2023
Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer
Rudin C, Cervantes A, Dowlati A, Besse B, Ma B, Costa D, Schmid P, Heist R, Villaflor V, Spahn J, Li S, Cha E, Riely G, Gettinger S. Safety and clinical activity of atezolizumab plus erlotinib in patients with non-small-cell lung cancer. ESMO Open 2023, 8: 101160. PMID: 36871392, PMCID: PMC10163154, DOI: 10.1016/j.esmoop.2023.101160.Peer-Reviewed Original ResearchConceptsTreatment-related adverse eventsCell lung cancerAdverse eventsLung cancerClinical activityEpidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) efficacyGrade 3 treatment-related adverse eventsEGFR TKI-naive patientsMedian progression-free survivalEGFR mutation-positive NSCLCAdvanced EGFR mutation-positive NSCLCTyrosine kinase inhibitor efficacyDurable clinical activityTolerable safety profileMedian overall survivalMedian response durationObjective response ratePhase Ib trialSerious adverse eventsProgression-free survivalStage 2 patientsMutation-positive NSCLCEGFR-mutant NSCLCTKI-naive patientsAtezolizumab 1200
2017
Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib
Horn L, Gettinger S, Camidge DR, Smit EF, Janjigian YY, Miller VA, Pao W, Freiwald M, Fan J, Wang B, Chand VK, Groen HJM. Continued use of afatinib with the addition of cetuximab after progression on afatinib in patients with EGFR mutation-positive non-small-cell lung cancer and acquired resistance to gefitinib or erlotinib. Lung Cancer 2017, 113: 51-58. PMID: 29110849, DOI: 10.1016/j.lungcan.2017.08.014.Peer-Reviewed Original ResearchMeSH KeywordsAdultAfatinibAgedAged, 80 and overAntineoplastic Combined Chemotherapy ProtocolsCarcinoma, Non-Small-Cell LungCetuximabCohort StudiesDiarrheaDisease ProgressionDrug Resistance, NeoplasmErbB ReceptorsErlotinib HydrochlorideExanthemaFemaleGefitinibHumansKaplan-Meier EstimateLung NeoplasmsMaleMiddle AgedMutationQuinazolinesConceptsEGFR mutation-positive NSCLCEpidermal growth factor receptorMutation-positive NSCLCCell lung cancerAdverse eventsAfatinib monotherapyMedian PFSLung cancerDrug-related grade 3/4 adverse eventsFrequent drug-related adverse eventsDrug-related adverse eventsGrade 3/4 adverse eventsAddition of cetuximabIntolerable adverse eventsPhase Ib trialT790M-negative tumorsPercent of patientsPredictable safety profileAfatinib dailyGrowth factor receptorIb trialSafety profileClinical activityDry skinSeparate cohortActivity of brigatinib (BRG) in crizotinib (CRZ)-resistant ALK+ NSCLC patients (pts) according to ALK plasma mutation status.
Bazhenova L, Hodgson J, Langer C, Simon G, Gettinger S, Ou S, Reckamp K, West H, Chiappori A, Koh H, Molina J, Shaw A, Patel J, Favaro J, Haney J, Reichmann W, Kerstein D, Rivera V, Camidge D. Activity of brigatinib (BRG) in crizotinib (CRZ)-resistant ALK+ NSCLC patients (pts) according to ALK plasma mutation status. Journal Of Clinical Oncology 2017, 35: 9065-9065. DOI: 10.1200/jco.2017.35.15_suppl.9065.Peer-Reviewed Original ResearchSecondary ALK mutationsNSCLC ptsALK mutationsALK fusionMutation statusObjective response ratePlasma samplesALK mutation statusSelective ALK inhibitorNSCLC patientsClinical activityEvaluable samplesALK inhibitorsResistance patternsSecondary resistanceTherapeutic implicationsComplex mutation patternsResponse rateBrigatinibPlasma specimensWild-type ALKALKTrialsGood responseMutation patternsP3.02c-046 Safety, Clinical Activity and Biomarker Results from a Phase Ib Study of Erlotinib plus Atezolizumab in Advanced NSCLC Topic: IT
Rudin C, Cervantes A, Dowlati A, Besse B, Ma B, Costa D, Schmid P, Heist R, Villaflor V, Sarkar I, Huseni M, Foster P, O'Hear C, Gettinger S. P3.02c-046 Safety, Clinical Activity and Biomarker Results from a Phase Ib Study of Erlotinib plus Atezolizumab in Advanced NSCLC Topic: IT. Journal Of Thoracic Oncology 2017, 12: s1302-s1303. DOI: 10.1016/j.jtho.2016.11.1841.Peer-Reviewed Original Research
2016
441O Preliminary safety and clinical activity of erlotinib plus atezolizumab from a Phase Ib study in advanced NSCLC
