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IMMUNOSCORE® WORKFLOWImmunoscore® is available as a full service solution
(performed at HalioDx CLIA laboratories).
REFERENCE PUBLICATIONSPages F, Andre T, Taieb J t al.
J Clin Oncol. 2019; 37 (no. 15_suppl)
Pagès F, Mlecnik B, Marliot F et al. Lancet. 2018; 391 (10135)
Sinicrope F, Shi Q, Hermitte F et al.J Clin Oncol. 2018; 36:4s (suppl; abstr 614)
Sinicrope F, Shi Q, Hermitte F et al. J Clin Oncol. 2017; 35:15s (suppl; abstr 3579)
Mlecnik B, Bindea G, Angell HK et al. Immunity. 2016;15;44(3)
Kirilovsky A, Marliot F, El Sissy C et al. Int Immunol. 2016;28(8)
Mlecnik B, Tosolini M, Kirilovsky A et al. J Clin Oncol. 2011;29(6)
Pagès F, Kirilovsky A, Mlecnik B et al. J Clin Oncol. 2009;27(35)
Galon J, Costes A, Sanchez-Cabo F et al. Science. 2006;313(5795)
Sinicrope F, Shi Q, Hermitte F et al. JNCI Cancer Spectrum 2020 4(3): pkaa023
Pages F, Andre T, Taieb J et al. Ann Oncol. 2020 Apr 12
Guide your therapeutic strategy and patient discussion with the most accurate information based on immune system response
IMMUNITY ASSESSEDPERSONALIZED TREATMENT
Tumor cells
CD3/CD8 T cells
Contact us
HalioDx Inc - Biotech Eight 737 N 5th St, 6th Floor - Richmond, VA 23219 - USAPhone: + 1 (804) 944-2000 - Fax: +1 (804) 533-1504
HalioDx - Luminy Biotech Entreprises163 Avenue de Luminy - 13009 Marseille - FRANCE
Phone: +33 (0) 4 91 29 30 90 - Fax: +33 (0) 4 91 29 30 99
www.haliodx.com
www.immunoscore-colon.com
Sales support
For commercial questions, please contact:[email protected]
Medical supportFor support to interpret the results, please contact:
Technical supportFor technical support, please contact:
Billing supportFor billing questions, please contact:
* Easy ordering* Clinically validated cut-offs* Accuracy through digital pathology* Reliable & reproducible result* Turn-around time compatible with post-surgery decision
Patientpost resection
surgery
Tumor block orunstained slides
ComputeImmunoscore®
HalioDx lab
Pathologylab
Stain & Scan Slides
10 working days after receipt of specimen
Report Immunoscore®
results
The Immunoscore® predicts response to longer duration of FOLFOX treatment in stage III colon cancer patients whatever the clinical risk.
Mucinous (colloid)MSISex
Clinical parameters plus Immunoscore®
Immunoscore (high, low)
LVI/PNIAJCC/UICCTNM stage
Differentiation
47%of prognosis
is explained by Immunoscore®
WHAT IS IMMUNOSCORE® *Decades of in-depth research has led to an appreciation for the role of the immune system in the evolution of colorectal cancer. A paradigm shift is occurring in the assessment of tumor-infiltrating lymphocytes (TILs) for prognostication and prediction of benefit from adjuvant therapies, with the emergence of a new clinical biomarker, the Immunoscore®. By measuring the host immune response at the tumor site, the in vitro diagnostic test predicts the risk of relapse in localized colon cancer patients.
IMMUNE INFILTRATIONLOCALIZED COLON CANCER PATIENTS RISK OF RELAPSE
High infiltration of T lymphocytes
Low infiltration of T lym
phocytes (in red)
LOW Immunoscore®
HIGH Immunoscore®
HIGHRISK
LOWRISK
CLINICAL UTILITY IN LOCALIZED COLON CANCER
ADD RESOLUTION TO YOUR TRADITIONAL RISK ASSESSMENT TOOLS
Pagès F et al. The Lancet 2018
Personalize your patients’ treatment by assessing their immune response.
Immunoscore® has demonstrated its prognostic performance in a large international SITC-led study (n= 2 681). Using it in addition to the TNM classification, it refines the patient’s risk profile.
