2025
Lenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous NSCLC: Phase 3 LEAP-006 Study
Herbst R, Cho B, Zhou C, Burotto M, Dols M, Sendur M, Moiseyenko V, Casarini I, Nishio M, Hui R, Pons-Tostivint E, Dudnik J, Ahmed S, Okpara C, Dutcus C, Yin L, Luo Y, Chirovsky D, Bhagwati N, Abreu D. Lenvatinib Plus Pembrolizumab, Pemetrexed, and a Platinum as First-Line Therapy for Metastatic Nonsquamous NSCLC: Phase 3 LEAP-006 Study. Journal Of Thoracic Oncology 2025, 20: 1302-1314. PMID: 40419140, DOI: 10.1016/j.jtho.2025.05.016.Peer-Reviewed Original ResearchNonsquamous non-small-cell lung cancerProgression-free survivalMetastatic nonsquamous non-small-cell lung cancerNonsquamous NSCLCNon-small-cell lung cancerFirst-line pembrolizumabOverall survivalTargetable genetic alterationsPlacebo armGenetic alterationsLung cancerTreatment-related adverse eventsFirst-line therapyMedian Follow-UpDouble-blind studyPrimary endpointPembrolizumabLenvatinibAdverse eventsChemotherapyFollow-upDisease progressionSafety signalsPemetrexedMonths
2024
Real-World Study of Systemic Treatment after First-Line Atezolizumab plus Bevacizumab for Hepatocellular Carcinoma in Asia-Pacific Countries
Lee C, Yoo C, Hong J, Park J, Kim J, Tai D, Kim H, Korphaisarn K, Tanasanvimon S, Chen S, Kim J, Kim I, Kim M, Choo J, Oh S, Chen C, Bae W, Kim H, Huh S, Yen C, Park S, Lee D, Chan L, Kang B, Kang M, Sundar R, Choi H, Chan S, Chon H, Lee M. Real-World Study of Systemic Treatment after First-Line Atezolizumab plus Bevacizumab for Hepatocellular Carcinoma in Asia-Pacific Countries. Liver Cancer 2024, 14: 127-141. PMID: 40255875, PMCID: PMC12005689, DOI: 10.1159/000540969.Peer-Reviewed Original ResearchFirst-line atezolizumabProgression-free survivalImmune checkpoint inhibitorsTyrosine kinase inhibitorsSecond-line regimensOverall survivalHepatocellular carcinomaSecond-line progression-free survivalSecond-line tyrosine kinase inhibitorsPatients treated with tyrosine kinase inhibitorsAssociated with improved OSImmune checkpoint inhibitor combinationsImmune checkpoint inhibitor useMedian progression-free survivalLow tumor burdenAdvanced hepatocellular carcinomaFirst-line regimenReal-world studyCheckpoint inhibitorsTumor burdenSystemic treatmentAtezolizumabBevacizumabRetrospective studyLenvatinib
2023
Pembrolizumab and lenvatinib in recurrent ovarian clear cell carcinoma resistant to chemotherapy
McNamara B, Bellone S, Demirkiran C, Hartwich T, Santin A. Pembrolizumab and lenvatinib in recurrent ovarian clear cell carcinoma resistant to chemotherapy. Gynecologic Oncology Reports 2023, 48: 101218. PMID: 37325296, PMCID: PMC10265468, DOI: 10.1016/j.gore.2023.101218.Peer-Reviewed Original ResearchOvarian clear cell carcinomaClear cell carcinomaCombination of pembrolizumabCell carcinomaTreatment optionsRecurrent ovarian clear cell carcinomaWeeks of therapyCT scan findingsMild side effectsEffective treatment optionOral multikinase inhibitorNew treatment optionsDurable responsesMetastatic diseaseScan findingsPD-1Disease burdenTarget lesionsMultikinase inhibitorDrug combinationsSide effectsPembrolizumabLenvatinibMonoclonal antibodiesCarcinomaLenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775
