2022
Reinfection and Risk Behaviors After Treatment of Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy : A Cohort Study.
Grebely J, Dore GJ, Altice FL, Conway B, Litwin AH, Norton BL, Dalgard O, Gane EJ, Shibolet O, Nahass R, Luetkemeyer AF, Peng CY, Iser D, Gendrano IN, Kelly MM, Hwang P, Asante-Appiah E, Haber BA, Barr E, Robertson MN, Platt H. Reinfection and Risk Behaviors After Treatment of Hepatitis C Virus Infection in Persons Receiving Opioid Agonist Therapy : A Cohort Study. Annals Of Internal Medicine 2022, 175: 1221-1229. PMID: 35939812, DOI: 10.7326/m21-4119.Peer-Reviewed Original ResearchConceptsOpioid agonist therapyLong-term extension studyHCV reinfectionDrug useExtension studyAgonist therapySuccessful treatmentHepatitis C virus (HCV) reinfectionHepatitis C virus infectionBenefits of cureC virus infectionChronic HCV infectionRate of reinfectionUrine drug screeningOngoing drug useClinical trial sitesSubsidiary of MerckHCV infectionCohort studyVirus reinfectionDohme Corp.Treatment completionGenotype 1Virus infectionHigh risk
2021
457 KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC)
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Finocchiaro G, Ahn M, Luft A, Landers G, Basso A, Ma H, Kobie J, Palcza J, Cristescu R, Fong L, Snyder A, Yuan J, Herbst R. 457 KEYNOTE-495/KeyImPaCT: interim analysis of a randomized, biomarker-directed, phase 2 trial of pembrolizumab-based combination therapy for non–small cell lung cancer (NSCLC). Journal For ImmunoTherapy Of Cancer 2021, 9: a485-a485. DOI: 10.1136/jitc-2021-sitc2021.457.Peer-Reviewed Original ResearchTreatment-related adverse eventsNon-small cell lung cancerAdvanced non-small cell lung cancerCombination therapyInterim analysisBiomarker subgroupsMost treatment-related adverse eventsT-cell-inflamed gene expression profileHigh subgroupBiomarker-defined subgroupsPrimary end pointPhase 2 studyPhase 2 trialFirst-line pembrolizumabCell lung cancerFirst interim analysisSubsidiary of MerckInstitutional review boardRECIST v1.1Data cutoffAdverse eventsDohme Corp.Lung cancerMature dataStudy protocol
2019
LBA4 Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in Keynote-042
Herbst R, Lopes G, Kowalski D, Kasahara K, Wu Y, De Castro G, Cho B, Turna H, Cristescu R, Aurora-Garg D, Lunceford J, Kobie J, Ayers M, Pietanza M, Piperdi B, Mok T. LBA4 Association of KRAS mutational status with response to pembrolizumab monotherapy given as first-line therapy for PD-L1-positive advanced non-squamous NSCLC in Keynote-042. Annals Of Oncology 2019, 30: xi63-xi64. DOI: 10.1093/annonc/mdz453.001.Peer-Reviewed Original ResearchTumor mutational burdenNon-squamous NSCLCKRAS mutational statusAdvanced non-squamous NSCLCFirst-line therapyWhole-exome sequencingKRAS mutationsPembrolizumab monotherapyPD-L1Mutational statusSubsidiary of MerckBoehringer IngelheimMerck SharpBristol-Myers SquibbDohme Corp.Merck SeronoStandard first-line treatment optionFirst-line treatment optionEli LillyAdvanced PD-L1Genentech/RocheNon-squamous histologyPD-L1 TPSPD-L1 expressionFirst-line treatment1115PD Analysis of efficacy outcomes based on programmed death ligand 1 (PD-L1) scoring techniques in patients with head and neck squamous cell carcinoma (HNSCC) from KEYNOTE-040
