoscore® 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.

Download general presentation of Immunoscore®

Download Immunoscore® white paper

Clinical Utility

Immunoscore® 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.

Largest contribution of Immunoscore® (47%) to survival risk

Figures extracted from Pagès F et al. The Lancet 2018

This information supports decision about adjuvant chemotherapy need (stage II) and duration of treatment (stage III).

In the large Immunoscore® SITC study (more than 2,500 stage I-III patients), Immunoscore® was strongly predictive of the patient outcome and surpassed the TNM classification prognostic performance.

Among stage II patients (n = 1,434), Immunoscore® identified a subgroup of high-risk patients (Immunoscore® Low) with a significantly higher risk of recurrence at 5 years (23% vs 8% in patients with Immunoscore® High).

TTR in Stage II untreated patients according to clinic-pathological risk

  • Untreated high-risk patients with High Immunoscore® have good clinical outcome similar to Low-risk patients (5Y TTR of 87.4 vs 89.1).
  • 7 out of 10 patients(n=438/630) with high-risk features might be spared from chemotherapy.

Immunoscore® confirms its ability to sharpen clinico-pathological risk features.

DFS in Stage II

  • Discrepancy between MSI/MSS status and Immunoscore® results has been identified for 1 out of 5 patients regarding the DFS(n=27-MSI;129-MSS/841).
  • Patients’ survival is driven by Immunoscore® regardless of their microsatellite stability status (MSI or MSS)

Use Immunoscore® in addition of MSI/MSS status would improve the management of Stage II colon cancer patients.

 

In a retro-prospective study from the prospective NCCTG N0147 clinical trial, Immunoscore® has been tested on 600 resected tumors of stage III CC patients from the FOLFOX arm.

DFS in Stage III

 

  • Overall, patients with High Immunoscore® have a significantly better DFS(HR=0.59, 95% CI, p=0.0013).
  • Among the low-risk group (T1-3 N1), 1 out of 2 patients have high risk of relapse (Low Immunoscore, n=153/287) associated with significantly worse 3 years DFS (DFS at 3 years=78% vs 92%).

These data demonstrate the ability of Immunoscore® to further refine prognostication.

 



A comprehensive body of clinical evidence

  • Immunoscore® surpasses TNM for prediction of tumor recurrence and survival in CRC patients.
  • Stage II CC patients with Immunoscore-Low have a higher risk of recurrence.
  • Immunoscore® is a stronger predictor of survival than MSI in CC.
  • Stage III CC patients with Immunoscore-High have a lower risk of recurrence regardless of the MSI status.
  • Immunoscore® provides prognostic information in low and high T/N risk subsets of Stage III CC.

 

See publications
Click here

HalioDx is conducting multiple studies to further support the Immunoscore®-based risk assessment for CC patients management.


Discover how Immunoscore® is predicting the risk of relapse in localized colon cancer in a short video

How to Order

Your contact:


HalioDx

Oncologists and patients are invited to contact HalioDx which market and distribute Immunoscore® assay in your country.


Luminy Biotech Entreprises
163 Avenue de Luminy
13288 Marseille Cedex 9
FRANCE

Phone: +33 (0) 4 91 29 30 90

 www.haliodx.com

 contact customer service by mail


Immunoscore® workflow

Interested in ordering Immunoscore® ? contact us

Scientific Data

A comprehensive body of clinical evidence

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

Pagès F, Mlecnik B, Marliot F et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018; 391 (10135)

Kirilovsky A, Marliot F, El Sissy C 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;28(8)

Mlecnik B, Tosolini M, Kirilovsky A et al. Histopathologic-based prognostic factors of colorectal cancers are associated with the state of the local immune reaction. J Clin Oncol. 2011;29(6)

Pagès F, Kirilovsky A, Mlecnik B et al. In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer. J Clin Oncol. 2009;27(35)

Galon J, Costes A, Sanchez-Cabo F et al. Type, density, and location of immune cells within human colorectal tumors predict clinical outcome. Science. 2006;313(5795)

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

Pagès F, Mlecnik B, Marliot F et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018; 391 (10135)

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

Pagès F, Mlecnik B, Marliot F et al. International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study. Lancet. 2018; 391 (10135)

Mlecnik B, Bindea G, Angell HK et al. Integrative Analyses of Colorectal Cancer Show Immunoscore Is a Stronger Predictor of Patient Survival Than Microsatellite Instability. Immunity.2016;15;44(3)

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

Sinicrope F, Shi Q, Hermitte F et al. Association of immune markers and Immunoscore with survival of stage III colon carcinoma (CC) patients (pts) treated with adjuvant FOLFOX: NCCTG N047 (Alliance). J Clin Oncol. 2017; 35:15s (suppl; abstr 3579)

Immunoscore® provides prognostic information in low and high T/N risk subsets of Stage III CC.

Sinicrope F, Shi Q, Hermitte F et al. Immunoscore to provide prognostic information in low- (T1-3N1) and high-risk (T4 or N2) subsets of stage III colon carcinoma patients treated with adjuvant FOLFOX in a phase III trial (NCCTG N0147; Alliance). J Clin Oncol. 2018; 36:4s (suppl; abstr 614)


Selected videos on Immunoscore®

Immunoscore® Webinar - March 21, 2019 | Jêrome Galon, PhD
Dr. Fakih Discusses the Utility of Immunoscore in CRC

Immunoscore® Symposium, June 2018, Chicago

Webinar on “Clinical utility of Immunoscore® in colon cancer” with Marc Van Den Eynde, MD, PhD | October 17, 2017
Webinar on Immunoscore® presented by Dr Jérôme Galon - July 2016
Dr Jerome Galon on the Prognostic Value of Immunoscore, Onclive - ASCO 2016

Posters on Immunoscore®


Selected publications

Pagès et al.

International validation of the consensus Immunoscore for the classification of colon cancer: a prognostic and accuracy study

The Lancet, 2018

May 10, 2018

More info

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

More info

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

More info

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

More info

Hermitte F

Biomarkers immune monitoring technology primer: Immunoscore® Colon

Journal for ImmunoTherapy of Cancer 2016

DOI: 10.1186/s40425-016-0161-x

More info

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)

More info

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.

More info

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.

More info

Galon J et al.

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

J Pathol. 2014

Jan;232(2):199-209.

More info

Galon J et al.

Cancer classification using the Immunoscore: a worldwide task force.

J Transl Med 2012 ;

10 : 205.

More info

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.

More info

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.

More info

Galon J et al.

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

Science 2006 ;

313 : 1960-4.

More info

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