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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
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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
Dr Su Pin Choo (Curie Oncology, Singapore) presenting Immunoscore as the tool to identify with confidence who really needs chemotherapy in stage II and who will benefit from 3 versus 6 months of chemotherapy in stage III Colon Cancer
Dr Juan Manuel O’Connor (Instituto Alexander Fleming in Buenos Aires, Argentina) testifies about the challenges to manage early colon cancer patients and the added-value of using Immunoscore in routine practice
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 and predictive information in low and high T/N risk subsets of Stage III CC.
Resources
#video | Oct. 2020
Dr Tony Dhillon (UK) presenting Immunoscore at the Digestive Cancers Europe Scientific Update: Role of the Immune Response in Early Stage Colorectal Cancers
#video | Oct. 2020
Testimonial: Dr Su Pin Choo (Curie Oncology, Singapore) on the utility of Immunoscore in early stage Colon Cancer
#video | Oct. 2020
Managing colorectal cancer patients in the COVID-19 era with Drs Benjamin Weinberg (USA), Matías Chacón and Juan Manuel O’Connor (both Argentina)
#publication | Sep. 2020
Mlecnik B Bifulco C, Bindea G, et al.
Multicenter International Society for Immunotherapy of Cancer Study of the Consensus Immunoscore for the Prediction of Survival and Response to Chemotherapy in Stage III Colon Cancer
J Clin Oncol.
#publication | Aug. 2020
El Sissy C, Kirilovsky A, Van den Eynde M et al.
A Diagnostic Biopsy-Adapted Immunoscore Predicts Response to Neoadjuvant Treatment and Selects Patients with Rectal Cancer Eligible for a Watch-and-Wait Strategy
Clin Cancer Res
#publication | Aug. 2020
F Pages, J Taieb, P Laurent-Puig, and J Galon
The consensus Immunoscore in phase 3 clinical trials; potential impact on patient management decisions
OncoImmunology
#publication | Aug. 2020
Bruni D, K Angell H and Galon J
The immune contexture and Immunoscore in cancer prognosis and therapeutic efficacy
Nature Reviews Cancer
#video | Jul. 2020
Immunoscore® highlights at ESMO GI. Presentations of Dr Le Bagousse and Jérôme Galon, PhD
#publication | Jul. 2020
A Lanzi,F.A Sinicrope, A.B Benson, and J Galon
The consensus Immunoscore in phase 3 clinical trial (N0147) and impact on patient management decisions
OncoImmunology
#publication | Jun. 2020
A Lanzi,F Pages, C Lagorce-Pages, and J Galon
The consensus immunoscore: toward a new classification of colorectal cancer
OncoImmunology
#publication | Jun. 2020
O’Connor JM, Esteso F & Chacón M
Official French SARS-CoV-2 guidelines for cancer patients, a triage solution with precision medicine
Future Medicine
#video | Jun. 2020
Testimonial: Dr Juan Manuel O’Connor (Instituto Alexander Fleming in Buenos Aires, Argentina) on the use of Immunoscore in routine practice in managing early Colon Cancer
#e-news | Jun. 2020
Factsheet Immunoscore® & COVID-19 Colon Cancer Guidelines
#poster | May. 2020
Poster presented at ASCO20 Virtual Scientific meeting#ASCO20
Immunoscore is the most powerful parameter predicting time to recurrence and disease-free survival in T4N0 stage II colon cancer patients Abstract 4105
#publication | May. 2020
Marliot F, Chen X, Kirilovsky A et al.
Analytical validation of the Immunoscore and its associated prognostic value in patients with colon cancer
BMJ
#e-news | May. 2020
Expert Opinion: The Role of Microbiota and its Impact on the Tumor Microenvironment in Colorectal Cancer | Dr Benjamin A. Weinberg, MD, Oncologist in Georgetown, Washington DC
#e-news | Apr. 2020
Expert Opinion: Immunity and cancer | Dr Angela Alistar, MD, Oncologist in Morristown, NJ
#publication | Apr. 2020
Pages F, Andre T, Taieb J et al.
Prognostic and Predictive Value of the Immunoscore in Stage III Colon Cancer Patients Treated With Oxaliplatin in the Prospective IDEA France PRODIGE-GERCOR Cohort Study
Annals of Oncology
#publication | Apr. 2020
Sinicrope F, Shi Q, Hermitte F et al.
Contribution of Immunoscore and Molecular Features to Survival Prediction in Stage III Colon Cancer
JNCI Cancer Spectrum
#publication | Mar. 2020
Blair H
Immunoscore®: A Diagnostic Assay for Clinical Management of Colon Cancer
Molecular Diagnosis & Therapy volume
#video | Mar. 2020
Franck Pagès, MD, PhD, on Selecting Patients With Advanced Colon Cancer for Treatment
#poster | Jan. 2020
Poster presented at Gastro Intestinal Symposium #GI20
Prognostic 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
#publication | Jan. 2020
Pagès F, Kirilovsky A, Mlecnik B et al.
In situ cytotoxic and memory T cells predict outcome in patients with early-stage colorectal cancer.
