DITEP 2018
01 � Gustave Roussy is one of the largest phase 1 centre, with more than 450 patients included per year in phase 1 trials. The mission of the DITEP is to accelerate the development of new anticancer drugs, to build an ambitious cancer research program (precision medicine, immunotherapy and new targets), and also to give a new hope to patients facing cancer battles. � Dr. Christophe Massard Head of DITEP
3 OUR STRATEGIC VISION AND MISSIONS
Created on September 1st, 2013 to strengthen the therapeutic innovation and the early clinical trials at Gustave Roussy.
In 2018, this medical department carries the ambition to be one of the top international players in early drug development, precision medicine and immunotherapy. OUR STRATEGIC VISION AND MISSIONS
Created on September 1st, 2013 to strengthen the therapeutic innovation and the early clinical trials at Gustave Roussy.
In 2018, this medical department carries the ambition to be one of the top international players in early drug development, precision medicine and immunotherapy. Oncology has become in the last decade an exciting therapeutic area bridging new scientific concepts and major clinical breakthroughs for the patients and their families. Our ambition is to foster a new era of cancer care and treatments by:
Promoting innovation and multidiscipli- Continuously developing the medico- nary collaborations to achieve higher scientific expertise of our investigators rates of treatment efficacy based on team and the skills and performance streamlined molecular analyses and of our clinical operations staff through predictive tools generated from our fruitful collaborations and partnerships precision medicine programs, as well with pharma and biotech companies. as innovative imaging methods. Pursuing our quality assurance Facilitating patients’ inclusion in phase management in the context of ISO- I/II studies at an earlier stage of the 9001 certification. disease to acknowledge the early clinical trial as a true therapeutic opportunity within an integrated cancer care management structure. Positioning cancer immunotherapy and the novel immunomodulators as early as possible as potential backbone therapies for combinations with other approaches. OVERALL ORGANIZATION OF THE DITEP DITEP KEY STEPS
September 2006 Early drug development and clinical trials identified as a strategic orientation of Gustave Roussy. Prof Soria appointed as the leader of a working group for therapeutic innovation and early clinical trials expansion. September 2007 Establishment of the early clinical trial pluridisciplinary committee (RCP-150)
September 2008 Creation of the « SITEP » (Service des Innovations Thérapeutiques et Essais Précoces), first hospitalization unit in France fully dedicated to early clinical trials in oncology (first-in-human administration, phase I trials, phase October 2010 I/II extension cohorts) with 8 beds and 6 out- patient seats. Recognition granted by the french National Cancer Institute (INCA, 4 years) of SITEP as an early trials center (CLIP²) July 2011
Certification of the french Health Regional Agency (ARS, 5 years) for first-in-human trials September 2013 Creation of the DITEP as a full medical department of Gustave Roussy , headed DITEP Drug Development Department by Prof. Soria. February 2015 Renewal of the CLIP² label by INCA (4 years)
May 2015 New premises gathering all the DITEP teams on one floor (4th)
September 2016 Renewal of the ARS certification for first-in-human trials
November 2016 ISO 9001 accreditation N°2016/72604.1
September 2017 Dr Massard appointed as Head of the DITEP Headed by Dr. Christophe Massard, in 2018 the DITEP encompasses 150 full-time equivalents dedicated to early clinical trials, translational research and precision medicine programs. Since November 2016, the DITEP has obtained the ISO 9001v2015 certification (Quality Management System) for its activities of access to therapeutic innovations, management of early clinical trials, and scientific outreach.
MEDICAL AND CLINICAL OPERATION TEAMS • Principal investigators and sub-investigators: 6 MD-PhD, 7 MDs (see CV p.28-40) • Medical and academic assistants & Managers: 13 • Clinical research nurses & Managers: 40 • Head of clinical operation unit: 1 • CRA managers: 2 • Project managers: 7 • Study coordinators: 26 • Clinical research technicians & sample managers: 17 • Schedulers: 3 • Medical research assistants & helpers: 7 • Quality assurance: 1 • Administrative & contracting: 3 • Chief scientific officer: 1
PLURIDISCIPLINARY CLINICAL RESEARCH AND DECISION-MAKING COMMITTEES • The early clinical trial multi-disciplinary tumor board (RCP-150), headed by Dr Vincent Ribrag, encompasses all DITEP experts in medical oncology, radiotherapy, hematology, immunotherapy, as well as experts in biopathology and imaging. This weekly committee is in charge of the validation of all patients’ referral to our phase I programs, and for the review of all on-going trials and medical decisions regarding any complex situations of safety or experimental treatment decisions. • The molecular pluridisciplinary committee (RCPM-150), dedicated to the weekly review of the molecular tumor profiles performed within our precision medicine programs aims at including each phase I-eligible patient in the most adapted clinical trial based on actionable molecular abnormalities. • A monthly Protocol Review Committee (PRC) to address the scientific value and feasibility of new trials proposals.
CARE WARDS & FACILITIES • A conventional week-hospitalization unit (4th floor) headed by Dr Antoine Hollebecque: 13 single-patient beds. This unit receives patients who require full-time hospitalization as per protocol or for safety surveillance due to side effects over the week. • An out-patient care unit (4th floor) headed by Dr Andrea Varga: 16 armchairs (whose 2 dedicated to PK). This outpatient unit is operational every day from Monday to Friday from 7:00 am to 7:00 pm (including PK sampling on Saturdays). This unit also receives patients who require nursing and related cares. • A consultation platform facility • An early phase clinical operations unit (4th floor) headed by Mrs Guylène Chartier gathering all staff in the same new premises that host all MDs offices, a local laboratory dedicated to the processing of biological samples, as well as confidential monitoring spaces dedicated to the trials sponsors.
09 ORGANIZATION CHART
Head of Department Dr A. Marabelle - Clinical Director of the Cancer Immunotherapy Program
functional link Dr E.Angevin - Industrial Partnerships Alliance Manager. Dr. C. Massard Dr J.P.Armand - Senior scientific consultant. Pr E.Deutsch - Head of Radiotherapy Department. Dr V.Ribrag - Head of Early Drug Development multidisciplinary tumor board Dr S. Postel-Vinay - Physician Senior Scientist (UMR 981)
functional link
Principal Academic functional link External consultant assistant J.Florance B.Thuillier
2 academic assistants
Head of early phase Executive Head of medical Head of Head of outpatient Clinical care Clinical care clinical operations unit Assistant secretary hospitalization unit care unit coordinator coordinator QA officer Manager P. Dielenseger G. Bernal- E. Netzer G. Chartier D. Aubry K. Willinger Dr A. Hollebecque Dr A. Varga Trinel
1 Head nurse DITEP 26 study-co 1 principal MA Dr A.Gazzah (day) Dr R.Bahleda 1 Head 2 CRA managers S. Orange Dr J.M.Michot S.Rodrigues nurse 10 data-managers Dr S. Champiat Dr C. Baldini (night) M.Houssaini 5 MA H. Zouhri 5 Sample managers + 25 nurses N. Meunier 2 Medical 1 assistant Administrative KEY FIGURES 1 Contract and Finance manager Secretaries 4 Nurse 7 nurses 1 Finance coordinator + helpers (night) L. Daley 1 Contract coordinator 1 professional training contract 1 Operations 4 Medical clinical Abbreviations coordinator research assistants S. Lancereau + 3 helpers AMR MA : Medical Assistant QA : Quality Assurance 3 schedulers EP : Early Phase
2 project managers CR : Clinical Research in personalized CRA : Clinical Research Associate medecine 2 Data Managers M. Ngo Camus C. Nicotra
1 project manager in Immunotherapy S. Fahrane
5 industrial partnerships project managers F.Colame N. Imam E. Toubiwou E. Zedouard H. Pousse
1 Chief Scientific Officer N. Hainault DITEP KEY FIGURES 2017 KEY FIGURES
3.946stays (Conventional Hospital and Day Hospital)
3.504 medical consultations 34 publications on early clinical trials results and precision medicine programs
11,2as the average journal Impact Factor 2.080 patient’s referrals for inclusion in early clinical trials
104 early clinical trials opened for inclusions
460 patients recruited in early clinical trials
806 patients recruited in precision medicine programs MAIN ACTIVITY INDICATORS
Yearly number of ongoing early clinical trials
104 100 96 91 90 88
80 70 70 68
60 55 50 41 40
30
20
10
0 20102011 2012 2013 2014 2015 2016 2017
Early clinical trials, as of January 2018 (in dose escalation and in organ-oriented extension cohorts)
8 3 Other Cell cycle & Apoptosis
6 Epigenetic & metabolic Inhibitors
41 86 Immune Checkpoints 10 & Immunomodulators Antibody Drug Conjugates EARLY CLINICAL & Bispecific Monoclonal TRIALS Antibodies
18 Tyrosine Kinase Inhibitors
13 Patients recruited in DITEP trials
1000 1266
932 900 863
800 757
700 647 600
519 500 460 444 410 443 400 385 344 336 345 300 279 278
200
100
0 2010 2011 2012 2013 2014 2015 2016 2017
Patients recruited in our studies (early clinical trials and precision medicine programs) Patients treated in our early clinical trials (inclusions in our precision medicine programs excluded)
Patients treated in early clinical trials in 2017
32% Gastrointestinal 1%1% 2% Hematology 2% Gynaeco 5% Lung 5% 460 GenitoUrinary Breast 5% PATIENTS HNSCC 14% Skin
10% Brain
Neuroendocrine
11% 12% Other
Sarcoma DITEP RESEARCH ACTIVITES DITEP RESEARCH AXIS
DITEP Research PRECISION MEDICINE IMMUNOTHERAPY NEW MOLECULAR ENTITIES Axis
MTAs ICB FIH & combos DNA repair Mol. Profiling/Serial Biopsies ADCs - BiTEs Epigenetic Targeted panel Cancer Vaccines Metabolism WES/RNASeq/ctDNA CAR-T cells
FIHs Dose Escalation (All comers)
Dose Extensions (All indications) Basket / Umbrella Trials DESIGNS
Neoadjuvant Settings / WoO Trials
Local Immunomodulation Intratumoral Injections SPECIFIC EXPERTISES Combos with Radiotherapy
FIELDS OF INTEREST EDD in Hematological Malignancies
ADC : Antibody Drug Conjugate ; BiTE : Bispecific T cell Engager ; EDD : Early Drug Development ; ICB : Immune Checkpoint Blocker ; MTA : Molecular Targeted Agent ; WoO : Window of Opportunity PRECISION MEDICINE PROGRAMS
MOSCATO program (“Molecular Screening for Cancer Treatment Optimization”)
1168 patients enrolled in MOSCATO-01 554 patients enrolled in MOSCATO-02
Dr MASSARD (as of February 2018)
This Gustave Roussy-sponsored biomedical The second part of the program, named research exploited the extensive molecular and MOSCATO-02, was launched in March 2016 by immunological characterization of on-purpose Dr. Antoine Hollebecque. It is an extension of fresh biopsies of metastatic sites in relapsed the first part and now includes, on top of the and refractory phase I-eligible patients in order molecular profiling, an immune contexture to orient these patients to the most adapted characterization and an evaluation of the molecular targeted or immune-based therapy. mutational load (WES) for the orientation of the patient to immunotherapy. In the first part of this program, named MOSCATO-01, over 1011 patients were included between November 2011 and March 2016. Four hundred eleven patients had an “actionable” PUBLICATION molecular abnormality (identified on NGS gene Massard C, et al. High-Throughput panel, CGHa, IHC analyses and more recently Genomics and Clinical Outcome in WES/RNASeq) and 199 out them have been Hard-to-Treat Advanced Cancers: treated with an ad hoc targeted molecule. The Results of the MOSCATO 01 Trial. objective of the study was to demonstrate that Cancer Discov. 2017 Jun;7(6):586-595. the progression-free survival of the first line of oriented treatment (PFS2) was significantly superior to the progression-free survival of the last treatment line before inclusion (PFS1). This judgment criterion was fully achieved with a PFS2/PFS1 ratio > 1.3 in 33% (IC95 PFS ratio: 26-39%) of the patients with a disease control rate of 62% and a median overall survival of 11.3 months. With these results, MOSCATO-01 is the first trial demonstrating a clinical benefit in advanced cancer patients by a large-scale molecular screening and precision medicine approach.
