21WCGIC 1--PD Abstract 88 Abstract • Secondary • Primary 1 Figure 1. Study Design for for APACTDesign Study 1. Figure • • • • content and editorial decisions for this poster. this for decisions editorial and content authors The Corporation. Celgene poster this of preparation the in support production and editorial received NJ. authors The Summit, Corporation, Celgene by supported was study This a orsodne rMceeRn [email protected] Correspondence: Dr Michele Reni – Institute/Tennessee Oncology, Nashville, TN, USA; Germany; Freie Universität Berlin, Humboldt-Universität zu Berl IRCCS Ospedale San Raffaele, Milan, Italy; Stratified by rese Overall survival and safety and tolerability and safety and survival Overall survival disease-free assessed Independently naive patients with surgically resected PC resected surgicallywith patients naive cancers all among rate survival lowest the has and gemcitabine vs gemcitabine alone ( alone gemcitabine vs gemcitabine of safety efficacyand the assessed III, phase open-labelinternational,The APACT trial PC with patients for option curative potentially only Presently,the is resection surgical combined PC of stages all for 10% < is rate survival 5-year The asso is (PC) cancer Pancreatic • • • • • • • - - CA19-9 < 100 U/mL within14 ofdays randomization Surgical staging: N0-1,T1-3, M0 Acceptable blood chemistrylevels Acceptable hematologyparameters ≤ 1 PS ECOG Histologically confirmed pancr Age ≥ 18 years or R1 resection or R1 Seoul, South Korea; This reflects the advanced stage of most diagnoses most of stage advanced the reflects This and radiation have a 5-y a have radiation and chemotherapy, resection, complete undergo who Those Radiological evaluation for up to 5 yearsafter last dose or un Michele Reni, Michele Johanna Bendell, Johanna nab Gemcitabine 1000 mg/m ction status (R0 vs R d’Hebron Institute of Oncology (VHIO), Barcelona, Spain; 1 -Paclitaxel 125 mg/m ACKNOWLEDGMENTS nab Michele Reni Clinical Pancreatic Cancer ® KeyInclusion Criteria 9 INTRODUCTION International, Randomized,Open-Label APACT Trial is a registered trademark of Celgene Corporation. Celgene of trademark registered is a Servicio de Oncología Médica, 1 Jordan Winter,Jordan 1), lym ×6 cycles Arm A 11 ph node Benjamin Garlipp, Benjamin Analysis of Patient Screening in the Phase III, in thePhase Analysis ofPatientScreening ear survival of only 20% onlyof survival ear from MediTechfrom by funded Media, status (l eatic adenocarcinoma R0 with a 2 ciated with a poor prognosis poor a with ciated University Hospitals Cleveland Medical Center, Cleveland, OH, U are fully responsible for all for responsible fullyare ymph node positive node positive ymph and negative), geographic vs region (North A 2 12 Figure 1 Figure 2 nab Otto-von-Guericke-Universit Giampaolo Tortora, Giampaolo 2 Safetyassessment for 28 daysafter last dose w34+ qw3/4 qw 3/4 qw ® Hospital Hospital Regional Universitario, ClinicalTrials.gov:NCT01964430 -paclitaxel plus plus -paclitaxel University of New South Wales, Randwick, NSW, Australia; in, in, Berlin, Germany; Berlin Institute of Health, Berlin, German ) in treatment- in ) 12 866 Patients Randomized 1:1 Margaret Tempero,Margaret 1 15 STUDY DESIGN 2 University Hospitals Gasthuisberg/Leuven and KU Leuven, Leuven, ENDPOINTS 3,4 ät Magdeburg, Magdeburg, Germany; Follow-Up Screening N = 1226 Uwe Pelzer,Uwe Malaga, Spain; • • • • • • • Exploratory • 1-3; ULN, upper limitof normal. thromboplastin time; qw 3/4, first 3 of 4 weeks; R0, tumor-free R0, weeks; 4 3 of first 3/4, qw time; thromboplastin imaging; N0-1, absence/presence of lymph node involvement; PC, International Normalized Ratio; M0,absence of metastasis; MPC, antigen 19-9; CT,computed tomography; ECOG PS, Eastern Coopera ALT, alanine aminotransferase; ANC, absolute neutrophil count; 2. 1. 