2025
Phase 2 trial of dual EGFR inhibition with cetuximab and afatinib in patients with recurrent/metastatic head and neck squamous cell cancers (HNSCC).
Bhatia A, Wei W, Chiorazzi M, Deshpande H, Reynolds J, Gehan D, Tara H, Newton B, Verma A, Sayed Z, Roche A, Mehra S, Judson B, Yarbrough W, Burtness B. Phase 2 trial of dual EGFR inhibition with cetuximab and afatinib in patients with recurrent/metastatic head and neck squamous cell cancers (HNSCC). Journal Of Clinical Oncology 2025, 43: 6023-6023. DOI: 10.1200/jco.2025.43.16_suppl.6023.Peer-Reviewed Original ResearchHead and neck squamous cell cancerEpidermal growth factor receptorMedian overall survivalCombination of cetuximabAdverse eventsHuman epidermal growth factor receptor (HER)-2Recurrent/metastatic head and neck squamous cell cancerRefractory to platinum-based chemotherapyEpidermal growth factor receptor targetEpidermal growth factor receptor inhibitionSingle-arm phase II trialPhosphorylated epidermal growth factor receptorCommonest adverse eventsP16+ diseaseProgression-free survivalImmune checkpoint therapyP16-positive tumorsPlatinum-based chemotherapyPrimary tumor locationPhase 2 trialPhase II trialSquamous cell cancerPost-treatment biopsiesTrials of chemotherapyEGFR inhibitor treatmentPhase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck
Bhatia A, Mehra R, Bauman J, Khan S, Wei W, Neumeister V, Sandoval‐Schaefer T, Alpaugh R, Lango M, Rimm D, Ridge J, Burtness B. Phase II Trial of Chemotherapy, Cetuximab, and Erlotinib in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck. Head & Neck 2025 PMID: 40166973, DOI: 10.1002/hed.28152.Peer-Reviewed Original ResearchHead and neck squamous cell cancerProgression-free survivalEpidermal growth factor receptorTyrosine kinase inhibitorsOverall survivalPhase II trial of chemotherapyMedian progression-free survivalRecurrent squamous cell carcinomaTreatment-related adverse eventsDual epidermal growth factor receptorTreated with carboplatinPhase 2 trialPhase II trialSecondary end pointsSquamous cell cancerNuclear translocation of epidermal growth factor receptorSquamous cell carcinomaTrials of chemotherapyHead and neckSmall patient sampleTranslocation of epidermal growth factor receptorGrowth factor receptorInhibited nuclear translocationEGFR blockadeChemotherapy backbone
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 ResearchHead and neck squamous cell cancerPhase 1 dose-escalationSquamous cell cancerCell cancerPembrolizumabMonotherapyPatientsCancerA Lymph Node Immune Score (LNIS) Identifies Prognostic Immune Phenotypes Shared across Head and Neck Cancers
Karpinets T, Garden A, Rosenthal D, Fuller C, Frank S, Gunn G, Phan J, Morrison W, Lee A, Moreno A, Song X, Mitani Y, Ferrarotto R, Gross N, Zhang J, Myers J, El-Naggar A, Spiotto M. A Lymph Node Immune Score (LNIS) Identifies Prognostic Immune Phenotypes Shared across Head and Neck Cancers. International Journal Of Radiation Oncology • Biology • Physics 2024, 120: s222-s223. DOI: 10.1016/j.ijrobp.2024.07.2308.Peer-Reviewed Original ResearchHead and neck squamous cell cancerNon-small cell lung cancerLymph node metastasisPrognostic gene signatureRelapse free survivalExtranodal extensionFree survivalGene signatureImmune microenvironmentImmune scoreLymph nodesImmune phenotypeRejection subtypeHPV-positive HNSCCImmune rejectionAbsence of extranodal extensionNon-small cell lung cancer cohortsHPV-negative HNSCC patientsUnivariate Cox proportional hazards modelHead and neck cancerImmunology-related genesMetastatic lymph nodesLymph node microenvironmentSquamous cell cancerCell lung cancerHERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors.
Bhatia A, Hayashi H, Kogawa T, Nishina T, Fountzilas C, Castillo D, McKean M, Colombo N, Smithy J, Fayette J, Chandra S, Powles T, Kudchadkar R, Sternberg D, Sullivan K, Yueh S, Clinthorne G, Burtness B. HERTHENA-PanTumor01: A global, multicohort, phase 2 trial of HER3-DXd in relapsed/refractory metastatic solid tumors. Journal Of Clinical Oncology 2024, 42: tps3164-tps3164. DOI: 10.1200/jco.2024.42.16_suppl.tps3164.Peer-Reviewed Original ResearchHead and neck squamous cell cancerHuman epidermal growth factor receptor 3Platinum-based chemotherapyHER3-DXdPhase 2 trialAntibody-drug conjugatesSolid tumorsHuman anti-HER3 monoclonal antibodyAnti-HER3 monoclonal antibodyAnti-PD-(L)1 therapyGastric cancerHER2-negative gastric cancerTopoisomerase I inhibitor payloadAssociated with poor clinical outcomesEpidermal growth factor receptor 3Anti-HER3 antibodiesGastroesophageal junction cancerHER2+ cancersMetastatic solid tumorsMetastatic breast cancerSquamous cell cancerBRAF wild-typePoor clinical outcomesMultiple tumor typesAcral subtypeA 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
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