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® (EU version)
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).
- 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.
- 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.
- 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 and was confirmed in the prospective IDEA France cohort study.
Furthermore, in the prospective IDEA France cohort study only patients with a High Immunoscore® did benefit from 6 months of FOLFOXtreatment compared with 3 months, both in low (T1-3, N1) and high (T4 and/or N2) clinical risk groups.
Stage III colon cancer patients with Immunoscore Low had no additional benefit to a longer treatment duration.
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
Extract of an interview by Cancer.fr of Professor Thierry André, on Immunoscore® in the IDEA France study (in French)
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
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.
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.
Selected videos on Immunoscore®
Webinar Immunoscore®: IDEA France study results - September 19, 2019 | Franck Pagès, Eric Van Cutsem
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
Dr Jerome Galon on the Prognostic Value of Immunoscore, Onclive - ASCO 2016
Posters on Immunoscore®
Poster presented at Gastro Intestinal Symposium #GI20Prognostic and predictive value of the Immunoscore in stage III colon cancer patients treated with mFOLFOX6 (3 vs 6 months) in the prospective IDEA France cohort study
Poster presented at ESMO GI 2019 Significant differences in outcome between Immunoscore categories in stage I colon cancer patients
Poster presented at ASCO 2019 by Franck PagèsValidation of the Immunoscore Prognostic Value in Stage III Colon Cancer Patients treated with Oxaliplatin in the prospective IDEA France cohort study (PRODIGE-GERCOR).
Poster presented at Gastrointestinal Cancers Symposium 2019Immunoscore clinical utility to identify good prognostic Colon Cancer Stage II patients with high-risk clinico-pathological features for whom adjuvant treatment may be avoided
Poster presented at ESMO IO 2018MSI status plus Immunoscore to select metastatic colorectal cancer patients for immunotherapies
Poster presented at ESMO ASIA 2018UCGI 34 - PROSCORE: A prospective study assessing whether Immunoscore® test impacts the choice of adjuvant chemotherapy, in a multidisciplinary meeting, for treating non-metastatic colon cancer patients after curative-intent surgery
Poster presented at ESMO ASIA 2018 by Karim BelalouiImmunoscore feasibility study in routine postsurgical pathologic review for early‐stage colon cancer (CC) cases risk‐assessment
Poster presented at Gastrointestinal Cancers Symposium 2018Immunoscore provides prognostic information in low (T3N1) and high (T4 or N2) risk subsets of stage III colon carcinoma patients treated with adjuvant FOLFOX in a phase III trial [NCCTG N0147 (Alliance)
Poster presented at ASCO 2017 by Frank A. Sinicrope, Mayo Clinic, Rochester, MNPrognostic utility of immune markers and validation of Immunoscore® in stage III colon carcinoma patients treated with adjuvant FOLFOX in a phase III trial [NCCTG N0147 (Alliance)]
Poster presented at SITC 2016 by Fabienne Hermitte, HalioDx Immunoscore® analytical performance
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 infoMlecnik 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 infoBerghoff 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 infoKirilovsky 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 infoHermitte F
Biomarkers immune monitoring technology primer: Immunoscore® Colon
Journal for ImmunoTherapy of Cancer 2016
DOI: 10.1186/s40425-016-0161-x
More infoGalon 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 infoMlecnik 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 infoMlecnik 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 infoGalon J et al.
Towards the introduction of the 'Immunoscore' in the classification of malignant tumours
J Pathol. 2014
Jan;232(2):199-209.
More infoGalon J et al.
Cancer classification using the Immunoscore: a worldwide task force.
J Transl Med 2012 ;
10 : 205.
More infoMlecnik 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 infoPagès 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 infoGalon J et al.
Type, density, and location of immune cells within human colorectal tumors predict clinical outcome.
Science 2006 ;
313 : 1960-4.
More info