13 cycle 1 dosing cycle begin to randomization of 3 days within returned Patients met were criteria inclusion/exclusion all and t once randomized were Patients postsurgery weeks12 within Treatmentstarted be to was within performed scan MRI or CT byassessed were patients period, screening the During Quality of life of Quality blood from acids nucleic tumor of Identification tissue tumor of profiling Molecular for exclusion in the the in exclusionAPACTfor trial reasons and identification patient for process the Evaluate figures/2019/cancer-facts-and-figures-2019.pdf. Accessed 24 Apr https://www.cancer.org/content/dam/cancer-org/research/cancer-f Mohammed S, et al. American Cancer Society. • • • • • Teresa Macarulla, requiring systemictherapy uncontrolledActive, bacterial, viral,or fungal infections otherAny malignancywithin prior years5 to randomization significantAny medical condition pancreatic adenocarcinoma Presence or or metastaticofhistorylocally recurrent therapyfor pancreatic adenocarcinoma Prior neoadjuvant treatment,radiation therapy, or systemic - A patient may have had ≥ 1 reason for exclusionfor reason 1 A≥ had have may patient 5 merica, Europe merica, and Australia vs Pacific). Asia Hanno Riess, Hanno til recurrence, cancer newtherapy, ordeath 10 Section Section of Oncology, Department of Medicine, University of Vero World J Gastroenterol.World J SA; Gemcitabine 1000 mg/m Cancer Facts & FiguresCancer Facts2019 & 3 Azienda Ospedaliera Universitaria, Verona, Italy; KeyExclusion Criteria 13 Poster presented at the European University of California, San Francisco, Helen Diller Comprehen 5 REFERENCES 14 18 Heung-Moon Chang, Heung-Moon Celgene Corporation, Summit, NJ, USA; OBJECTIVE y; Eric VanEric Cutsem, METHODS 2014;20:9354-9360. 6 Asan Asan Medical Center, Seoul, South Korea; DOI: 10.3252/pso.eu.21wcgic.2019 ×6 cycles Arm B Arm . Atlanta, GA: American Cancer Society;2019. margin; R1, microscopically positive margin; T1-3, tumor stage tumor T1-3, margin; positive microscopically R1, margin; 14 days prior to randomization to prior days14 AST,aspartate aminotransferase; CA19-9, carbohydrate metastatic pancreatic cancer; MRI,magnetic resonance pancreatic cancer; PT, prothrombin time; PTT,partial il2019. acts-and-statistics/annual-cancer-facts-and- hey recovered from surgeryfrom recovered hey Belgium; tive Oncology Group performance status; INR, a 15 16 Jordan D. Berlin, D. Jordan 6 Vanderbilt-Ingram Cancer Center, Nashville, TN, USA; 2 Eileen M. O’Reilly,M. Eileen Society for Medical Oncology2 qw 3/4 qw 4 19 Fondazione Policlinico Universitario Gemelli, IRCCS, Rome, Ital Karmanos Cancer Institute, Detroit, MI, USA presented 7 Memorial Sloan Kettering Cancer Center, , NY, USA; aSho fMdcn Verona University Hospital Trust,na School of Medicine Verona- Poster 16 David Goldstein, David at: 7

Do-YounOh, sive sive Cancer Center, San Francisco, CA, USA; Janssen, Leap Therapeut Janssen, Genent FORMATherapeutics, Therapeutics, Prime Five Serono, EMD Bristol-Myer Ingelheim,Boehringer Bayer,Beigene, AstraZeneca, Pharma; Oncogenex, OncoMed, Phoenix Biotech, Prelude Therapeutics, Sanof Prelude Therapeutics, Biotech, Phoenix OncoMed, Oncogenex, AstraZeneca, , Genentech/Roche, Merck Serono, Bayer, Serono, TaMerck Genentech/Roche, Novartis, AstraZeneca, Merck, Merck KGaA, SERVIER, Bristol-Myers Squibb; Squibb; Bristol-Myers SERVIER, KGaA, Merck Merck, funding, Research AmgNovartis, AstraZeneca; KGaA, Merck Dohme, Roche, Teson, Shire, Botxer,Celgene; T Pharmaceuticals, Inc.,Tolero Therapeutics, Tizona Therapeutics, Pharmacyslics, Pharmcyte, Biotech, Tocagen; Biotech, Pharmcyte, Board, Pharmacyslics, Ast Advisory Medical; Research funding, Sirtex Medical; Medical; Sirtex funding, Research Medical; Celgene; and honoraria, funding Incyte; Advisory board fees, Celgene; Speaker Bureau fees, Baye fees, Bureau Speaker Celgene; fees, board