2016
Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial
Seiwert TY, Burtness B, Mehra R, Weiss J, Berger R, Eder JP, Heath K, McClanahan T, Lunceford J, Gause C, Cheng JD, Chow LQ. Safety and clinical activity of pembrolizumab for treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (KEYNOTE-012): an open-label, multicentre, phase 1b trial. The Lancet Oncology 2016, 17: 956-965. PMID: 27247226, DOI: 10.1016/s1470-2045(16)30066-3.Peer-Reviewed Original ResearchConceptsMetastatic squamous cell carcinomaSquamous cell carcinomaDrug-related adverse eventsPost-baseline scanPhase 1b trialProportion of patientsCell carcinomaAdverse eventsPD-L1Anti-programmed death receptor 1 antibodyDeath receptor-1 (PD-1) antibodiesPositive squamous cell carcinomaActivity of pembrolizumabDose of pembrolizumabDrug-related rashMeaningful antitumour activityFull analysis setHPV-negative patientsSerious adverse eventsHPV-positive patientsPD-L1 expressionResponse Evaluation CriteriaTreatment of recurrentOverall responseDrug-related deaths
2015
Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort.
Seiwert T, Haddad R, Gupta S, Mehra R, Tahara M, Berger R, Lee S, Burtness B, Le D, Heath K, Blum A, Dolled-Filhart M, Emancipator K, Pathiraja K, Cheng J, Chow L. Antitumor activity and safety of pembrolizumab in patients (pts) with advanced squamous cell carcinoma of the head and neck (SCCHN): Preliminary results from KEYNOTE-012 expansion cohort. Journal Of Clinical Oncology 2015, 33: lba6008-lba6008. DOI: 10.1200/jco.2015.33.18_suppl.lba6008.Peer-Reviewed Original ResearchRecurrent/metastatic SCCHNOverall response rateDrug-related adverse eventsProgression-free survivalAdverse eventsMetastatic SCCHNPD-L1KEYNOTE-012Expansion cohortOverall survivalCommon drug-related adverse eventsTumor-specific effector T cellsResponse rateAdvanced squamous cell carcinomaDrug-related gradePost-baseline scanSafety of pembrolizumabPrimary end pointLines of therapyPD-L1 expressionEffector T cellsSquamous cell carcinomaHumanized monoclonal antibodyPreliminary efficacy analysisAdvanced SCCHN
2014
LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc)
Chow L, Burtness B, Weiss J, Berger R, Eder J, Gonzalez E, Pulini J, Johnson J, Dolled-Filhart M, Emancipator K, Lunceford J, Pathiraja K, Gause C, Cheng J, Seiwert T. LBA31 A Phase Ib Study of Pembrolizumab (Pembro; Mk-3475) in Patients (Pts) with Human Papiilloma Virus (Hpv)-Positive and Negative Head and Neck Cancer (Hnc). Annals Of Oncology 2014, 25: v1. DOI: 10.1093/annonc/mdu438.32.Peer-Reviewed Original ResearchOverall response ratePD-L1 expressionDrug-related adverse eventsAdverse eventsRECIST v1.1Subsidiary of MerckBristol-Myers SquibbInvestigator reviewAntitumor activityCommon drug-related adverse eventsAdvisory board membershipHigh PD-L1 expressionBoehringer IngelheimMerck SharpGenentech/RochePhase Ib studyPrimary end pointDrug-related deathsMeasurable diseaseMedian OSMedian PFSMetastatic HNCAdvanced HNCUnacceptable toxicityComplete response