2020
A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753)
Waqar SN, Redman MW, Arnold SM, Hirsch FR, Mack PC, Schwartz LH, Gandara DR, Stinchcombe TE, Leighl NB, Ramalingam SS, Tanna SH, Raddin RS, Minichiello K, Bradley JD, Kelly K, Herbst RS, Papadimitrakopoulou VA. A Phase II Study of Telisotuzumab Vedotin in Patients With c–MET-positive Stage IV or Recurrent Squamous Cell Lung Cancer (LUNG-MAP Sub-study S1400K, NCT03574753). Clinical Lung Cancer 2020, 22: 170-177. PMID: 33221175, PMCID: PMC8044254, DOI: 10.1016/j.cllc.2020.09.013.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAntibodies, MonoclonalAntineoplastic AgentsCarcinoma, Non-Small-Cell LungCarcinoma, Squamous CellCohort StudiesFemaleHumansLung NeoplasmsMaleMiddle AgedNeoplasm Recurrence, LocalNeoplasm StagingPneumoniaProgression-Free SurvivalProto-Oncogene Proteins c-metSurvival RateTreatment OutcomeConceptsSquamous cell carcinomaProgression-free survivalTelisotuzumab vedotinCohort 1Recurrent squamous cell lung cancerSquamous cell lung cancerGrade 5 eventsMET-positive tumorsSolid Tumors v1.1Disease control ratePhase II studyResponse Evaluation CriteriaCell lung cancerDuration of responseLack of efficacyEvaluable patientsStable diseasePrimary endpointSecondary endpointsUnacceptable toxicityII studyOverall survivalCell carcinomaControl rateLung cancer
2019
Phase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753).
Waqar S, Redman M, Arnold S, Hirsch F, Mack P, Schwartz L, Gandara D, Stinchcombe T, Leighl N, Ramalingam S, Tanna S, Raddin R, Minichiello K, Kelly K, Bradley J, Herbst R, Papadimitrakopoulou V. Phase II study of ABBV-399 (Process II) in patients with C-MET positive stage IV/recurrent lung squamous cell cancer (SCC): LUNG-MAP sub-study S1400K (NCT03574753). Journal Of Clinical Oncology 2019, 37: 9075-9075. DOI: 10.1200/jco.2019.37.15_suppl.9075.Peer-Reviewed Original ResearchProgression-free survivalOverall survivalCohort 1Interim analysisLung squamous cell cancerAdequate organ functionDisease control rateMedian overall survivalPhase II studySquamous cell cancerDuration of responseEvaluable patientsG3 eventsImmunotherapy exposureRECIST 1.1Stable diseasePrimary endpointSecondary endpointsUnacceptable toxicityAdverse eventsII studyHepatic involvementCell cancerPositive tumorsControl rate
2013
Comprehensive Biomarker Analysis and Final Efficacy Results of Sorafenib in the BATTLE Trial
Blumenschein GR, Saintigny P, Liu S, Kim ES, Tsao AS, Herbst RS, Alden C, Lee JJ, Tang X, Stewart DJ, Kies MS, Fossella FV, Tran HT, Mao L, Hicks ME, Erasmus J, Gupta S, Girard L, Peyton M, Diao L, Wang J, Davis SE, Minna JD, Wistuba I, Hong WK, Heymach JV, Lippman SM. Comprehensive Biomarker Analysis and Final Efficacy Results of Sorafenib in the BATTLE Trial. Clinical Cancer Research 2013, 19: 6967-6975. PMID: 24166906, PMCID: PMC3905243, DOI: 10.1158/1078-0432.ccr-12-1818.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerDisease control rateProgression-free survivalWild-type EGFROverall survivalClinical benefitEGFR gene copy number gainMedian progression-free survivalWild-type EGFR tumorsImproved progression-free survivalComprehensive biomarker analysisCell lung cancerGene copy number gainEGFR gene copy numberNSCLC cell linesGrowth factor-1Patient tumor biopsiesFibroblast growth factor 1Unacceptable toxicityEGFR tumorsClinical efficacyFuture trialsControl rateLung cancerEGFR mutations
2009
Antitumor activity of cediranib in patients with metastatic or recurrent head and neck cancer (HNC) or recurrent non-small cell lung cancer (NSCLC): An open-label exploratory study
Saura C, Baselga J, Herbst R, del Campo J, Marotti M, Tessier J, Collins B, Heymach J. Antitumor activity of cediranib in patients with metastatic or recurrent head and neck cancer (HNC) or recurrent non-small cell lung cancer (NSCLC): An open-label exploratory study. Journal Of Clinical Oncology 2009, 27: 6023-6023. DOI: 10.1200/jco.2009.27.15_suppl.6023.Peer-Reviewed Original ResearchNon-small cell lung cancerFDG-PETTumor sizeCediranib monotherapyDay 22Manageable adverse event profileOpen-label exploratory studyEffects of cediranibRECIST response rateAntitumor activityCommon adverse eventsPre-treated patientsAdverse event profileCell lung cancerTumor metabolic activityPost-baseline measurementEvidence of responseEvaluable patientsRecurrent HNCUnacceptable toxicityAdverse eventsRecurrent headFDG uptakeClinical benefitEvent profile