Ma B, Rudin C, Cervantes A, Dowlati A, Costa D, Schmid P, Heist R, Villaflor V, Sarkar I, Huseni M, Foster P, O’Hear C, Gettinger S, Besse B. 441O Preliminary safety and clinical activity of erlotinib plus atezolizumab from a Phase Ib study in advanced NSCLC. Annals Of Oncology 2016, 27: ix141. DOI: 10.1016/s0923-7534(21)00599-8.Peer-Reviewed Original Research441O Preliminary safety and clinical activity of erlotinib plus atezolizumab from a Phase Ib study in advanced NSCLC
Ma B, Rudin C, Cervantes A, Dowlati A, Costa D, Schmid P, Heist R, Villaflor V, Sarkar I, Huseni M, Foster P, O'Hear C, Gettinger S, Besse B. 441O Preliminary safety and clinical activity of erlotinib plus atezolizumab from a Phase Ib study in advanced NSCLC. Annals Of Oncology 2016, 27 DOI: 10.1093/annonc/mdw594.005.Peer-Reviewed Original ResearchPS01.62: Long-Term Safety and Clinical Activity of Atezolizumab Monotherapy in Metastatic NSCLC: Final Results from a Phase Ia Study Topic: Medical Oncology
Gordon M, Herbst R, Horn L, Soria J, Gandhi L, Felip E, Sequist L, Spigel D, Antonia S, Balmanoukian A, Cassier P, Liu B, Kowanetz M, O'Hear C, Fassò M, Sandler A, Gettinger S. PS01.62: Long-Term Safety and Clinical Activity of Atezolizumab Monotherapy in Metastatic NSCLC: Final Results from a Phase Ia Study Topic: Medical Oncology. Journal Of Thoracic Oncology 2016, 11: s309-s310. DOI: 10.1016/j.jtho.2016.09.097.Peer-Reviewed Original Research1425PD Clinical activity, safety and predictive biomarkers results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC)
Sequist L, Chiang A, Gilbert J, Gordon M, Conkling P, Thompson D, Marcoux J, Antonia S, Liu B, Shames D, Lopez-Chavez A, O'Hear C, Fasso M, Gettinger S. 1425PD Clinical activity, safety and predictive biomarkers results from a phase Ia atezolizumab (atezo) trial in extensive-stage small cell lung cancer (ES-SCLC). Annals Of Oncology 2016, 27: vi493. DOI: 10.1093/annonc/mdw389.03.Peer-Reviewed Original Research
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 ResearchClinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): update from a phase Ia study.
Horn L, Spigel D, Gettinger S, Antonia S, Gordon M, Herbst R, Sequist L, Chappey C, Kowanetz M, Sandler A, Soria J. Clinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): update from a phase Ia study. Journal Of Clinical Oncology 2015, 33: 8029-8029. DOI: 10.1200/jco.2015.33.15_suppl.8029.Peer-Reviewed Original Research
2014
Circulating and tumor-based biomarkers predict clinical activity in cancer patients treated with the engineered anti-PD-L1 antibody MPDL3280A
Kowanetz M, Rabe C, Xiao Y, Wu Q, Koeppen H, Leddy C, Patel R, Powderly J, Kohrt H, Gettinger S, Soria J, Herbst R, Desai R, Denker M, Ruppel J, Boe M, Nakamura R, Fu L, Sumiyoshi T, Mokatrin A, Shen X, Fine G, Chen D, Hegde P. Circulating and tumor-based biomarkers predict clinical activity in cancer patients treated with the engineered anti-PD-L1 antibody MPDL3280A. Journal For ImmunoTherapy Of Cancer 2014, 2: p136. PMCID: PMC4288453, DOI: 10.1186/2051-1426-2-s3-p136.Peer-Reviewed Original ResearchLong-term Survival, Clinical Activity, and Safety of Nivolumab (Anti-PD-1; BMS-936558, ONO-4538) in Patients (Pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) Metastatic Non-Small Cell Lung Cancer
Gettinger S, Horn L, Gandhi L, Spigel D, Antonia S, Rizvi N, Powderly J, Heist R, Carvajal R, Jackman D, Sequist L, Smith D, Leming P, Topalian S, Hodi F, Sznol M, Harbison C, Kollia G, Brahmer J. Long-term Survival, Clinical Activity, and Safety of Nivolumab (Anti-PD-1; BMS-936558, ONO-4538) in Patients (Pts) With Advanced Non-Small Cell Lung Cancer (NSCLC) Metastatic Non-Small Cell Lung Cancer. International Journal Of Radiation Oncology • Biology • Physics 2014, 90: s34. DOI: 10.1016/j.ijrobp.2014.08.209.Peer-Reviewed Original Research1322P Biomarkers Associated with Clinical Activity of Pd-L1 Blockade in Non-Small Cell Lung Cancer (Nsclc) Patients (Pts) in a Phase I Study of Mpdl3280A
