Unicancer-Innovation Through Cooperation - Thomas Bachelot, Président UCBG
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Plan History From « Copil Pacs » to UCBG, alliance with GINECO Actual Organization, numbers Main strategies and recent achievement Research interest International collaboration Focus on recent realization Perspectives Research program Collaboration February 2020— R&D UNICANCER 2
Plan History From « Copil Pacs » to UCBG, alliance with GINECO Actual Organization, numbers Main strategies and recent achievement Research interest International collaboration Focus on recent realization Perspectives Research program Collaboration February 2020— R&D UNICANCER 3
History Until 1990, there was no official national cooperative group for breast cancer research in France In 1994, the French federation of comprehensive cancer center decided to create a coordinating structure => CCMI: Commissions de Coopération Médicale Intercentre => Programmes d’actions concertées (PACS) Adjuvant taxan and trastuzumab February 2020— R&D UNICANCER 5
Historic Until 1990, there was no official national cooperative group for breast cancer research in France In 1994, the French federation of comprehensive cancer center decided to create a coordinating structure => CCMI: Commissions de Coopération Médicale Intercentre => Programmes d’actions concertées (PACS) Adjuvant taxan and trastuzumab February 2020— R&D UNICANCER 6
Historic Until 1990, there was no official national cooperative group for breast cancer research in France In 1994, the French federation of comprehensive cancer center decided to create a coordinating structure => CCMI: Commissions de Coopération Médicale Intercentre => Programmes d’actions concertées (PACS) Adjuvant taxan and trastuzumab February 2020— R&D UNICANCER 7
Historic Until 1990, there was no official national cooperative group for breast cancer research in France In 1994, the French federation of comprehensive cancer center decided to create a coordinating structure => CCMI: Commissions de Coopération Médicale Intercentre => Programmes d’actions concertées (PACS) Adjuvant taxan and trastuzumab February 2020— R&D UNICANCER 8
Historic Until 1990, there was no official national cooperative group for breast cancer research in France In 1994, the French federation of comprehensive cancer center decided to create a coordinating structure => CCMI: Commissions de Coopération Médicale Intercentre => Programmes d’actions concertées (PACS) Adjuvant taxan and trastuzumab => Join the BIG for MINDACT in 2005 February 2020— R&D UNICANCER 9
History Too much franco-french Highly Hardactive when to move motivated forward with big! studies Adjuvant taxan and trastuzumab 7038 => Join the BIG for MINDACT in 2005 February 2020— R&D UNICANCER 11
History 2010: UNICANCER R&D -> Unicancer Breast Group (UCBG) -> Président H Bonnefoi New leader : Fabrice André, Suzette Delaloge, Mario Campone, JeanYves Pierga, Thomas Bachelot, Etienne Brain Association with the GINECO group (for Breast cancer research) Accreditation from the French National Cancer Institute (INCA) February 2020— R&D UNICANCER 12
History 2010: UNICANCER R&D -> Unicancer Breast Group (UCBG) -> Président H Bonnefoi 2015. President : Suzette Delaloge 2019. President : Thomas Bachelot 30 Members Scientific committee (CS3), including representative from GINECO, Cancer Centers, University Hospital (Belgian included), Public Hospital, Private practice, Patients. 10 members restricted board (Suzette Delaloge, Fabice André, Hervé Bonnefoi, Jean-Yves Pierga, Anne-Claire Hardy, Paul Cottu, Anthony Gonçalves, Frédérique Penault Llorca, Jérome Lemonnier) February 2020— R&D UNICANCER 13
A large base of investigator February 2020— R&D UNICANCER 14
Inclusion by years and open studies Hospital category 1% 8% 12% CLCC CHU Privés AP-HP 79% February 2020— R&D UNICANCER 15
Inclusion by years and open studies Hospital category Hospital category GINECO 2019 1% Hospital\Pub 8% lic hospital 23,29% 12% CLCC CHU Privés AP-HP Hospital\Anti 79% Hospital\Priv -cancer ate hospital center 20,62% 56,09% February 2020— R&D UNICANCER 16
Plan Historic From « Copil Pacs » to UCBG, alliance with GINECO Actual Organization, numbers Main strategies and recent achievement Research interest International collaboration Focus on recent realization Perspectives Research program Collaboration February 2020— R&D UNICANCER 17