*IVD test performed in a CLIA certified laboratory
Refine the risk profile of stage II patientsPrognostic value of Immunoscore® in stage II:
Validated on the international SITC study among Stage II patients (n = 1,434), Immunoscore® assesses relapse risk in stage II colon cancer patients (5-year recurrence risk: IS Low=23% vs IS High= 12%) and identifies patients for whom surgery would be sufficient.
Choose the best treatment duration for stage III patientsPrognostic & predictive value of Immunoscore® in stage III:
Demonstrated on the prospective IDEA France study (n=1062):- Immunoscore Low: 3-year DFS= 67% [95%CI 62- 71] - Immunoscore High: 3-year DFS=77% [95%CI 74-80]
Similar prognostic results obtained in the FOLFOX arm of NCCTG N0147 prospective clinical trial.
Immunoscore® prediction of FOLFOX efficacy (n=973)
Immunoscore® is more informative than traditional risk assessment tools and clearly identifies patients who could be spared chemotherapy.
Pat
ien
t w
ith
ou
t ev
ent
(%)
Time to recurrence (Years)
20
0
40
60
80
100
10 3 4 5 6 7 82
Low clinical risk
High clinical risk + IS High (2-3-4)
High clinical risk+ IS Low (0-1)
Low clinical risk patients: 50/500 (44.25%) 5Y: 89.1 (86.1-92.1)
High clinical risk + IS High (2-3-4): 49/438 (38.76%) 5Y: 87.4 (83.9-91)
High clinical risk + IS Low (0-1): 49/192 (16.99%) 5Y: 72.2 (65.6-79.6)
TTR in Stage II untreated patients according to clinico-pathological risk (n=1130)
70% of patients with high clinical risk might be spared chemotherapy
HR=0.68 (0.4−0.9)p<0.05
HR=0.6 (0.43−0.8)p<0.01
Dis
ease
−F
ree
Surv
ival
(DF
S) (%
)
Survival (Years)
20
0
40
60
80
100
10 3 4 5 6 7 82
Immunoscore High/MSI events = 37/162 - 5Y DFS: 60.6 (53.8-68.3)
Immunoscore High/MSS events = 126/474 - 5Y DFS: 66.2 (50.3- 87.1)
Immunoscore Low/MSI events = 11/27 - 5Y DFS : 75.8 (71.9-79.9)
Immunoscore Low/MSS events = 75/178 - 5Y DFS: 82 (75.9-88.6)
DFS in Stage II patients (n=841)
Survival is driven by
Immunoscore® regardless
MSI/MSS status
Dis
ease
−F
ree
Surv
ival
Pro
bab
ility
Time since random assignment (Years)
0.25
0
0.50
0.75
1.00
10 3 4 5 62
6 months FOLFOX (N=206)
3 months FOLFOX (N=217)
IS Low (0-1) Patients
68 %
65 %
HR=0.84 (95% CI 0.61-1.15). Logrank p-0.270
Dis
ease
−F
ree
Surv
ival
Pro
bab
ility
Time since random assignment (Years)
0.25
0
0.50
0.75
1.00
10 3 4 5 62
IS High (2-3-4) Patients
84 %
72 %
6 months FOLFOX (N=275)
3 months FOLFOX (N=275)
HR=0.53 (96% CI 0.37-0.75). Logrank p-0.0003
Dis
ease
−F
ree
Surv
ival
Pro
bab
ility
Time since random assignment (Years)
0.25
0
0.50
0.75
1.00
10 3 4 5 62
6 months FOLFOX (N=206)
3 months FOLFOX (N=217)
IS Low (0-1) Patients
68 %
65 %
HR=0.84 (95% CI 0.61-1.15). Logrank p-0.270
Dis
ease
−F
ree
Surv
ival
Pro
bab
ility
Time since random assignment (Years)
0.25
0
0.50
0.75
1.00
10 3 4 5 62
IS High (2-3-4) Patients
84 %
72 %
6 months FOLFOX (N=275)
3 months FOLFOX (N=275)
HR=0.53 (96% CI 0.37-0.75). Logrank p-0.0003
No significant benefit of extended FOLFOX treatmentbeyond 3 months
Only patients with Immunoscore®
High benefit from 6 months of
FOLFOX
Demonstrated in over 6000 patients
