Abstract
Background:First-linechemotherapyforadvancedormetastatichumanepidermalgrowthfactorreceptor2(HER2)-negativegastricorgastro-oesophagealjunctionadenocarcinomahasamedianoverallsurvival(OS)oflessthan1year.Weaimedtoevaluatefirst-lineprogrammedcelldeath(PD)-1inhibitor-basedtherapiesingastric,gastro-oesophagealjunction,andoesophagealadenocarcinoma.Wereportthefirstresultsfornivolumabpluschemotherapyversuschemotherapyalone.
Methods:Inthismulticentre,randomised,open-label,phase3trial(CheckMate),weenrolledadults(≥18years)withpreviouslyuntreated,unresectable,non-HER2-positivegastric,gastro-oesophagealjunction,oroesophagealadenocarcinoma,regardlessofPD-ligand1(PD-L1)expressionfromhospitalsandcancercentresin29countries.Patientswererandomlyassigned(1:1:1whileallthreegroupswereopen)viainteractivewebresponsetechnology(blocksizesofsix)tonivolumab(mgevery3weeksormgevery2weeks)pluschemotherapy(capecitabineandoxaliplatinevery3weeksorleucovorin,fluorouracil,andoxaliplatinevery2weeks),nivolumabplusipilimumab,orchemotherapyalone.PrimaryendpointsfornivolumabpluschemotherapyversuschemotherapyalonewereOSorprogression-freesurvival(PFS)byblindedindependentcentralreview,inpatientswhosetumourshadaPD-L1