17 MATCH-R program 223 patients enrolled
Prof. BESSE
The MATCH-R trial started in 2014 (PI : Prof. archived initial tumor material. Benjamin Besse, Head of the Medical Oncology This MATCH-R program also includes several Department). It is a two-centre prospective sub-studies : trial sponsored by Gustave Roussy which - The Bégin Hospital and Gustave Roussy have aims at characterizing the evolution of clonal collaborated to establish one focusing on cancer architecture of tumors from patients treated of the prostate (Dr. Yohann Loriot) in patients with molecular targeted therapies. resistant to enzalutamide and abiraterone. It is designed to collect fresh tumor biopsies - The MATCH-R IMMUNO is a prospective study at relapse/recurrence in patients treated with that aims at identifying molecular mechanisms molecular targeted agents (either approved of resistance to immunotherapies in patients or in early clinical trials of the DITEP portfolio with unresectable or metastatic cancers. of studies). Eligible patients are patients in Eligible patients in this trial are patients eligible progressive disease who previously experienced for a treatment with an anti-PD-1 or anti-PD-L1 a significant benefit to a targeted molecules monoclonal antibody, either in monotherapy or (objective response or long-lasting disease in combination. stabilization > 6 months) and availability of an PUBLICATION Planchard D, et al. EGFR-independent mechanisms of acquired resistance to AZD9291 in EGFR T790M-positive NSCLC patients. Ann Oncol. 2015 Oct;26(10):2073-8.
Precision medecine scheme
MOLECULAR CLINICAL FRESH TUMOR TREATMENT SCREENING DECISION
pathological CGH Array & NGS/WES/RNAseq biopsy control ctDNA
Max 21 calendar days
RELEVANT ACTIONABLE TARGETED TARGET THERAPY
IMPROVE OUTCOME LIQUID BIOPSY program 1221 patients enrolled (CTC)
The « Liquid Biopsy » Program is based on mutations, amplifications, translocations) on the detection in the blood of circulating tumor oncogeneic drivers (EGFR, ALK, MET, FGFR…) residues, such as circulating tumor cells (CTC), and to evidence any new one that could be nucleic acids (ctDNA or ctRNA) using specific associated to primary or secondary resistance highly sensitive and specific assays. The general (e.g. to immune checkpoints blockers or specific goal of this approach is to monitor, through a tyrosine-kinase inhibitors). repeatable and safe blood sampling, the clonal evolution of tumors at the cellular and molecular levels under the pressure of targeted therapies and to characterize resistance mechanisms. This program is currently deployed across multiple indications, with a focus on lung cancers, for the tracking of already known (in initial tumor biopsies) molecular aberrations (i.e.
PUBLICATION Planchard D, et al. EGFR-independent mechanisms of acquired resistance to AZD9291 in EGFR T790M-positive NSCLC patients. Ann Oncol. 2015 Oct;26(10):2073-8.
Jovelet C, et al. Circulating Cell-Free Tumor DNA Analysis of 50 Genes by Next-Generation Sequencing in the Prospective MOSCATO Trial. Clin Cancer Res. 2016 Jun 15;22(12):2960- 8.
Koeppel F, et al. Whole exome sequencing for determination of tumor mutation load in liquid biopsy from advanced cancer patients. PLoS One. 2017 Nov 21;12(11):e0188174.
19 IMMUNOTHERAPY
Dr MARABELLE Recent years have seen the emergence of new rare toxic effects are potentially severe and require immunotherapies finally effective. These new molecules, early detection. As part of the GRIP, Gustave Roussy mainly monoclonal Antibodies (mAbs), present a novel has implemented a program designed to manage the mechanism of action: by blocking co-inhibitory receptors adverse effects of immunotherapies. This program expressed by T cell they unleash their effector functions. has 4 components: a network of organ specialist, The first generation of these immune-targeted mAbs are institutional management guidelines, the REISAMIC blocking immune checkpoint receptors such as CTLA4* pharmacovigilance registry (Registry of Severe Adverse and PD1 ** and have revolutionized the treatment of Effects of Immunomodulating Monoclonal Antibodies melanoma with metastatic response rates and survival in Oncology), and dedicated multidisciplinary team exceptionally increased. (MDT) meetings. The PD1/PD-L1 blocking mAbs also give very encouraging results in cancers of the kidney, lung and other advanced cancers are currently being explored. A new generation of Clinical Research in immunotherapy treatments against cancer is born! Number of active Immunotherapy Trials * CTLA4: cytotoxic T-lymphocyte-associated protein 4 Number of active Immunotherapy Trials/Year 140 ** PD1: Programmed cell death protein 1 120 Number of active Immunotherapy Trials/Year 140100 65 A program dedicated to 12080 10060 immunotherapy: GRIP 30 8040 65 14 52 6020 8 38 21 30 3 4 11 In 2015, Gustave Roussy launched an institutional 400 2 23 4 7 2010 2011 2012 2013 2014 2015 2016 2017 14 52 program dedicated to immunotherapy: GRIP (Gustave 20 Phase II/III Phase I/II 8 38 21 3 4 11 Roussy Immunotherapy Program). This program aims 0 2 23 4 7 Number 2010of patients2011 treated in2012 Immunotherapy2013 Trials2014 /Year 2015 2016 2017 at strengthening translational research on these new Number of patientsPhase II/III treated inPhase Immunotherapy I/II Trials 600 539 treatments, and accelerating the clinical development of immunotherapy, in order to give access to these Number500 of patients treated in Immunotherapy Trials /Year 600 419 treatments to the largest number of patients. Initiated 400 539 by Professor Alexander Eggermont, General Director of 500 300 Gustave Roussy, the GRIP program is under the clinical 419 400 200 204 200 direction of Dr. Aurélien Marabelle and under the scientific 134 300 97 100 direction of Professor Laurence Zitvogel. 204 31 200 By reactivating the immune system against cancer 200 28 0 134 2010 2011 201297 2013 2014 2015 2016 2017 cells, these immunotherapies may sometimes provoke 100 auto-immune reactions. These reactions are new and 28 31 0 2010 2011 2012 2013 2014 2015 2016 2017 necessitate specific management. In addition, some SPECIFIC EXPERTISES
RADIOTHERAPY HEMATOLOGY
Prof. DEUTSCH Dr RIBRAG Radiotherapy combinations With 19 trials open for hematological malignancies, the DITEP has emerged as a key The link between development of new anticancer player in hematology drug development. More drugs and radiation therapy has been part of the than 90 patients were enrolled in these trials activity of DITEP since its creation. in 2016 with myeloid and lymphoid diseases. Combination of radiotherapy with First in man studies targeting epigenetics nanoparticles, therapies targeting DNA (IDH2 and EZH2) open new areas for treating repair mechanisms and immunomodulatory patients and now will enter in phase II and III agents are under study. A significant portion of drug development given the high level of activity this activity is at the interface with the preclinical observed in trials where the DITEP was largely research activity developed at Gustave Roussy. involved. The combination of radiotherapy with other anticancer agents is therefore part of a On the other hand, targeting immune comprehensive development strategy. checkpoints proved to be extremely effective in For these studies, academic funding is of special lymphomas such as Hodgkin disease. During importance notably in the case of combinations the recent years, a dedicated hematology team of antiviral agents and radiotherapy. within the translational research laboratory has been created and offers now the opportunity to add biological cellular collection and a molecular Radiomics profile of the patient’s tumors. This molecular The Radiomics team of the INSERM U1030 unit profile is implemented for patient’s screening. (led by Prof. Eric Deutsch) has established a very Our aim will be to characterize more precisely fruitful collaboration with the group of Pr Nikos the patient’s tumors and more efficiently propose Paragios (Centrale Supelec INRIA), bringing world- the relevant trial to the patients according to this renowned expertise in imaging analysis and artificial updated molecular characterization. intelligence. Medical image processing and analysis (i.e. radiomics) is a promising and rapidly growing discipline. This new approach consists of the analysis of high dimensional data (typically > 1000 features per volume of interest) extracted from standard medical imaging such as CT-scans, PET or MRI. The underlying assumption is that imaging reflects not only the architecture of the tissues, but also their cellular and molecular composition. The end goal of radiomics is to generate imaging biomarkers as decision support tools for clinical practice and to better understand cancer biology. One of the axes of research is the use of radiomics as a predictor of lymphocytic tumor infiltration and thus of the efficacy of immunotherapies.
