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 treatmentEfficacy659MO 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 Research
2020
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)
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 (P) or P + chemotherapy (C) versus EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): analysis of KEYNOTE-048 by disease state.
Rischin D, Harrington K, Greil R, Soulieres D, Tahara M, Castro G, Psyrri A, Baste N, Neupane P, Bratland Å, Fuereder T, Hughes B, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak W, Lin J, Gumuscu B, Swaby R, Burtness B. Pembrolizumab (P) or P + chemotherapy (C) versus EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): analysis of KEYNOTE-048 by disease state. Journal Of Clinical Oncology 2020, 38: 6530-6530. DOI: 10.1200/jco.2020.38.15_suppl.6530.Peer-Reviewed Original ResearchTreatment-related adverse eventsIncurable recurrentMetastatic subgroupM HNSCCSuperior OSMedian OSPFS benefitGrade 3MS subgroupsRecurrent/metastatic headNeck squamous cell carcinomaKEYNOTE-048 trialPD-L1 CPSDisease statesECOG performance statusFirst-line therapyPD-L1 statusKaplan-Meier methodTotal study populationSquamous cell carcinomaCox regression modelKEYNOTE-048Metastatic headAdverse eventsHazard ratioKEYNOTE-048: Progression after the next line of therapy following pembrolizumab (P) or P plus chemotherapy (P+C) vs EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Harrington K, Rischin D, Greil R, Soulieres D, Tahara M, Castro G, Psyrri A, Baste N, Neupane P, Bratland Å, Fuereder T, Hughes B, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak W, Zhang Y, Gumuscu B, Swaby R, Burtness B. KEYNOTE-048: Progression after the next line of therapy following pembrolizumab (P) or P plus chemotherapy (P+C) vs EXTREME (E) as first-line (1L) therapy for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: 6505-6505. DOI: 10.1200/jco.2020.38.15_suppl.6505.Peer-Reviewed Original ResearchPD-L1 CPSSubsequent anticancer therapyM HNSCCMedian PFS2Subsequent therapyRecurrent/metastatic headNeck squamous cell carcinomaNext-line therapyObjective tumor progressionImmune checkpoint inhibitorsFirst-line therapyKaplan-Meier methodAnticancer therapySquamous cell carcinomaCox regression modelTotal populationKEYNOTE-048Superior OSCheckpoint inhibitorsMetastatic headSystemic therapyComparable safetyCell carcinomaFavorable safetyPatient outcomes
2019
Immunotherapy for head and neck cancer: Recent advances and future directions
Cramer JD, Burtness B, Ferris RL. Immunotherapy for head and neck cancer: Recent advances and future directions. Oral Oncology 2019, 99: 104460. PMID: 31683169, PMCID: PMC7749717, DOI: 10.1016/j.oraloncology.2019.104460.Peer-Reviewed Original ResearchConceptsM HNSCCPembrolizumab monotherapyPD-L1Clinical trialsAnti-PD1 antibody nivolumabPhase III randomized trialsRandomized phase III trialCo-stimulatory agonistsImmune cell stainingInvestigator-choice chemotherapyPD-L1 CPSPhase III trialsRecurrent/metastaticDetailed clinical dataEXTREME regimenKEYNOTE-048Advanced diseaseCheckpoint inhibitorsIII trialsProlong survivalAntibody nivolumabRandomized trialsTherapeutic vaccinesNeck cancerTherapeutic advancesProtocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC).
Rischin D, Harrington K, Greil R, Soulieres D, Tahara M, de Castro G, Psyrri A, Baste N, Neupane P, Bratland A, Fuereder T, Hughes B, Mesia R, Ngamphaiboon N, Rordorf T, Wan Ishak W, Zhang Y, Jin F, Gumuscu B, Burtness B. Protocol-specified final analysis of the phase 3 KEYNOTE-048 trial of pembrolizumab (pembro) as first-line therapy for recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC). Journal Of Clinical Oncology 2019, 37: 6000-6000. DOI: 10.1200/jco.2019.37.15_suppl.6000.Peer-Reviewed Original ResearchCombined positive scorePD-L1 combined positive scoreM HNSCCKEYNOTE-048Median DoRSuperior OSComparable safetyFavorable safetyRecurrent/metastatic headNeck squamous cell carcinomaKEYNOTE-048 trialSecond interim analysisFirst-line therapyPD-L1 testingPhase 3 studySquamous cell carcinomaTotal populationMetastatic headData cutoffSystemic therapyCell carcinomaE. ConclusionInterim analysisAE ratesTumor samples
2018
LBA8_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 Research
2015
342TiP Phase 3 trial of pembrolizumab as a first-line treatment in subjects with recurrent/metastatic head and neck squamous cell carcinoma: KEYNOTE-048
Yen C, Klochikhin A, Cohen E, Vermorken J, Harrington K, Tahara M, Ge J, Geib J, Jin F, Burtness B. 342TiP Phase 3 trial of pembrolizumab as a first-line treatment in subjects with recurrent/metastatic head and neck squamous cell carcinoma: KEYNOTE-048. Annals Of Oncology 2015, 26: ix93. DOI: 10.1093/annonc/mdv527.29.Peer-Reviewed Original Research11TiP Phase 3 trial of pembrolizumab as a first-line treatment in subjects with recurrent/metastatic head and neck squamous cell carcinoma: KEYNOTE-048
Klochikhin A, Greil R, Cohen E, Vermorken J, Harrington K, Tahara M, Ge J, Geib J, Jin F, Burtness B. 11TiP Phase 3 trial of pembrolizumab as a first-line treatment in subjects with recurrent/metastatic head and neck squamous cell carcinoma: KEYNOTE-048. Annals Of Oncology 2015, 26: viii5. DOI: 10.1093/annonc/mdv514.01.Peer-Reviewed Original Research