2024
907P Biomarker analysis of the phase III KEYNOTE-040 study of pembrolizumab (pembro) versus methotrexate, docetaxel, or cetuximab (SOC) for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC)
Soulieres D, Le Tourneau C, Machiels J, Burtness B, Harrington K, Shen J, Tao J, Webber A, Vajdi A, Loboda A, Lerman N, Gumuscu B, Licitra L. 907P Biomarker analysis of the phase III KEYNOTE-040 study of pembrolizumab (pembro) versus methotrexate, docetaxel, or cetuximab (SOC) for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC). Annals Of Oncology 2024, 35: s639-s640. DOI: 10.1016/j.annonc.2024.08.968.Peer-Reviewed Original ResearchPembrolizumab 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-L1Correlative and spatial biomarker analysis of a phase 1/2b study to evaluate pepinemab in combination with pembrolizumab for first-line treatment of patients with recurrent or metastatic head and neck cancer.
Evans E, Fisher T, Mallow C, Foster A, Leonard J, Chaney M, Mekhail T, Seetharamu N, Steuer C, Saba N, Adkins D, Beck J, Algazi A, Burtness B, Baumgart M, Giampoli E, Hager S, Chay C, Spira A, Zauderer M. Correlative and spatial biomarker analysis of a phase 1/2b study to evaluate pepinemab in combination with pembrolizumab for first-line treatment of patients with recurrent or metastatic head and neck cancer. Journal Of Clinical Oncology 2024, 42: 2603-2603. DOI: 10.1200/jco.2024.42.16_suppl.2603.Peer-Reviewed Original ResearchHead and neck squamous cell carcinomaMyeloid suppressor cellsImmune checkpoint inhibitorsFirst-line treatmentDendritic cellsT cellsB cellsTumor biopsiesLymphoid structuresImmune cellsMetastatic head and neck squamous cell carcinomaActivity of immune checkpoint inhibitorsEfficacy of immune checkpoint inhibitorsSingle-arm open-label studyFirst-line treatment of patientsMetastatic head and neck cancerHead and neck squamous cell carcinoma tumorsImmune checkpoint inhibitor activationOn-treatment tumor biopsiesSuppression of adaptive immunityCD8+ T cellsNeck squamous cell carcinomaHead and neck cancerAnalysis of tumor biopsiesMechanism of immune enhancementHealth-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Machiels J, TAO Y, Burtness B, Tahara M, Rischin D, Alves G, Lima I, Hughes B, Pointreau Y, Aksoy S, Laban S, Greil R, Burian M, Hetnal M, Licitra L, Black C, Norquist J, Gumuscu B, Bidadi B, Siu L. Health-Related Quality of Life (HRQoL) Data From KEYNOTE-412: Chemoradiotherapy (CRT) with or Without Pembrolizumab (pembro) in Patients (pts) with Locally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC). International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e39-e40. DOI: 10.1016/j.ijrobp.2024.01.091.Peer-Reviewed Original ResearchBL to weekLA-HNSCCEQ-5D VASLSM changeLocally advanced head and neck squamous cell carcinomaAdvanced head and neck squamous cell carcinomaQLQ-H&N35Head and neck squamous cell carcinomaNeck squamous cell carcinomaEnd pointsPrespecified secondary end pointsSecondary end pointsSquamous cell carcinomaExploratory end pointsCompliance rateQLQ-C30Disease symptom scoreDose of treatmentPatient-reported outcomesPhysical function scoresCell carcinomaPembroHealth-related quality of lifeChemoradiotherapyAnalysis populationLenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study
Harrington K, Kim H, Salas S, Oliva M, Metcalf R, Bernsdorf M, Kim J, Cohen E, Siu L, Rischin D, Licitra L, Vermorken J, Le Q, Tahara M, Machiels J, O'Hara K, Pathiraja K, Gumuscu B, Bidadi B, Burtness B. Lenvatinib ± Pembrolizumab Versus Chemotherapy for Recurrent/Metastatic (R/M) Head and Neck Squamous Cell Carcinoma (HNSCC) That Progressed after Platinum and Immunotherapy: The Phase 2 LEAP-009 Study. International Journal Of Radiation Oncology • Biology • Physics 2024, 118: e42. DOI: 10.1016/j.ijrobp.2024.01.095.Peer-Reviewed Original ResearchR/M HNSCCHead and neck squamous cell carcinomaPD-1/L1 inhibitorsPlatinum-based therapyPlatinum-based chemotherapyDisease progressionLenvatinib monotherapyECOG PSRecurrent/metastatic (R/M) head and neck squamous cell carcinomaPD-L1 tumor proportion scoreStandard-of-care chemotherapyNeck squamous cell carcinomaTumor proportion scoreProgression-free survivalDuration of responseEfficacy of lenvatinibSecondary end pointsFirst-line treatmentSquamous cell carcinomaEfficacious treatment optionStandard of careOral lenvatinibPembrolizumab monotherapyRECIST v1.1Monotherapy arm
2022
A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer.
Chung C, Colevas A, Adkins D, Gibson M, Rodriguez C, Sukari A, Bauman J, Wirth L, Johnson F, Saba N, Burtness B, Dunn L, Seiwert T, Worden F, Muzaffar J, Margossian S, Moniz R, Quayle S, Levisetti M, Pai S. A phase 1 dose-escalation and expansion study of CUE-101, a novel HPV16 E7-pHLA-IL2-Fc fusion protein, given alone and in combination with pembrolizumab in patients with recurrent/metastatic HPV16+ head and neck cancer. Journal Of Clinical Oncology 2022, 40: 6045-6045. DOI: 10.1200/jco.2022.40.16_suppl.6045.Peer-Reviewed Original ResearchCD8+ T cellsHuman leukocyte antigenT cellsInterleukin-2R/M HNSCCHLA-A*0201Recurrent/metastatic head and neck squamous cell carcinomaTumor antigen-specific T cellsHead and neck squamous cell carcinomaDelivery of interleukin-2Phase 1 dose-escalationRecommended phase 2 doseTumor antigen-specific CD8Neck squamous cell carcinomaFirst-in-human studyAntitumor activityDose-escalation cohortsHLA-A*0201 patientsPhase 2 doseTumor-specific CD8Data cut-offSpecific T cellsFirst-line treatmentSquamous cell carcinomaDose-dependent increase