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1、 Journal of Clinical Oncology List of Issues Volume 39,Issue 3_suppl Meeting Abstract|2021 Gastrointestinal Cancers SymposiumHEPATOBILIARY CANCERLenvatinib plus pembrolizumab for patientswith previously treated biliary tract cancersin the multicohort phase II LEAP-005 study.Rights&PermissionsOPTIONS

2、&TOOLSExport CitationTrack CitationAdd To FavoritesADVERTISEMENTADADVERTISEMENTLog InSubmitE-AlertsCartOpenAthens/Shibboleth MENU Article ToolsLuis Villanueva,Zarnie Lwin,Hyun Cheol Chung,Carlos Gomez-Roca,Federico Longo,Eduardo Yanez,.Show MoreAbstract Disclosures321Background:Second-line treatment

3、 options forpatients with biliary tract cancers(BTC)arelimited.Lenvatinib,an anti-angiogenic multikinaseinhibitor,in combination with the programmeddeath-1 immune checkpoint inhibitorpembrolizumab,has demonstrated promisingantitumor activity with a manageable safetyprofile in patients with select ad

4、vanced solidtumors.LEAP-005(NCT03797326)is evaluating theefficacy and safety of lenvatinib pluspembrolizumab in patients with previously treatedadvanced solid tumors;here we present resultsfrom the BTC cohort of LEAP-005.Methods:In thisCOMPANION ARTICLESNo companion articlesARTICLE CITATIONDOI:10.12

5、00/JCO.2021.39.3_suppl.321Journal of Clinical Oncology 39,no.3_suppl(January 20,2021)321-321.Published online January 22,2021.WE RECOMMENDADVERTISEMENTEmployer:Merritt HawkinsApply for this job Employer:Potomac Oncology&HematologyApply for this job Hematology-Oncology OpportunityJust Outside of Chic

6、agoRockford,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,ex

7、ceptional productivity incentives,and apartnership track.Hematology/Oncology-at the Beach inLow Tax Delaware!Delaware(US);Family-oriented resort area inbeautiful south coastal DelawareAbstractPhase Ib Study of Lenvatinib PlusPembrolizumab in Patients WithUnresectable HepatocellularCarcinomaRichard S

8、.Finn et al.,J Clin Oncol,20202018 ASCO:KEYNOTE-427 TrialEvaluates Pembrolizumab inAdvanced Clear Cell Renal CellCarcinomaBy The ASCO Post,The ASCO Post,20182018 ASCO:KEYNOTE-427 TrialEvaluates Immunotherapy inAdvanced Clear Cell Renal CellCarcinomanonrandomized,open-label,phase II study,eligible pa

9、tients were aged 18 years withhistologically or cytologically documentedadvanced(metastatic and/or unresectable)BTCwith disease progression after 1 prior line oftherapy,measurable disease per RECIST v1.1,ECOG PS of 01,and tissue sample evaluable forPD-L1 expression.Patients received lenvatinib 20mg

10、once daily plus pembrolizumab 200 mg Q3Wfor up to 35 cycles(approximately 2 years)or untilconfirmed disease progression,unacceptabletoxicity,or withdrawal of consent.Treatment withlenvatinib could continue beyond 2 years inpatients experiencing clinical benefit.Primaryendpoints were ORR(per RECIST v

11、1.1 by blindedindependent central review)and safety.Secondaryendpoints were the disease control rate(DCR;comprising CR,PR,and SD),duration of response(DOR),PFS,and OS.Tumor imaging wasperformed Q9W from treatment initiation for 54weeks,then Q12W to week 102,and Q24Wthereafter.Results:31 patients wer

12、e enrolled inthe BTC cohort(ECOG PS 1,55%;84%ex-US).As ofADVERTISEMENTBy The ASCO Post et al.,KidneyCancer,2018Lenvatinib Plus Pembrolizumab inPatients With Advanced EndometrialCancerVicky Makker et al.,J Clin Oncol,2020Open-Label,Single-Arm,Phase IIStudy of PembrolizumabMonotherapy as First-Line Th

13、erapy inPatients With Advanced NonClearCell Renal Cell CarcinomaDavid F.McDermott et al.,J ClinOncol,2021351 KEYNOTE-365 cohort D:pembrolizumab plus abirateroneacetate and prednisone in patientswith chemotherapy-naive metastaticcastration-resistant prostate cancer(mCRPC)Josep Piulats et al.,Jitc347

14、KEYNOTE-365 cohort C:pembrolizumab+enzalutamide inpatients with abiraterone acetatepretreated metastatic castration-resistant prostate cancer(mCRPC)data after minimum of 22 months offollow-upLeonard Appleman et al.,Jitc323 ENGOT-en9/LEAP-001:a phase 3study of first-line pembrolizumabplus lenvatinib

15、compared withchemotherapy in advanced orrecurrent endometrial cancerL Randall et al.,International Journalof Gynecologic Cancer,2020April 10,2020,median time from first dose to datacutoff(DCO)was 9.5 months(range,3.111.9),with 16 patients on treatment at DCO.There were3(10%)PRs and 18(58%)SDs.ORR wa

16、s 10%(95%CI,226),and DCR was 68%(95%CI,4983).Median DOR was 5.3 months(range,2.1+to 6.2).Median PFS was 6.1 months(95%CI,2.16.4).Median OS was 8.6 months(95%CI,5.6 to NR).Treatment-related AEs occurred in 30 patients(97%),including 15(48%)who had grade 34 AEs;there were no treatment-related deaths.2

17、(6%)discontinued treatment due to treatment-relatedAEs(myocarditis,pyrexia;n=1 each).The mostfrequent treatment-related AEs were hypertension(42%),dysphonia(39%),diarrhea(32%),fatigue(32%),and nausea(32%).14 patients(45%)hadimmune-mediated AEs and 1 patient(3%)had aninfusion-related reaction.Conclus

18、ions:Lenvatinibplus pembrolizumab demonstrated encouragingefficacy and manageable toxicity in patients withadvanced BTC who had received 1 line of priortherapy.Based on these data,enrollment in the297 Leap-005:evaluating the safetyand efficacy of lenvatinib andpembrolizumab in patientspreviously tre

19、ated for ovariancancer,a multi-cohort phase 2 studyAntonio Gonzalez-Martin et al.,International Journal of GynecologicCancer,2020IDDF2020-ABS-0103 Efficacy andsafety of programmed cell deathprotein 1 inhibitor and theassociated prognostic factors inpatients with hepatitis b virus-related advanced he

20、patocellularcarcinomaLingeng Wu et al.,Gut,2020Powered byBTC cohort has been expanded to 100 patients.Clinical trial information:NCT03797326.2021 American Society of Clinical OncologyResearch Sponsor:Merck Sharp&Dohme Corp.,a subsidiary of Merck&Co.,Inc.,Kenilworth,NJ,USA.QUICK LINKSContentNewest Ar

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