phase ii study of lorlatinib advanced alk ros1 nsclc高级或ROS1NSCLC中LorlatinibI II阶段研究.pptx

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phase ii study of lorlatinib advanced alk ros1 nsclc高级或ROS1NSCLC中LorlatinibI II阶段研究.pptx

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CCOIndependentConferenceCoverage*

ofthe2016ASCOAnnualMeeting,June3-7,2016PhaseI/IIStudyofLorlatinibinAdvancedALK+orROS1+NSCLC*CCOisanindependentmedicaleducationcompanythatprovidesstate-of-the-artmedicalinformationtohealthcareprofessionalsthroughconferencecoverageandothereducationalprograms.ThisactivityissupportedbyeducationalgrantsfromAmgen,Ariad,

BayerHealthcarePharmaceuticals,CelgeneCorporation,Genentech,Incyte,Merck,andTaihoPharmaceuticals.

LorlatinibinAdvancedALK+orROS1+NSCLC:BackgroundALK+andROS1+NSCLCptsfrequentlydevelopresistancetoTKIsthroughsecondarymutations[1,2]Lorlatinib:novel,broadspectrum,potentALKandROS1inhibitorActiveagainstmultiplemutationsconferringresistancetootherALKandROS1TKIs,includingcrizotinib,ceritinib,alectinib[3]CurrentreportondoseescalationcomponentofongoingphaseI/IIstudyoflorlatinibinadvancedALK+orROS1+NSCLC[4]1.JohnsonTW,etal.JMedChem.2014;57:4720-4744.2.ZouHY,etal.ProcNatlAcadSciUSA.2015;112:3493-3498.3.ZouHY,etal.AACR-NCI2013.AbstractA277.4.SolomonBJ,etal.ASCO2016.Abstract9009.Slidecredit:

LorlatinibinAdvancedALK+orROS1+NSCLC:StudyDesignOpen-labelphaseI/IItrialPrimaryobjective:safety/tolerabilityatincreasingdoselevelstoestablishRP2DSecondaryobjectives:antitumoractivity,PK,pt-reportedes,correlativestudiesALK+orROS1+NSCLC;treatment-naiveorPDafter≥1priorALK/ROS1TKI;≥1measurableextracraniallesion(N=54)Lorlatinib10,25,50,75,100*,150,or200?mgQDQ3W35,75,or100mgBIDQ3WSlidecredit:SolomonBJ,etal.ASCO2016.Abstract9009.*ChosenasRP2D,n=17.?OneDLTobserved.DoseEscalationTxuntilPDorunacceptabletoxicity

LorlatinibinAdvancedALK+orROS1+NSCLC:BaselineCharacteristicsCharacteristicAllPts(N=54)Meanage,yrs(SD)51.9(12.8)Female,%59Race,%White/black/Asian/other78/7/13/2Brainmetastasespresent,%72AL