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1 Brussels, October

2 Which organizations do clinical research? Pharmaceutical industry [in vitro]medical device industry Academic sponsors Universities & hospitals Networks of investigators Networks of networks (global effort) Drug / product development Treatment optimization New indications

3 Treatment optimization: Immunotherapy Length 6 months? 1 year? 2 years? Surgery Surgery Surgery Immunotherapy Immunotherapy Immunotherapy Continous? Intermittent? Surgery Immunotherapy Surgery Surgery IT IT Immunotherapy IT IT IT IT Surgery Immunotherapy IT Sequence? Surgery IT Surgery Immunotherapy Immunotherapy 3

4 4

5 CAREFOR: 3 strategic axes UNITE & EDUCATE -> WG 1 structuring the role of academic groups in Europe reaching out to more groups & professional societies illustrate unique lifesaving achievements of academia FACILITATE -> WG 2 assess the impact of legal frameworks on independent clinical cancer research in EU map the needs of cross-border collaborations share existing solutions & produce more support tools INVOLVE PATIENTS -> WG 3 ensure systematic integration of patient perspective into CAREFOR activities 5

6 Definition of EU academic research Current proposal Non-commercial trial is a clinical trial for which: Sponsor is a university or a hospital or any other healthcare organization as defined by the applicable national law or a non-for profit organization, association or body or a researcher that is recognized as noncommercial sponsor by any of EU member states. The design, conduct, access to data and biological material, recording and reporting of the clinical trial should be under the control of the sponsor.

7 Definition of EU academic research Current proposal The ownership of all data* and results of these trials should belong to the sponsor listed in the first bullet point. Sponsor may put in place agreements with third parties, including with commercial entities, to secure trial funding or to delegate some of sponsors tasks (e.g. drug supply or monitoring) provided above three conditions are still met. *By data shall be understood all types of data resulting from this clinical trials, not only clinical data, but also data on biomarkers explored in this scope and any other type of data directly resulting from the project

8 Definition of EU academic research Pending issue subsequent use of the data and results of a non-commercial trial for registration or extension of registration shall be allowed do we need to describe or define rules of engagement? need for a larger dialogue subsequently involving industrial partners

9 Landscape of Academic Clinical Trials in Oncology in Europe: the Breast Cancer Case Fatima Cardoso MD: EORTC Breast Cancer Group Dimitrios Zardavas MD: Breast International Group

10 INTRODUCTION PURPOSE: to provide an overview of the academic trials of breast cancer oncology conducted in Europe DEFINITION: any trial having as sponsor an academic/non-commercial entity SEARCH DATABASE: clinicaltrials.gov SEARCH STRATEGY: scan the first 10 consecutive academic breast cancer clinical trials appearing at clinicaltrials.gov with the search term breast cancer

11 RESULTS

12 Academic Clinical Lung Cancer Research in Europe 2015 Rolf A. Stahel

13 13 Methodology Direct contact with European collaborative groups for information on ongoing trials Presentation Development of oncology platforms in lung cancer across Europe at ELCC2015 in Geneva Supplementary trial information retrieved from ClinicalTrials.gov ETOP meeting 2015 in Zürich Selection criteria: - NSCLC, SCLC, mesothelioma - interventional trials (including radiation therapy) - currently recruiting or not yet recruiting trials - European, non-industry sponsors Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

14 14 Advanced NSCLC Randomised phase III 1 st line, not biomarker selected MILES-3: Gemcitabine vs gemcitabine plus cisplatin in elderly patients ( 70 years) with advanced NSCLC (NCI Naples) [NCT ]. MILES-4: Gemcitabine or pemetrexed, with or without cisplatin, in in elderly patients with non-squamous NSCLC (NCI Naples) [NCT ]. SPLENDOUR: Addition of denosumab to standard first-line anticancer treatment in advanced NSCLC (ETOP / EORTC) [NCT ]. Primary endpoint Overall survival Overall survival Overall survival Sample size 480 pts 550 pts 1000 pts Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

15 15 United Kingdom Participating Countries X sites 13 countries Total 9 activated countries 52 activated sites Ireland Germany Belgium Switzerland France Spain Poland Czech Republic Austria Hungary Slovenia Italy Israel under ETOP Umbrella under EORTC Umbrella To be activated To be activated Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

16 16 Advanced NSCLC: Randomised phase II 2 nd and later line, biomarker selected GOAL: Gefitinib in combination with olaparib vs gefitinib alone, in patients with EGFR+ advanced NSCL (GECP/SLCG) [NCT ]. LADIE: Gefinitib or erlotinib (EGFR-TKI) vs gefinitib or erlotinib with fulvestrant in women with advanced stage EGFR+ NSCLC (IFCT) [NCT ]. National lung matrix trial: multi-drug, genetic marker-directed, noncomparative, multi-arm trial in NSCLC (Birmingham, UK) [NCT N/A]. SAFIR02_Lung: Efficacy of targeted drugs guided by genomic profiles in metastatic NSCLC (IFCT) [NCT ]. In development: Activity of alectinib for pretreated RET-rearranged advanced NSCLC patients (ETOP/EORTC/CGM SPLECTAlung) [NCT N/A]. Primary endpoint Maximum tolerated dose Progression-free survival Progression-free survival Overall response Sample size 186 pts 358 pts 410 pts 650 pts 36 pts Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