Makker V, Colombo N, Herráez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Baron-Hay S, Ray-Coquard I, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Bird S, Orlowski R, McKenzie J, Okpara C, Barresi G, Lorusso D. Lenvatinib Plus Pembrolizumab in Previously Treated Advanced Endometrial Cancer: Updated Efficacy and Safety From the Randomized Phase III Study 309/KEYNOTE-775. Journal Of Clinical Oncology 2023, 41: 2904-2910. PMID: 37058687, PMCID: PMC10414727, DOI: 10.1200/jco.22.02152.Peer-Reviewed Original ResearchConceptsObjective response rateProgression-free survivalPrimary end pointAdvanced endometrial cancerOverall survivalEndometrial cancerEnd pointMismatch repair-proficient tumorsClinical trial updateMetastatic endometrial cancerNew safety signalsSubgroups of interestManageable safetyPrespecified analysisTrial updateProficient tumorsClinical trialsSafety signalsPembrolizumabLenvatinibPhysician's choiceMultiple end pointsResponse rateSecondary analysisChemotherapyLenvatinib or anti-VEGF in combination with anti-PD-1 differentially augments anti-tumor activity in melanoma
Tran T, Caulfield J, Zhang L, Schoenfeld D, Djureinovic D, Chiang V, Oria V, Weiss S, Olino K, Jilaveanu L, Kluger H. Lenvatinib or anti-VEGF in combination with anti-PD-1 differentially augments anti-tumor activity in melanoma. JCI Insight 2023, 8: e157347. PMID: 36821392, PMCID: PMC10132152, DOI: 10.1172/jci.insight.157347.Peer-Reviewed Original ResearchConceptsTumor microenvironmentAnti-VEGFCytokine/chemokine signalingCytokine/chemokine profilingBlood-brain barrier modelBlood vesselsLeukocyte transmigrationTumor-associated blood vesselsTumor-associated macrophagesIntratumoral blood vesselsAnti-angiogenesis effectAnti-tumor activityExtracranial diseasePlasmacytoid DCsImmune checkpointsPD-1Melanoma murine modelImmune infiltrationBBB modelChemokine profilingEndothelial stabilizationMurine modelLenvatinibCombined targetingMelanoma model
2022
O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775
Makker V, Colombo N, Herráez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Xie R, Zale M, Mckenzie J, Barresi G, Lorusso D. O018/#482 Updated safety of lenvatinib + pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer: study 309/keynote-775. International Journal Of Gynecological Cancer 2022, 32: a11. DOI: 10.1136/ijgc-2022-igcs.20.Peer-Reviewed Original Research2022-RA-653-ESGO The impact of histology, prior therapy, and dMMR status on lenvatinib + pembrolizumab outcomes in patients with advanced endometrial cancer: A subgroup analysis of Study 309/KEYNOTE-775
Lorusso D, Makker V, Herraez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Huang J, McKenzie J, Barresi G, Colombo N. 2022-RA-653-ESGO The impact of histology, prior therapy, and dMMR status on lenvatinib + pembrolizumab outcomes in patients with advanced endometrial cancer: A subgroup analysis of Study 309/KEYNOTE-775. International Journal Of Gynecological Cancer 2022, 32: a102. DOI: 10.1136/ijgc-2022-esgo.223.Peer-Reviewed Original Research525MO Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775
Makker V, Colombo N, Herraez A, Monk B, Mackay H, Santin A, Miller D, Moore R, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Yonemori K, Kim Y, Alia E, Sanli U, Huang J, McKenzie J, Barresi G, Lorusso D. 525MO Updated efficacy and safety of lenvatinib (LEN) + pembrolizumab (pembro) vs treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Study 309/KEYNOTE-775. Annals Of Oncology 2022, 33: s785-s786. DOI: 10.1016/j.annonc.2022.07.653.Peer-Reviewed Original ResearchEfficacy of next line of therapy after treatment with lenvatinib (LEN) in combination with pembrolizumab (pembro) versus treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Exploratory analysis of Study 309/KEYNOTE-775.
