2014
1292P Alk Inhibitor Ap26113 in Patients with Advanced Malignancies, Including Alk+ Non-Small Cell Lung Cancer (Nsclc): Updated Efficacy and Safety Data
Gettinger S, Bazhenova L, Salgia R, Langer C, Gold K, Rosell R, Shaw A, Weiss G, Narasimhan N, Dorer D, Rivera V, Clackson T, Haluska F, Camidge R. 1292P Alk Inhibitor Ap26113 in Patients with Advanced Malignancies, Including Alk+ Non-Small Cell Lung Cancer (Nsclc): Updated Efficacy and Safety Data. Annals Of Oncology 2014, 25: iv455. DOI: 10.1093/annonc/mdu349.71.Peer-Reviewed Original ResearchBrain metastasesNSCLC ptsAdvanced malignanciesCommon treatment-emergent adverse eventsNon-small cell lung cancerMedian progression-free survivalTreatment-emergent adverse eventsIndependent radiological reviewProgression-free survivalCell lung cancerDuration of responseTyrosine kinase inhibitorsActive tyrosine kinase inhibitorPhase 2 portionAnti-tumor activityEvaluable ptsPrior crizotinibStable diseasePulmonary symptomsFree survivalGrade 1/2Radiological reviewAdverse eventsMulticenter studyLung cancer
2013
BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC).
Papadimitrakopoulou V, Wistuba I, Lee J, Tsao A, Kalhor N, Fossella F, Heymach J, Alden C, Gettinger S, Coombes K, Saintigny P, Tang X, Duffield E, Boyer J, Davis S, Powis G, Mauro D, Rubin E, Hong W, Herbst R. BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: tps8118-tps8118. DOI: 10.1200/jco.2013.31.15_suppl.tps8118.Peer-Reviewed Original ResearchNon-small cell lung cancerDisease control rateEvaluable ptsKRAS statusPredictive biomarkersRefractory non-small cell lung cancerAdvanced non-small cell lung cancerEML4/ALK translocationsPhase II clinical trialStage 1Lung Cancer EliminationOptimal patient selectionCell lung cancerEffective therapeutic strategyMEK inhibitor selumetinibUnmet medical needBiomarkers of resistanceAKT inhibitor MKPersonalized medicine approachPI3K/AktStage 2NCSLC patientsNSCLC ptsPatient selectionNSCLC treatment
2012
1237PD Clinical Activity and Safety of Anti-Programmed Death-1 (PD-1) (BMS-936558/MDX-1106/ONO-4538) in Patients (PTS) with Advanced Non-Small Cell Lung Cancer (NSCLC)
Gettinger S, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Wigginton J, Kollia G, Gupta A, Brahmer J. 1237PD Clinical Activity and Safety of Anti-Programmed Death-1 (PD-1) (BMS-936558/MDX-1106/ONO-4538) in Patients (PTS) with Advanced Non-Small Cell Lung Cancer (NSCLC). Annals Of Oncology 2012, 23: ix405. DOI: 10.1016/s0923-7534(20)33809-6.Peer-Reviewed Original ResearchAdvanced non-small cell lung cancerNon-small cell lung cancerBristol-Myers SquibbBMS-936558NSCLC ptsStable diseasePartial responseClinical activitySquamous non-small cell lung cancerAdditional long-term followCommon drug-related AEsDrug-related AEsECOG performance statusObjective response rateCo-inhibitory receptorsLong-term followCell lung cancerCycles of treatmentDrug-related deathsHuman monoclonal antibodyActivated T cellsCohort expansionEvaluable ptsPrior therapyRECIST v1.0Anti-PD-1 (BMS-936558, MDX-1106) in patients with advanced solid tumors: Clinical activity, safety, and a potential biomarker for response.
Topalian S, Brahmer J, Hodi F, McDermott D, Smith D, Gettinger S, Taube J, Drake C, Pardoll D, Antonia S, Spigel D, Atkins M, Lawrence D, McDonald D, Jure-Kunkel M, Korman A, Kollia G, Gupta A, Wigginton J, Sznol M. Anti-PD-1 (BMS-936558, MDX-1106) in patients with advanced solid tumors: Clinical activity, safety, and a potential biomarker for response. Journal Of Clinical Oncology 2012, 30: cra2509-cra2509. DOI: 10.1200/jco.2012.30.18_suppl.cra2509.Peer-Reviewed Original ResearchPD-1/PD-L1 pathwayPD-L1 pathwayPotential predictive biomarkersBMS-936558Predictive biomarkersNon-small cell lung cancerPre-treatment tumor biopsiesCastrate-resistant prostate cancerCo-inhibitory receptorsPD-L1 expressionPD-1 ligandsCell lung cancerOverall tumor burdenActivated T cellsCohort expansionEvaluable ptsRECIST 1.0Advanced NSCLCMedian durationDeath-1PD-1PD-L1Therapy cyclesNew lesionsTumor burden
2007
A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases
Mekhail T, Gettinger S, Blumenschein G, Axelrod R, Haigentz M, Guarino M, Cahill A, Spigel D, Greco F. A phase II trial of VNP40101M in patients with relapsed or refractory small cell lung cancer (SCLC) with or without brain metastases. Journal Of Clinical Oncology 2007, 25: 7724-7724. DOI: 10.1200/jco.2007.25.18_suppl.7724.Peer-Reviewed Original ResearchSmall cell lung cancerBrain metastasesBrain metsSCLC patientsRelapse groupVNP40101MGrade 3Refractory small cell lung cancerNon-hematologic toxicitiesRefractory SCLC patientsPhase II trialCell lung cancerBlood-brain barrierResistant tumor cell linesECOG PSEvaluable diseaseEvaluable ptsLine chemotherapyPrior chemotherapyRelapse diseaseSensitive relapseStable diseaseII trialRECIST criteriaStarting dose