2024
A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC).
Colevas A, Chung C, 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, Margossian S, Levisetti M, Pai S. A phase 1 dose-escalation and expansion study of CUE-101, given as monotherapy and in combination with pembrolizumab, in patients with recurrent/metastatic HPV16+ head and neck squamous cell cancer (R/M HNSCC). Journal Of Clinical Oncology 2024, 42: 6004-6004. DOI: 10.1200/jco.2024.42.16_suppl.6004.Peer-Reviewed Original ResearchCD8+ T cellsR/M HNSCCHuman leukocyte antigenT cellsMedian OSCheckpoint inhibitorsHLA-A*0201Adverse eventsInterleukin-2Combined cohortHead and neck squamous cell cancerE7-specific T cellsPhase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8First-in-human studyTargeted delivery of cytokinesHLA-A*0201 patientsPhase 2 doseDisease control rateGrade 3 AEsInfusion-related reactionsT-cell engagersSquamous cell cancerDelivery of cytokines
2023
Digital spatial profiling links beta-2-microglobulin expression with immune checkpoint blockade outcomes in head and neck squamous cell carcinoma
Gavrielatou N, Vathiotis I, Aung T, Shafi S, Burela S, Fernandez A, Moutafi M, Burtness B, Economopoulou P, Anastasiou M, Foukas P, Psyrri A, Rimm D. Digital spatial profiling links beta-2-microglobulin expression with immune checkpoint blockade outcomes in head and neck squamous cell carcinoma. Cancer Research Communications 2023, 3: 558-563. PMID: 37057033, PMCID: PMC10088911, DOI: 10.1158/2767-9764.crc-22-0299.Peer-Reviewed Original ResearchConceptsDigital spatial profilingB2M expressionOverall survivalM HNSCCImmunotherapy outcomesNeck squamous cell carcinoma (HNSCC) treatmentHigh beta-2 microglobulinSquamous cell carcinoma treatmentCell death protein 1Neck squamous cell carcinomaM expressionPretreatment biopsy samplesImmune checkpoint inhibitorsPD-L1 expressionImmune checkpoint markersDeath protein 1Squamous cell carcinomaB2MBeta-2-microglobulinBeta 2 microglobulin expressionImproved PFSCheckpoint inhibitorsMetastatic headCheckpoint markersImproved survival
2022
Phase 1/2 study of pepinemab, an inhibitor of semaphorin 4D, in combination with pembrolizumab as first-line treatment of recurrent or metastatic head and neck cancer (KEYNOTE-B84).
Fisher T, Evans E, Mallow C, Foster A, Boise M, Smith E, Leonard J, Chaney M, Beck J, Hager S, Mekhail T, Seetharamu N, Baumgart M, Saba N, Steuer C, Adkins D, Burtness B, Zauderer M. Phase 1/2 study of pepinemab, an inhibitor of semaphorin 4D, in combination with pembrolizumab as first-line treatment of recurrent or metastatic head and neck cancer (KEYNOTE-B84). Journal Of Clinical Oncology 2022, 40: e18033-e18033. DOI: 10.1200/jco.2022.40.16_suppl.e18033.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsFirst-line treatmentDose-expansion phaseM HNSCCComplete responsePD-L1Tumor microenvironmentClinical benefitSingle-arm open-label studyPrior immune checkpoint inhibitorsNeck squamous cell carcinomaSemaphorin 4DActivation of DCsExploratory biomarker analysisImmunosuppressive myeloid cellsTumor PD-L1Open-label studyPrimary efficacy endpointSquamous cell carcinomaPK/PDBiomarker analysisECOG 0Measurable diseaseTreatment biopsiesCheckpoint inhibitors
2020
Head and neck squamous cell carcinoma