Main strategies and recent achievement 2015 : Strategy defined by the Scientific committee (CS3) 1. Biomarker-based precision medicine and immune therapy in adjuvant and advanced settings • Including Development of circulating precision oncology 2. Survivorship and long term safety 3. Elderly program (collab. Gerico) 4. Precision prevention February 2020— R&D UNICANCER 18
Recent and Current studies Setting Prevention Early BC Advanced disease Impassion 030 BIG/Roche PALATINE DOLAF MyPeBS ROMANCE European TracerX START Grant HypoG01 PATINA Ultimate Alliance UCBG/BIG UNIRAD (UCBG/UK) PENELOPE PADA1 (1050 pts) GBG/BIG OLYMPIA (121/1250) BIG/AZ (142/1824) CANTO SAFIR2 ASTER70 (12 000 pts) LIBER (1989 pts) RxPonder (1460 pts) SWOG 1022/5000 TRIAL MATURATION Accural February 2020— R&D UNICANCER 20 Follow-up
Recent and Current studies Setting Prevention Early BC Advanced disease Impassion 030 BIG/Roche PALATINE DOLAF MyPeBS ROMANCE European TracerX START Grant HypoG01 PATINA Ultimate Alliance UCBG/BIG UNIRAD (UCBG/UK) PENELOPE PADA1 (1050 pts) GBG/BIG OLYMPIA (121/1250) BIG/AZ (142/1824) CANTO SAFIR2 ASTER70 (12 000 pts) LIBER (1989 pts) RxPonder (1460 pts) SWOG 1022/5000 TRIAL MATURATION Accural February 2020— R&D UNICANCER 21 Follow-up
Biomarker-based precision medicine 2011-2012 : SAFIR1 => CGH array and DNA sequencing to direct treatment of metastatic breast cancer => 423 patients enrolled, 299 genomic analysis, 195 targetable genomic alterations, 55 patients received matched therapy February 2020— R&D UNICANCER 22 André et al. Lancet Oncol 2014; 15: 267–74
Biomarker-based precision medicine 2011-2012 : SAFIR1 => CGH array and DNA sequencing to direct treatment of metastatic breast cancer => 423 patients enrolled, 299 genomic analysis, 195 targetable genomic alterations, 55 patients received matched therapy February 2020— R&D UNICANCER 23 André et al. Lancet Oncol 2014; 15: 267–74
Biomarker-based precision medicine 2014-2020 : SAFIR2 February 2020— R&D UNICANCER 29
Biomarker-based precision medicine 2014-2020 : SAFIR2 February 2020— R&D UNICANCER 30
Biomarker-based precision medicine 2014-2020 : SAFIR2 February 2020— R&D UNICANCER 31 F Dalenc et al. SABCS 2019
Biomarker-based precision medicine 2014-2020 : SAFIR2 February 2020— R&D UNICANCER 33 F Dalenc et al. SABCS 2019
Biomarker-based precision medicine 2014-2020 : SAFIR2 February 2020— R&D UNICANCER 34 F Dalenc et al. SABCS 2019
Biomarker-based precision medicine 2014-2020 : SAFIR2 February 2020— R&D UNICANCER 35 F Dalenc et al. SABCS 2019
Biomarker-based precision medicine 2017-2020 : PADA1 : Science + Access program P.I. : Francois-Clement BIDARD February 2020— R&D UNICANCER 36
Biomarker-based precision medicine 2017-2020 : PADA1 : Science + Access program P.I. : Francois-Clement BIDARD February 2020— R&D UNICANCER 37
Elderly program (collaboration with Gerico). ASTER 70 / GERICO11 P.I. : Etienne Brain February 2020— R&D UNICANCER 39
Elderly program (collaboration with Gerico). ASTER 70 / GERICO11 Final analysis at 4 year follow up (April 2020) P.I. : Etienne Brain February 2020— R&D UNICANCER 40
Adjuvant high risk : UNIRAD study (collaboration UK : David Cameron) Everolimus in the adjuvant setting (PI T Bachelot & F André) Breast cancer RE+/HER2- > 3N+ Or HT and 2 years placebo ≥ 1N+ after neo adjuvant Or R 1-3 N+ Genomic High risk (endopredict) HT + 2 years everolimus 10 mg/d Any time from 1 to 4 years (start 5mg) post surgery February 2020— R&D UNICANCER 41
Adjuvant high risk : UNIRAD study (collaboration UK : David Cameron) Everolimus in the adjuvant setting (PI T Bachelot & F André) Breast cancer HT and 2 years placebo RE+/HER2- 4N+ or ≥ 1n+ after neo adjuvant R Treatment Or HT Genomic High risk + 2 years everolimus 10 mg/d (endopredict) (start 5mg) Any time from 1 to 4 years post surgery First interim analysis ongoing February 2020— R&D UNICANCER 42
Survivorship and long term safety : CANcer Toxicities (CANTO) CANTO (CANcer TOxicities; NCT01993498) • prospective longitudinal cohort started in 2012 (Ines Vaz-Luis & F André) • 26 French comprehensive cancer centers Primary Objectives Identify factors predictive of long term breast cancer treatment-related toxicities Secondary Objectives Describe long term toxicities incidence/prevalence and psychological, social and economic, functional impact Build a French prospective database of long term toxicities among breast cancer survivors and a multi- disciplinary network that will leveraged on the dataset findings Inclusion criteria • 18+ years old at breast cancer diagnosis • Histologically confirmed invasive breast cancer • Stage I-II-III • Untreated at time of inclusion (including primary surgery) February 2020— R&D UNICANCER 44