2007
First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors
LoRusso P, Hong D, Heath E, Kurzrock R, Wang D, Hsu M, Goyal L, Wiezorek J, Storgard C, Herbst R. First-in-human study of AMG 655, a pro-apoptotic TRAIL receptor-2 agonist, in adult patients with advanced solid tumors. Journal Of Clinical Oncology 2007, 25: 3534-3534. DOI: 10.1200/jco.2007.25.18_suppl.3534.Peer-Reviewed Original ResearchNon-small cell lung cancerMetabolic partial responseAdvanced solid tumorsPartial responseStable diseaseColorectal cancerHuman studiesSolid tumorsMaximum standardized uptake valueDose-linear kineticsElevated serum lipaseSequential dose cohortsOnly grade 3Cell lung cancerReceptor 2 agonistStandardized uptake valueHuman monoclonal agonist antibodyMonoclonal agonist antibodyAnti-tumor activitySensitive tumor cellsTumor response dataSerious AEsDose cohortsProgressive diseaseUnacceptable toxicityA phase I safety and pharmacokinetic study of apomab, a human DR5 agonist antibody, in patients with advanced cancer
Camidge D, Herbst R, Gordon M, Eckhardt S, Kurzroc R, Durbin B, Ing J, Ling J, Sager J, Mendelson D. A phase I safety and pharmacokinetic study of apomab, a human DR5 agonist antibody, in patients with advanced cancer. Journal Of Clinical Oncology 2007, 25: 3582-3582. DOI: 10.1200/jco.2007.25.18_suppl.3582.Peer-Reviewed Original ResearchTreatment-refractory solid tumorsPhase I safetyColorectal cancer patientsPre-clinical dataEvidence of benefitDR5 agonist antibodyAnti-cancer efficacyIgG1 monoclonal antibodyAsymptomatic transaminitisCohort expansionECOG PSHAHA responseUnacceptable toxicityI safetyObjective responseSymptomatic improvementAdvanced cancerCancer patientsMinor responseReceptor agonistTarget lesionsApomabDisease progressionEfficacy dataPreclinical models
2002
Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition.
Albanell J, Rojo F, Averbuch S, Feyereislova A, Mascaro J, Herbst R, LoRusso P, Rischin D, Sauleda S, Gee J, Nicholson R, Baselga J. Pharmacodynamic studies of the epidermal growth factor receptor inhibitor ZD1839 in skin from cancer patients: histopathologic and molecular consequences of receptor inhibition. Journal Of Clinical Oncology 2002, 20: 110-24. PMID: 11773160, DOI: 10.1200/jco.2002.20.1.110.Peer-Reviewed Original ResearchMeSH KeywordsAdministration, OralAdultAgedAntineoplastic AgentsApoptosisBiomarkersCell Cycle ProteinsCyclin-Dependent Kinase Inhibitor p27Dose-Response Relationship, DrugErbB ReceptorsFemaleGefitinibHumansKeratinocytesMaleMAP Kinase Signaling SystemMiddle AgedNeoplasmsQuinazolinesSkinStatistics, NonparametricTumor Suppressor ProteinsConceptsCancer patientsEpidermal growth factor receptor tyrosine kinase inhibitor ZD1839Tyrosine kinase inhibitor ZD1839Phase I clinical trialMaximum-tolerated doseDose-limiting toxicityEGFR activationReceptor-dependent processUnacceptable toxicityDefinitive efficacyPharmacodynamic assessmentSafety trialPharmacodynamic effectsClinical trialsKeratin plugsReceptor inhibitionMaturation markersSkin biopsiesPharmacodynamic studiesProliferation indexDose levelsOral ZD1839PatientsOptimal dosesZD1839
2001
Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck
Tseng J, Glisson B, Khuri F, Shin D, Myers J, El‐Naggar A, Roach J, Ginsberg L, Thall P, Wang X, Teddy S, Lawhorn K, Zentgraf R, Steinhaus G, Pluda J, Abbruzzese J, Hong W, Herbst R. Phase II study of the antiangiogenesis agent thalidomide in recurrent or metastatic squamous cell carcinoma of the head and neck. Cancer 2001, 92: 2364-2373. PMID: 11745292, DOI: 10.1002/1097-0142(20011101)92:9<2364::aid-cncr1584>3.0.co;2-p.Peer-Reviewed Original ResearchConceptsMetastatic squamous cell carcinomaSquamous cell carcinomaPhase II studyCell carcinomaProgressive diseaseII studySurvival timeAntiangiogenic effectsAdvanced squamous cell carcinomaBasic fibroblast growth factor levelsMedian overall survival timeFibroblast growth factor levelsSingle-agent thalidomideSingle-agent antitumor activityEarly-stage diseasePopulation of patientsOverall survival timeGrowth factor levelsVascular endothelial growth factorMinimal residual diseaseSignificant antitumor effectEndothelial growth factorMechanism of actionStage diseaseUnacceptable toxicity