Journal of Clinical Oncology
#brochure | Dec. 2019
Brochure Immunoscore® in Localized Colon Cancer
For Patients & Caregivers (English)
#brochure | Dec. 2019
Brochure Immunoscore® in Localized Colon Cancer
For Healthcare Professionals (CLIA US version)
#brochure | Dec. 2019
Brochure Immunoscore® in Localized Colon Cancer
For Healthcare Professionals (CE/IVD version)
#brochure | Dec. 2019
Brochure Immunoscore® in Localized Colon Cancer
For Patients & Caregivers (Spanish)
#video | Sep. 2019
Webinar Immunoscore®: IDEA France study results in Stage III Colon Cancer - Sept. 19, 2019 | Franck Pagès, Eric Van Cutsem
#publication | Aug. 2019
Angell HK, Bruni D, Barrett JC et al.
The Immunoscore: Colon Cancer and Beyond.
Clin Cancer Res.
#poster | Jul. 2019
Poster presented at ESMO GI 2019
Significant differences in outcome between Immunoscore categories in stage I colon cancer patients
#video | Jun. 2019
Extract of an interview by Cancer.fr of Professor Thierry André, on Immunoscore® in the IDEA France study (in French)
#video | Jun. 2019
Jérôme Galon, winner for the European Inventor Award 2019 for Immunoscore®
#poster | Jun. 2019
Poster presented at ASCO 2019
Validation of the Immunoscore Prognostic Value in Stage III Colon Cancer Patients treated with Oxaliplatin in the prospective IDEA France cohort study (PRODIGE-GERCOR).
#publication | May. 2019
Pages F, Andre T, Taieb J et al.
Validation of the Immunoscore prognostic value in stage III colon cancer patients treated with oxaliplatin in the prospective IDEA France cohort study (PRODIGE-GERCOR)
Journal of Clinical Oncology
#video | Apr. 2019
Dr. Fakih Discusses the Utility of Immunoscore® in CRC
#video | Mar. 2019
Immunoscore® Webinar New data in Stage II Colon Cancer - March 21, 2019 | Jêrome Galon, PhD
#publication | Mar. 2019
Zeitoun G, Sissy CE, Kirilovsky A et al.
The Immunoscore in the Clinical Practice of Patients with Colon and Rectal Cancers.
Chirurgia (Bucur).
#video | Jan. 2019
Discover how Immunoscore® is predicting the risk of relapse in localized colon cancer in a short video
#poster | Jan. 2019
Poster presented at Gastrointestinal Cancers Symposium 2019
Immunoscore 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 | Dec. 2018
Poster presented at ESMO ASIA 2018
UCGI 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 | Dec. 2018
Poster presented at ESMO IO 2018
MSI status plus Immunoscore to select metastatic colorectal cancer patients for immunotherapies
#poster | Nov. 2018
Poster presented at ESMO ASIA 2018
Immunoscore feasibility study in routine postsurgical pathologic review for early‐stage colon cancer (CC) cases risk‐assessment
#publication | Oct. 2018
Angelova M, Mlecnik B, Vasaturo A et al.
Evolution of Metastases in Space and Time under Immune Selection.
Cell
#video | Aug. 2018
Webinar on “Clinical utility of Immunoscore® in colon cancer” with Marc Van Den Eynde, MD, PhD | October 17, 2017
#video | Aug. 2018
Dr Jerome Galon on the Prognostic Value of Immunoscore, Onclive - ASCO 2016
#video | Aug. 2018
Immunoscore® Colon Symposium - June 1, 2018, Chicago | Discussion on clinical cases
#video | Aug. 2018
Immunoscore® Colon Symposium - June 1, 2018, Chicago | Jérôme Galon, PhD
#video | Aug. 2018
Immunoscore® Colon Symposium - June 1, 2018, Chicago | Stanley Hamilton, MD
#publication | May. 2018
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
#poster | Feb. 2018
Poster presented at ASCO GI 2018
Immunoscore 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)
#publication | Feb. 2018
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.
#publication | Jan. 2018
Mlecnik B, Van den Eynde M, Bindea G et al.
Comprehensive Intrametastatic Immune Quantification and Major Impact of Immunoscore on Survival.
J Natl Cancer Inst.
#poster | Jun. 2017
Poster presented at ASCO 2017
Prognostic 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)]
#publication | May. 2017
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 N0147 (Alliance).
J Clin Oncol.
#publication | May. 2017
Galon J, Mlecnik B, Marliot F 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.
J Clin Oncol.
#poster | Nov. 2016
Poster presented at SITC 2016
Immunoscore® analytical performance
#publication | Sep. 2016
Hermitte F
Biomarkers immune monitoring technology primer: Immunoscore® Colon.
Journal for ImmunoTherapy of Cancer
#publication | Aug. 2016
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.
#publication | Mar. 2016
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
#publication | Feb. 2016
Mlecnik B, Bindea G, Kirilovsky A et al.
The tumor microenvironment and Immunoscore are critical determinants of dissemination to distant metastasis.
Sci Transl Med.
#publication | Feb. 2011
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.
Journal of Clinical Oncology
#publication | Sep. 2006
Galon J, Costes A, Sanchez-Cabo F et al.
Type, density, and location of immune cells within human colorectal tumors predict clinical outcome.
Science