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Personalized Medicine: A nationwide initiative for an equal access to cancer treatment in France Frédérique Nowak Institut National du Cancer 18/04/2012
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Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Jan 13, 2015

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Health & Medicine

EuroBioForum

EuroBioForum 2012 | 18 April 2012
Presentation by Frédérique Nowak, Head of Pathology and Genetics, French National Cancer Institute
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Page 1: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Personalized Medicine: A nationwide initiative for an equal access to cancer

treatment in France

Frédérique Nowak

Institut National du Cancer – 18/04/2012

Page 2: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

2

Institut national du cancer (INCa)

• The French National Cancer Institute is a health and science agency dedicated to oncology.

• INCa was created through the Public Health Act of 9 August 2004

• INCa is involved in all aspects of the fight:

- Public health : Observation – Prevention - Screening

- Care: Improve the quality of care for all cancer patients

- Research: Orient the national cancer policy towards international competition

- Information: Give every individual the means to help fight cancer

Page 3: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

3

The cancer plan 2009-2013

The Cancer Plan 2009-2013:

• follows on from the Cancer Plan 2003-2007

• 5 areas :

Research

Observation

Prevention-screening

Patient care

Life during and after cancer

• 30 measures/ 118 actions

Page 4: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Towards molecular subsets of cancers

Molecular genetics deciphers severe frequent cancers into specific rare cancers

Molecular alterations shared in several cancers

One drug is now efficient for the treatment of several « rare cancers »

4

Molecular subsets of non small cell lung cancer : 20,000 patients

The shift of paradigm for cancer treatment

Page 5: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Predictive tests for targeted therapies prescription

5

BCR-ABL translocation: 1- BCR-ABL detection

2- BCR-ABL quantification

3- ABL mutation

Chronic Myeloïd Leukemia/ Acute Lymphoblastic Leukemia

Imatinib prescription

1- Imatinib prescription

2- Monitoring of minimal residual disease

3- Resistance to Imatinib

KIT and PDGFRA mutations

GIST Imatinib prescription

HER2 amplification Breast and gastric cancers Trastuzumab prescription

KRAS mutations Colorectal cancer Panitumumab and cetuximab prescription

EGFR mutations Lung cancer Gefitinib and erlotinib prescription

ALK translocations Lung cancer Crizotinib prescription

BRAFV600 mutation Melanoma Vemurafenib prescription

Page 6: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Ensuring equity of access to innovation: France organisation of molecular centres for personalized medicine

The programme is operated by the INCa/Ministry of Health since 2006

6

28 regional centres

Partnerships between

several laboratories located

in University hospitals and

cancer centres

Regional organization

Cooperation between

pathologists and biologists

Objectives

Perform molecular testing

for all patients;

Whatever the healthcare

institution status (public

hospitals, private

hospitals…);

Perform high quality tests;

leukemia, solid tumours

Brest•

• Marseille

Bordeaux •

• Besançon• Nantes

Caen •

• Lyon

• Lille

• Poitiers

Rennes •

• Angers

• Nancy

• Clermont

Ferrand

• Dijon

Montpellier/

Nîmes •

• NiceToulouse •

• St Etienne

• Tours

• Rouen

• Grenoble

• Reims

• Limoges

• Strasbourg/

Mulhouse/

Colmar

Brest•

• Marseille

Bordeaux •

• Besançon• Nantes

Caen •

• Lyon

• Lille

• Poitiers

Rennes •

• Angers

• Nancy

• Clermont

Ferrand

• Dijon

Montpellier/

Nîmes •

• NiceToulouse •

• St Etienne

• Tours

• Rouen

• Grenoble

• Reims

• Limoges

Brest•

• Marseille

Bordeaux •

• Besançon• Nantes

Caen •

• Lyon

• Lille

• Poitiers

Rennes •

• Angers

• Nancy

• Clermont

Ferrand

• Dijon

Montpellier/

Nîmes •

• NiceToulouse •

• St Etienne

• Tours

• Rouen

• Grenoble

• Reims

• Limoges

• Strasbourg/

Mulhouse/

Colmar

St Cloud/

Versailles • •

Villejuif

• Paris (2) : AP-HP, Curie St Cloud/

Versailles • •

Villejuif

• Paris (2) : AP-HP, Curie

Provides nationwide molecular diagnostic tests

Page 7: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

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Benefit for all patients

Molecular tests are performed :

