Public-Private Partnerships in early phase clinical research: Spurring access to innovative therapeutics

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1 EPAAC WP8 Research Forum - 2 July, Sofitel Hotel Europe, Brussels Public-Private Partnerships in early phase clinical research: Spurring access to innovative therapeutics JY Blay, Past President EORTC Director SIRIC Lyon (LYRIC) Chair of the French Sarcoma Group

2 A new vision of the disease Histology Patient PS,..,SNP Molecular typing 2

3 A new vision of the disease Histology Trials on subsets of histotypes Patient PS,..,SNP Molecular typing Trials on genotype? e.g. CREATE 3

4 Omics in the clinic Gene expression profile Mindact EORTC 141 4

5 Omics in the clinics Which subset? Which target? Which agents? 5

6 Treatment of cancer needs genomics KIT exon 9 mutants (1% of patients) Median PFS (months) 6 / 19 3-year estimate (%) 5 / 17 P value (logrank test) KIT exon 9 mutants: 4 mg / 8 mg Other patients: 4 mg / 8 mg GIST are at least 1 diseases Years Dose KIT Exon 11 Im 4 + KIT exon 9 Im 8 + PDGFRA Non D842V Im 4 + D842V: Adjuvant KIT/PDGFR WT Im 4 +/? NF1?/Im 4 +/? SDHB?/Im 4 +/? Raf?? Pediatric?? 6

7 Fragmentation of disease classification vs Efficacy of clinical development of novel agents Rare histological and molecular subtypes Unmet needs Novel strategies

8 Target the histotype? The histotype, the driver mutation, the drug Leukemia CML,CMML, HES Sarcoma GIST, DFSP, PVNS, IMT, WPLPS Melanoma KIT or BRAF mutations NSCLC HER1 or Alk or DDR2 mutations BCC, Medulloblastoma Hh pathway alterations Breast Carcinoma HER2, BRCA1 Gastric adenocarcinoma HER2 amplification Renal cell carcinoma VHL loss.. 8

9 Target the primary mutation? The histotype, the driver mutation, the drug KIT GIST, Melanoma, ALL, Mast. PDGFR CMML, HES, DFSP Alk NSCLC, IMT, Neuroblastoma? HER1 NSCLC, HN? HER2 Breast Ca, Gastric Ca Hh BCC, Medullo, chondros VHL/HIF1A/VEGF RCC, NET mtor (TSC/PI3K/Akt) RCC, NET, Breast Ca BRAF MMM, other BRAF mut? 9

10 PEComa, Novartis Sponsored Study 1

11 PEComa, Novartis study Phase II Single arm BEZ235 monotherapy Multicenter trial Region Europe

12 12

13

14 LYRIC Trials MOST: My own specific treatment Metastatic patient Advanced phase Screened within Lyric Progression in advanced phase Maintenance with adapted Targeted therapy Prog 14

15 LYRIC MOST The MOST trial 15

16 The MOST trial Genetic alterations identified Tumors with mutations of ABL, PDGFRA, CSF-1R, DDR1/2, or amplification/translocation of the genes and/or of the ligands. Tumors with mutations of the PIK3CA or AKT genes, or with TSC1/2 loss or PTEN loss. Pancreatic neuroendocrine tumors and renal cell carcinomas (RCC) are excluded. Tumors with mutations of VEGFR1-3, PDGFRA/B, FLT3, KIT or RET or amplification/translocation of the genes and/or of their ligands. RCC and hepatocellular carcinomas are excluded. Tumors with mutations or amplification of HER1/EGFR or HER2. Tumors with mutations of BRAF V6. Metastatic melanomas are excluded. Tumors with mutations or amplifications of ALK, MET, RON, AXL, TYRO3 or ROS1. NSCLC are excluded. Tumors with amplifications of IGF-1R. Corresponding arm of MTT Tyrosine kinase inhibitor of BCR-ABL, KIT, PDGFRa/b, CSF-1R, DDR1/2: Nilotinib Inhibitor of the serine threonine kinase mtor: Everolimus Tyrosine protein kinase inhibitor of VEGFR, PDGFRA/B, Flt3, KIT and RET: Sorafenib Tyrosine kinase inhibitor of HER1/EGFR and HER2: Lapatinib or erlotinib* Serine threonine kinase inhibitor of BRAF with V6 mutation: Vemurafenib* Tyrosine protein kinase inhibitor of ALK and c-met: Crizotinib* Tyrosine protein kinase inhibitor of IGF- 1R* 16

17 The MOST trial Prevailing order? 17

18 14 questions for the next 2 years 1. Is it possible to organize the health care systems to ensure optimal local treatments, surgery and radiotherapy, for all patients? 2. How to build simple academic clinical trials? 3. Is it possible to organize annotated multinational tumor collection and storage to enable clinical research on molecular subtypes? How to recognize the driving mutations in individual patients to guide the treatment? 6. Can health care systems absorb the cost of targeted treatments? Blay et al. Personnalized medicine for oncology: questions for the next 2 years. Lancet Oncol 212; May 13 18

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