2024
649 A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer
Chung C, Dimitrios Colevas A, Adkins D, Rodriguez C, Park J, Gibson M, Sukari A, Worden F, Johnson F, Saba N, Burtness B, Julian R, Bauman J, Jotte R, Seiwert T, Dunn L, Chaney M, Agensky L, Goel A, Levisetti M, Margossian S, Quayle S, Pai S. 649 A phase 1 dose-escalation and expansion study of CUE-101 as monotherapy and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer. 2024, a745-a745. DOI: 10.1136/jitc-2024-sitc2024.0649.Peer-Reviewed Original Research907P Biomarker analysis of the phase III KEYNOTE-040 study of pembrolizumab (pembro) versus methotrexate, docetaxel, or cetuximab (SOC) for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Soulieres D, Le Tourneau C, Machiels J, Burtness B, Harrington K, Shen J, Tao J, Webber A, Vajdi A, Loboda A, Lerman N, Gumuscu B, Licitra L. 907P Biomarker analysis of the phase III KEYNOTE-040 study of pembrolizumab (pembro) versus methotrexate, docetaxel, or cetuximab (SOC) for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2024, 35: s639-s640. DOI: 10.1016/j.annonc.2024.08.968.Peer-Reviewed Original ResearchSafety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients
Brahmer J, Long G, Hamid O, Garon E, Herbst R, Andre T, Armand P, Bajorin D, Bellmunt J, Burtness B, Choueiri T, Cohen E, Diaz L, Shitara K, Kulkarni G, McDermott D, Shah M, Tabernero J, Vogel A, Zinzani P, Jafari N, Bird S, Snyder E, Gause C, Bracco O, Pietanza M, Gruber T, Ribas A. Safety profile of pembrolizumab monotherapy based on an aggregate safety evaluation of 8937 patients. European Journal Of Cancer 2024, 199: 113530. PMID: 38295556, PMCID: PMC11227881, DOI: 10.1016/j.ejca.2024.113530.Peer-Reviewed Original ResearchConceptsImmune-mediated adverse eventsAdverse eventsInfusion reactionsSafety profileClinical trialsPembrolizumab discontinuationPembrolizumab monotherapyNon-small cell lung cancerSafety of pembrolizumabDose of pembrolizumabTreated with prednisoneCell lung cancerLow steroid dosesPopulation of patientsSteroid doseMedian durationPembrolizumabAE onsetPooled analysisLung cancerCancer clinical trialsSafety dataPatientsCancer typesInfusion
2023
Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): Subgroup analysis by pattern of disease recurrence
Harrington K, Cohen E, Soulières D, Dinis J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Swaby R, Lin J, Ge J, Lerman N, Tourneau C. Pembrolizumab versus methotrexate, docetaxel, or cetuximab in recurrent or metastatic head and neck squamous cell carcinoma (KEYNOTE-040): Subgroup analysis by pattern of disease recurrence. Oral Oncology 2023, 147: 106587. PMID: 37925894, DOI: 10.1016/j.oraloncology.2023.106587.Peer-Reviewed Original ResearchConceptsSubgroup analysisRecurrence patternsNeck squamous cell carcinomaDisease recurrence patternsPlatinum-containing treatmentSquamous cell carcinomaLonger OSProlonged OSAdvanced diseaseData cutoffDefinitive therapyMetastatic headDurable responsesHazard ratioDisease recurrenceMetastatic HNSCCTreatment armsCell carcinomaM diseaseInvestigator's choicePatientsPembrolizumabRecurrentOnly subgroupSubgroupsPS3-3 Pembrolizumab + chemoradiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC): KEYNOTE-412
Tahara M, Machiels J, Tao Y, Burtness B, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Swaby R, Zhang Y, Bidadi B, Siu L. PS3-3 Pembrolizumab + chemoradiation therapy for locally advanced head and neck squamous cell carcinoma (HNSCC): KEYNOTE-412. Annals Of Oncology 2023, 34: s1380. DOI: 10.1016/j.annonc.2023.09.109.Peer-Reviewed Original Research
2022
Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study