Soria J, Gettinger S, Gordon M, Heist R, Horn L, Spigel D, Kowanetz M, Mokatrin A, Xiao Y, Sandler A, Felip E. 1322P Biomarkers Associated with Clinical Activity of Pd-L1 Blockade in Non-Small Cell Lung Cancer (Nsclc) Patients (Pts) in a Phase I Study of Mpdl3280A. Annals Of Oncology 2014, 25: iv465. DOI: 10.1093/annonc/mdu349.101.Peer-Reviewed Original ResearchPD-L1 expressionPD-L1 blockadeIHC 2PD-L1Immune cellsNSCLC ptsB7-H4B7-H3PD-L2Tumor cellsIHC 0Clinical activityNon-small cell lung cancer patientsTumor-infiltrating immune cellsCell lung cancer patientsEmployees of GenentechReceptor PD-1Tumor immune microenvironmentLung cancer patientsPD-L1 IHCPD-L1 bindingRoche/GenentechImmune-related genesBristol-Myers SquibbPFS ratesDual Inhibition of EGFR with Afatinib and Cetuximab in Kinase Inhibitor–Resistant EGFR-Mutant Lung Cancer with and without T790M Mutations
Janjigian YY, Smit EF, Groen HJ, Horn L, Gettinger S, Camidge DR, Riely GJ, Wang B, Fu Y, Chand VK, Miller VA, Pao W. Dual Inhibition of EGFR with Afatinib and Cetuximab in Kinase Inhibitor–Resistant EGFR-Mutant Lung Cancer with and without T790M Mutations. Cancer Discovery 2014, 4: 1036-1045. PMID: 25074459, PMCID: PMC4155006, DOI: 10.1158/2159-8290.cd-14-0326.Peer-Reviewed Original ResearchConceptsEGFR-mutant lung cancerT790M mutationLung cancerM mutationGrade 3/4 adverse eventsMedian progression-free survivalEGFR T790M mutationErlotinib/gefitinibRobust clinical activityT790M-negative tumorsManageable safety profileObjective response ratePhase Ib studyProgression-free survivalMutant lung cancerGefitinib/erlotinibFirst clinical proofReversible EGFR inhibitorsAdverse eventsMedian durationObjective responseSafety profilePreclinical hypothesisEGFR mutationsClinical activityNivolumab (anti-PD-1, BMS-936558, ONO-4538) in patients (pts) with advanced non-small-cell lung cancer (NSCLC): Survival and clinical activity by subgroup analysis.
Brahmer J, Horn L, Gandhi L, Spigel D, Antonia S, Rizvi N, Powderly J, Heist R, Carvajal R, Jackman D, Sequist L, Smith D, Leming P, Topalian S, Hodi F, Sznol M, Harbison C, Kollia G, Gupta A, Gettinger S. Nivolumab (anti-PD-1, BMS-936558, ONO-4538) in patients (pts) with advanced non-small-cell lung cancer (NSCLC): Survival and clinical activity by subgroup analysis. Journal Of Clinical Oncology 2014, 32: 8112-8112. DOI: 10.1200/jco.2014.32.15_suppl.8112.Peer-Reviewed Original Research
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 v1.0Clinical activity and safety of anti-PD1 (BMS-936558, MDX-1106) in patients with advanced non-small-cell lung cancer (NSCLC).
Brahmer J, Horn L, Antonia S, Spigel D, Gandhi L, Sequist L, Wigginton J, McDonald D, Kollia G, Gupta A, Gettinger S. Clinical activity and safety of anti-PD1 (BMS-936558, MDX-1106) in patients with advanced non-small-cell lung cancer (NSCLC). Journal Of Clinical Oncology 2012, 30: 7509-7509. DOI: 10.1200/jco.2012.30.15_suppl.7509.Peer-Reviewed Original ResearchBMS-936558Advanced NSCLCClinical activityPrior tyrosine kinase inhibitorsPrior chemotherapy regimenECOG performance statusCo-inhibitory receptorsPlatinum-based chemotherapyCell lung cancerOverall tumor burdenCycles of treatmentPercent of ptsDrug-related deathsTyrosine kinase inhibitorsActivated T cellsCohort expansionNSCLC ptsPrior therapyRECIST 1.0Chemotherapy regimenMedian durationMetastatic diseaseMultiple histologiesPerformance statusLymph nodesAnti-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.2012.30.15_suppl.cra2509.Peer-Reviewed Original Research
2010
Association between anaplastic lymphoma kinase rearrangements (rALK) and the clinical activity of IPI-504 (retaspimycin hydrochloride), a novel Hsp90 inhibitor, in patients with non-small cell lung cancer (NSCLC).
Sequist L, Natale R, Senzer N, Martins R, Lilenbaum R, Gray J, Borger D, Paez G, Grayzel D, Gettinger S. Association between anaplastic lymphoma kinase rearrangements (rALK) and the clinical activity of IPI-504 (retaspimycin hydrochloride), a novel Hsp90 inhibitor, in patients with non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2010, 28: 7517-7517. DOI: 10.1200/jco.2010.28.15_suppl.7517.Peer-Reviewed Original Research