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:infos@haliodx.com

Medical supportFor support to interpret the results, please contact:

customer.care@haliodx.com

Technical supportFor technical support, please contact:

tech.support@haliodx.com

* 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

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nce,

Eur

ope,

Uni

ted

Stat

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nd J

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f.: IC

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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