2019
A phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors.
Chesney J, Lutzky J, Thomas S, Nieva J, Munoz Couselo E, Martin-Liberal J, Rodriguez-Moreno J, Cacovean A, Li H, Fardis M, Gettinger S. A phase II study of autologous tumor infiltrating lymphocytes (TIL, LN-144/LN-145) in patients with solid tumors. Journal Of Clinical Oncology 2019, 37: tps2648-tps2648. DOI: 10.1200/jco.2019.37.15_suppl.tps2648.Peer-Reviewed Original ResearchImmune checkpoint inhibitorsPrior immune checkpoint inhibitorsObjective response rateTIL therapyAdoptive cell therapySystemic therapyCohort 1Cohort 3RECIST 1.1Metastatic melanomaNeck cancerPhase 2 multicenterPrior systemic therapyDurable complete responseOpen-label studyPhase II studyMetastatic melanoma patientsCo-primary endpointsHigh mutational burdenAutologous tumorECOG PSMeasurable diseaseAcceptable toxicityCheckpoint inhibitorsImmunogenic tumors
2018
FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC
Spigel DR, Chaft JE, Gettinger S, Chao BH, Dirix L, Schmid P, Chow LQM, Hicks RJ, Leon L, Fredrickson J, Kowanetz M, Sandler A, Funke R, Rizvi NA. FIR: Efficacy, Safety, and Biomarker Analysis of a Phase II Open-Label Study of Atezolizumab in PD-L1–Selected Patients With NSCLC. Journal Of Thoracic Oncology 2018, 13: 1733-1742. PMID: 29775807, PMCID: PMC7455890, DOI: 10.1016/j.jtho.2018.05.004.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsObjective response ratePD-L1 expressionAdverse eventsCohort 1Immune cell PD-L1 expressionInvestigator-assessed objective response ratePhase II open-label studyResponse rateIC PD-L1 expressionTumor cellsBaseline tumor samplesOpen-label studyPhase II studyProgression-free survivalResponse Evaluation CriteriaDuration of responseAtezolizumab monotherapyAdvanced NSCLCBrain metastasesMonotherapy studiesPrimary endpointSecondary endpointsII studyOverall survival
2015
Clinical activity and safety from a phase II study (FIR) of MPDL3280A (anti-PDL1) in PD-L1–selected patients with non-small cell lung cancer (NSCLC).
Spigel D, Chaft J, Gettinger S, Chao B, Dirix L, Schmid P, Chow L, Chappey C, Kowanetz M, Sandler A, Funke R, Rizvi N. Clinical activity and safety from a phase II study (FIR) of MPDL3280A (anti-PDL1) in PD-L1–selected patients with non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2015, 33: 8028-8028. DOI: 10.1200/jco.2015.33.15_suppl.8028.Peer-Reviewed Original Research
2012
Results of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC).
Kim D, Ahn M, Shi Y, De Pas T, Yang P, Riely G, Crinò L, Evans T, Liu X, Han J, Salgia R, Moro-Sibilot D, Ou S, Gettinger S, Wu Y, Lanzalone S, Polli A, Iyer S, Shaw A. Results of a global phase II study with crizotinib in advanced ALK -positive non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2012, 30: 7533-7533. DOI: 10.1200/jco.2012.30.15_suppl.7533.Peer-Reviewed Original ResearchNon-small cell lung cancerAdvanced ALK-positive non-small cell lung cancerALK-positive non-small cell lung cancerPatient-reported symptomsTumor responseFrequent treatment-related AEsECOG PS 0Efficacy of crizotinibPrior chemotherapy regimensTreatment-related AEsTreatment-related SAEsDisease control rateMedian treatment durationPhase II studyFavorable tolerability profileMajority of patientsCell lung cancerEnd of treatmentEORTC QLQ-C30Standard of careALK gene rearrangementHigh response rateFebrile neutropeniaLC-13Median PFS
2010
Activity of IPI-504, a Novel Heat-Shock Protein 90 Inhibitor, in Patients With Molecularly Defined Non–Small-Cell Lung Cancer
Sequist LV, Gettinger S, Senzer NN, Martins RG, Jänne PA, Lilenbaum R, Gray JE, Iafrate AJ, Katayama R, Hafeez N, Sweeney J, Walker JR, Fritz C, Ross RW, Grayzel D, Engelman JA, Borger DR, Paez G, Natale R. Activity of IPI-504, a Novel Heat-Shock Protein 90 Inhibitor, in Patients With Molecularly Defined Non–Small-Cell Lung Cancer. Journal Of Clinical Oncology 2010, 28: 4953-4960. PMID: 20940188, PMCID: PMC4676802, DOI: 10.1200/jco.2010.30.8338.Peer-Reviewed Original ResearchMeSH KeywordsAdultAgedAged, 80 and overAnaplastic Lymphoma KinaseBenzoquinonesCarcinoma, Non-Small-Cell LungErbB ReceptorsFemaleGene RearrangementHSP90 Heat-Shock ProteinsHumansLactams, MacrocyclicLung NeoplasmsMaleMiddle AgedMutationProspective StudiesProtein-Tyrosine KinasesReceptor Protein-Tyrosine KinasesConceptsObjective response rateProgression-free survivalCell lung cancerIPI-504Lung cancerEpidermal growth factor receptor tyrosine kinase inhibitor therapyUnited States cancer centersTyrosine kinase inhibitor therapyState Cancer CenterCommon adverse eventsLiver function abnormalitiesPhase II studyOverall study populationKinase inhibitor therapyHeat shock protein 90 inhibitorNovel heat shock protein 90 inhibitorALK gene rearrangementStable diseaseAdvanced NSCLCAdverse eventsFunction abnormalitiesII studyPartial responseInhibitor therapyPrimary outcome
2009
Axitinib: The evidence of its potential in the treatment of advanced thyroid cancer
Deshpande HA, Gettinger S, Sosa JA. Axitinib: The evidence of its potential in the treatment of advanced thyroid cancer. Core Evidence 2009, Volume 4: 43-48. PMID: 20694064, PMCID: PMC2899774, DOI: 10.2147/ce.s5996.Peer-Reviewed Original ResearchThyroid cancerVascular endothelial growth factor receptor 1Common grade 3Refractory thyroid cancerUse of axitinibGood tolerability profilePhase II studyAdvanced thyroid cancerGrowth factor receptor 1Greater side effectsFactor receptor 1Growth factor receptorStable diseaseTolerability profileII studyHistological typeCancer deathGrade 3New small molecule inhibitorsRare diseaseSide effectsSmall molecule inhibitorsResponse rateNew treatmentsReceptor 1