21 DITEP COLLABORATIONS RELATIONSHIP WITH INTERNAL (RCP) AND EXTERNAL ONCOLOGISTS
EXTERNAL INTERNAL
Active file of DITEP Experts & Gustave Roussy Referents to RCP Tumor Boards (RCP) patients in 2016 1 338 national Soft Tissues – Bone external referrals in 2017 R. Bahleda 2 268 C. Honoré Thoracic Pathology A. Gazzah 2 198 B. Besse Gastro-digestive 2 818 D. Malka A. Hollebecque Endocrine Tumours 4 198 É. Baudin Dermatology 4 330 C. Robert A. Marabelle Cervico-facial Pathology 4 749 I. Breuskin Urology L. Albigès 4 204 C. Massard Neurology F. Dhermain 826 V. Ribrag Haematology 3 550 JM. Michot S. De Botton Breast S. Delaloge 10 651 A. Varga Gynecology P. Pautier 3 351 Paediatric Pathology J. Grill 2 448 Genetical Oncologist O. Caron 972
Organ-oriented expertise with all other Strong links with other French Early Drug tumor boards and medical departments for Development Centers (CLIP² centers) and the patient referral and facilitation of the networks of international centers in Europe transition between early and late phase (VHIO, NKI, Cambridge, DKFZ, KI within the clinical trials. Most of the DITEP physicians Cancer Core Europe consortium headed by Pr are also organ-specialists partially affiliated to Eggermont and Pr Calvo). different organ-oriented tumor boards. The radiotherapy (Pr Deutsch, Dr Levy) department is strongly connected to DITEP and the surgery departments participate according to specific needs, especially with the HNSCC Tumor Board (Dr Temam). RELATIONSHIP WITH PLATFORMS & RESEARCH TEAMS
CLINICAL RESEARCH Early Drug Development @ DITEP
IMMUNOLOGY MECHANISMS OF BIOPATHOLOGY & IMMUNO- BIOINFORMATICS RESISTANCE MOLECULAR DNA REPAIR TRANSLATIONAL & BIOLOGICAL MONITORING RESEARCH RADIOTHERAPY EPIGENETIC RESOURCES D. Gautheret L. Friboulet L. Zitvogel L. Verlingue B. Besse E. Deutsch S. Postel-Vinay JY. Scoazec A. Marabelle C. Massard N. Chaput CRB Biopat. HCP BioInfo Pt UMR981 UMR1015 LIO LRTI UMR1030 ATIP-Avenir
Dir. Prof. E. Deutsch BASIC RESEARCH
Strong interactions with the Clinical Active contribution in early clinical trials Research Division (DRC), headed by Pr of multiple experts: Biopathology/CRB Vassal for the initiation and conduct of and Translational Research Platforms (Pr Gustave Roussy-sponsored early clinical Scoazec) including high-throughput trials & Investigator-initiated Studies molecular profiling (Dr Lacroix), IHC (Dr (ISS). The DRC encompasses different Adam), circulating cells (Dr Farace), entities: the SPEC, headed by Ms Vuillier, in immunomonitoring (Pr Chaput-Gras), charge of the regulatory affairs and bioinformatics (Mr Meurice); Functional monitoring of investigation sites; the SBE, Imaging (Dr Balleyguier, Dr Ammary, Dr headed by Dr Benhamou, in charge of early Lassau); Nuclear Medicine (Dr Dercle) with clinical trial biostatistics design (Dr Lanoy, a specific innovative program of PET-MRI; Dr Paoletti), medically-driven data Interventional Radiology (Pr De Baere) for management and analyses of ISS; the sequential biopsies in precision medicine UFPV headed by Dr Laghouati, is in programs; Pharmacology & charge of the pharmacovigilance pharmacokinetics (Dr Paci). declarations and of immune-related SAE, a specific registry (REISAMIC) of immune- checkpoint treatments.
25 INDUSTRIAL PARTNERSHIPS
Dr ANGEVIN
The development of collaborations and of their effectiveness. This is also the partnerships with industry are a major opportunity to collaborate on preclinical objective for Gustave Roussy, and espe- and translational studies in biology or ima- cially DITEP. This objective is supported by ging, connecting academic and industrial an active policy of attracting global phar- researchers and clinicians, thus genera- maceutical and biotechnology companies. ting significant benefits in terms of patents and know-how. It is based on the value of our medical and scientific expertise, our operational skills Finally, these collaborations are accompa- CV OF DITEP and our clinical and biological resources. nied by significant funding to retain skilled personnel and develop new methods. Through industry partnerships, our priority is to have access to the most innovative and To this end, DITEP promotes privileged PRINCIPAL potentially effective agents for our patients partnerships with pharmaceutical compa- early in their development. nies likely to give us a substantial portfolio of molecules and early trials. Our teams are able to propose ancillary INVESTIGATORS & projects to optimize development of these molecules, establish the mechanism of Contact: Dr Angevin, Alliance Manager their action or define predictive biomarkers [email protected] SUB-INVESTIGATORS CV OF DITEP PRINCIPAL INVESTIGATORS & SUB-INVESTIGATORS EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS EORTC-NCI-AACR 2016 • First-in-human study of LY3039478, an oral Notch signaling inhibitor in advanced or metastatic cancer
ASCO 2016 • Safety and efficacy of durvalumab (MEDI4736), a PD-L1 antibody, in urothelial bladder cancer
TAT 2016 • Dose escalation study of ODM-203, a selective dual FGFR/VEGFR inhibitor, in patients with advanced solid tumours Christophe Massard PUBLICATIONS • Massard C, Mateo J, Loriot Y, Pezaro C, Albiges MD L, Mehra N, Varga A, Bianchini D, Ryan CJ, Petrylak DP, Attard G, Shen L, Fizazi K, de Bono PhD J. Phase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone. Ann Oncol.2017 Jan 1;28(1):90-95.
• Massard C, Gordon MS, Sharma S, Rafii S, Wainberg ZA, Luke J, Curiel TJ, Colon-Otero G, General background Hamid O, Sanborn RE, O’Donnell PH, Drakaki A, Tan W, Kurland JF, Rebelatto MC, Jin X, Christophe Massard (MD, PhD) medical oncologist, is Blake-Haskins JA, Gupta A, Segal NH. Safety and Efficacy of Durvalumab (MEDI4736), an Chair of Drug Development Department (DITEP), Gustave Anti-Programmed Cell Death Ligand-1 Immune Checkpoint Inhibitor, in Patients With Advanced Roussy, Villejuif, France. He is Consultant Medical Urothelial Bladder Cancer. J Clin Oncol. Oncologist and full time cancer specialist at Gustave 2016;34(26):3119-25. Roussy, half time at Drug Development department (DDD) • Massard C, Michiels S, Ferte C, Le Deley MC, and joined the faculty in 2006. He is primarily involved in Lacroix L, Hollebecque A, Verlingue L, Ileana E, Rosellini S, Ammari S, Ngo-Camus M, Bahleda translational cancer research and the design and conduct R, Gazzah A, Varga A, Postel-Vinay S, Loriot Y, of early-phase biomarker-driven clinical trials, with a Even C, Breuskin I, Auger N, Job B, De Baere T, Deschamps F, Vielh P, Scoazec JY, Lazar special interest in Genito urinary cancer and Central V, Richon C, Ribrag V, Deutsch E, Angevin E, Vassal G, Eggermont A, Andre F, Soria JC. High- Nervous System tumor. Throughput Genomics and Clinical Outcome in Hard-to-Treat Advanced Cancers: Results of the MOSCATO 01 Trial. Cancer Discov. 2017 Dr Massard received his medical degree from PARIS XI Jun;7(6):586-595. University in 2006, and he got a MSc and PhD from PARIS
• Massard C, Borget I, Farace F, Aspeslagh S, Le XI University in 2013. He completed his residency training Deley MC, Le Tourneau C, Bidard FC, Pierga JY, in Paris Hospital, followed by his fellowship in medical Dieras V, Hofman P, Spano JP, Ferte C, Lacroix L, Soria JC. RECIST response and variation of oncology at Gustave Roussy. He is board-certified in circulating tumour cells in phase 1 trials: A prospective multicentric study. Eur J Cancer. Medical Oncology. He did a post-doctoral fellowship in Prof 2017;83:185-193. DeBono’s lab at the Royal Marsden Hospital of London and
• Massard C, Chi KN, Castellano D, de Bono J, Institute of Cancer Research (London). Gravis G, Dirix L, Machiels JP, Mita A, Gonzalez BM, Turri S, Maier J, Csonka D, Chakravartty A, Fizazi K (2017) Phase Ib dose-finding study of Dr Massard is member of ESMO, ASCO, AACR. Over abiraterone acetate plus buparlisib (BKM120) or the last 5 years, he was the principal investigators of 15 dactolisib (BEZ235) in patients with castration- resistant prostate cancer. Eur J Cancer 76:36-44. phase I trials, 1 phase II trial (prostate cancer), and sub- investigator of more than 80 clinical trials (phase 1 trials and GU cancers). He is also involved in translational research aspects related to precision medicine(MOSCATO, MATCH R and PETRUS program). Dr Massard has contributed to over 180 peer-reviewed publications, including publications in European Urology, Annals of Oncology and Journal of Clinical Oncology. . He is also a member of the editorial boards of Bulletin du Cancer, Investigational New Drugs, and European Journal of Cancer.
