CDK4 6抑制剂在HR+HER2-转移性乳腺癌中II期临床研究.pdfVIP

PhaseIIMONARCH1:CDK4/6

InhibitorAbemaciclibin

HR+/HER2-MBCAfter

Chemotherapy

CCOtConferenceCoverage*

ofthe2016ASCOAnnualMeeting,June3-7,2016

*CCOisantmedicaleducationcompanythatprovidesstate-of-the-artmedical

informationtohealthcareprofessionalsthroughconferencecoverageandothereducationalprograms.

ThisactivityissupportedbyeducationalgrantsfromAmgen,Ariad,

BayerHealthcarePharmaceuticals,CelgeneCorporation,Genentech,

Incyte,Merck,andTaihoPharmaceuticals.

MONARCH1:AbemaciclibinRefractory

HR+/HER2-MBC

▪CDK4andCDK6importanttargetsinbreastcancer[1,2]

▪Abemaciclib:selectiveinhibitorofCDK4andCDK6[3]

–PhaseI:abemaciclibactiveassingleagentinptswith

heavilypretreatedHR+MBC[4]

▪ForptswithHR+/HER2-MBCwhohavebeenpreviously

treatedwithtaxanesandrequireadditionalchemotherapy,

medianPFSis3-4moswithcurrentcytotoxic

chemotherapyoptions[5]

▪MONARCH1evaluatedsafetyandefficacyofabemaciclib

inthispatientpopulation[6]

1.AltucciL,etal.Oncogene.1996;12:2315-2324.2.GelbertLM,etal.Invest

NewDrug.2014;32:825-837.3.LallenaMJ,etal.CancerResearch.AACR

2015.3101.4.PatnaikA,etal.CancerDiscov.2016;[aheadof

print].5.NCCNclinicalpracticeguidelinesinoncology:breastcancer.

v.2.2016.6.DicklerMN,etal.ASCO2016.510.Slidecredit:

PhaseIIMONARCH1:Abemaciclibin

PreviouslyTreatedHR+/HER2-MBC

▪Treatment:abemaciclib200mgPOevery12hrsuntilunacceptable

toxicityorPD

▪Inclusioncriteria(N132)

–Progressiononorafterendocrinetherapy

–≥2previouschemotherapyregimens(≥1formetastaticdiseaseand

≥1withtaxane;noprevioustreatmentwithCDK4/6inhibitors)

–ECOGPS0or1

–Measurabledisease(RECISTv1