Harrington KJ, Burtness B, Greil R, Soulières D, Tahara M, de Castro G, Psyrri A, Brana I, Basté N, Neupane P, Bratland Å, Fuereder T, Hughes BGM, Mesia R, Ngamphaiboon N, Rordorf T, Ishak W, Lin J, Gumuscu B, Swaby RF, Rischin D. Pembrolizumab With or Without Chemotherapy in Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Updated Results of the Phase III KEYNOTE-048 Study. Journal Of Clinical Oncology 2022, 41: 790-802. PMID: 36219809, PMCID: PMC9902012, DOI: 10.1200/jco.21.02508.Peer-Reviewed Original ResearchConceptsPD-L1 CPSNeck squamous cell carcinomaSquamous cell carcinomaRecurrent/metastatic headMetastatic headCell carcinomaOverall survivalNext-line therapyObjective response ratePembrolizumab-based therapyProgression-free survivalDeath ligand 1Long-term efficacyKEYNOTE-048Data cutoffSurvival benefitTotal populationMedian studyPembrolizumabResponse rateCarcinomaPositive scoreLigand 1Subsequent treatmentEfficacy658MO Pembrolizumab (pembro) vs standard-of-care (SOC) in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 6-year follow-up of KEYNOTE-040
Soulieres D, Harrington K, Le Tourneau C, Silva J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Lin J, Lerman N, Gumuscu B, Cohen E. 658MO Pembrolizumab (pembro) vs standard-of-care (SOC) in previously treated recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 6-year follow-up of KEYNOTE-040. Annals Of Oncology 2022, 33: s843. DOI: 10.1016/j.annonc.2022.07.782.Peer-Reviewed Original Research659MO Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 5-year results from KEYNOTE-048
Tahara M, Greil R, Rischin D, Harrington K, Burtness B, De Castro G, Psyrri A, Brana I, Neupane P, Bratland Å, Fuereder T, Hughes B, Nin R, Ngamphaiboon N, Rordorf T, Ishak W, Lin J, Gumuscu B, Lerman N, Soulieres D. 659MO Pembrolizumab with or without chemotherapy for first-line treatment of recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): 5-year results from KEYNOTE-048. Annals Of Oncology 2022, 33: s844. DOI: 10.1016/j.annonc.2022.07.783.Peer-Reviewed Original ResearchLBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC)
Machiels J, Tao Y, Burtness B, Tahara M, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Swaby R, Zhang Y, Gumuscu B, Bidadi B, Siu L. LBA5 Primary results of the phase III KEYNOTE-412 study: Pembrolizumab (pembro) with chemoradiation therapy (CRT) vs placebo plus CRT for locally advanced (LA) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2022, 33: s1399. DOI: 10.1016/j.annonc.2022.08.029.Peer-Reviewed Original Research
2021
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
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 ResearchLong-term outcomes from KEYNOTE-048: Pembrolizumab (pembro) alone or with chemotherapy (pembro+C) vs EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Greil R, Rischin D, Harrington K, Soulières D, Tahara M, de Castro G, Psyrri A, Baste N, Neupane P, Bratland Å, Fuereder T, Hughes B, Mesia R, Ngamphaiboon N, Rordorf T, Ishak W, Lin J, Swaby R, Gumuscu B, Burtness B. Long-term outcomes from KEYNOTE-048: Pembrolizumab (pembro) alone or with chemotherapy (pembro+C) vs EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2020, 31: s660-s661. DOI: 10.1016/j.annonc.2020.08.1030.Peer-Reviewed Original ResearchPembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412
Machiels JP, Tao Y, Burtness B, Tahara M, Licitra L, Rischin D, Waldron J, Simon C, Gregoire V, Harrington K, Alves GV, Lima I, Pointreau Y, Hughes B, Aksoy S, Hetnal M, Ge JY, Brown H, Cheng J, Bidadi B, Siu LL. Pembrolizumab given concomitantly with chemoradiation and as maintenance therapy for locally advanced head and neck squamous cell carcinoma: KEYNOTE-412. Future Oncology 2020, 16: 1235-1243. PMID: 32490686, DOI: 10.2217/fon-2020-0184.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaPhase III trialsSquamous cell carcinomaChemoradiation therapyAdvanced headIII trialsCell carcinomaImmune checkpoint inhibitor pembrolizumabLarge phase III trialsCheckpoint inhibitor pembrolizumabUse of pembrolizumabCurrent treatment guidelinesAdvanced HNSCCAdvanced diseaseMaintenance therapyMetastatic HNSCCTreatment guidelinesMaintenance treatmentMultimodal treatmentPembrolizumabPatientsAntitumor activityIB dataChemoradiationHNSCCQuality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040