17 17 Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

18 18 Locally advanced NSCLC: Randomised multimodality questions Phase III LUNG ART: Post-operative conformal radiotherapy (PORT) to no post-operative radiotherapy in patients with completely resected NSCLC and mediastinal N2 involvement (Gustave Roussy) [NCT ]. Primary endpoint Disease-free survival Sample size 700 pts Phase II REMNANT: Neoadjuvant afatinib in early stage EGFR+ NSCLC (EORTC) [NCT ]. Primary endpoint Decrease in ct stage at 8 weeks Sample size 38 pts Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

19 19 Lung ART Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

20 20 SCLC - phase II Randomised STIMULI: Consolidation of nivolumab plus ipilimumab in limited stage SCLC after chemo-radiotherapy (ETOP/IFCT) [NCT ]. Primary endpoint Overall survival and progression-free survival Sample size 260 pts THORA: Two schedules of hyperfractionated thoracic radiotherapy in limited disease SCLC (Norwegian University of Science and Technology) [NCT ]. 2-Year survival 154 pts Single arm SAKK 15/12: Early hippocampal avoidance prophylactic cranial irradiation (PCI) in patients with limited disease SCLC (SAKK) [NCT ]. Primary endpoint Neurocognitive functioning Sample size 42 pts Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

21 21 STIMULI protocol amendment 1 (continued) Chemo-Radiotherapy: Consolidation vs observation: Screening: cis-/carboplatin + etoposide 4 cycles Tumour evaluation: induction maintenance max 1 year LD SCLC RT RT PCI yes PD off no R combination nivolumab/ipilimumab observation nivolumab Week from start of chemotherapy after randomisation FDG-PET-CT or CT CT CT Brain MRI or CT Biomaterial for translational research: RT (Thoracic Radiotherapy): CT scans for tumour assessment accelerated schedule preferred - up to 18 months: every 9 weeks start: day 1 of chemo cycle 1 or - up to 2 years: every 12 weeks day 1 of chemo cycle 2 - years 3 & 4: every 6 months - at 5 years At progression: Serum Serum Serum Serum Whole blood Whole blood Whole blood Biopsy: FFPE block or slides Co-primary endpoints: PFS & OS Sample Size: 260 randomized patients Voluntary re-biopsy: FFPE block ETOP Annual Meeting Zürich, 13 & 14 Nov 2015 ETOP / IFCT 4-12 STIMULI

22 22 Mesothelioma Phase III PIT: Prophylactic irradiation of tracts in patients with malignant pleural mesothelioma (Christie Hospital NHS, UK) [NCT ]. Primary endpoint Maximum tolerated dose Sample size 374 pts PROMISE-ME (in development): Pembrolizumab vs standard chemotherapy for advanced progressive pretreated malignant pleural mesothelioma (ETOP) [NCT N/A]. Progression-free survival 142 pts Phase II - Single arm MESO-02: Ganetespib with platinum, in patients with malignant pleural mesothelioma (University College, London) [NCT ]. Primary endpoint Maximum tolerated dose Sample size 24 pts Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

23 23 Platform Studies CPCT-02: Center for personalized cancer treatment. DNAbased cancer research. Next generation sequencing technology to map genetic changes (The Netherlands) [NCT ]. Network Genomic Medicine: Genomics-based classification of human lung tumours. Clinical trial program covering nearly all genotypes (University Cologne, Germany) [NCT N/A]. SPECTAlung: Screening patients with thoracic tumours for efficient clinical trial access (EORTC / ETOP) [NCT ]. TRACERx: Tracking NSCLC evolution through therapy (Rx). Sequencing study of NSCLC from diagnosis to relapse (Cancer research UK) [NCT ]. Primary endpoint Observational Observational Observational Observational Current sample size 1240 pts 4000 pts 3500 pts 842 pts Rolf A. Stahel - Academic Clinical Lung Cancer Research in Europe ESMO-ASIA 2015

24 18 SPECTAlung participating sites Ireland Stephen Finn - St James Institute UK Sanjay Popat Royal Marsden France Benjamin Besse Gustave Roussy Julien Mazieres - Hôpital Larrey Netherlands Egbert Smit - VU University Medical Center Germany Martin Reck - Center of Pneumology and Thoracic Surgery of Grosshansdorf Switzerland Rolf Stahel University Hospital of Zurich Solange Peters University of Lausanne Central Biobank Gustave Roussy Cancer Campus Belgium Thierry Berghmans - Institute Jules Bordet Johan Vansteenkiste - Institute KU Leuven Jan Van Meerbeeck - Antwerpen University Hospital Spain Enriqueta Felip Vall d'hebron University Hospital Luis Paz-Ares - Hospital Universitario Doce de Octubre Italy Silvia Novello University of Turin Andrea Ardizzoni - S. Orsola-Malpighi Hospital Slovenia Tanja Cufer University Clinic Golnik Denmark P. Meldgaard - Aarhus University Hospital Poland Rafal Dziadziuszko Medical University of Gdansk 24

25 WG I: Common Position Statement Safeguarding the Future of Independent, Academic Clinical Cancer Research in Europe for the Benefit of Patients Affordability of cancer care and added value of academic clinical research Independent research is endangered in Europe Collaboration for patient-centered innovation New methodologies for evidence generation and evaluation Barriers to academic clinical cancer research Conclusions and the role of CAREFOR