Makker V, Colombo N, Santin A, Miller D, Fujiwara K, Pignata S, Ray-Coquard I, Kim Y, Guerra E, Huang J, Barresi G, McKenzie J, Lorusso D. Efficacy of next line of therapy after treatment with lenvatinib (LEN) in combination with pembrolizumab (pembro) versus treatment of physician’s choice (TPC) in patients (pts) with advanced endometrial cancer (aEC): Exploratory analysis of Study 309/KEYNOTE-775. Journal Of Clinical Oncology 2022, 40: 5587-5587. DOI: 10.1200/jco.2022.40.16_suppl.5587.Peer-Reviewed Original ResearchAdvanced endometrial cancerComers populationTPC armEastern Cooperative Oncology Group performance statusPrior platinum-based chemotherapy regimenPlatinum-based chemotherapy regimenObjective response rateOverall survival benefitPrespecified exploratory analysisSystemic anticancer therapyPlatinum-based treatmentMedian PFS2PMMR tumorsChemotherapy regimenPelvic radiationData cutoffPerformance statusEndometrial cancerInvestigator assessmentSurvival benefitStudy treatmentMMR statusLenvatinibPembroPhysician's choice20MO Time to deterioration in quality of life in patients (pts) with advanced endometrial cancer (aEC) treated with lenvatinib plus pembrolizumab (L+P) or treatment of physician’s choice (TPC)
Lorusso D, Colombo N, Herraez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Kim Y, McCormack M, Massaad R, Nguyen A, Zhao Q, McKenzie J, Prabhu V, Makker V. 20MO Time to deterioration in quality of life in patients (pts) with advanced endometrial cancer (aEC) treated with lenvatinib plus pembrolizumab (L+P) or treatment of physician’s choice (TPC). Annals Of Oncology 2022, 33: s391-s392. DOI: 10.1016/j.annonc.2022.04.038.Peer-Reviewed Original ResearchLenvatinib Plus Pembrolizumab for Advanced Endometrial Cancer
Makker V, Colombo N, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim Y, Guerra E, Sanli U, McCormack M, Smith A, Keefe S, Bird S, Dutta L, Orlowski R, Lorusso D. Lenvatinib Plus Pembrolizumab for Advanced Endometrial Cancer. Obstetrical & Gynecological Survey 2022, 77: 275-276. DOI: 10.1097/ogx.0000000000001032.Peer-Reviewed Original ResearchEndometrial cancerRecurrent endometrial cancerSecond-line treatmentAdvanced endometrial cancerPlatinum-based chemotherapyRecurrent endometrial carcinomaTyrosine kinase inhibitorsEndometrial carcinomaOptimal treatmentDisease progressionLimited efficacySingle agentKinase inhibitorsLenvatinibCancerTreatmentPembrolizumabLittle consensusChemotherapyCarcinomaProgressionLenvatinib plus Pembrolizumab for Advanced Endometrial Cancer
Makker V, Colombo N, Casado Herráez A, Santin AD, Colomba E, Miller DS, Fujiwara K, Pignata S, Baron-Hay S, Ray-Coquard I, Shapira-Frommer R, Ushijima K, Sakata J, Yonemori K, Kim YM, Guerra EM, Sanli UA, McCormack MM, Smith AD, Keefe S, Bird S, Dutta L, Orlowski RJ, Lorusso D. Lenvatinib plus Pembrolizumab for Advanced Endometrial Cancer. New England Journal Of Medicine 2022, 386: 437-448. PMID: 35045221, PMCID: PMC11651366, DOI: 10.1056/nejmoa2108330.Peer-Reviewed Original ResearchConceptsAdvanced endometrial cancerProgression-free survivalEndometrial cancerOverall survivalMedian progression-free survivalPlatinum-based chemotherapy regimenLonger progression-free survivalEnd pointBlinded independent central reviewMedian overall survivalPrimary end pointPhase 3 trialResponse Evaluation CriteriaPlatinum-based chemotherapyIndependent central reviewChemotherapy regimenAdverse eventsStandard therapyCentral reviewPembrolizumabGrade 3LenvatinibChemotherapyPhysician's choicePatients
2021
145 Characterization of adverse reactions in patients with advanced endometrial cancer (aec) receiving lenvatinib + pembrolizumab (Study 309/KEYNOTE-775)
Colombo N, Lorusso D, Santin A, Kim Y, Herráez A, Yonemori K, Fujiwara K, Colomba E, Miller D, Pignata S, Monk B, Guerra E, Kristeleit R, Orlando M, Sanli U, Dutta L, Orlowski R, Ren M, Makker V. 145 Characterization of adverse reactions in patients with advanced endometrial cancer (aec) receiving lenvatinib + pembrolizumab (Study 309/KEYNOTE-775). International Journal Of Gynecological Cancer 2021, 31: a78-a78. DOI: 10.1136/ijgc-2021-esgo.120.Peer-Reviewed Original ResearchPalmar-plantar erythrodysesthesiaLenvatinib dose reductionAdverse reactionsMusculoskeletal painDose reductionPrior platinum-based therapyAEC patientsTarget lesion diametersCommon adverse reactionsAdvanced endometrial cancerManagement of patientsPlatinum-based therapyQd poEndometrial cancerTreatment initiationMedian timeEndometrial carcinomaHypertensionLenvatinibPrompt identificationPhysician's choiceDiarrheaPatientsFirst onsetMeaningful improvements726MO Outcomes by histology and prior therapy with lenvatinib plus pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer (Study 309/KEYNOTE-775)