Cohen E, Harrington K, Soulières D, Le Tourneau C, Licitra L, Burtness B, Bal T, Juco J, Aurora-Garg D, Huang L, Swaby R, Emancipator K. 1115PD Analysis of efficacy outcomes based on programmed death ligand 1 (PD-L1) scoring techniques in patients with head and neck squamous cell carcinoma (HNSCC) from KEYNOTE-040. Annals Of Oncology 2019, 30: v452-v453. DOI: 10.1093/annonc/mdz252.007.Peer-Reviewed Original ResearchTumor proportion scoreSecond-line treatmentSubsidiary of MerckMerck SeronoPD-L1Dohme Corp.Boehringer IngelheimTrial conductEfficacy outcomesMerck SharpEfficacy resultsDeath ligand 1 (PD-L1) expressionNeck squamous cell carcinomaGenentech/RocheObjective response rateSecond-line therapyLigand 1 expressionPD-L1 expressionPD-L1 statusProgression-free survivalSquamous cell carcinomaStandard of careSimilar survival resultsExpression levelsEuropean Medicines Agency1589TiP KEYNOTE-495/KeyImPaCT: A randomized, biomarker-directed, phase II trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC)
Gutierrez M, Lam W, Hellmann M, Gubens M, Aggarwal C, Tan D, Felip E, Chiu J, Lee J, Yang J, Garon E, Basso A, Ma H, Fong L, Snyder A, Yuan J, Herbst R. 1589TiP KEYNOTE-495/KeyImPaCT: A randomized, biomarker-directed, phase II trial of pembrolizumab-based therapy for non–small cell lung cancer (NSCLC). Annals Of Oncology 2019, 30: v656. DOI: 10.1093/annonc/mdz260.111.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced non-small cell lung cancerPhase II trialSubsidiary of MerckDohme Corp.Boehringer IngelheimRECIST v1.1II trialMerck SharpEli LillyInvestigator-assessed objective response rateRoche/GenentechEnd pointECOG PS 0Genentech/RochePembrolizumab-based therapyObjective response ratePrimary end pointSecondary end pointsProgression-free survivalROS1 gene rearrangementTumor mutation burdenCell lung cancerAbsence of EGFRYears of age891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC)
Petrylak D, Li B, Schloss C, Fizazi K. 891TiP KEYNOTE-921: Phase III study of pembrolizumab (pembro) plus docetaxel and prednisone for enzalutamide (enza)- or abiraterone (abi)-pretreated patients (pts) with metastatic castration-resistant prostate cancer (mCRPC). Annals Of Oncology 2019, 30: v351. DOI: 10.1093/annonc/mdz248.048.Peer-Reviewed Original ResearchMetastatic castration-resistant prostate cancerPrednisone/prednisoloneAndrogen deprivation therapySubsidiary of MerckDohme Corp.Merck SharpKey secondary efficacy end pointsRadiographic progression-free survivalRandomized phase 3 trialSecondary efficacy end pointsCastration-resistant prostate cancerAdequate organ functionECOG PS 0/1Subsequent anticancer therapyEfficacy end pointPhase 3 trialProgression-free survivalRadiographic disease progressionCT/MRIBristol-Myers SquibbAdult ptsDeprivation therapyPS 0/1RECIST v1.1Unacceptable toxicity1375TiP Pembrolizumab (pembro) plus lenvatinib (len) for first-line treatment of patients (pts) with advanced melanoma: Phase III LEAP-003 study
