A national perspective: the French case
Jean-Yves Blay, M.D., Ph.D.,Centre Léon Bérard, Univ Cl. Bernard Lyon I
INNOVATIVE SOLUTIONS FOR RESEARCH IN HEALTHCAREDeveloping a novel approach to deliver better precision medicine in Europe
SESSION II: ROLE OF GOVERNAMENTAL & REGULATORY BODIES
NATIONAL PERSPECTIVE
Individualized medecine for cancer
Genomic platforms & FMG2025
ACSE trials
SIRICs and their programs
Rare cancers
Histology
Nosology and treatment
Stroma(Immune cells, ICP…)
Molecularcharacterisation
Histology
Basket/Umbrella trials
Trials onHistological & molecular
subgroups
Nosology and treatment 2017+
Integrated Dataset: Larotrectinib Is EfficaciousRegardless of Tumor Type1
1. Lanssen U et al. ESMO 2018. Abstract 409O.
Integratedc (n = 109)
ORR, % (95% CI) 81 (72-88)
Best response, %PRCR
6317
Investigator response assessments, as of July 30, 2018
NATIONAL PERSPECTIVE
Individualized medecine for cancer
Genomic platforms & FMG2025
ACSE trials
SIRICs and their programs
Rare cancers
Panels for the analysis of somatic alterations
• INCA Panel: 20 genes with therapeutic implications
• Academic panel(s) : 40-70 gènes
• Commercial panels ( eg FMI): 315 genes
• WES/WGS
• (last 3 reimbursed by RIHN)
Etude ProfilER : diagramme CONSORTEtude ProfilER : diagramme CONSORT
Presented by: O.TREDAN Abstract # LBA100
EnrolledN= 2,676
Tumor genomic profilesN= 1,944
At least one actionable alterationsN= 1,004 (52%)
At least one MTA recommendedN= 676 (35%)
Patients treated with recommendedpersonalized treatment
N= 143 (7%)
Premature withdrawals N= 416 (16%) Tumor sample not exploitable, n= 339
Less than 10% tumor cells, n= 19
DNA extraction issues, n= 19
aCGH or NGS failures, n= 13
Other reasons, n= 31
No recommendation N= 328 (33%) MTA not available, n= 135 MTA previously administered, n= 30 Early death, n= 65 Others, n= 98
The “Plan France Medecine Génomique 2025”Key numbers and facts
approx. 500K whole genomes (200K genomes/yr. at the end of the Plan) > 800 M€ (670M€ + 230M€) 100K patients/yr. at the end of the Plan
12 Very High Throughput sequencing Platforms (18K WG /yr eq. Xten Illumina) One R&D center (CREFIX )
One “Center for data storage and analysis” (CAD)
Focus on cancer & genetic (Mendelian) diseases > multi-factorial diseases
3 pilot projects (colon carcinoma, sarcomas, mental retardation, type2 diabete)
FS/2016
NATIONAL PERSPECTIVE
Individualized medecine for cancer
Genomic platforms & FMG2025
ACSE trials
SIRICs and their programs
Rare cancers
ACSE (NATIONAL, INCA)
NATIONAL PERSPECTIVE
Individualized medecine for cancer
Genomic platforms
ACSE trials
SIRICs and their programs
FMG2025
8 SIRIC FUNDEDExisting sites:• SOCRATE 2.0 : Stratified Oncology Cell dna Repair and Tumor Elimination 2.0
Pr Eric DEUTSCH, Institut Gustave Roussy-VILLEJUIF
• SIRIC Montpellier CancerPr Marc YCHOU, Institut régional du Cancer Montpellier-MONTPELLIER
• INSTITUT CURIE SIRICDr Sergio ROMAN-ROMAN, Institut Curie-PARIS
• BRIO -Bordeaux Recherche Intégrée OncologiePr Pierre-Louis SOUBEYRAN, Institut Bergonié-BORDEAUX
