2023
Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG).
Lee S, Fan W, Wang A, Vaidya R, Redman M, Gettinger S, Bazhenova L, Herbst R, Hershman D, Unger J. Novel Approaches for Dynamic Visualization of Adverse Event Data in Oncology Clinical Trials: A Case Study Using Immunotherapy Trial S1400-I (SWOG). JCO Clinical Cancer Informatics 2023, 7: e2200165. PMID: 37084329, PMCID: PMC10281446, DOI: 10.1200/cci.22.00165.Peer-Reviewed Original ResearchConceptsSystem organ classAdverse event dataRandomized phase III trialPhase III trialsCell lung cancerOncology clinical trialsOverall toxicity profileIII trialsNeurologic toxicityTreatment armsCardiac toxicityLung cancerClinical trialsGrade 3High prevalenceOrgan classToxicity profileNivolumabTreatment groupsStage IVEndocrine toxicityType of AEToxicity typesAE termsIpilimumab
2022
2MO First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in metastatic non-small cell lung cancer (mNSCLC): Clinical outcomes and biomarker analyses from CheckMate 592
Gettinger S, Schenker M, De Langen J, Fischer J, Morgensztern D, Ciuleanu T, Beck T, De Castro Carpeno J, Schumann C, Yang X, Telivala B, Deschepper K, Nadal E, Schalper K, Spires T, Balli D, Nassar A, Karam S, Bhingare A, Spigel D. 2MO First-line (1L) nivolumab (NIVO) + ipilimumab (IPI) in metastatic non-small cell lung cancer (mNSCLC): Clinical outcomes and biomarker analyses from CheckMate 592. Immuno-Oncology Technology 2022, 16: 100107. DOI: 10.1016/j.iotech.2022.100107.Peer-Reviewed Original Research
2019
O.02 Long-term Survival Outcomes with Nivolumab (NIVO) in Pts with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC): Impact of Early Disease Control and Response
Brahmer J, Horn L, Hossein B, Ramalingam S, Pluzanski A, Burgio M, Garassino M, Chow L, Gettinger S, Crino L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson G, Agrawal S, Li A, Penrod J, Antonia S, Bautista Y. O.02 Long-term Survival Outcomes with Nivolumab (NIVO) in Pts with Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC): Impact of Early Disease Control and Response. Journal Of Thoracic Oncology 2019, 14: s1152-s1153. DOI: 10.1016/j.jtho.2019.09.089.Peer-Reviewed Original ResearchOA14.04 Five-Year Outcomes From the Randomized, Phase 3 Trials CheckMate 017/057: Nivolumab vs Docetaxel in Previously Treated NSCLC
Gettinger S, Borghaei H, Brahmer J, Chow L, Burgio M, De Castro Carpeno J, Pluzanski A, Arrieta O, Frontera O, Chiari R, Butts C, Wojcik-Tomaszewska J, Coudert B, Garassino M, Ready N, Felip E, Garcia M, Waterhouse D, Domine M, Barlesi F, Antonia S, Wohlleber M, Gerber D, Czyzewicz G, Spigel D, Crino L, Eberhardt W, Li A, Marimuthu S, Vokes E. OA14.04 Five-Year Outcomes From the Randomized, Phase 3 Trials CheckMate 017/057: Nivolumab vs Docetaxel in Previously Treated NSCLC. Journal Of Thoracic Oncology 2019, 14: s244-s245. DOI: 10.1016/j.jtho.2019.08.486.Peer-Reviewed Original ResearchOA04.01 A Phase III Randomized Study of Nivolumab/Ipilimumab vs Nivolumab for Previously Treated Stage IV Squamous Cell Lung Cancer
Bazhenova L, Redman M, Gettinger S, Hirsch F, Mack P, Schwartz L, Gandara D, Bradley J, Stinchcombe T, Leighl N, Ramalingam S, Tavernier S, Minichiello K, Kelly K, Papadimitrakopoulou V, Herbst R. OA04.01 A Phase III Randomized Study of Nivolumab/Ipilimumab vs Nivolumab for Previously Treated Stage IV Squamous Cell Lung Cancer. Journal Of Thoracic Oncology 2019, 14: s214. DOI: 10.1016/j.jtho.2019.08.423.Peer-Reviewed Original ResearchFour-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis
Antonia SJ, Borghaei H, Ramalingam SS, Horn L, De Castro Carpeño J, Pluzanski A, Burgio MA, Garassino M, Chow LQM, Gettinger S, Crinò L, Planchard D, Butts C, Drilon A, Wojcik-Tomaszewska J, Otterson GA, Agrawal S, Li A, Penrod JR, Brahmer J. Four-year survival with nivolumab in patients with previously treated advanced non-small-cell lung cancer: a pooled analysis. The Lancet Oncology 2019, 20: 1395-1408. PMID: 31422028, PMCID: PMC7193685, DOI: 10.1016/s1470-2045(19)30407-3.Peer-Reviewed Original ResearchConceptsPD-L1 expressionCell lung cancerOverall survivalCheckMate 017Progressive diseaseHazard ratioSurvival outcomesLung cancerLong-term survival advantageDose of nivolumabTrials of nivolumabNew safety signalsFour-year survivalLonger overall survivalLonger response durationBristol-Myers SquibbStable diseaseAdvanced NSCLCObjective responsePooled analysisLong-term benefitsNivolumabSafety signalsClinical dataClinical studiesA phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952).