Eggermont A, Carlino M, Hauschild A, Ascierto P, Arance A, Daud A, O’Day S, Taylor M, Smith A, Rodgers A, Moreno B, Diede S, Kluger H. 1375TiP Pembrolizumab (pembro) plus lenvatinib (len) for first-line treatment of patients (pts) with advanced melanoma: Phase III LEAP-003 study. Annals Of Oncology 2019, 30: v561. DOI: 10.1093/annonc/mdz255.063.Peer-Reviewed Original ResearchBlinded independent central reviewPD-1 inhibitorsAdvanced melanomaSanofi GenzymeSubsidiary of MerckArray BioPharmaDohme Corp.Pierre FabreRoche-GenentechEnd pointMerck SharpBaseline tumor samplesNCI CTCAE v4.0Performance status 0/1Antitumor activityPrimary end pointSecondary end pointsFirst-line standardFirst-line treatmentUntreated stage IIIIndependent central reviewMurine tumor modelsPDGF receptor αEligible ptsQd poLBA21 KEYNOTE-119: Phase III study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple negative breast cancer (mTNBC)
Cortés J, Lipatov O, Im S, Gonçalves A, Lee K, Schmid P, Tamura K, Testa L, Witzel I, Ohtani S, Zambelli S, Harbeck N, André F, Dent R, Zhou X, Karantza V, Mejia J, Winer E. LBA21 KEYNOTE-119: Phase III study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple negative breast cancer (mTNBC). Annals Of Oncology 2019, 30: v859-v860. DOI: 10.1093/annonc/mdz394.010.Peer-Reviewed Original ResearchMetastatic triple-negative breast cancerCombined positive scoreSubsidiary of MerckGerman Study GroupDohme Corp.Merck SharpSeattle GeneticsGrade 3Study groupOpen-label phase III studyPD-L1 combined positive scoreEnd pointTriple-negative breast cancerDaiichi SankyoF. Hoffman-La RochePrior systemic treatmentPrimary end pointSecondary end pointsSingle-agent chemotherapyPhase III studyHigh-grade toxicityNegative breast cancerPD-L1 enrichmentTreatment effectsBristol-Myers Squibb608P Pembrolizumab (pembro) plus mFOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC): KEYNOTE-651 cohorts B and D
Kim R, Chaves J, Kavan P, Fakih M, Kortmansky J, Spencer K, Wong L, Tehfe M, Li J, Lee M, Mayo C, Marinello P, Chiorean E. 608P Pembrolizumab (pembro) plus mFOLFOX or FOLFIRI in patients with metastatic colorectal cancer (mCRC): KEYNOTE-651 cohorts B and D. Annals Of Oncology 2019, 30: v229-v230. DOI: 10.1093/annonc/mdz246.085.Peer-Reviewed Original ResearchMetastatic colorectal cancerTreatment-related AEsSubsidiary of MerckCohort BCohort DDohme Corp.Merck SharpEastern Cooperative Oncology Group performance status 0/1Stage IV metastatic colorectal cancerArray BioPharmaOxaliplatin-based regimenPerformance status 0/1Phase 2 dosePrior systemic chemotherapySafety/tolerabilityObjective response ratePD-1 inhibitorsDose-limiting toxicitySmall intestinal obstructionData cutoffImmunotherapy agentsSystemic chemotherapyMethods PatientsColorectal cancerEMD SeronoLBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC)
Schmid P, Cortés J, Dent R, Pusztai L, McArthur H, Kuemmel S, Bergh J, Denkert C, Park Y, Hui R, Harbeck N, Takahashi M, Foukakis T, Fasching P, Cardoso F, Jia L, Karantza V, Zhao J, Aktan G, O’Shaughnessy J. LBA8_PR KEYNOTE-522: Phase III study of pembrolizumab (pembro) + chemotherapy (chemo) vs placebo (pbo) + chemo as neoadjuvant treatment, followed by pembro vs pbo as adjuvant treatment for early triple-negative breast cancer (TNBC). Annals Of Oncology 2019, 30: v853-v854. DOI: 10.1093/annonc/mdz394.003.Peer-Reviewed Original ResearchEarly triple-negative breast cancerTriple-negative breast cancerEvent-free survivalSubsidiary of MerckGerman Study GroupBristol-Myers SquibbPD-L1Dohme Corp.Daiichi SankyoSeattle GeneticsChemo groupYpT0 ypN0Merck SharpGenomic HealthStudy groupFavorable trendF. Hoffmann-La Roche LtdCycles of paclitaxelDual primary endpointsI-SPY 2Cycles of doxorubicinPhase III studyWolters Kluwer HealthEli LillyKyowa Hakko Kirin1482O Outcomes with pembrolizumab (pembro) monotherapy in patients (pts) with PD-L1–positive NSCLC with brain metastases: Pooled analysis of KEYNOTE-001, -010, -024, and -042