Incyte; Advisory Celgene; ownership, stock and leadership or Pfizer; Celgene, role, Consultant/Advisory Pharma; Celg Bristol-Myers-Squibb, Bayer,Boehringer-Ingelheim, Bureau, Bris Bayer,Role, Boehringer-Ingelheim, HR: Consulting/Advisory Pfizer; personal fees, Novocure; personal fees, Novartis; other Novartis; fees, personal Novocure; fees, personal Pfizer; MR Exclusion criteria met, n (%)met,criteria Exclusion treatments study. prior months this to 6 completed treatments a with evidence of prior or signs of active withchronic active or evidence hepatitis. priorsigns of of • • • Screening • • • • B or C B or hepatitis orhistoryof HIVKnown infection active interpretdata abilityto confoundthe that conditions Any study that mayinterferewith the interventionalagent with an studyinvestigational orprotocol other clinical in anyEnrollment therapyrequiringsystemicinfections Active treatmentPriorneoadjuvant PCfor disorderspsychiatricserioussystemsororgan anymajorinvolving factorsrisk Serious medical phosphatase ≤ 2. ≥ ≥ 1500/mm Acceptable hematology parametershematologyAcceptable resection confirmedcompletePC with Histologically otherprotocolrequirements and visit schedule studyto adhereto Ability stagingsurgicalcancerPancreatic consent informedand voluntarilysign Understand Table 2. ExclusionCriteria Met c a (%)n criteria failed, Inclusion Failed Criteria Table Inclusion 1. CA19-9 < 100 U/mL 100 < CA19-9 the study in were participateto riskif theyat unacceptable the patient places that abnormalities,laboratory of the presence condition, including Any randomization 5 yearsof otherwithin Any malignancy abnormality,illness or psychiatric laboratorymedicalcondition, significant Any protocol to complywith study Unwillingness/inability of MPCPresence/history Acceptable coagulation studies coagulation Acceptable 1 ≤ PS ECOG postsurgery treatment12 weeks to start≤ abilityPatient Acceptable blood chemistryblood Acceptable within normal limits (± 15%). 15%). within normal limits (± Acceptable staging Acceptable included M0. T1-3, N0-1, Excludes adequately treated in situ carcinoma of the cervix, Excludes ut adequately situ cervix, the treated of carcinoma in Assessed randomization. days Assessed after ≤ 14 : grants, personal fees, and non-financial support, Celgene; pe Celgene; support, and non-financial fees, personal grants, : (≥ 17% of screened patients; patients; of screened 17% (≥ disease metastatic or residual potential either of evidence to due was exclusionfor Collectively,reason common most the screening during excluded (29%) were360 eligibility for screened were patients 1226 Overall, after surgery before dec before surgeryafter recommended CT stronglyare scans and threshold CA19-9 population adjuvant “true” a of selection allowedwhich screened), were who patients of 17% (≥ disease residual/metastatic with patients excluded and U/mL100 < of identified threshold CA19-9 a and randomization of weeks2 withinCT scans therapy adjuvant start to ability and disease residual postsurgical regarding in process screening APACTThe information provided the in inclusion APACT trial for ineligible deemed were patients screened of 29% 1st World Congress on Gastroint - JB HMC osligo dioyRl n eerhfnig , Apexi funding, and research or Consulting Role : Advisory treatment most appropriate for appropriate most treatment receive to patients allow criteria selection Stringent b eerhFnig egn,PamccisLC ehaBioscienc Senhwa LLC, Pharmacyclics Celgene, Funding, Research : 3 , , 100,000/mm platelet count ≥ d 8 ULN, serum cr 5 × ics, Lilly,Macrogeni ics, Inmaculada C. C. Inmaculada Alés-Díaz, 17 a DYO Brian Lu, Brian 17 : Research funding, AstraZeneca, Research : EVC a Nelune Cancer Centre, Prince of Wales Hospital, BL MT : Consulting/Advisory role, Bayer, Lilly, Roche, SERVIER, Brist SERVIER, Lilly,Bayer,Roche, role, Consulting/Advisory : cs, MedImmune, Merc MedImmune,cs, PP : employee and shareholder, Celgene Corporation; Corporation; and shareholder,Celgene : employee CONCLUSIONS oslig bVe dac eia,Bohr Communications, : Consulting, AbbVie,BioPharm Medical, Advance DISCLOSURES : Research Funding, Celgene, Bayer,Celgene, Funding, Research : eatinine ≤ ULNor calculated cl Copies of this poster obtai poster this of Copies withoutpermission from ESMOand the author o Code are for personal use onlyand may not be reproduced 18 JDB, b RESULTS 3 b , , and hemoglobin g/dL. ≥ 9 Julie Jeanes, Julie nldsATAT≤25×ULN, tota Includes AST/ALT ≤ 2.5 × personal fees, Celgene; fees, personal iding on systemic therapy systemicon iding , AstraZeneca; other, Boston Pharmaceutics; Pharmaceutics; other, , Boston AstraZeneca; d f estinal Cancer; 3-6 July 2019; B tol-Myers-Squibb, Celgene, Daiichi-Sankyo, Johnson & Johnson, P Johnson, & Johnson Daiichi-Sankyo, Celgene, tol-Myers-Squibb, ene, Daiichi-Sankyo, Leo-Pharma, Pfizer; Research Baye funding, Research Pfizer; Leo-Pharma, Daiichi-Sankyo, ene, s Squibb, Celgene, Cerulean Pharma, Continuum Clinical, Cyteir,Clinical, Continuum Pharma,Cerulean Celgene, Squibb, s Complete resection resection Complete or R0as defined R1. r, Roche, Sanofi, r,Roche, Amgen rsonal fees, Baxalta; personal fees, Shire; personal fees, Eli- fees, personal Shire; fees, personal Baxalta; fees, rsonal orque; orque; raZeneca, CPRIT, Immunovia; Research Contract, Halozyme; CPRIT,Contract, Research raZeneca, Immunovia; k, Merrimack, Moderna Therapeutics, Molecular Partners, Novartis Partners, Molecular Therapeutics, Moderna k, Merrimack, iho, iho, ASLAN; b en, Bayer, Boehringer en, c ech/Roche, Gilead Sciences, GlaxoSmithKline, Incyte, Innate Pha Innate Incyte, GlaxoSmithKline, Sciences, Gilead ech/Roche, i, Seattle Genetics, TaihoGenetics, SeattleTanabe i, Pharmaceutical, Research, TD2 Includes Includes are whopatients serologically currently positive Novartis, Lilly, Novartis, Array,Gr Eli e y; y; BG: BG: Tables2) and 1 14 5 Vall d’Hebron University Hospital and Vall Charité-Universitätsm Honoraria and Consulting/advisory role, Amgen, Merck, Roche, Si Roche, Merck, role, Amgen, andConsulting/advisory Honoraria gen, Oncology,Arch BioPharma, BioSciences, Array ARMO MM ned through Quick Response (QR) Italy; , the stage of their disease their of stage the es, Halozyme INC, Taiho INC, INC; Oncology Halozyme es, : Advisory board, Pfizer; Speakers fee, AstraZeneca, EUSA fee, AstraZeneca, Speakers Pfizer; board, : Advisory DG

erus, or nonmelanomatous nonmelanomatous erus, or withskin cancer 8 9 Seoul National Unive : Institutional research funding, Celgene Pfizer; Celgene funding, research Institutional: earance ≥ 50 mL/min/1.73 earance m mL/min/1.73 ≥ 50 18 Michele Milella, Michele Ingelheim, Lilly, Novartis, Roche, Celgen Roche, Lilly,Novartis, Ingelheim, 11 f Philip Philip Philip Sarah Cannon Research Demonstrated PTbyDemonstrated and INR PTT or JJ: JJ: een Cross; Consulting/Advisory role, role, Consulting/Advisory een Cross; employment All ScreenedPatientsAll All ScreenedPatientsAll ol-Myers Squibb, Celgene, Merck Sharp & Sharp Merck Celgene, Squibb, ol-Myers f this poster. f this JW,GT, UP IAD, l bilirubin ≤ ULN, alkaline edizin Berlin, Berlin, N = 1226 N = BMS, Celgene, Eisai, Ignyta, Eisai, Celgene, BMS, N = 1226 N = 125 (10) 125 2 (< 1) 2 (< 1) 2 (< 1) 2 (< 1) 2 (< 1 (< 1) 1 (< 1) 1 (< 28 (2) 81 (7) 11 (1) 11 2 (< 1) 2 (< 1) 2 (< 2 (< 1) 2 (< 12 (1) 13 (1) 37 (3) 45 (4) 9 (1) 9 (1) 7 (1) 9 (1) arcelona, Spain e Includes Includes ANC rsity Hospital, 19 : Nothing to disclose; to disclose; Nothing : EMO Lilly; personal fees, fees, personal Lilly; 10 TM: 2 . : Research Research : Daiichi Sankyo,Daiichi r, Celgene, Leo Celgene, r, fizer; Speakers Speakers fizer; e, Ipsen, e, Consultancy, , rma, Ipsen, rma, , TG , rtex