Guide your therapeuc strategy and paent discussion with the most accurate informaon based on immune system response IMMUNITY ASSESSED PERSONALIZED TREATMENT Tumor cells CD3/CD8 T cells
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
Mucinous (colloid)MSISex
Clinical parameters plus Immunoscore®
Immunoscore(high, intermediate, 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
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 infilt
ration of T lymphocytes (in red)
LOW Immunoscore®
HIGH Immunoscore®
HIGHRISK
LOWRISK
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
The Immunoscore® predicts response to longer duration of FOLFOX treatment in stage III colon cancer patients whatever the clinical risk.
CLINICAL UTILITY IN LOCALIZED COLON CANCER
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= 8%) and
.
Patie
nt w
ithou
t eve
nt (%
)
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 from
chemotherapy
HR=0.68 (0.4−0.9)p<0.05
HR=0.6 (0.43−0.8)p<0.01
Dise
ase−
Free
Sur
viva
l (D
FS) (
%)
Survival (Years)
20
0
40
60
80
100
10 3 4 5 6 7 82
Immunoscore High/MSI events = 37/162
Immunoscore High/MSS events = 126/474
Immunoscore Low/MSI events = 11/27
Immunoscore Low/MSS events = 75/178
DFS in Stage II patients (n=841)
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.
Dise
ase−
Free
Sur
viva
l Pro
babi
lity
Time since random assignment (Years)
0.25
0
0.50
0.75
1.00
10 3 4 52
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
Dise
ase−
Free
Sur
viva
l Pro
babi
lity
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
Dise
ase−
Free
Sur
viva
l Pro
babi
lity
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
Dise
ase−
Free
Sur
viva
l Pro
babi
lity
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
Immunoscore® is more informative than traditional risk assessment tools
Survival is driven by
Immunoscore® regardless
MSI/MSS status
of extended FOLFOX treatmentbeyond 3 months
Only patients with Immunoscore®
from 6 months of FOLFOX
Demonstrated in over 6000 patients
IMMUNOSCORE® WORKFLOWImmunoscore® is available as a full service solution
(performed at HalioDx CLIA laboratories).
Sales support
For commercial questions, please contact:[email protected]
Medical supportFor support to interpret the results, please contact:
Technical supportFor technical support, 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 Compute
Immunoscore®
HalioDx lab
Pathologylab
Stain & Scan Slides
10 working days after receipt of specimen
Report Immunoscore®
results
Cop
yrig
ht H
alio
Dx®
201
9, D
esig
n: A
TCG
Par
tner
s - S
ophi
e G
eide
r. H
alio
Dx
and
Imm
unos
ign
are
regi
ster
ed tr
adem
arks
in F
ranc
e an
d Im
mun
osco
re is
a re
gist
ered
trad
emar
k in
Fra
nce,
Eur
ope,
Uni
ted
Stat
es a
nd J
apan
. Re
f.: IC
O03
-000
-057
V07-
11-
2019
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)
Immunoscore®, IS2C402Dispositif médical de Diagnostic in Vitro pour aider au pronostic des patients atteints de cancer localisé du colon HalioDx SAS (France)Lire attentivement les instructions fournies dans le document dédié à la préparation de l’échantillon disponible en ligne (www.immunoscore-colon.com)
Contact us
HalioDx - Luminy Biotech Entreprises163 Avenue de Luminy - 13288 Marseille Cedex 9 - FRANCE
Phone: +33 (0) 4 91 29 30 90 - Fax: +33 (0) 4 91 29 30 99
HalioDx Inc - Biotech Eight 737 N 5th St, 6th Floor - Richmond, VA 23219 - USAPhone: + 1 (804) 944-2000 - Fax: +1 (804) 533-1504
www.haliodx.com
www.immunoscore-colon.com