Harrington KJ, Soulières D, Le Tourneau C, Dinis J, Licitra LF, Ahn MJ, Soria A, Machiels JH, Mach N, Mehra R, Burtness B, Ellison MC, Cheng JD, Chirovsky DR, Swaby RF, Cohen EEW. Quality of Life With Pembrolizumab for Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma: KEYNOTE-040. Journal Of The National Cancer Institute 2020, 113: 171-181. PMID: 32407532, PMCID: PMC7850527, DOI: 10.1093/jnci/djaa063.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDisease-Free SurvivalDocetaxelHumansMaleMiddle AgedNeoplasm MetastasisNeoplasm Recurrence, LocalPatient Reported Outcome MeasuresQuality of LifeSquamous Cell Carcinoma of Head and NeckConceptsGHS/QoL scoresStandard of careNeck squamous cell carcinomaGlobal health statusSquamous cell carcinomaQOL scoresWeek 15KEYNOTE-040Metastatic HNSCCCell carcinomaNeck cancer-specific modulePlatinum-containing regimenHealth-related qualityCancer-specific moduleQuality of lifeHRQoL benefitsHRQoL populationMetastatic headHRQoL analysisMedian timeLife HeadPembrolizumabPatientsHealth statusEuropean Organization
2018
1121TiP KEYNOTE-412: Phase III study of pembrolizumab plus chemoradiation vs chemoradiation alone for locally advanced head and neck squamous cell carcinoma (HNSCC)
Machiels J, Licitra L, Tao Y, Yen C, Rischin D, Waldron J, Burtness B, Gregoire V, Agarwala S, Yorio J, Delord J, Aksoy S, Ikeda S, Hong R, Ge J, Brown H, Bidadi B, Siu L. 1121TiP KEYNOTE-412: Phase III study of pembrolizumab plus chemoradiation vs chemoradiation alone for locally advanced head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2018, 29: viii398. DOI: 10.1093/annonc/mdy287.078.Peer-Reviewed Original Research1047PD Pembrolizumab for recurrent head and neck squamous cell carcinoma (HNSCC): Post hoc analyses of treatment options from the phase III KEYNOTE-040 trial
Le Tourneau C, Cohen E, Harrington K, Dinis J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby R, Soulières D. 1047PD Pembrolizumab for recurrent head and neck squamous cell carcinoma (HNSCC): Post hoc analyses of treatment options from the phase III KEYNOTE-040 trial. Annals Of Oncology 2018, 29: viii373-viii374. DOI: 10.1093/annonc/mdy287.003.Peer-Reviewed Original ResearchLBA8_PR KEYNOTE-048: Phase III study of first-line pembrolizumab (P) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC)
Burtness B, Harrington K, Greil R, Soulières D, Tahara M, De Castro G, Psyrri A, Rotllan N, Neupane P, Bratland Å, Fuereder T, Hughes B, Mesia R, Ngamphaiboon N, Rordorf T, Ishak W, Roy A, Cheng J, Jin F, Rischin D. LBA8_PR KEYNOTE-048: Phase III study of first-line pembrolizumab (P) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Annals Of Oncology 2018, 29: viii729. DOI: 10.1093/annonc/mdy424.045.Peer-Reviewed Original ResearchHealth-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040.
Cohen E, Soulieres D, Le Tourneau C, Dinis J, Licitra L, Ahn M, Soria A, Machiels J, Mach N, Mehra R, Burtness B, Ellison M, Cheng J, Chirovsky D, Swaby R, Harrington K. Health-related quality of life (HRQoL) of pembrolizumab (pembro) vs standard of care (SOC) for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) in KEYNOTE-040. Journal Of Clinical Oncology 2018, 36: 6013-6013. DOI: 10.1200/jco.2018.36.15_suppl.6013.Peer-Reviewed Original Research
2017
1105TiP Pembrolizumab plus chemoradiation (CRT) for the treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC): Phase 3 KEYNOTE-412 trial
Machiels J, Licitra L, Rischin D, Waldron J, Burtness B, Grégoire V, Shekar T, Brown H, Cheng J, Siu L. 1105TiP Pembrolizumab plus chemoradiation (CRT) for the treatment of locally advanced head and neck squamous cell carcinoma (LA-HNSCC): Phase 3 KEYNOTE-412 trial. Annals Of Oncology 2017, 28: v392. DOI: 10.1093/annonc/mdx374.056.Peer-Reviewed Original Research