Research axes: early clinical trials, precision medicine, GU cancers (prostate cancer, bladder cancer and testis), glioma, and circulating biomarkers. EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS NCI-EORTC-AACR 2014 • Phase I trial evaluating the antiviral agent CIDOFOVIR in combination whit chemoradiation in cervical cancer patients : a novel approach to treat HPV related malignancies ?
ESMO 2014 • Desing of clinical trials integrating local treatments with systemic therapy for M1 disease.
ICTR PHE 2014 • Combination of vascular disrupting agents and ionizing radiation.
Eric Deutsch PUBLICATIONS • Bonvalot S, Le Pechoux C, De Baere T, Kantor G, MD Buy X, Stoeckle E, Terrier P, Sargos P, Coindre PhD JM, Lassau N, Ait Sarkouh R, Dimitriu M, Borghi E, Levy L, Deutsch E, Soria JC. First-in-Human Study Testing a New Radioenhancer Using Nanoparticles (NBTXR3) Activated by Radiation Therapy in Patients with Locally Advanced Soft Tissue Sarcomas. Clin Cancer Res 2017. 23:908-917.
• Deutsch E, Cohen-Jonathan Moyal E, Gregorc V, General background Zucali PA, Menard J, Soria JC, Kloos I, Hsu J, Luan Y, Liu E, Vezan R, Graef T, Rivera S. A phase 1 Eric Deutsch, MD, PhD, full-Professor in Radiation dose-escalation study of the oral histone deacetylase inhibitor abexinostat in combination Oncology at South-Paris University, head of the Inserm with standard hypofractionated radiotherapy in Unit 1030 « Molecular Radiology Laboratory » and Head advanced solid tumors. Oncotarget. 2016 Dec 24 of the Radiation Oncology Department in Villejuif, France. [Epub ahead of print] He is teaching radiobiology and medical physics at the • Levy A, Massard C, Soria JC, Deutsch E. Concurrent irradiation with the anti-programmed Medical School of South-Paris University. cell death ligand-1 immune checkpoint blocker durvalumab: Single centre subset analysis from a phase 1/2 trial. Eur J Cancer. 2016;68:156-162. Eric Deutsch’s research has been dedicated to combination • Deutsch E, Haie-Meder C, Bayar MA, Mondini M, of novel anticancer drugs either used alone or in Laporte M, Mazeron R, Adam J, Varga A, Vassal G, combination to radiotherapy. His interest focuses on cell Magne N, Chargari C, Lanoy E, Pautier P, Levy A, Soria JC. Phase I trial evaluating the antiviral death mecanisms, HPV related tumours and the tumour- agent Cidofovir in combination with stroma interplay, on the clinical side, he is versed into the chemoradiation in cervical cancer patients. Oncotarget. field of translational research and early clinical trials. 2016;7(18):25549-57. He has investigated several first in human novel drugs- • Deutsch E, Le Péchoux C, Faivre L, Rivera S, Tao radiotherapy combinations such as mTOR inhibitors, Y, Pignon JP, Angokai M, Bahleda R, Deandreis D, Angevin E, Hennequin C, Besse B, Levy A, Soria antiviral agents, immune modifyers and nanoparticles. JC. Phase I trial of everolimus in combination with thoracic radiotherapy in non-small-cell lung Research axes: Early clinical trials and phase I, novel cancer. Ann Oncol. 2015;26(6):1223-9. anticancer drugs, radiation biology, HPVs related tumors, combination with new drugs and Radiotherapy.
29 EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS ASH 2015 • Phase 1 Study of Tazemetostat (EPZ-6438), an Inhibitor of Enhancer of Zeste-Homolog 2 (EZH2): Preliminary Safety and Activity in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL) Patients. • Safety and Efficacy of Abexinostat, a Pan- Histone Deacetylase (HDAC) Inhibitor, in Non- Hodgkin Lymphoma and Chronic Lymphocytic Leukemia: Results of an Ongoing Phase 2 Study.
TAT 2015 • Phase 1 first-in-human study of the enhancer of zeste-homolog 2 (EZH2) histone methyl Vincent Ribrag transferase inhibitor E7438.
PUBLICATIONS MD • Zinzani PL, Ribrag V, Moskowitz CH, Michot JM, Kuruvilla J, Balakumaran A, Zhang Y, Chlosta S, Shipp MA, Armand P. Safety and tolerability of pembrolizumab in patients with relapsed/ refractory primary mediastinal large B-cell lymphoma. Blood. 2017 Jul 20;130(3):267-270.
• Ribrag V, Kim WS, Bouabdallah R, Lim ST, Coiffier B, Illes A, Lemieux B, Dyer MJS, General background Offner F, Felloussi Z, Kloos I, Luan Y, Vezan R, Graef T, Morschhauser F. Safety and efficacy Vincent Ribrag attended the University of Science and Medical of abexinostat, a pan-histone deacetylase inhibitor, in non-Hodgkin lymphoma and chronic School of South-Paris University between 1978 and 1985. In lymphocytic leukemia: results of a phase II study. 1990-1991 he obtained his Master of Science in Molecular Haematologica. 2017 May;102(5):903-909. Biology, with Professor JC Kaplan. In the years 1990-1992 • Ribrag V, Koscielny S, Bosq J, Leguay T, he also received his Diplôme d’Études Approfondies in Casasnovas O, Fornecker LM, Recher C, Ghesquieres H, Morschhauser F, Girault S, Le molecular and cellular pharmacology at the Pierre et Marie Gouill S, Ojeda-Uribe M, Mariette C, Cornillon Curie (Paris Vl) University with Professor Ascher. He obtained J, Cartron G, Verge V, Chassagne-Clément C, Dombret H, Coiffier B, Lamy T, Tilly H, Salles G. his board certification in Hematology and discussed a thesis Rituximab and dose-dense chemotherapy for adults with Burkitt’s lymphoma: a randomised, (silver medal) at the Paris Xl Faculty of Medicine entitled “VIP controlled, open-label, phase 3 trial. 2016 Nov (etoposide,ifosfamide, cisplatinum) as a salvage intensification 1;34(31):3733-3739. program in relapsed or refractory Hodgkin’s disease.” • Armand P, Shipp MA, Ribrag V, Michot JM, Zinzani PL, Kuruvilla J, Snyder ES, Ricart AD, Balakumaran A, Rose S, Moskowitz Dr Ribrag is a tenure-track specialist at Gustave-Roussy CH. Programmed Death-1 Blockade With lnstitute and has been nominated head of the Hematology Pembrolizumab in Patients With Classical Hodgkin Lymphoma After Brentuximab Vedotin multidisciplinary committee in Gustave-Roussy. Among Failure. J Clin Oncol. 2016 Jun 27. pii: JCO673467 [Epub ahead of print] numerous experimental activities, he counts a Laboratoire in clinical pharmacology (URA 147 CNRS, U-140 INSERM) with • Infante JR, Cassier PA, Gerecitano JF, Witteveen PO, Chugh R, Ribrag V, Chakraborty A, Matano A, Dr A Gouyette; works in enzymology , the ICGM: INSERM Dobson JR, Crystal AS, Parasuraman S, Shapiro U-363 at the Hôpital Cochin in Paris; the Unité INSERM GI. A Phase I Study of the Cyclin-Dependent Kinase 4/6 Inhibitor Ribociclib (LEE011) in Patients U U1170: Animal MCL models and drug discovery and is With Advanced Solid Tumors and Lymphomas. head of the translational research lab in hematology. Dr Clin Cancer Res. 2016;22(23):5696-5705. Ribrag is member of several international cancer societies, namely the American Association for Cancer Research (AACR), the American Society of Hematology (ASH), the Société Française de Greffe de Moelle (SFGM), the Société Française d’Hématologie (SFH), the Groupe Français des Myélodysplasies (GFM) where he serves as scientific secretary since 1998. He is also part of the Lysa Scientific and Administrative Committees and of the European Scientific Committee of the Mantle Cell Lymphoma study group since 2001 and associated Head of early trials with Martin Dreyling. IMMUNOTHERAPY & EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS
SITC 2017 • Phase I study of E7046, a novel PGE2-receptor type-4 inhibitor, in patients with advanced solid tumors: clinical results and effects on myeloid- and T-lymphoid cell-mediated immunosuppression
ASCO GI 2016 • Understanding the relevant immune mechanisms in GI cancer
ITOC3 2016 • Prioritisation of potential immunotherapy Aurélien Marabelle combination studies
TAT 2015 MD • “Novel Immunostimulatory Antibodies: What’s PhD next?”
PUBLICATIONS
• Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria JC, Ferte C. General background Hyperprogressive Disease Is a New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1. Clin Cancer Res 2017 Apr Aurélien Marabelle MD, PhD, is a Senior Medical Oncologist 15;23(8):1920-1928. in the Drug Development Department (DITEP), a group • Marabelle A, Aspeslagh S, Postel-Vinay S, Soria leader in Prof Laurence Zitvogel’s lab (INSERM U1015) JC. JAK Mutations as Escape Mechanisms to Anti- and the Clinical Director of the Cancer Immunotherapy PD-1 Therapy. Cancer Discov. 2017;7(2):128-130. Program at Gustave Roussy. He joined the faculty in Oct • Aspeslagh S, Postel-Vinay S, Rusakiewicz S, Soria JC, Zitvogel L, Marabelle A. Rationale for 2014. anti-OX40 cancer immunotherapy. Eur J Cancer. 2016;52:50-66.
