A national perspective: the French case

Transcription

1 INNOVATIVE SOLUTIONS FOR RESEARCH IN HEALTHCARE Developing a novel approach to deliver better precision medicine in Europe SESSION II: ROLE OF GOVERNAMENTAL & REGULATORY BODIES A national perspective: the French case Jean-Yves Blay, M.D., Ph.D., Centre Léon Bérard, Univ Cl. Bernard Lyon I

2 NATIONAL PERSPECTIVE Individualized medecine for cancer Genomic platforms & FMG2025 ACSE trials SIRICs and their programs Rare cancers

3 Nosology and treatment Histology

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5 Nosology and treatment Histology Trials on Histological & molecular subgroups Basket/Umbrella trials Stroma (Immune cells, ICP ) Molecular characterisation

6 Integrated Dataset: Larotrectinib Is Efficacious Regardless of Tumor Type 1 Integrated c (n = 109) ORR, % (95% CI) 81 (72-88) Best response, % PR CR Investigator response assessments, as of July 30, Lanssen U et al. ESMO Abstract 409O.

7 NATIONAL PERSPECTIVE Individualized medecine for cancer Genomic platforms & FMG2025 ACSE trials SIRICs and their programs Rare cancers

8 Panels for the analysis of somatic alterations INCA Panel: 20 genes with therapeutic implications Academic panel(s) : gènes Commercial panels ( eg FMI): 315 genes WES/WGS (last 3 reimbursed by RIHN)

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10 Etude ProfilER : diagramme CONSORT Enrolled N= 2,676 Tumor genomic profiles N= 1,944 At least one actionable alterations N= 1,004 (52%) At least one MTA recommended N= 676 (35%) Patients treated with recommended personalized 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 Presented by: O. TREDAN Abstract # LBA100

11 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 Focus on cancer & genetic (Mendelian) diseases > multi-factorial diseases 3 pilot projects (colon carcinoma, sarcomas, mental retardation, type2 diabete) 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) FS/2016

12 NATIONAL PERSPECTIVE Individualized medecine for cancer Genomic platforms & FMG2025 ACSE trials SIRICs and their programs Rare cancers

13 ACSE (NATIONAL, INCA)

14 NATIONAL PERSPECTIVE Individualized medecine for cancer Genomic platforms ACSE trials SIRICs and their programs FMG2025

15 8 SIRIC FUNDED Existing sites: SOCRATE 2.0 : Stratified Oncology Cell dna Repair and Tumor Elimination 2.0 Pr Eric DEUTSCH, Institut Gustave Roussy-VILLEJUIF SIRIC Montpellier Cancer Pr Marc YCHOU, Institut régional du Cancer Montpellier-MONTPELLIER INSTITUT CURIE SIRIC Dr Sergio ROMAN-ROMAN, Institut Curie-PARIS BRIO -Bordeaux Recherche Intégrée Oncologie Pr Pierre-Louis SOUBEYRAN, Institut Bergonié-BORDEAUX CARPEM - Cancer Research and Personalized Medicine PARIS Pr 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 -ANGERS Pr Philippe MOREAU, CHU Nantes - Hôtel Dieu-NANTES CURAMUS-Cancer United Research Associating Medicine, University & Society PARIS Pr Marc SANSON, Groupe Hospitalier Pitié Salpétrière-PARIS INCa, Inserm and DGOS support and financing

16 FROM LYric TO LYriCAN Personalized medicine based on genomic context and tumoral heterogeneity Personalised medicine based on genomic context New targets and treatments Tumor cell AURAGEN, EURACAN, TumAdoR, SSH Chair Hermione2Man DevWeCan, PlasCan Overcomin g cell plasticity Combining treatments to prevent resistance Physical Agents Cancer cells and immune targets ProfiLER MOST Macroscopic tumor Immun othera py BASIC RESEARCH

17 NATIONAL PERSPECTIVE Individualized medecine for cancer Genomic platforms & FMG2025 ACSE trials SIRICs and their programs Rare cancers

18 Clinical networks for rare cancers Cancers rares Nom du réseau Coordonnateur national (et cocoordonnateurs) Centre expert national (un ou plusieurs sites) Sarcomes des tissus mous et des viscères NETSARC Pr Jean-Yves Blay Dr Binh Bui Dr Axel Le Cesne Centre Léon Bérard Institut Bergonié Institut Gustave Roussy Sarcomes osseux RESOS Pr François Gouin CHU de Nantes Tumeurs neuroendocrines malignes rares 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 haut grade POLA Pr Jean-Yves Delattre Pr Dominique Figarella-Branger Hôpital Pitié- Salpêtrière, AP-HP Hôpital de la Timone, AP-HM Cancers cutanés rares CARADERM Pr Laurent Mortier CHRU de Lille Cancers ORL rares REFCOR Dr François Janot Pr Baujat Institut Gustave Roussy Hôpital Tenon, AP-HP Thymomes malins et carcinomes thymiques RYTHMIC Dr Benjamin Besse Pr Nicolas Girard Mésothéliomes malins pleuraux MESOCLIN Pr Arnaud Scherpereel Pr Françoise Le Pimpec-Barthes Pr Jacques Margery Institut Gustave Roussy, Hôpital Louis Pradel, HCL CHRU Lille Hôpital Européen Georges Pompidou, AP-HP Institut Gustave Roussy

19 NetSARC: a network of 26 sarcoma reference centers in France pts with follow-up presented in MDT since centers of reference in Netsarc Linked with Pathology network (RREPS) Linked with Bone Network RESOS (2014) 3 networks to be merged (2019) Single website Soft tissue Soft tissue Entry in the site by CRAs Not a clinical trial, a registry Aims: Guidelines Guiding best practices/patient pathways Measuring Research Viscer al Bone

20 LRFS & OS : incident patient population N=35784 sarcoma patients P< P< Operated - In NETSARC, N=9910 (33.9%) - Outside NETSARC, N=19307 (66.1%)

21 Now this is not the end. It is not even the beginning of the end. But it is, perhaps, the end of the beginning.

22 Conclusions National initiatives Molecular platforms Basket trials Sites of innovative research (SIRICs) Larger panels/platforms : are they better? Nationwide with FMG2025 Initial treatment in curative phases