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1、PresentedbyVAPapadimitrakopoulouattheWorldConferenceonLungCancer2016PlenarySession PL03PresidentialSymposium abstractPL03 03 VassilikiAPapadimitrakopoulou1 Yi LongWu2 Myung JuAhn3 SureshSRamalingam4 MarinaChiaraGarassino5 HyeRyunKim6 FrancesAShepherd7 HiroakiAkamatsu8 WillemijnSMETheelen9 CheeKhoonL
2、ee10 MartinSebastian11 AlisonTempleton12 MarceloMarotti12 SerbanGhiorghiu12 TonyMok13 RandomisedPhaseIIIstudyofosimertinibvsplatinum pemetrexedforEGFRT790M positiveadvancedNSCLC AURA3 1DepartmentofThoracic HeadandNeckMedicalOncology TheUniversityofTexasMDAndersonCancerCenter Houston TX USA 2Guangdon
3、gLungCancerInstitute GuangdongGeneralHospital13KeyLaboratoryofSouthChina DepartmentofClinicalOncology TheChineseUniversityofHongKong ShaTin HongKong Disclosures VassilikiAPapadimitrakopoulou consultancyforAstraZeneca ARIAD BMS Genentech Biothera Janssen Clovis Merck EliLilly grants researchsupportfr
4、omAstraZeneca Genentech Merck BMS Novartis Janssen ACEABiosciences Celgene Clovis honorariafromprIMEOncology Imedex CancerNet CECYi LongWu honoraria speakerfeesfromAstraZeneca Roche EliLilly Pfizer SanofiSureshSRamalingam consultancyforAmgen Abbvie AstraZeneca BMS BI Celgene Merck Lilly GenentechFra
5、ncesAShepherd consultancyforAstraZeneca Roche stockshareholderinandhonorariafromAstraZenecaHiroakiAkamatsu honorariafromAstraZeneca EliLilly Chugaipharmaceuticals BI Merck Pfizer Onopharmaceutical Taihopharmaceutical NovartisCheeKhoonLee honorariafromAstraZenecaMartinSebastian consultancyforandhonor
6、ariafromRoche BI AstraZeneca Novartis PfizerAlisonTempleton MarceloMarotti SerbanGhiorghiu employedbyandstockshareholderinAstraZenecaTonyMok employedbyTheChineseUniversityofHongKong speakersbureauforAstraZeneca Roche Genentech Pfizer EliLilly BI MSD Amgen Janssen ClovisOncology GSK Novartis BMS PrIM
7、EOncology grants researchsupportfromAstraZeneca BI Pfizer Novartis SFJ Roche MSD ClovisOncology BMS consultancyforAstraZeneca Roche Genentech Pfizer EliLilly BI MerckSerono MSD Janssen ClovisOncology BioMarin GSK Novartis SFJPharmaceutical ACEABiosciences Inc VertexPharmaceuticals AveohonorariaforAs
8、traZeneca Roche Genentech Pfizer EliLilly BI MerckSerono MSD Janssen ClovisOncology BioMarin GSK Novartis SFJPharmaceutical ACEABiosciences Inc VertexPharmaceuticals BMS AVEO Biodesix PrimeOncology Amgen OncoGenexPharmaceuticals Inc CelgeneMarinaChiaraGarassino consultancyforAstraZeneca Roche EliLil
9、lyMyung JuAhn HyeRyunKim WillemijnSMETheelen nonedeclared Introduction Osimertinibisanoral irreversible CNS active EGFR TKIselectiveforbothsensitising EGFRm andEGFRT790Mresistancemutations1 2PreviousglobalPhaseIIstudiesshowedosimertinib80mgQDprovidesclinicallymeaningfulefficacywithminimalsideeffects
10、inpatientswithEGFRT790M positiveNSCLC whosediseasehadprogressedonEGFR TKItherapy3 4AURAextension N 201 ORR byBICR was62 medianPFS12 3monthsandmedianDoR15 2monthsAURA2 N 210 ORR byBICR was70 medianPFS9 9monthsandmedianDoR11 4monthsAURA3isthefirstrandomisedPhaseIIIstudytocompareanEGFRT790M selectiveEG
11、FR TKI osimertinib againstplatinum baseddoubletchemotherapyinpatientswithcentrally confirmedEGFRT790M positiveadvancedNSCLCwhosediseasehadprogressedonfirst lineEGFR TKItherapy 1 Crossetal CancerDiscov2014 4 1046 61 2 Ballardetal ClinCancerRes2016 22 5130 40 3 Yangetal AURAextensionmanuscriptinprepar
12、ation 4 Gossetal LancetOncol2016 ePubaheadofprint AURAextension NCT01802632 AURA2 NCT02094261 AURA3 NCT02151981BICR BlindedIndependentCentralReview CNS centralnervoussystem DoR durationofresponse EGFR epidermalgrowthfactorreceptor ORR objectiveresponserate NSCLC non smallcelllungcancer PFS progressi
13、on freesurvival QD oncedaily TKI tyrosinekinaseinhibitor AURA3studydesign Keyeligibilitycriteria 18years 20yearsinJapan LocallyadvancedormetastaticNSCLCEvidenceofdiseaseprogressionfollowingfirst lineEGFR TKItherapyDocumentedEGFRmandcentralconfirmationoftumourEGFRT790Mmutationfromatissuebiopsytakenaf
14、terdiseaseprogressiononfirst lineEGFR TKItreatmentWHOperformancestatusof0or1NomorethanonepriorlineoftreatmentforadvancedNSCLCNopriorneo adjuvantoradjuvantchemotherapytreatmentwithin6monthspriortostartingfirstEGFR TKItreatmentStable asymptomaticCNSmetastasesallowed R2 1 Osimertinib n 279 80mgorallyQD
15、 Platinum pemetrexed n 140 Pemetrexed500mg m2 carboplatinAUC5orcisplatin75mg m2Q3Wforupto6cycles optionalmaintenancepemetrexed OptionalcrossoverProtocolamendmentallowedpatientsonchemotherapytobeginpost BICRconfirmedprogressionopen labelosimertinibtreatment EndpointsPrimary PFSbyinvestigatorassessmen
16、t RECISTv1 1 Secondaryandexploratory OverallsurvivalObjectiveresponserateDurationofresponseDiseasecontrolrateTumourshrinkageBICR assessedPFSPatientreportedoutcomesSafetyandtolerability Patientswerestratifiedatrandomisationbasedonethnicity Asian Non Asian RECISTv1 1assessmentsperformedevery6weeksuntilobjectivediseaseprogression patientscouldreceivestudytreatmentbeyondRECISTv1 1definedprogressionaslongastheyexperiencedclinicalbenefitWith221eventsofprogressionordeath thestudywouldhave80 powertoreje