He got a MSc & PhD in Oncology & Immunology from • Boutros C, Tarhini A, Routier E, Lambotte O, Ecole Normale Supérieure de Lyon, King’s College London Ladurie FL, Carbonnel F, Izzeddine H, Marabelle A, Champiat S, Berdelou A, Lanoy E, Texier M, & University of Lyon. He did a post-doctoral fellowship in Libenciuc C, Eggermont AM, Soria JC, Mateus C, Prof Ronald Levy’s lab at Stanford University, California. Robert C. Safety profiles of anti-CTLA-4 and anti-PD-1 antibodies alone and in combination. Nature reviews Clinical oncology. 2016;13(8):473- He trained at the University of Paris VI medical school 486. and received his medical degree from the University of • Postel-Vinay S, Aspeslagh S, Lanoy E, Robert C, Soria JC, Marabelle A. Challenges of phase 1 Clermont-Ferrand. He completed his residency training in clinical trials evaluating immune checkpoint- between Clermont-Ferrand & Lyon, followed by a clinical targeted antibodies. Ann Oncol. 2016;27(2):214- fellowship at Léon Bérard Cancer Center in Lyon. 224. • Jacquelot N, Roberti MP, Enot DP, Rusakiewicz S, Ternes N, Jegou S, Woods DM, Sodre AL, Dr Marabelle is a member of ASCO & AACR. Dr Marabelle Hansen M, Meirow Y, Sade-Feldman M, Burra A, Kwek SS, Flament C, Messaoudene M, Duong is board-certified in Pediatric Oncology & Cell Therapy. CPM, Chen L, Kwon BS, Anderson AC, Kuchroo VK, Weide B, Aubin F, Borg C, Dalle S, Beatrix O, Ayyoub M, Balme B, Tomasic G, Di Giacomo AM, Research axes: Cancer Immunotherapy & Early Phase Maio M, Schadendorf D, Melero I, Dreno B, Studies Khammari A, Dummer R, Levesque M, Koguchi Y, Fong L, Lotem M, Baniyash M, Schmidt H, Svane IM, Kroemer G, Marabelle A, Michiels S, Cavalcanti A, Smyth MJ, Weber JS, Eggermont AM, Zitvogel L. Predictors of responses to immune checkpoint blockade in advanced melanoma. Nat Commun. 2017 Sep 19;8(1):592.
• Shekarian T, Valsesia-Wittmann S, Brody J, Michallet MC, Depil S, Caux C, Marabelle A. Pattern recognition receptors: immune targets to enhance cancer immunotherapy. Ann Oncol. 2017 Aug 1;28(8):1756-1766.
31 EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS IASLC WCLC 2016 • First-In-Human Phase 1 Study of ABBV-399, an Antibody-Drug Conjugate (ADC) Targeting C-Met, in Patients with Non-Small Cell Lung Cancer (NSCLC)
ASCO 2015 • First-in-human phase I administration of YS110, a monoclonal antibody directed against the CD26 immunostimulatory molecule in advanced cancer patients (Poster Discussion)
ASCO 2014 • A first-in-human (FIH) phase I study of Eric Angevin SAR125844, a novel selective MET kinase inhibitor, in patients (pts) with advanced solid tumors MD PUBLICATIONS PhD • Angevin E, Spitaleri G, Rodon J, Dotti K, Isambert N, Salvagni S, Moreno V, Assadourian S, Gomez C, Harnois M, Hollebecque A, Azaro A, Hervieu A, Rihawi K, De Marinis F. A first-in- human phase I study of SAR125844, a selective MET tyrosine kinase inhibitor, in patients with advanced solid tumours with MET amplification. Eur J Cancer. 2017 Dec;87:131-139. General background • Angevin E, Cassier PA, Italiano A, Gonçalves A, Eric Angevin obtained his medical and biology degree at Gazzah A, Terret C, Toulmonde M, Gravis G, Varga A, Parlavecchio C, Paci A, Poinsignon V, Soria J-C, Paris VI University and a PhD degree of cancerology and Drubay D, Hollebecque A. Safety, tolerability and antitumour activity of LY2780301 (p70S6K/AKT tumor immunology at South Paris XI University, while inhibitor) in combination with gemcitabine in being appointed at Gustave Roussy as medical oncologist molecularly selected patients with advanced or metastatic cancer: a phase IB dose escalation in 1995 in the Immunotherapy and Novel Therapies unit of study. Eur J Cancer. 2017;83:194-202. the Medical Oncology Department.
• Angevin E, Isambert N, Trillet-Lenoir V, You B, Alexandre J, Zalcman G, Vielh P, Farace F, Valleix In 2006, he was appointed Assistant Director of Clinical F, Podoll T, Kuramochi Y, Miyashita I, Hosono O, Dang NH, Ohnuma K, Yamada T, Kaneko Y, Research in charge of innovation and valorisation, and joins Morimoto C. First-in-Human phase 1 of YS110, a monoclonal antibody directed against CD26 in the newly created Early Clinical Trial/phase I Department advanced CD26-expressing cancers. Br J Cancer. (DITEP). He has been involved as principal or sub- 2017 Apr 25;116(9):1126-1134. investigator of more than 200 clinical trials during the last • Angevin E, Tabernero J, Elez E, Cohen SJ, 15 years, including FIH phase I studies across all tumor Bahleda R, van Laethem JL, Ottensmeier C, Lopez-Martin JA, Clive S, Joly F, Ray-Coquard I, types. With a specific expertise in immunotherapy and Dirix L, Machiels JP, Steven N, Reddy M, Hall B, targeted molecules, both at the clinical and translational Puchalski TA, Bandekar R, van de Velde H, Tromp B, Vermeulen J, Kurzrock R. A phase I/II, research levels, he published more than 100 papers in multiple-dose, dose-escalation study of siltuximab, an anti-interleukin-6 monoclonal international peer-reviewed journals. antibody, in patients with advanced solid tumors. Clin Cancer Res. 2014;20:2192-2204. As GR Alliance Manager, he is also in charge of the • Angevin E, Lopez-Martin JA, Lin CC, Gschwend industrial partnering and collaboration initiatives with JE, Harzstark A, Castellano D, Soria JC, Sen P, Chang J, Shi M, Kay A, Escudier B. Phase I study pharma/biotech companies at the institutional level. He of dovitinib (TKI258), an oral FGFR, VEGFR, and has been invited to several advisory boards and is an active PDGFR inhibitor, in advanced or metastatic renal cell carcinoma. Clin Cancer Res. 2013 Mar member of the French Cancer Institute Early Clinical Trials 1;19(5):1257-68. working group (INCA-CLIP²) and of ASCO, AACR, ESMO, EORTC-NCI-AACR and TAT international meetings. EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS ASCO 2017 • An Open-Label, Multicohort, Phase 1/2 Study of Nivolumab in Patients With Virus-Associated Tumors (CheckMate 358): Efficacy and Safety in Recurrent or Metastatic (R/M) Cervical, Vaginal, and Vulvar Cancers.
ASCO 2013 • Molecular screening for cancer treatment optimization (MOSCATO 01): A prospective molecular triage trial- Interim results
TAT 2012 • A phase Ib trial of LY2584702 tosylate, a p70 S6 Antoine Hollebecque inhibitor, in combination with erlotinib or everolimus in patients with solid tumours
PUBLICATIONS MD • Tacher V, Le Deley MC, Hollebecque A, Deschamps F, Vielh P, Hakime A, Ileana E, Abedi-Ardekani B, Charpy C, Massard C, Rosellini S, Gajda D, Celebic A, Ferte C, Ngo-Camus M, Gouissem S, Koubi-Pick V, Andre F, Vassal G, Deandreis D, Lacroix L, Soria JC, De Baere T. Factors associated with success of image-guided tumour biopsies: Results from a prospective molecular triage study (MOSCATO-01). Eur J Cancer. 2016;59:79- General background 89. Antoine Hollebecque (M.D.) is a senior medical physician • Jovelet C, Ileana E, Le Deley M-C, Motte N, Rosellini S, Romero A, Lefebvre C, Pedrero M, Pata-Merci N, at Gustave Roussy Cancer Center in Paris. He received Droin N, Deloger M, Massard C, Hollebecque A, Ferte C, Boichard A, Postel-Vinay S, Ngo-Camus M, De Baere his medical degree from Lille2 University in 2008. He T, Vielh P, Scoazec J-Y, Vassal G, Eggermont AM, Andre completed his residency training followed by his fellowship F, Soria J-C, Lacroix L. Circulating cell-free tumor DNA (cfDNA) analysis of 50-genes by next-generation in hepato-gastroenterology at Lille2 University. sequencing (NGS) in the prospective MOSCATO trial. Clin Cancer Res. 2016;22(12):2960-8.
He spent 2 years as an Assistant Professor in the Drug • Isambert N, Delord JP, Soria JC, Hollebecque A, Development Department at Gustave Roussy Cancer Gomez-Roca C, Purcea D, Rouits E, Belli R, Fumoleau P. Debio0932, a second-generation oral heat shock protein Center in 2012-2013. He completed his training with (HSP) inhibitor, in patients with advanced cancer-results of a first-in-man dose-escalation study with a fixeddose a one-year post-doctoral fellowship in the Clinical extension phase. Ann Oncol. 2015;26(5):1005-1011. and Experimental Pharmacology (CEP) (Pr C. Dive), • Infante JR, Hollebecque A, Postel-Vinay S, Bauer Manchester Institute, Cancer Research UK, Manchester TM, Blackwood E, Evangelista M, Mahrus S, Peale F, where he worked on cell-free DNA. Lu X, Sahasranaman S, Zhu R, Chen Y, Ding X, Murray E, Schutzman J, Lauchle JO, Soria JC, LoRusso PM. Phase I Study of GDC-0425, a checkpoint kinase 1 Over the last 5 years, Dr Hollebecque was the principal inhibitor, in combination with gemcitabine in patients with refractory solid tumors. Clin Cancer Res. 2017 May investigator of 20 phase I trials and sub-investigator of 15;23(10):2423-2432 more than 100 phase I. He has contributed to over 64 • Temam S, Spicer J, Farzaneh F, Soria JC, Oppenheim peer-reviewed publications, including publications in New D, McGurk M, Hollebecque A, Sarini J, Hussain K, Soehrman Brossard S, Manenti L, Evers S, Delmar P, England Journal of Medicine, Journal of Clinical Oncology, Di Scala L, Mancao C, Feuerhake F, Andries L, Ott MG, European Journal of Cancer, Gastroenterology, Hepatology. Passioukov A, Delord JP. An exploratory, open-label, randomized, multicenter study to investigate the Dr Hollebecque is a member of the European Society of pharmacodynamics of a glycoengineered antibody Medical Oncology (ESMO), the American Society of Clinical (imgatuzumab) and cetuximab in patients with operable head and neck squamous cell carcinoma. Ann Oncol. Oncology (ASCO) and the American Association for Cancer 2017 Nov 1;28(11):2827-2835.