For all patients

free of charge for patients & hospitals

With compensation of local pathologists for sample shipments

Ensure that all patients effectively benefit from molecular testing

Page 8: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Rapid access to innovation: EGFR testing in lung cancer

Mutations : 9,6%

60 % of external prescriptions

Median time for results : 7 days

Non contributive results :

June 2009 : gefitinib approvals by EMA for patients with activating mutations of

EGFR in their tumours

3,7%

1,5%

5,2%

0,0

5,0

non amplifiable DNA

depleted sample Rate of tumor cells below detection

thresold

No

n c

on

trib

uti

ve r

esu

lts

(%)

1269 2667

16834

20761

0

10000

20000

2008 2009 2010 2011

Nom

bre

de p

ati

ents

Page 9: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Funding mechanisms

Offer the best treatment to patients considering the cost – effectiveness ratio

Seed fundings from INCa for the test set-up

Performance and cost evaluation

Recurrent annual fundings from the French Ministry of Health insurance

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This programme benefits also from INCa/private partnerships

Page 10: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

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EGFR testing for lung cancer patients

1 724 patients + 15 000 patients -

Cost of gefitinib treatment

Example of gefitinib treatment : €69M spared cost for the health insurance

(gefinitib treatment:

38 weeks DFS; Mok 2009)

(gefinitib treatment:

8 weeks DFS; Mok 2009)

€ 35M

€ 69M

Spared cost of gefitinib treatment

€ 1.7M

Page 11: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Ensure the best quality for molecular tests

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Implementation of a quality assurance programme

• Elaboration of guidelines for:

- the detection of mutations in solid tumors;

- the organization of molecular testing;

- Reports of molecular tests

• Implementation in 2011 of a national External Quality

Assessment for the 28 centres (BCR-ABL, KRAS, EGFR)

Assurance quality optimization

guide the molecular genetics centres to becoming accredited to

ISO 15189 standard as soon as possible

Page 12: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

A new approach for rapid access to targeted therapies

Biomarkers for targeted therapies currently

evaluated in clinical trials (Phases I to III) :

Cancer Molecular target

Lung

EGFR mutations

KRAS mutations

HER2 mutations

BRAF mutation

PI3KCA mutations

ALK translocations

Colon - rectum

KRAS mutations

BRAF mutations

microsatellite instability if < 60 years

Melanoma BRAF mutations

KIT mutations

Page 13: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Anticipate the launch of new molecules

For the 20,000 patients with lung adenocarcinoma,

additional analysis of :

- EGFR mutations conferring resistance to TKI-EGFR;

- KRAS, HER2, PI3KCA and BRAF mutations;

- ALK translocation.

For the 17,000 patients with colorectal cancer,

additional analysis of :

- BRAF mutation;

- MSI test.

BRAF and cKIT mutations for patients with melanoma

The INCa allocated €3.5M in 2010 and €2.8M in 2011 for the prospective detection

of emerging biomarkers

Be ready to perform the test as soon as the therapy is available

Page 14: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Improve interface with research

Make the most of the generated data=> implementation of a lung cancer

database :

funded by INCa, coordinated by IFCT (Intergroupe Français de Cancérologie

Thoracique) and molecular genetics centres representatives

evaluate the correlation between molecular alteration identification and targeted

therapy prescription

collect both clinical data, molecular data and clinical follow up of patients

Improve interfaces with clinical research

Potential evolution of their mission : molecular genetics centres could

become testing laboratories for clinical trials

Improve interfaces with translational research

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Page 15: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Towards an « all in one approach »: implementation of next generation sequencing techniques for clinical diagnostics

An expanding list of predictive tests

Page 16: Personalised Medicine: a nationwide initiative for an equal access to cancer treatment in France

Conclusions and perspectives

o This initiative for targeted cancer treatment in France shows that :

innovation can be successfully integrated into the healthcare system

molecular stratification is cost effective

this organization could be easily expanded in other european settings

o These molecular genetics centres are key to help develop translationnal research and to sustain progress

o They are instrumental to facilitate access to the best care and improve patient’s survival and quality of life

o Training of medical students and professionals to personalised medicine

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