2022
Phase 1/2 Study of Pepinemab in Combination with Pembrolizumab as First-Line Treatment of Advanced, 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, Saba N, Steuer C, Adkins D, Burtness B, Zauderer M. Phase 1/2 Study of Pepinemab in Combination with Pembrolizumab as First-Line Treatment of Advanced, Recurrent or Metastatic Head and Neck Cancer (KEYNOTE B84). International Journal Of Radiation Oncology • Biology • Physics 2022, 112: e36. DOI: 10.1016/j.ijrobp.2021.12.084.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsDose-expansion phaseFirst-line treatmentM HNSCCTumor microenvironmentPD-L1Clinical benefitT cellsSingle-arm open-label studyPrior immune checkpoint inhibitorsMore effective treatment optionsNeck squamous cell carcinomaActivation of DCsActivity of pembrolizumabExploratory biomarker analysisImmunosuppressive myeloid cellsTumor PD-L1Open-label studyPrimary efficacy endpointDuration of responseEffective treatment optionSquamous cell carcinomaClear unmet needPK/PDMore effective treatments
2018
Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study
Cohen EEW, Soulières D, Le Tourneau C, Dinis J, Licitra L, Ahn MJ, Soria A, Machiels JP, Mach N, Mehra R, Burtness B, Zhang P, Cheng J, Swaby RF, Harrington KJ, investigators K, Acosta-Rivera M, Adkins D, Aghmesheh M, Ahn M, Airoldi M, Aleknavicius E, Al-Farhat Y, Algazi A, Almokadem S, Alyasova A, Bauman J, Benasso M, Berrocal A, Bray V, Burtness B, Caponigro F, Castro A, Cescon T, Chan K, Chaudhry A, Chauffert B, Cohen E, Csoszi T, De Boer J, Delord J, Dietz A, Dinis J, Dupuis C, Digue L, Erfan J, Alvarez Y, Evans M, Fidler M, Forster M, Friesland S, Ganti A, Geoffrois L, Grant C, Gruenwald V, Harrington K, Hoffmann T, Horvai G, Inciura A, Jang R, Jankowska P, Jimeno A, Joseph M, Ramiro A, Karaszewska B, Kawecki A, Keilholz U, Keller U, Kim S, Kocsis J, Kotecki N, Kozloff M, Lambea J, Landherr L, Lantsukhay Y, Lazarev S, Lee L, Le Tourneau C, Licitra L, Lifirenko I, Mach N, Martincic D, Matorin O, McGrath M, Machiels J, Mehra R, Misiukiewicz K, Morris J, Mufazalov F, Niu J, Srinivasan D, Segura P, Rauch D, Ribeiro M, Rodriguez C, Rolland F, Russo A, Ruzsa A, Sanches F, Shin S, Shtiveland M, Soulieres D, Soria A, Specenier P, Szekanecz E, Szota J, van Herpen C, Velez-Cortes H, Walsh W, Wilop S, Winterhalder R, Wojtukiewicz M, Wong D, Zandberg D. Pembrolizumab versus methotrexate, docetaxel, or cetuximab for recurrent or metastatic head-and-neck squamous cell carcinoma (KEYNOTE-040): a randomised, open-label, phase 3 study. The Lancet 2018, 393: 156-167. PMID: 30509740, DOI: 10.1016/s0140-6736(18)31999-8.Peer-Reviewed Original ResearchMeSH KeywordsAgedAntibodies, Monoclonal, HumanizedAntineoplastic Combined Chemotherapy ProtocolsCetuximabDisease ProgressionDocetaxelDrug Administration ScheduleFemaleHead and Neck NeoplasmsHumansKaplan-Meier EstimateMaleMethotrexateMiddle AgedNeoplasm Recurrence, LocalSquamous Cell Carcinoma of Head and NeckConceptsNeck squamous cell carcinomaSquamous cell carcinomaStandard of careTreatment-related adverse eventsCell carcinomaMetastatic headOverall survivalTreat populationAdverse eventsCommon treatment-related adverse eventsWorse treatment-related adverse eventsPlatinum-containing treatmentTreatment-related deathsMedian overall survivalWeb response systemEffective treatment optionFavorable safety profileEarly phase trialsTreatment of headSubsidiary of MerckManageable toxicityMeaningful prolongationAdvanced diseasePrimary endpointMetastatic disease
2017
Phase II trial of ribociclib and everolimus in p16 low anaplastic thyroid cancer (ATC).
Tawfik B, Gerber D, Burtness B, Hughes R, Myers L, Sumer B, Truelson J, Strom T, Kurian P, Saleem S, Pearson J, Zhu H, Khan S. Phase II trial of ribociclib and everolimus in p16 low anaplastic thyroid cancer (ATC). Journal Of Clinical Oncology 2017, 35: tps6098-tps6098. DOI: 10.1200/jco.2017.35.15_suppl.tps6098.Peer-Reviewed Original ResearchAnaplastic thyroid cancerThyroid cancerCell cycle progressionII trialCycle progressionResponse ratePhase I/II trialOpen-label trialRare thyroid cancerPhase II trialAggressive clinical courseCDK 4/6 inhibitorsEffective treatment optionOverall response rateMTOR inhibitor everolimusATC cell linesRapid cell cycle progressionMedian OSATC patientsPrimary endpointSecondary endpointsMetastatic diseaseTrue response rateAdditional patientsClinical course