Research (AACR). • Hollebecque A, Bahleda R, Faivre L, Adam J, Poinsignon V, Paci A, Gomez-Roca C, Thery JC, Le Deley MC, Varga A, Gazzah A, Ileana E, Gharib M, Angevin E, Research axes: early phase studies, gastro-intestinal Malekzadeh K, Massard C, Soria JC, Spano JP. Phase cancers, cell-free DNA, Next Generation Sequencing. I study of temsirolimus in combination with cetuximab in patients with advanced solid tumours. Eur J Cancer 2017:81:81-89.
33 EARLY CLINICAL TRIALS EXPERTISE
ORAL & POSTER PRESENTATIONS
EORTC-NCI-AACR 2016 • A first-in-human phase I study to evaluate the ERK1/2 inhibitor GDC-0994 in patients with advanced solid tumors
ASCO 2015 • Antitumor activity and safety of pembrolizumab in patients with PD-L1 positive advanced ovarian cancer: Interim results from a phase Ib study
ECC 2015 • Activity of rociletinib in EGFR mutant NSCLC patients with a history of CNS Andrea Varga involvement
PUBLICATIONS MD •Massard C, Mateo J, Loriot Y, Pezaro C, Albiges L, Mehra N, Varga A, Bianchini D, Ryan CJ, Petrylak DP, Attard G, Shen L, Fizazi K, de Bono J. Phase I/II trial of cabazitaxel plus abiraterone in patients with metastatic castration-resistant prostate cancer (mCRPC) progressing after docetaxel and abiraterone. Ann Oncol. 2016 Oct 18. pii: mdw441 [Epub General background ahead of print] Andreea Varga, MD, Senior Medical Oncologist in the Drug • Jung J, Lee JS, Dickson MA, Schwartz GK, Le Cesne A, Varga A, Bahleda Development Department of Gustave Roussy Cancer R, Wagner AJ, Choy E, de Jonge MJ, Campus since 2011. She received her medical degree Light M, Rowley S, Mace S, Watters J. TP53 mutations emerge with HDM2 from Medical Faculty Cluj-Napoca Rumania in 2004. inhibitor SAR405838 treatment in de- differentiated liposarcoma. Nat Commun. 2016;7:12609. She started her training in Medical Oncology at Cluj- Napoca University (2005-2010) in oncology, cardiology, • Morschhauser F, Terriou L, Coiffier B, Bachy E, Varga A, Kloos I, Lelievre H, internal medecine and radiology units ,then at Paul Sarry AL, Depil S, Ribrag V. Phase 1 study of the oral histone deacetylase inhibitor Brousse Hospital in Paris (2008-2009) and breast cancer abexinostat in patients with Hodgkin unit of Institut Gustave Roussy (2009-2010). lymphoma, non-Hodgkin lymphoma, or chronic lymphocytic leukaemia. Invest New Drugs. 2015;33 (2):423-431. She continued her clinical research residency at IGR
• Bahleda R, Sessa C, Del Conte G, (2009-2010) and became medical oncologist of phase I Unit Gianni L, Capri G, Varga A, Oprea C, (Pr Soria) in 2011. In september 2017, she was appointed Daglish B, Hospitel M, Soria JC. Phase I clinical and pharmacokinetic study Head of the DITEP out-patient day care unit. Dr Varga is of ombrabulin (AVE8062) combined with cisplatin/docetaxel or carboplatin/ board-certified in Medical Oncology since 2010. paclitaxel in patients with advanced solid tumors. Invest New Drugs. 2014; 32(6):1188-96. Research axes: phase I trials, drug development, targeted and personalized therapy of breast cancer, lung and other • Frenel JS, Le Tourneau C, O’Neil B, Ott PA, Piha-Paul SA, Gomez-Roca C, van solid tumors. Brummelen EMJ, Rugo HS, Thomas S, Saraf S, Rangwala R, Varga A . Safety and Efficacy of Pembrolizumab in Advanced, Programmed Death Ligand 1-Positive Cervical Cancer: Results From the Phase Ib KEYNOTE-028 Trial. J Clin Oncol. 2017 Dec 20;35(36):4035-4041. EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS ESMO 2017 • Long-Term Safety and Clinical Outcomes of Atezolizumab in Head and Neck Cancer: Phase Ia Trial Results
ASCO 2014 • Phase 1 study of JNJ-42756493, a pan-fibroblast growth factor receptor (FGFR) inhibitor, in patients with advanced solid tumors (oral)
PUBLICATIONS
Rastislav Bahleda • Bahleda R, Varga A, Berge Y, Soria JC, Schnell D, Tschoepe I, Uttenreuther-Fischer M, Delord JP. Phase I open-label study of afatinib plus vinorelbine in patients with solid tumours overexpressing EGFR and/or HER2. MD Br J Cancer. 2018 Feb 6;118(3):344-352.
• Bahleda R, Baker J, Massard C, Gadgeel SM, Rogers JE, Izzedine H, Deutsch E, Garris JL, Khan A, Boelle E, Assadourian S, Soria JC, Ajani JA. Phase I Dose- Escalation and Pharmacokinetic Study of Intravenous Aflibercept in Combination with Docetaxel, Cisplatin, and 5-Fluorouracil in Patients with Advanced Solid General background Malignancies. Oncology. 2016;90(1):10-20. • Awada A, Campone M, Varga A, Aftimos P, Frenel Rastislav Bahleda, MD, Senior Medical Oncologist in the J-S, Bahleda R, Gombos A, Bourbouloux E, Soria J-C. Drug Development Department of Gustave Roussy Cancer An open-label, dose-escalation study to evaluate the safety and pharmacokinetics of CEP-9722 (a PARP-1 Campus since 2007. He received his medical degree from and PARP-2 inhibitor) in combination with gemcitabine Medical Faculty of Comenius University in Bratislava (1995) and cisplatin in patients with advanced solid tumors. and completed his clinical residency in Internal Medicine Anti-Cancer Drugs. 2016;27(4):342-8. (1998). • Calvo E, Soria JC, Ma WW, Wang T, Bahleda R, Tolcher A, Gernhardt D, O’Connell J, Millham R, Giri N, Wick MJ, Adjei AA, Hidalgo M. A Phase I Clinical Trial and Independent Patient-derived Xenograft Study of He continued his training to complete a fellowship in Combined Targeted Treatment with Dacomitinib and Clinical Oncology at Comenius University and National Figitumumab in Advanced Solid Tumors. Clin Cancer Cancer Institut in Bratislava (1995-2001). He continued Res. 2017 Mar 1;23(5):1177-1185. clinical and molecular research (Inserm U 268) in • Bahleda R, Grilley-Olson JE, Govindan R, Barlesi F, Greillier L, Perol M, Ray-Coquard I, Strumberg D, sarcomas at Institut Gustave Roussy (2002-2003) and Schultheis B, Dy GK, Zalcman G, Weiss GJ, Walter AO, received University Diploma in Clinical Research from Kornacker M, Rajagopalan P, Henderson D, Nogai H, Ocker M, Soria JC. Phase I dose-escalation studies University of Paris XI. of roniciclib, a pan-cyclin-dependent kinase inhibitor, in advanced malignancies. Br J Cancer. 2017 Jun 6;116(12):1505-1512. He continued his clinical research residency at IGR (2003- 2006) and became medical oncologist at the Medical Oncology Department (2007), and the Drug Development Department (2013).
Dr Bahleda is board-certified in Internal Medicine and Medical Oncology and a member of ASCO.
Research axes: phase I trials, drug development, oncogenic mutations, FGFR pathway, personnalized and molecular targeted therapy.
35 EARLY CLINICAL TRIALS EXPERTISE
ORAL & POSTER PRESENTATIONS
EORTC-NCI-AACR 2016 • First-in-human phase I trial of the anti-CEACAM5 antibody-drug conjugate SAR408701 in patients with advanced solid tumors (oral)
EORTC-NCI-AACR 2016 • Phase Ib study of afatinib plus standard-dose cetuximab in patients with advanced solid tumours (poster)
ASCO 2015 • Phase Ib study of afatinib plus standard-dose cetuximab in patients (pts) Anas Gazzah with advanced solid tumors (poster).
PUBLICATIONS MD • Tabernero J, Bahleda R, Dienstmann R, Infante JR, Mita A, Italiano A, Calvo E, Moreno V, Adamo B, Gazzah A, Zhong B, Platero SJ, Smit JW, Stuyckens K, Chatterjee-Kishore M, Rodon J, Peddareddigari V, Luo FR, Soria J-C. Phase I Dose-Escalation Study of JNJ- 42756493, an Oral Pan–Fibroblast Growth General background Factor Receptor Inhibitor, in Patients With Advanced Solid Tumors. J Clin Oncol. Anas Gazzah, MD, Senior Medical Oncologist in the Drug 2015;33(30):3401-8. Development Department of Gustave Roussy Cancer • Remon J, Gazzah A, Besse B, Soria Campus since 2010. He received his medical degree from JC. Crizotinib Improves Osteoarthritis Symptoms in a ROS1-Fusion Advanced Medical Faculty Sousse Tunisia in 2004. He continued his Non-Small Cell Lung Cancer Patient. J training to complete a fellowship in Medical Oncology at Thorac Oncol. 2015;10(8):e72-73. Paris University VII (Denis Diderot) and VI (Pierre et Marie • Hollebecque A, Deutsch E, Massard Curie) from 2005 to 2009. C, Gomez-Roca C, Bahleda R, Ribrag V, Bourgier C, Lazar V, Lacroix L, Gazzah A, Varga A, de Baere T, Beier F, Kroesser S, Trang K, Zenke FT, Klevesath M, He completed training in onco-hematology and Soria JC. A phase I, dose-escalation radiotherapy (2006-2007) and continued his clinical study of the Eg5-inhibitor EMD 534085 in patients with advanced solid tumors residency training (Institut Gustave Roussy, Assistance or lymphoma. Invest New Drugs. Publique Hôpitaux de Paris, Centre René Huguenin). 2013;31(6):1530-8. • Gazzah A, Gonzales DB, Levy A, He continued his clinical research training at Gustave Bahleda R, Ducreux M, Lacroix L, Soria JC. Molecular guided therapy for Roussy (2008-2010) and became medical oncologist within advanced pancreatic cancer patients with PI3K activated mutation: vision or the Drug Development Department (Pr Soria) in 2010. Dr illusion? Onco Targets Ther. 2013; 6:95-7. Gazzah is board-certified in Medical Oncology since 2009.