Colombo N, Lorusso D, Herráez A, Santin A, Colomba E, Miller D, Fujiwara K, Pignata S, Floquet A, Monk B, Banerjee S, Penson R, Kristeleit R, Fabbro M, Orlando M, Mackay H, Jensen E, Dutta L, Orlowski R, Makker V. 726MO Outcomes by histology and prior therapy with lenvatinib plus pembrolizumab vs treatment of physician’s choice in patients with advanced endometrial cancer (Study 309/KEYNOTE-775). Annals Of Oncology 2021, 32: s729-s730. DOI: 10.1016/j.annonc.2021.08.1169.Peer-Reviewed Original ResearchP-88 First-Line Pembrolizumab With or Without Lenvatinib in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC): Phase 3 LEAP-010 Study
Harrington K, Siu L, Burtness B, Cohen E, Licitra L, Rischin D, Zhu Y, Okpara C, Pinheiro C, Swaby R, Machiels J, Tahara M. P-88 First-Line Pembrolizumab With or Without Lenvatinib in Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC): Phase 3 LEAP-010 Study. Oral Oncology 2021, 118: 7-8. DOI: 10.1016/s1368-8375(21)00375-4.Peer-Reviewed Original ResearchP-94 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009
Harrington K, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, Hawk N, Ge J, Bidadi B, Swaby R, Burtness B. P-94 Pembrolizumab plus lenvatinib vs chemotherapy and lenvatinib monotherapy for recurrent/metastatic head and neck squamous cell carcinoma that progressed on platinum therapy and immunotherapy: LEAP-009. Oral Oncology 2021, 118: 10-11. DOI: 10.1016/s1368-8375(21)00381-x.Peer-Reviewed Original Research
2020
LEAP-010: Phase III study of first-line pembrolizumab with or without lenvatinib in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Siu L, Burtness B, Cohen E, Harrington K, Licitra L, Rischin D, Zhu Y, Okpara C, Pinheiro C, Swaby R, Machiels J, Tahara M. LEAP-010: Phase III study of first-line pembrolizumab with or without lenvatinib in patients (pts) with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2020, 31: s683-s684. DOI: 10.1016/j.annonc.2020.08.1088.Peer-Reviewed Original ResearchLEAP-012 trial in progress: Pembrolizumab plus lenvatinib and transarterial chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma (HCC) not amenable to curative treatment
Llovet J, El-Khoueiry A, Vogel A, Madoff D, Finn R, Ogasawara S, Ren Z, Mody K, Li J, Siegel A, Dubrovsky L, Kudo M. LEAP-012 trial in progress: Pembrolizumab plus lenvatinib and transarterial chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma (HCC) not amenable to curative treatment. Annals Of Oncology 2020, 31: s702-s703. DOI: 10.1016/j.annonc.2020.08.1132.Peer-Reviewed Original ResearchP-107 LEAP-012: A randomized, double-blind, phase 3 study of pembrolizumab plus lenvatinib in combination with transarterial chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma not amenable to curative treatment
Ogasawara S, Llovet J, El-Khoueiry A, Vogel A, Madoff D, Finn R, Ren Z, Modi K, Li J, Siegel A, Dubrovsky L, Kudo M. P-107 LEAP-012: A randomized, double-blind, phase 3 study of pembrolizumab plus lenvatinib in combination with transarterial chemoembolization (TACE) in patients with intermediate-stage hepatocellular carcinoma not amenable to curative treatment. Annals Of Oncology 2020, 31: s124-s125. DOI: 10.1016/j.annonc.2020.04.189.Peer-Reviewed Original Research
2018
Number needed to treat in indirect treatment comparison
Guyot P, Cheng W, Tremblay G, Copher R, Burnett H, Li X, Makin C. Number needed to treat in indirect treatment comparison. Journal Of Comparative Effectiveness Research 2018, 7: 259-269. PMID: 29537878, DOI: 10.2217/cer-2017-0023.Peer-Reviewed Original ResearchConceptsRR-DTC patientsIndirect treatment comparisonIndirect comparisonRadioiodine-refractory differentiated thyroid cancer patientsDifferentiated thyroid cancer patientsTreatment comparisonsThyroid cancer patientsCancer patientsDichotomous outcomesLenvatinibPatientsSorafenibTreatment effectsNNTSummary measures
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