Johnson DE, Burtness B, Leemans CR, Lui VWY, Bauman JE, Grandis JR. Head and neck squamous cell carcinoma. Nature Reviews Disease Primers 2020, 6: 92. PMID: 33243986, PMCID: PMC7944998, DOI: 10.1038/s41572-020-00224-3.Peer-Reviewed Original ResearchConceptsNeck squamous cell carcinomaSquamous cell carcinomaHuman papillomavirusCell carcinomaOral cavityLarynx cancerAJCC/UICC staging systemEGFR monoclonal antibody cetuximabLate stage HNSCCLeast toxic therapyImmune checkpoint inhibitorsHPV-positive HNSCCTreatment of recurrentHPV-positive diseaseOral cavity cancerUICC staging systemHPV-negative HNSCCPre-malignant lesionsDegree of dysplasiaMonoclonal antibody cetuximabUnresectable diseaseCheckpoint inhibitorsPrimary chemoradiotherapyCytotoxic chemotherapyMost patientsComparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer
Emancipator K, Huang L, Aurora-Garg D, Bal T, Cohen EEW, Harrington K, Soulières D, Le Tourneau C, Licitra L, Burtness B, Swaby R. Comparing programmed death ligand 1 scores for predicting pembrolizumab efficacy in head and neck cancer. Modern Pathology 2020, 34: 532-541. PMID: 33239737, DOI: 10.1038/s41379-020-00710-9.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, Monoclonal, HumanizedAntineoplastic Agents, ImmunologicalB7-H1 AntigenBiomarkers, TumorBiopsyClinical Decision-MakingClinical Trials, Phase III as TopicDecision Support TechniquesDisease ProgressionHead and Neck NeoplasmsHumansImmunohistochemistryPredictive Value of TestsProgression-Free SurvivalRandomized Controlled Trials as TopicRetrospective StudiesSquamous Cell Carcinoma of Head and NeckTime FactorsConceptsTumor proportion scoreObjective response ratePD-L1 expression statusDeath ligand 1 (PD-L1) expressionNeck squamous cell carcinomaImmune checkpoint inhibitorsLigand 1 expressionPD-L1 statusProgression-free survivalSquamous cell carcinomaKEYNOTE-040Pembrolizumab efficacyCheckpoint inhibitorsOverall survivalMetastatic HNSCCCell carcinomaNeck cancerClinical trialsProportion scoreInvestigator's choiceResponse rateExpression statusYouden indexHNSCCPatientsKEYNOTE-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 advancesThe Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC)
Cohen EEW, Bell RB, Bifulco CB, Burtness B, Gillison ML, Harrington KJ, Le QT, Lee NY, Leidner R, Lewis RL, Licitra L, Mehanna H, Mell LK, Raben A, Sikora AG, Uppaluri R, Whitworth F, Zandberg DP, Ferris RL. The Society for Immunotherapy of Cancer consensus statement on immunotherapy for the treatment of squamous cell carcinoma of the head and neck (HNSCC). Journal For ImmunoTherapy Of Cancer 2019, 7: 184. PMID: 31307547, PMCID: PMC6632213, DOI: 10.1186/s40425-019-0662-5.Peer-Reviewed Original ResearchConceptsSquamous cell carcinomaTreatment of patientsCell carcinomaNeck cancerAnti-PD-1 immune checkpoint inhibitorPD-L1 combined positive scoreMetastatic squamous cell carcinomaRecurrent squamous cell carcinomaApproval of nivolumabCancer consensus statementFirst new therapyImmune checkpoint inhibitorsPlatinum-based regimensPlatinum-containing chemotherapyRole of immunotherapyCombined positive scoreFirst-line treatmentPD-1 inhibitionTreatment of recurrentTumor proportion scoreAppropriate patient selectionAdverse event managementSame patient populationImmunotherapy of cancerCheckpoint inhibitorsHyperprogression after one dose of nivolumab in sinonasal cancer: A case report
Xiang JJ, Uy NF, Minja FJ, Verter EE, Burtness BA. Hyperprogression after one dose of nivolumab in sinonasal cancer: A case report. The Laryngoscope 2019, 130: 907-910. PMID: 31058321, DOI: 10.1002/lary.28042.Peer-Reviewed Original ResearchConceptsImmune checkpoint inhibitorsDose of nivolumabSquamous cell carcinomaSinonasal cancerCell carcinomaDisease progressionMaxillary sinus squamous cell carcinomaSinus squamous cell carcinomaNeck squamous cell carcinomaComplete vision lossICI initiationCheckpoint inhibitorsFirst doseLytic metastasesDistal metastasisCase reportIntracranial invasionVision lossImproved outcomesHyperprogressionIndividual riskDoseNivolumabCarcinomaMetastasis