• Hollebecque A, Bahleda R, Faivre L, Adam J, Poinsignon V, Paci A, Gomez- Research axes: phase I trials, drug development, targeted Roca C, Thery JC, Le Deley MC, Varga A, Gazzah A, Ileana E, Gharib M, Angevin and personnalized therapy of lung cancer. E, Malekzadeh K, Massard C, Soria JC, Spano JP. Phase I study of temsirolimus in combination with cetuximab in patients with advanced solid tumours. 2017. European Journal of Cancer 81:81-89. EARLY CLINICAL TRIALS EXPERTISE
ORAL PRESENTATIONS ICML 2017 • Phase Ib study of CC-122 in combination with obinutuzumab (GA101): relapsed or refractory (R/R) patients with B-cell non-Hodgkin lymphoma (NHL)
TAT 2017 • Phase IB study of CC-122 and obinutuzumab in relapsed or refractory diffuse large B-cell lymphoma and indolent non-Hodgkin lymphoma (oral)
PUBLICATIONS Jean-Marie Michot • Armand P, Shipp MA, Ribrag V, Michot JM, Zinzani PL, Kuruvilla J, Snyder ES, Ricart AD, Balakumaran A, Rose S, Moskowitz CH. Programmed Death-1 Blockade With Pembrolizumab in Patients With Classical Hodgkin Lymphoma After Brentuximab MD Vedotin Failure. J Clin Oncol. 2016 Jun 27. pii: JCO673467 [Epub ahead of print]
• Michot JM, Mazeron R, Dercle L, Ammari S, Canova C, Marabelle A, Rose S, Rubin E, Deutsch E, Soria JC, Ribrag V, Levy A. Abscopal effect in a Hodgkin lymphoma patient treated by an anti-programmed death 1 antibody. Eur J Cancer. 2016;66:91-4. General background • Thijssen R, Ter Burg J, Garrick B, van Bochove GG, Jean-Marie Michot is a full-time medical internist at Brown JR, Fernandes SM, Rodriguez MS, Michot JM, Hallek M, Eichhorst B, Reinhardt HC, Bendell J, Derks Gustave Roussy. He was first trained in Normandy at the IA, van Kampen RJ, Hege K, Kersten MJ, Trowe T, Filvaroff EH, Eldering E, Kater AP (2016) Dual TORK/ University of Rouen until 2004. He began his training in DNA-PK inhibition blocks critical signaling pathways in Paris in 2004 at the University Paris Diderot and obtained chronic lymphocytic leukemia. Blood. 2016;128(4):574- a Master 2 specialization in Immunology from the Pasteur 583. Institute of Paris in 2009. He is certified in Internal • Aftimos P, Rolfo C, Rottey S, Offner F, Bron D, Maerevoet M, Soria JC, Moshir M, Dreier T, Van Medicine and received the Silver Medal from the Faculty of Rompaey L, Michot JM, Silence K, Hultberg A, Gandini Medicine of Paris in 2010. Dr. Michot is affiliated with the D, de Haard H, Ribrag V, Peeters M, Thibault A, Leupin N, Awada A. Phase I Dose-Escalation Study of the Anti- Department of Internal Medicine and Clinical Immunology CD70 Antibody ARGX-110 in Advanced Malignancies. at University Paris-South Hospital since 2010. He joined Clin Cancer Res. 2017 Nov 1;23(21):6411-6420. the Hematology Unit of Gustave Roussy in 2013 where he • Zinzani PL, Ribrag V, Moskowitz CH, Michot JM, Kuruvilla J, Balakumaran A, Zhang Y, Chlosta S, developed phase 1 hematology clinical trials with Vincent Shipp MA, Armand P. Safety and tolerability of Ribrag and Stéphane De Botton. pembrolizumab in patients with relapsed/refractory primary mediastinal large B-cell lymphoma. Blood. 2017 Jul 20;130(3):267-270. He had a focus for new treatments in lymphoproliferative disorders. His wish is to advance new therapies, and to develop personalized medicine approaches. He aims to improve the management of immunological related adverse events of new immune-checkpoint inhibitors.
37 EARLY CLINICAL TRIALS EXPERTISE
ORAL & POSTER PRESENTATIONS EORTC-NCI-AACR 2016 • First-in-human phase I dose escalation study of the Bromodomain and Extra-Terminal motif (BET) inhibitor BAY 1238097 in subjects with advanced malignancies (poster)
ESMO ASIA 2015 • First-in-human study of oral S 49076, a MET/ AXL/FGFR inhibitor, in advanced solid tumors (poster discussion)
ECCO-ESMO 2013 • Towards new methods for the determination of Dose Limiting Toxicities and Recommended Dose Sophie Postel-Vinay of Molecularly Targeted Agents
PUBLICATIONS MD PhD • Infante JR, Hollebecque A, Postel-Vinay S, Bauer TM, Blackwood E, Evangelista M, Mahrus S, Peale F, Lu X, Sahasranaman S, Zhu R, Chen Y, Ding X, Murray E, Schutzman J, Lauchle JO, Soria JC, LoRusso PM. Phase I Study of GDC-0425, a checkpoint kinase 1 inhibitor, in combination with gemcitabine in patients with refractory solid tumors. Clin Cancer Res. 2017 May General background 15;23(10):2423-2432.
• Postel-Vinay S, Aspeslagh S, Lanoy E, Robert Sophie Postel-Vinay (MD, Ph.D), is currently Physician C, Soria JC, Marabelle A. Challenges of phase Scientist at the Drug Development Department and 1 clinical trials evaluating immune checkpoint- targeted antibodies. Ann Oncol. 2016;27(2):214- U981 INSERM research unit of Gustave Roussy Cancer 224. Campus, where she leads an independent research group
• Postel-Vinay S, Boursin Y, Massard C, as of January 2018 thanks to the ATIP-Avenir INSERM/ Hollebecque A, Ileana E, Chiron M, Jung J, Lee CNRS grant. JS, Balogh Z, Adam J, Vielh P, Angevin E, Lacroix L, Soria JC. Seeking the driver in tumours with apparent normal molecular profile on comparative genomic hybridiz ation and targeted gene panel She received her medical degree from the Université sequencing: what is the added value of whole René Descartes Paris V in 2010, and joined the faculty exome sequencing? Ann Oncol. 2016;27(2):344-52. in November 2013 after completion of her PhD. She • Dercle L, Ammari S, Champiat S, Massard C, completed her residency training in Paris, and spent 18 Ferte C, Taihi L, Seban RD, Aspeslagh S, Mahjoubi L, Kamsu-Kom N, Robert C, Marabelle A, months at the Royal Marsden Hospital of London in Pr Schlumberger M, Soria JC, Postel-Vinay S. Rapid Stan Kaye Drug Development Unit. Dr Postel-Vinay is and objective CT scan prognostic scoring identifies metastatic patients with long-term clinical member of AACR and ASCO, from which she received a benefit on anti-PD-1/-L1 therapy. Eur J Cancer. 2016;65:33-42. merit award in 2010. She is also an ESMO member, has been representative of the French Young Oncologist at • Shaw AT, Felip E, Bauer TM, Besse B, Navarro A, Postel-Vinay S, Gainor JF, Johnson M, the Young Oncologists Committee from 2013-2016, and Dietrich J, James LP, Clancy JS, Chen J, Martini received the ESMO translational research fellowship for JF, Abbattista A, Solomon BJ. Lorlatinib in non-small-cell lung cancer with ALK or ROS1 her PhD that was performed at the Institute of Cancer rearrangement: an international, multicentre, Research (London) in Pr Alan Ashworth laboratory, open-label, single-arm first-in-man phase 1 trial. Lancet Oncol. 2017 Dec;18(12):1590-1599. focusing on DNA repair and synthetic lethality.
Rodon J, Postel-Vinay S, Hollebecque A, Nuciforo P, Azaro A, Cattan V, Marfai L, Sudey I, Brendel K, Dr Postel-Vinay has a physician scientist position Delmas A, Malasse S, Soria JC. First-in-human phase I study of oral S49076, a unique MET/AXL/ since 2016, which allows her to have a fundamental FGFR inhibitor, in advanced solid tumours. Eur J research activity within the INSERM Unit 981 (80% of Cancer 2017. 81:142-150. her time), in parallel of her clinical drug development activity (phase 1 trials). She obtained in 2017 the ATIP- Avenir “Young Group Leader” grant from INSERM/ CNRS, which now allows her to develop her own group as an independent research team. Her research activity focuses on chromatin remodeling and its interplay with DNA damage repair and immune modulation in solid tumor cancer models. Her research interests include DNA repair, chromatin remodeling and synthetic lethality, sarcoma, drug development, predictive biomarkers and emerging targets. PUBLICATIONS
• Champiat S, Dercle L, Ammari S, Massard C, Hollebecque A, Postel-Vinay S, Chaput N, Eggermont A, Marabelle A, Soria JC, Ferté C. HYPERLINK «https://www-ncbi-nlm-nih-gov.gate2.inist.fr/ pubmed/27827313» Hyperprogressive Disease Is a MD New Pattern of Progression in Cancer Patients Treated by Anti-PD-1/PD-L1. Clin Cancer Res. 2017 Apr 15;23(8):1920-1928.
