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1、 Journal of Clinical Oncology List of Issues Volume 39,Issue 15_suppl Meeting Abstract|2021 ASCO Annual Meeting IGASTROINTESTINAL CANCERGASTROESOPHAGEAL,PANCREATIC,ANDHEPATOBILIARYPemigatinib for previously treated locallyadvanced/metastatic cholangiocarcinoma(CCA):Update of FIGHT-202.Rights&Permiss

2、ionsOPTIONS&TOOLSExport CitationTrack CitationAdd To FavoritesCOMPANION ARTICLESADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article ToolsGhassan K.Abou-Alfa,Vaibhav Sahai,Antoine Hollebecque,Gina M.Vaccaro,Davide Melisi,Raed Mohd Taiseer Al-Rajabi,.Show MoreAbstrac

3、t Disclosures4086Background:Pemigatinib(PEMI),a potent,selective,oral FGFR1-3 inhibitor,has shownefficacy and safety in patients(pts)with CCA andFGFR2 rearrangements/fusions in FIGHT-202(NCT02924376;objective response rate ORR,35.5%;duration of response DOR,7.2 monthsmo).Overall survival(OS:21.1 mo)

4、was notmature in the primary report(Abou-Alfa.LancetOncol 2020;cutoff:Mar 22,2019);herein we reportmatured efficacy and safety data from FIGHT-202(cutoff:Apr 7,2020).Methods:Pts(18 y)withknown FGF/FGFR alterations and progression after1 prior therapy had FGFR2No companion articlesARTICLE CITATIONDOI

5、:10.1200/JCO.2021.39.15_suppl.4086Journal of Clinical Oncology 39,no.15_suppl(May 20,2021)4086-4086.Published online May 28,2021.WE RECOMMENDADVERTISEMENTEmployer:Merritt HawkinsApply for this job Employer:Potomac Oncology&HematologyApply for this job Hematology-Oncology OpportunityJust Outside of C

6、hicagoRockford,Illinois N/AA reputable integrated health system seekinga board-certified or board-eligiblehematologist-oncologist to join its team.Oncology&Hematology AssociatePositionRockville,Maryland Competitive SalaryThis position offers a competitive base salary,a comprehensive benefits package

7、,exceptional productivity incentives,and apartnership track.Hematology/Oncology-at the Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractFinal Phase II Data SupportInfigratinib in Chemotherapy-refractory CholangiocarcinomaHarboring FGFR2 Fusi

8、onsASCO Daily News,2021Lack of Targetable FGFR2 Fusions inEndemic Fluke-AssociatedCholangiocarcinomaSarinya Kongpetch et al.,JCO GlobalOncology,2020Cholangiocarcinoma With FGFRGenetic Aberrations:A UniqueClinical PhenotypeApurva Jain et al.,JCO PO,2018Phase II Study of BGJ398 in PatientsWith FGFR-Al

9、tered AdvancedCholangiocarcinomaMilind Javle et al.,J Clin Oncol,20172018 ASCO:KEYNOTE-427 TrialEvaluates Immunotherapy inAdvanced Clear Cell Renal CellCarcinomarearrangements/fusions(cohort A),otherFGF/FGFR alterations(B),or no FGF/FGFRalterations(C).Pts received PEMI 13.5 mg QD(21-d cycle;2 wks on

10、,1 wk off)until progression ortoxicity.Primary endpoint:independent,centrallyconfirmed ORR(cohort A);secondary endpoints:ORR(cohorts B,C;cohorts A and B combined);DOR,disease control rate(DCR),progression freesurvival(PFS),OS,and safety.A post-hoc analysisin cohort A evaluated mOS in responders(pts

11、withcomplete response CR or partial response PR)vs non-responders(pts with progressive diseasePD or stable disease(SD).Results:At cutoff,147pts were enrolled(cohort A,n=108;B,n=20;C,n=17;FGF/FGFR status undetermined,n=2);median follow-up was 30.4(range,4.938.7)moand median treatment duration was 5.9

12、(0.236.5)mo.In cohort A,9.3%of pts remained on therapyat cutoff;in cohorts B and C,all pts haddiscontinued.Pts discontinued mainly for PD(67.6%,75%,and 64.7%in cohorts A,B,and Crespectively).Independent,centrally confirmedORR was 37.0%;mOS was 17.5 mo(95%CI,14.4-ADVERTISEMENTBy The ASCO Post et al.,

13、KidneyCancer,2018Systemic therapy for advancedcholangiocarcinoma:new options onthe horizonSaleh A.Alqahtani et al.,HepatomaResearch-OAE Publishing,2020Durable ibrutinib responses inrelapsed/refractory marginal zonelymphoma:long-term follow-up andbiomarker analysisAriela Noy et al.,Blood Advances,202

14、0Zanubrutinib Monotherapy forRelapsed or Refractory Non-Germinal Center Diffuse Large B-CellLymphomaHaiyan Yang et al.,Blood AdvancesUncoupling fibroblast growth factorreceptor 2 ligand binding specificityleads to Apert syndrome-likephenotypes.K Yu et al.,Proc Natl Acad Sci U S A,2001Tislelizumab Pl

15、us Chemotherapy vsChemotherapy Alone as First-lineTreatment for Advanced SquamousNonSmall-Cell Lung Cancer:APhase 3 Randomized Clinical TrialJie Wang et al.,JAMA Oncology,2021Powered by22.9)in cohort A(Table 1).mOS for responders(n=40)vs non-responders(n=68)was 30.1(95%CI,21.5-NE)mo vs 13.7(9.6-16.1

16、)mo.Overall,mostcommon all-cause treatment-emergent adverseevents(TEAEs)were hyperphosphatemia(58.5%;grade 3,0%),alopecia(49.7%;0%),diarrhea(46.9%;3.4%),fatigue(43.5%;5.4%),nausea(41.5%;2%),and dysgeusia(40.8%;0%);10.2%,13.6%and 42.2%of pts discontinued,had dosereduction,and treatment interruption d

17、ue toTEAEs,respectively.Conclusions:These resultsreinforce the primary data,showing continued,durable responses and sustained tolerability in ptsreceiving PEMI for CCA harboring FGFR2rearrangements/fusions.Notably,the matured OSis longer than historical data;OS for responderswas more than twice as l

18、ong vs for non-responders.Clinical trial information:NCT02924376.Efficacy.Cohort A(n=108)B(n=20)C(n=17)Cohort A(n=108)B(n=20)C(n=17)Best ORR 37.0(27.946.9)0.0(0.016.8)0.0(0.019.5)CR 4(3.7)0 0 PR 36(33.3)0 0 SD 49(45.4)8(40.0)3(17.6)PD 16(14.8)7(35.0)11(64.7)NE 3(2.8)5(25.0)3(17.6)mDOR 8.1(5.713.1)NE

19、 NE DCR 82.4(73.989.1)40.0(19.163.9)17.6(3.843.4)mPFS 7.0(6.110.5)2.1(1.24.9)1.5(1.41.8)mOS 17.5(14.422.9)6.7(2.110.5)4.0(2.04.6)NE,not evaluable;Data are%(95%CI),n(%),ormonths(95%CI).2021 by American Society of Clinical OncologyResearch Sponsor:Incyte CorporationQUICK LINKSContentResourcesASCO FAMI

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