2024
Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial
Dzienis M, Cundom J, Fuentes C, Spreafico A, Nordlinger M, Pastor A, Alesi E, Neki A, Fung A, Lima I, Oppelt P, da Cunha G, Burtness B, Franke F, Tseng J, Joshi A, McCarthy J, Swaby R, Sidi Y, Gumuscu B, Naicker N, de Castro G. Pembrolizumab Plus Carboplatin and Paclitaxel as First-Line Therapy for Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (KEYNOTE-B10): A Single-Arm Phase IV Trial. Journal Of Clinical Oncology 2024, 42: 2989-2999. PMID: 39038265, PMCID: PMC11361359, DOI: 10.1200/jco.23.02625.Peer-Reviewed Original ResearchBlinded independent central reviewRecurrent/metastatic head and neck squamous cell carcinomaHead and neck squamous cell carcinomaNeck squamous cell carcinomaR/M HNSCCSquamous cell carcinomaRECIST v1.1Cell carcinomaSingle-armStandard-of-care first-line treatmentSafety of first-line pembrolizumabEastern Cooperative Oncology Group performance statusDay 1Treatment-related adverse eventsAlternative chemotherapy combinationsFirst-line pembrolizumabPD-L1 statusMedian follow-upFirst-line therapyIndependent central reviewFirst-line treatmentPhase IV trialChemotherapy combinationsComplete responsePD-L1
2022
A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202.
Bhatia A, Flamand Y, Johnson J, Ishizuka J, Duan F, Tang M, Karivedu V, Subramaniam R, Burtness B. A phase II/III trial of chemotherapy plus cetuximab versus chemotherapy plus bevacizumab versus atezolizumab plus bevacizumab following progression on immune checkpoint inhibition in recurrent/metastatic head and neck cancers: ECOG-ACRIN EA3202. Journal Of Clinical Oncology 2022, 40: tps6098-tps6098. DOI: 10.1200/jco.2022.40.16_suppl.tps6098.Peer-Reviewed Original ResearchProgression-free survivalVascular endothelial growth factorM HNSCCOverall survivalPrimary endpointExperimental armControl armHigher treatment-related adverse eventsPhase II/III trialsOne-sided alpha levelRecurrent/metastatic headTreatment-related adverse eventsEffector T cell responsesMyeloid-derived suppressor cellsPhase II/IIIPhase IIStratified log-rank testEfficacy of atezolizumabPlatinum-doublet chemotherapyImmune checkpoint inhibitionFirst-line pembrolizumabAnti-tumor immunityPhase IIIDendritic cell maturationPhase III evaluation
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 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 ResearchPhase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in 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, Lee C, Pinheiro C, Swaby R, Machiels J, Tahara M. Phase III LEAP-010 study: first-line pembrolizumab with or without lenvatinib in recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Journal Of Clinical Oncology 2020, 38: tps6589-tps6589. DOI: 10.1200/jco.2020.38.15_suppl.tps6589.Peer-Reviewed Original ResearchBlinded independent central reviewCombined positive scoreFirst-line pembrolizumabM HNSCCDisease progressionRECIST v1.1PD-L1PD-L1 combined positive scoreECOG performance status 0PD-1 inhibitor pembrolizumabRecurrent/metastatic headEnd pointNeck squamous cell carcinomaCycles of pembrolizumabFirst-line monotherapyPerformance status 0Phase 1b/2 trialManageable safety profileObjective response ratePrimary end pointSecondary end pointsHuman papillomavirus (HPV) statusPD-L1 statusPhase 3 studyProgression-free survival
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