Michot JM, Bigenwald C, Champiat S, Collins M, Carbonnel F, Postel-Vinay S, Berdelou A, Varga A, Bahleda R, Hollebecque A, Massard C, Fuerea A, Ribrag V, Gazzah A, Armand JP, Amellal N, Angevin E, Noel N, Boutros C, Mateus C, Robert C, Soria JC, Stéphane Champiat Marabelle A, Lambotte O. HYPERLINK «https://www- ncbi-nlm-nih-gov.gate2.inist.fr/pubmed/26765102» Immune-related adverse events with immune MD checkpoint blockade: a comprehensive review. Eur J PhD Cancer. 2016 Feb;54:139-148.
Champiat S, Lambotte O, Barreau E, Belkhir R, Berdelou A, Carbonnel F, Cauquil C, Chanson P, Collins M, Durrbach A, Ederhy S, Feuillet S, François H, Lazarovici J, Le Pavec J, De Martin E, Mateus C, Michot JM, Samuel D, Soria JC, Robert C, Eggermont A, Marabelle A. HYPERLINK «https://www-ncbi-nlm- General background nih-gov.gate2.inist.fr/pubmed/26715621» Management of immune checkpoint blockade dysimmune toxicities: a collaborative position paper. Ann Oncol. 2016 Stéphane Champiat MD, PhDc is currently Assistant Apr;27(4):559-74. Professor at the Drug Development Department of Ederhy S, Voisin A-L, Champiat S. HYPERLINK Gustave Roussy Cancer Campus. «https://www-ncbi-nlm-nih-gov.gate2.inist.fr/ pubmed/28102662» Myocarditis with Immune Checkpoint Blockade. He trained at the University of Paris VI medical school and N Engl J Med. 2017 Jan 19;376(3):290-1. received his medical degree from the University of Nantes Sun R, Champiat S, Dercle L, Aspeslagh S, Castanon in 2014. He completed his residency training in Medical E, Limkin EJ, Baldini C, Postel-Vinay S, Hollebecque A, Massard C, Ammari S, Deutsch E, Soria JC, Marabelle Oncology at the Institute of Cancer Research in Nantes and A, Ferté C. HYPERLINK «https://www-ncbi-nlm- at Gustave Roussy Cancer Center. He joined the faculty in nih-gov.gate2.inist.fr/pubmed/28826073» Baseline lymphopenia should not be used as exclusion criteria November 2017. in early clinical trials investigating immune checkpoint blockers (PD-1/PD-L1 inhibitors). Eur J Cancer. 2017 Dr Champiat worked for one year as a postdoctoral Oct;84:202-211. researcher at University California San Francisco focusing on T cell immunity. He started in 2014 a PhD at Paris XI University in the INSERM Unit 981 “Predictive biomarkers and new therapeutic strategies” research group.
He has been working since 2012 at Gustave Roussy where he is growing clinical experience with immunomodulatory antibodies in cancer patients. He is particularly involved in the strategy for managing immune-related toxicities and has setup the immune-related toxicities management program (iTOX program) at Gustave Roussy.
Dr Champiat is a member of the European Society of Medical Oncology (ESMO) and the Society for Immunotherapy of Cancer (SITC).
Research axes: thoracic oncology, early phase studies and cancer immunotherapy.
39 EARLY CLINICAL TRIALS EXPERTISE
RECENT ORAL PRESENTATIONS IGOM 2017 • Setting up a geriatric oncology unit
ESMO 2017 • Immunotherapy phase I trials in patients over 70 years with advanced solid tumours: The Gustave Roussy experience
SIOG 2015 • FOLFIRINAGE : Tolerance and efficacy of FOLFIRINOX in elderly patients with metastatic pancreatic adenocarcinoma PUBLICATIONS Capucine Baldini • Baldini C, Le Saux O, Helissey C, Aspeslagh S, Castanon E, Varga A, Gazzah A, Bahleda R, Mir O, Massard C, Soria JC, Hollebecque A. Are Phase I trials safe for older patients? J Geriatr Oncol. MD 2018 Mar;9(2):87-92.
• Loh KP, Soto-Perez-de-Celis E, Hsu T, de Glas NA, Battisti NML, Baldini C, Rodrigues M, Lichtman SM, Wildiers H. What Every Oncologist Should Know About Geriatric Assessment for Older Patients With Cancer: Young International Society of Geriatric Oncology Position Paper. J General background Oncol Pract. 2018 Feb;14(2):85-94.
• Bigot F, Castanon E, Baldini C, Hollebecque A, Capucine Baldini (MD) is a medical oncologist working Carmona A, Postel-Vinay S, Angevin E, Armand at the Drug Development Department (DITEP), Gustave JP, Ribrag V, Aspeslagh S, Varga A, Bahleda R, Menis J, Gazzah A, Michot JM, Marabelle A, Soria Roussy,Villejuif, France. JC, Massard C. Prospective validation of a She is involved in early phase trials with a special interest in prognostic score for patients in immunotherapy phase I trials: The Gustave Roussy Immune Score geriatric oncology, gastro-intestinal cancer, genito urinary (GRIm-Score). Eur J Cancer. 2017 Oct;84:212-218. cancer, Central Nervous System tumor. • Baldini C, Escande A, Bouché O, El Hajbi F, Volet J, Bourgeois V, Renaut Vantroys T, Ploquin A, Desauw C, Hebbar M. Safety and efficacy of Dr Baldini received her medical degree from Lille II FOLFIRINOX in elderly patients with metastatic or University in 2014 and got a MSc from PARIS XI University locally advanced pancreatic cancer: a retrospective analysis. Pancreatology. 2017 Jan - in 2013. She completed her fellowship in medical oncology Feb;17(1):146-149. at Lille University Hospital with a specialization in geriatric
• Mislang AR, Wildes TM, Kanesvaran R, Baldini oncology and at Gustave Roussy in early phase trials at C, Holmes HM, Nightingale G, Coolbrandt A, DITEP. Biganzoli L. Adherence to oral cancer therapy in older adults: The International Society of Geriatric She is a member of ESMO, ASCO, AACR, SIOG, SoFOG Oncology (SIOG) taskforce recommendations. Cancer Treat Rev. 2017 Jun;57:58-66. and involved in young SIOG and SoFOG interest group leadership. She is working on early phase trials and immunotherapy in older patients. She is a subinvestigator of more than 80 clinical trials (phase 1 trials).
Research axes: early clinical trials, geriatric oncology, GU cancers (prostate cancer, bladder cancer), glioma. PAST LEADERS IN EARLY DRUG DEVELOPMENT AT GUSTAVE ROUSSY
Jean-Charles Soria
MD PhD
Prof. Jean-Charles Soria, M.D., Ph.D., is since September 2017, Senior Vice President and Head of the Oncology Innovative Medicines unit (iMED) at MedImmune.
Prof. Soria served as a Professor of Medicine and Medical Oncology at South-Paris University and a Cancer Specialist at Gustave Roussy. Prof. Soria was Chair of the Drug MD Development Department at Gustave Roussy and was a member of the lung cancer unit with a focus on targeted therapies. His main research interests are early clinical development, phase I trials across solid tumors, pharmacodynamic biomarkers, lung cancer and personalized medicine.
Prof. Soria trained as a medical oncologist and obtained the Silver medal from Paris Medical School in 1997. He gained a PhD degree in the fundamental basis of oncogenesis in 2001, and completed his training with a two-year postdoctoral fellowship in the Department of Thoracic Head and Neck Medical Oncology at MD Anderson Cancer Center, Houston, USA, where he has held an Adjunct Professorship in 2012.
He has contributed to over 550 peer-reviewed publications, including publications as first or last author in the New England Journal of Medicine, Lancet Oncology, JCO, Annals of Oncology. He has been appointed Editor in Chief of Annals of Oncology for 2014-2018.
Jean-Pierre Armand
MD
Dr Jean-Pierre Armand focuses his cancer research in the field of new mechanism of oncogenese and early drug development. Jean-Pierre Armand MD, MSc, is certified in Medical Oncology (University of Toulouse III and Paris XI). He is presently senior consultant at Gustave Roussy.
He was General Director of the Institut Claudius Regaud in Toulouse (2007 -2012). Over the last years he has been in charge of the construction of a new cancer center, in a European research hub created in the Toulouse cancer campus (Institut Universitaire du Cancer).
Although expert in breast, head&neck, and neuro-oncology, the first field of Dr Armand was very early drug development in phase 1 and 2. He has been the founder of the IGR Phase I Unit in the early 80s. He did the first in human phase I in the world at IGR of numerous drugs, including classicals cytotoxics, (Irinotecan, Oxaliplatin, Taxotere, Navelbine, Vinflunine), and more recently targeted therapies, (Sutent, Sorafenib, Temsirolismus...)
41 DITEP EXECUTIVE SUMMARY & DEVELOPMENT PROJECT
Mission/core identity of the DITEP Development dynamics Our mission is to provoke radical changes, Our goal is to remain in the group of the qualitative and quantitative strides forward world leaders in drug development, and to in cancer care. be a key player, driver and facilitator in the The DITEP team embodies, develops evaluation of tomorrow’s medicine in onco- and promotes clinical research that is logy. conceived as patient-centered care and The way to do so is to maintain and to based on offering the greatest number of spread enthusiasm, open intelligence and patients’ access to innovative therapies proactive practices regarding future medi- and to early clinical trials. cal and scientific evolutions. The innovation is placed at the crossroads between early clinical trials and tumor bio- Activity model and quality management logy, especially precision medicine. Since November 2016, the DITEP is certi- The DITEP is a key player in the develop- fied ISO 9001v2015 (Quality Management ment of immunotherapy, innovative mole- System) for its activities of access to the- cules in hematological malignancies and rapeutic innovations, management of early combinations to radiotherapy. clinical trials, and scientific outreach. Our managerial values are to establish Institutional anchoring solidarity and cooperation between DITEP The DITEP is structurally and functionally professionals and jobs a cornerstone of our integrated within Gustave Roussy. practices. This integration is implemented as a dyna- The strategic stakes are to ensure and mic process of interactions with the other develop the quality of our partnerships, medical departments, research units and both private and public with industrial and technical platforms along the whole drug academic teams. development path. / DRUG DEVELOPMENT DEPARTMENT
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