2020
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.
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
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).
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