Mansfield A, Herbst R, Castro G, Hui R, Peled N, Kim D, Novello S, Satouchi M, Wu Y, Garon E, Reck M, Robinson A, Samkari A, Piperdi B, Ebiana V, Lin J, Mok T. 1482O Outcomes with pembrolizumab (pembro) monotherapy in patients (pts) with PD-L1–positive NSCLC with brain metastases: Pooled analysis of KEYNOTE-001, -010, -024, and -042. Annals Of Oncology 2019, 30: v604-v606. DOI: 10.1093/annonc/mdz260.004.Peer-Reviewed Original ResearchStable brain metastasesSubsidiary of MerckGenentech/RocheBrain metastasesDohme Corp.PD-L1Personal feesMerck SeronoPositive NSCLCEMD SeronoBoehringer IngelheimMerck SharpKEYNOTE-001Clovis OncologyData cutoffAdvisory board membersEli LillyRoche/GenentechMesothelioma Applied Research FoundationSeattle GeneticsVertex PharmaceuticalsAdvanced PD-L1Baseline brain metastasesBrain metastasis statusTreatment-related AEsLBA79 Association between tissue TMB (tTMB) and clinical outcomes with pembrolizumab monotherapy (pembro) in PD-L1-positive advanced NSCLC in the KEYNOTE-010 and -042 trials
Herbst R, Lopes G, Kowalski D, Nishio M, Wu Y, de Castro G, Baas P, Kim D, Gubens M, Cristescu R, Aurora-Garg D, Albright A, Ayers M, Loboda A, Lunceford J, Kobie J, Lubiniecki G, Pietanza M, Piperdi B, Mok T. LBA79 Association between tissue TMB (tTMB) and clinical outcomes with pembrolizumab monotherapy (pembro) in PD-L1-positive advanced NSCLC in the KEYNOTE-010 and -042 trials. Annals Of Oncology 2019, 30: v916-v917. DOI: 10.1093/annonc/mdz394.077.Peer-Reviewed Original ResearchBristol-Myers SquibbTissue TMBGenentech/RocheSubsidiary of MerckDohme Corp.KEYNOTE-010KEYNOTE-042PD-L1Merck SeronoBoehringer IngelheimMerck SharpAdvanced NSCLCClinical outcomesEli LillyOno PharmaceuticalCox proportional hazards modelPositive advanced NSCLCResults Baseline characteristicsSubset of ptsOpen-label trialTotal study populationProportional hazards modelRoche/GenentechMultiple tumor typesWhole-exome sequencing919P Three-year follow-up from the phase III KEYNOTE-045 trial: Pembrolizumab (Pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC)
Necchi A, Fradet Y, Bellmunt J, de Wit R, Lee J, Fong L, Vozelgang N, Climent M, Petrylak D, Choueiri T, Gerritsen W, Gurney H, Quinn D, Culine S, Sternberg C, Nam K, Frenkl T, Godwin J, Bajorin D, Vaughn D. 919P Three-year follow-up from the phase III KEYNOTE-045 trial: Pembrolizumab (Pembro) versus investigator’s choice (paclitaxel, docetaxel, or vinflunine) in recurrent, advanced urothelial cancer (UC). Annals Of Oncology 2019, 30: v366-v367. DOI: 10.1093/annonc/mdz249.018.Peer-Reviewed Original ResearchGenentech/RocheDuration of responseCaris Life SciencesBristol-Myers SquibbMetastatic urothelial cancerSubsidiary of MerckUrothelial cancerDohme Corp.US OncologyMerck SharpAdverse eventsRoche LaboratoriesJanssen-CilagInvestigator's choiceKey secondary end pointMedian DORTreatment-related adverse eventsSeattle GeneticsAdvanced urothelial cancerECOG PS 0Kidney Cancer AssociationPlatinum-containing regimenSecondary end pointsAstellas PharmaCancer Study Group