• CARPEM - Cancer Research and Personalized Medicine PARISPr Pierre LAURENT-PUIG, Hôpital Européen Georges Pompidou-HEGP AP-HP-PARIS
New sites:• ILIAD-Imaging and Longitudinal Investigations to Ameliorate Decision making in multiple
myeloma and breast cancer NANTES -ANGERSPr Philippe MOREAU, CHU Nantes - Hôtel Dieu-NANTES
• CURAMUS-Cancer United Research Associating Medicine, University & Society PARISPr Marc SANSON, Groupe Hospitalier Pitié Salpétrière-PARIS
INCa, Inserm and DGOS support and financing
FROM LYric TO LYriCAN
Cancer cellsand immune
targets
Combiningtreatments to
preventresistance
PhysicalAgents
Overcoming cellplasticity
Tumorcell
Macro-scopictumor
Immunothera
py
New targetsand
treatments
Personalised medicinebased on genomic
context
DevWeCan,PlasCan
TumAdoR,Hermione2Man
Personalized medicine based ongenomic context and
tumoral heterogeneity
AURAGEN,EURACAN,SSH Chair
ProfiLERMOST
BASIC RESEARCH
NATIONAL PERSPECTIVE
Individualized medecine for cancer
Genomic platforms & FMG2025
ACSE trials
SIRICs and their programs
Rare cancers
Clinical networks for rare cancersCancers rares Nom du
réseauCoordonnateurnational (et co-coordonnateurs)
Centre expertnational(un ou plusieurs sites)
Sarcomes des tissus mous et desviscères
NETSARC Pr Jean-Yves BlayDr Binh BuiDr Axel Le Cesne
Centre Léon BérardInstitut BergoniéInstitut GustaveRoussy
Sarcomes osseux RESOS Pr François Gouin CHU de NantesTumeurs neuroendocrines malignesrares
RENATEN Pr Patricia Niccoli Hôpital de la Timone,AP-HM
Tumeurs cérébrales rares TUCERA Pr Hugues Loiseau Hôpital Pellegrin,CHU de Bordeaux
Tumeurs oligodendrogliales de hautgrade
POLA Pr Jean-YvesDelattrePr DominiqueFigarella-Branger
Hôpital Pitié-Salpêtrière, AP-HPHôpital de la Timone,AP-HM
Cancers cutanés rares CARADERM Pr Laurent Mortier CHRU de Lille
Cancers ORL rares REFCOR Dr François JanotPr Baujat
Institut GustaveRoussyHôpital Tenon, AP-HP
Thymomes malins et carcinomesthymiques
RYTHMIC Dr Benjamin BessePr Nicolas Girard
Institut GustaveRoussy, Hôpital LouisPradel, HCL
Mésothéliomes malins pleuraux MESOCLIN Pr ArnaudScherpereelPr Françoise LePimpec-BarthesPr Jacques Margery
CHRU LilleHôpital EuropéenGeorges Pompidou,AP-HPInstitut GustaveRoussy
Bone
Soft tissue
Visceral
NetSARC: a network of 26 sarcoma reference centers in France35784 pts with follow-up presented in MDT since 2010
• 26 centers of reference in Netsarc• Linked with Pathology network (RREPS)• Linked with Bone Network RESOS (2014)
• 3 networks to be merged (2019)
• Single website
• Entry in the site by CRAs• Not a clinical trial, a registry
• Aims:• Guidelines• Guiding best practices/patient pathways• Measuring• Research
Soft tissue
LRFS & OS : incident patient populationN=35784 sarcoma patients
Operated- In NETSARC, N=9910 (33.9%)- Outside NETSARC, N=19307 (66.1%)
P<0.0001 P<0.0001
Now this is not the end.It is not even the beginning of the end.
But it is, perhaps, the end of the beginning.
ConclusionsNational initiatives
Molecular platforms
Basket trials
Sites of innovative research (SIRICs)
Larger panels/platforms : are they better?
Nationwide with FMG2025
Initial treatment in curative phases