June4-8,2010Chicago,IllinoisHematologicMalignanciesCCOIndependentConferenceCoverageofthe2010AmericanSocietyofClinicalOncologyAnnualMeeting**CCOisanindependentmedicaleducationcompanythatprovidesstate-of-the-artmedicalinformationtohealthcareprofessionalsthroughconferencecoverageandothereducationalprograms.ThisprogramissupportedbyeducationalgrantsfromAmgen,Bristol-MyersSquibb,Celgene,GenentechBioOncology,MillenniumPharmaceuticals,Inc.,NovartisOncology,andPfizer,Inc.clinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesAboutTheseSlidesOurthankstothepresenterswhogavepermissiontoincludetheiroriginaldataUsersareencouragedtousetheseslidesintheirownnoncommercialpresentations,butweaskthatcontentandattributionnotbechanged.UsersareaskedtohonorthisintentTheseslidesmaynotbepublishedorpostedonlinewithoutpermissionfromClinicalCareOptions(emailpermissions@clinicaloptions.com)DisclaimerThematerialspublishedontheClinicalCareOptionsWebsitereflecttheviewsoftheauthorsoftheCCOmaterial,notthoseofClinicalCareOptions,LLC,theCMEproviders,orthecompaniesprovidingeducationalgrants.ThematerialsmaydiscussusesanddosagesfortherapeuticproductsthathavenotbeenapprovedbytheUnitedStatesFoodandDrugAdministration.Aqualifiedhealthcareprofessionalshouldbeconsultedbeforeusinganytherapeuticproductdiscussed.Readersshouldverifyallinformationanddatabeforetreatingpatientsorusinganytherapiesdescribedinthesematerials.clinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesFacultyNicholasJ.DiBella,MDCo-Chairman,HematologyResearchCommittee,USOncologyPresident,RockyMountainCancerCentersAurora,Coloradoclinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesAnUpdateonHematologicMalignancies:OverviewPRIMA:rituximabmaintenancevsobservationinpatientswithfollicularlymphomawhorespondedtoinductionwithrituximabpluschemotherapyPhaseIItrialofpanobinostatinrelapsed/refractoryHodgkin’slymphomaPhaseIItrialofR-GemOxforpatientswithrelapsed/refractoryDLBCLnotcandidatesforhigh-dosetherapyDASISION:phaseIIItrialofimatinibvsdasatinibinuntreatedCP-CMLENESTndphaseIIItrialofnilotinib300mgBIDor400mgBIDvsimatinib400mgQDinnewlydiagnosedPh-positiveCP-CMLInvestigationofazacitidineinchronicmyelomonocyticleukemiaInvestigationofbortezomib,lenalidomide,dexamethasoneinnewlydiagnosedmultiplemyelomaCALGB100104:lenalidomidemaintenancevsplacebofollowingASCTinmultiplemyelomaLymphomasclinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesUntreatedpatientswithhightumorburdenfollicularlymphomaInductionImmunochemotherapy8cyclesR-CHOPorR-CVPorR-FCMRituximabmaintenance375mg/m2q8wfor2yrs(n=505)Observation(n=513)Response*(N=1019)*OnlypatientswithCR/CRu/PRrandomizedtomaintenancetherapy;1patientdiedduringrandomization.Stratifiedbyresponsetoinduction,chemotherapyregimen,andgeographiclocationpriorto1:1randomization5-yrfollow-upSallesGA,etal.ASCO2010.Abstract8004.PRIMA:RituximabMaintenancevsObservationinPatientsWithFLclinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesPRIMA:PrimaryEndpoint(PFS)MetatPlannedInterimAnalysisRituximabmaintenancereducedtheriskofprogressionby50%SallesGA,etal.ASCO2010.Abstract8004.Reprintedwithpermission.1.00.80.60.40.20061218243036Progression-FreeRateMosStratifiedHR:0.5095%CI:0.39-0.64P.000182%66%Rituximabmaintenance(n=505)Observation(n=513)PatientsatRisk,n506513472469443411336289230195103821815clinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesPRIMA:BenefitsofRituximabMaintenancebySubgroupSallesGA,etal.ASCO2010.Abstract8004.Reprintedwithpermission.All≥60FLIPI≤1FLIPI=2FLIPI≥3R-CHOPR-CVPR-FCMCR/CRuPR0123CategorySubgroupHRnHR*95%CIAllAgeFLIPIindexInductionchemotherapyResponsetoinduction1018624394216370431768222287212900.490.450.590.380.390.610.430.690.510.520.450.38-0.640.33-0.620.39-0.900.19-0.770.25-0.610.43-0.670.31-0.590.44-1.080.13-2.070.38-0.700.29-0.72FavorsMaintenanceFavorsObservation*Nonstratifiedanalysis.60clinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesPRIMA:RituximabMaintenanceAssociatedWithImprovedResponsesSallesGA,etal.ASCO2010.Abstract8004.Reprintedwithpermission.Response,%Observation(n=398)*Rituximab(n=389)*PD40.720.3SD0.30PR7.37.2CR/CRu47.766.8n=190n=258†PatientswithCR/CRuafterinductionremaininginCR/CRu5675PatientswithPR/SDafterinductionconvertingtoCR/CRu3045*Patientsnotevaluated/missingdata:n=16inobservationarm;n=22inrituximabarm.†Notevaluatedinrituximabmaintenancearm:n=2.clinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesPRIMA:SafetyDuringRituximabMaintenanceSallesGA,etal.ASCO2010.Abstract8004.Reprintedwithpermission.100806040200Patients(%)AnyAdverseEventGrade≥2InfectionsGrade3/4AdverseEventsGrade3/4NeutropeniaGrade3/4InfectionsObservation(n=508)Rituximabmaintenance(n=501)1144355222371623clinicaloptions.com/oncologyAnUpdateonHematologicMalignanciesPRIMA:Conclusions2yrsofrituximabmaintenanceassociatedwithsignificantlylongerPFSvsobservationinpatientswithfollicularlymphomawhorespondedtoinductionwithrituximabpluschemotherapy–RituximabmaintenancefollowingR-CHOPmaybenefitpreviouslyuntreatedpat