2018
Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study
Cohen EEW, Soulières D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ, investigators K, Acosta-Rivera M, Adkins D, Aghmesheh M, Ahn M, Airoldi M, Aleknavicius E, Al-Farhat Y, Algazi A, Almokadem S, Alyasova A, Bauman J, Benasso M, Berrocal A, Bray V, Burtness B, Caponigro F, Castro A, Cescon T, Chan K, Chaudhry A, Chauffert B, Cohen E, Csoszi T, De Boer J, Delord J, Dietz A, Dinis J, Dupuis C, Digue L, Erfan J, Alvarez Y, Evans M, Fidler M, Forster M, Friesland S, Ganti A, Geoffrois L, Grant C, Gruenwald V, Harrington K, Hoffmann T, Horvai G, Inciura A, Jang R, Jankowska P, Jimeno A, Joseph M, Ramiro A, Karaszewska B, Kawecki A, Keilholz U, Keller U, Kim S, Kocsis J, Kotecki N, Kozloff M, Lambea J, Landherr L, Lantsukhay Y, Lazarev S, Lee L, Le Tourneau C, Licitra L, Lifirenko I, Mach N, Martincic D, Matorin O, McGrath M, Machiels J, Mehra R, Misiukiewicz K, Morris J, Mufazalov F, Niu J, Srinivasan D, Segura P, Rauch D, Ribeiro M, Rodriguez C, Rolland F, Russo A, Ruzsa A, Sanches F, Shin S, Shtiveland M, Soulieres D, Soria A, Specenier P, Szekanecz E, Szota J, van Herpen C, Velez-Cortes H, Walsh W, Wilop S, Winterhalder R, Wojtukiewicz M, Wong D, Zandberg D. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. The Lancet 2018, 393: 156-167. PMID: 30509740, DOI: 10.1016/s0140-6736(18)31999-8.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDisease ProgressionDocetaxelDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansKaplan-Meier EstimateMaleMethotrexateMiddle AgedNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckConceptsNeck squamous cell carcinomaSquamous cell carcinomaStandard of careTreatment-related adverse eventsCell carcinomaMetastatic headOverall survivalTreat populationAdverse eventsCommon treatment-related adverse eventsWorse treatment-related adverse eventsPlatinum-containing treatmentTreatment-related deathsMedian overall survivalWeb response systemEffective treatment optionFavorable safety profileEarly phase trialsTreatment of headSubsidiary of MerckManageable toxicityMeaningful prolongationAdvanced diseasePrimary endpointMetastatic disease
2014
LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc)
Chow L, Burtness B, Weiss J, Berger R, Eder J, Gonzalez E, Pulini J, Johnson J, Dolled-Filhart M, Emancipator K, Lunceford J, Pathiraja K, Gause C, Cheng J, Seiwert T. LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc). Annals Of Oncology 2014, 25: v1. DOI: 10.1093/annonc/mdu438.32.Peer-Reviewed Original ResearchOverall response ratePD-L1 expressionDrug-related adverse eventsAdverse eventsRECIST v1.1Subsidiary of MerckBristol-Myers SquibbInvestigator reviewAntitumor activityCommon drug-related adverse eventsAdvisory board membershipHigh PD-L1 expressionBoehringer IngelheimMerck SharpGenentech/RochePhase Ib studyPrimary end pointDrug-related deathsMeasurable diseaseMedian OSMedian PFSMetastatic HNCAdvanced HNCUnacceptable toxicityComplete response
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