Survivorship and long term safety : CANcer Toxicities (CANTO) (Ines Vaz-Luis & F André) Started in 2012 Inclusions completed with 12,012 patients in 2018 February 2020— R&D UNICANCER 45
Survivorship and long term safety : CANcer Toxicities (CANTO) (Ines Vaz-Luis & F André) Baseline Follow-up after treatment Long-term follow-up Collected Information Diagnosis 3-6 months 12 months 24 months^ 36 months 60 months yearly for 5 years Inclusion criteria Signed informed consent Clinical examination Prolonged and Blood tests long-term toxicity Paraclinical examination Survival Outcomes Questionnaires (PROs)* Biological samples *EORTC-QLQ C30, B23, FA12, GPAQ-16, HADS, SF-12, IOCv2, social and financial reports ^telephone-based (remote) assessment of patient follow-up booklet and professional situation February 2020— R&D UNICANCER 46
Survivorship and long term safety : CANcer Toxicities (CANTO) (Ines Vaz-Luis & F André) February 2020— R&D UNICANCER 48
Survivorship and long term safety : CANcer Toxicities (CANTO) (Ines Vaz-Luis & F André) February 2020— R&D UNICANCER 49
Plan Historic From « Copil Pacs » to UCBG, alliance with GINECO Actual Organization, numbers Main strategies and recent achievement Research interest International collaboration Focus on recent realization Perspectives Research program Collaboration February 2020— R&D UNICANCER 50
Research program Screening/ Prevention Implementation of MyPebs Program To develop prevention clinical trials in high risk persons Adjuvant setting To build new strategic clinical trials from CANTO data - Chemo-free regimen (APOLON) - Reasonnable de-escalation (LESS) - Chemobrain prevention in young women To treat at molecular relapses - cTRACK programme Metastatic setting To develop a prospective program on epigenetics To develop studies for patients progressing on CDK4/6 inhibitor Consolidation of international collaborations To consolidate preferential international collaborations (with mainly 3-4 countries: Spain/Portugal/UK/Germany) to foster the development of studies February 2020— R&D UNICANCER 51
Screening: MyPeBS : Suzette Delaloge This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement N° 755394 International Randomized Study Comparing Personalized, Risk- Stratified to Standard Breast Cancer Screening In Women Aged 40-70 February 2020— R&D UNICANCER 52
Screening: MyPeBS : Suzette Delaloge February 2020— R&D UNICANCER 54
Screening: MyPeBS : Suzette Delaloge Planned accrual – 5 countries UK 10,000 women / 3 centers France 20,000 Belgium 10,000 women / 3 regions women / 30 areas Italy 30,000 women/ 6 regions Israël 15,000 women / 11 centres February 2020— R&D UNICANCER 56
Adjuvant setting: Apolon Aim : To prove that HT + Palbociclib allows for a minimum of 93% iDFS at 3 years in this “intermediate +” population Secondary end point : PRO : QOL, depression, fatigue, Physical activity, work, Cognitive function • pT1/pN0 AND grade 3 or pT2/pN0 AND histological grade 2 Letrozol + palbociclib (2 years) Or: • pN1 (1-3 N+) AND histological grade 1/2 Design: Single arm, Non crossing threshold study. N = 1500 Coordinating investigators : Thomas Bachelot February 2020— R&D UNICANCER 58
Molecular relapse: cTRAK-ER: Collaboration ICR A randomised phase III trial of early detection of molecular relapse with circulating tumor DNA tracking and treatment with palbociclib Coordinating investigators : Nicholas TURNER plus fulvestrant versus standard endocrine Institute of Cancer Research – London –UK therapy in patients with ER positive HER2 Co-Coordinating investigator : negative breast cancer (cTRAK-ER) Fabrice ANDRE Gustave Roussy –Villejuif - France Biostatistician : Judith BLISS Institute of Cancer Research – London –UK February 2020— R&D UNICANCER 59
Molecular relapse: cTRAK-ER: Collaboration ICR February 2020— R&D UNICANCER 60
Metastatic post CDKi: DOLAF Collaboration SOLTI Molecular analysis Faslodex + « HRD+ » 158 Olaparib + HRD+ BRCA1/2; ATM, Durvalumab BARD1, BRCA1, BRCA2, BRIP1, 790 MBC CDK12, CHEK1, patients CHEK2, FANCA, ER+/HER2- MBC FAND2, FANCL, Progressive on MRE11A, NBN, AI + Palbo PALB2, PPP2R2A, RAD51B, RAD51C, HRD - Other RAD51D, RAD54L, and TP53 or MSI + + ESR1; AKT; PIK3CA February 2020— R&D UNICANCER 61
Consolidation of international collaborations International consortium Preferential collaboration BIG UK : ICR ALLIANCE Spain : SOLTI IBCSG… Germany : GBG => Regular scientific meetings => Constructive discussion => Common goal, common project ! February 2020— R&D UNICANCER 62
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