Bazhenova L, Redman M, Gettinger S, Hirsch F, Mack P, Schwartz L, Gandara D, Bradley J, Stinchcombe T, Leighl N, Ramalingam S, Tavernier S, Minichiello K, Kelly K, Papadimitrakopoulou V, Herbst R. A phase III randomized study of nivolumab plus ipilimumab versus nivolumab for previously treated patients with stage IV squamous cell lung cancer and no matching biomarker (Lung-MAP Sub-Study S1400I, NCT02785952). Journal Of Clinical Oncology 2019, 37: 9014-9014. DOI: 10.1200/jco.2019.37.15_suppl.9014.Peer-Reviewed Original ResearchInvestigator-assessed progression-free survivalOverall survivalInterim analysisStage IV squamous cell lung cancerSquamous cell lung cancerGrade 5 AEsImmunotherapy-naïve patientsStudies of nivolumabTreatment-related AEsPD-L1 expressionProgression-free survivalPhase IIICell lung cancerECOG 0Primary endpointRECIST 1.1Baseline characteristicsPD-L1Lung cancerLung-MAPNivolumabStage IVPatientsResponse rateMaster protocolsCheckMate 592: a phase 2 exploratory study of biomarkers associated with the efficacy of first-line nivolumab (nivo) plus ipilimumab (ipi) in patients (pts) with stage IV or recurrent NSCLC
Christoph D, Gettinger S, Beck J, Yang X, Telivala B, Morgensztern D, Velcheti V, Ramalingam S, Schalper K, Dajee M, Ranck A, Yang R, Spigel. CheckMate 592: a phase 2 exploratory study of biomarkers associated with the efficacy of first-line nivolumab (nivo) plus ipilimumab (ipi) in patients (pts) with stage IV or recurrent NSCLC. Pneumologie 2019, 73 DOI: 10.1055/s-0039-1678250.Peer-Reviewed Original Research
2018
1503TiP CheckMate 592: A phase II exploratory study of biomarkers associated with the efficacy of first-line nivolumab (nivo) plus ipilimumab (ipi) in patients (pts) with stage IV or recurrent NSCLC
Gettinger S, Beck T, Yang X, Telivala B, Morgensztern D, Velcheti V, Ramalingam S, Schalper K, Dajee M, Ranck A, Yang R, Spigel D. 1503TiP CheckMate 592: A phase II exploratory study of biomarkers associated with the efficacy of first-line nivolumab (nivo) plus ipilimumab (ipi) in patients (pts) with stage IV or recurrent NSCLC. Annals Of Oncology 2018, 29: viii544-viii545. DOI: 10.1093/annonc/mdy292.124.Peer-Reviewed Original ResearchP1.01-02 Long-Term Outcomes with First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 3-Year Follow-Up from CheckMate 012
Antonia S, Gettinger S, Borghaei H, Goldman J, Brahmer J, Ready N, Gerber D, Chow L, Juergens R, Laurie S, Shepherd F, Li X, Li A, Geese W, Hellmann M. P1.01-02 Long-Term Outcomes with First-Line Nivolumab Plus Ipilimumab in Advanced NSCLC: 3-Year Follow-Up from CheckMate 012. Journal Of Thoracic Oncology 2018, 13: s458. DOI: 10.1016/j.jtho.2018.08.558.Peer-Reviewed Original ResearchNivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC
Gettinger S, Hellmann MD, Chow LQM, Borghaei H, Antonia S, Brahmer JR, Goldman JW, Gerber DE, Juergens RA, Shepherd FA, Laurie SA, Young TC, Li X, Geese WJ, Rizvi N. Nivolumab Plus Erlotinib in Patients With EGFR-Mutant Advanced NSCLC. Journal Of Thoracic Oncology 2018, 13: 1363-1372. PMID: 29802888, DOI: 10.1016/j.jtho.2018.05.015.Peer-Reviewed Original ResearchConceptsAdvanced EGFR-mutant NSCLCEGFR-mutant NSCLCTreatment-related grade 3 toxicitiesEGFR-mutant advanced NSCLCProgression-free survival ratesEGFR T790M mutationEGFR tyrosine kinase inhibitorsGrade 3 toxicityObjective response rateTKI-naive patientsCompound EGFR mutationsT790M mutationTyrosine kinase inhibitorsImmune-related responsesInvestigator recordsAdvanced NSCLCDurable responsesUnacceptable toxicityComplete responseFourth patientDisease progressionEGFR mutationsMutant NSCLCTumor biopsiesNivolumabNKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT.
Diab A, Hurwitz M, Cho D, Papadimitrakopoulou V, Curti B, Tykodi S, Puzanov I, Ibrahim N, Tolaney S, Tripathy D, Gao J, Siefker-Radtke A, Clemens W, Tagliaferri M, Gettinger S, Kluger H, Larkin J, Grignani G, Sznol M, Tannir N. NKTR-214 (CD122-biased agonist) plus nivolumab in patients with advanced solid tumors: Preliminary phase 1/2 results of PIVOT. Journal Of Clinical Oncology 2018, 36: 3006-3006. DOI: 10.1200/jco.2018.36.15_suppl.3006.Peer-Reviewed Original Research
2017
1301PD Three-year follow-up from CheckMate 017/057: Nivolumab versus docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC)
Font E, Gettinger S, Burgio M, Antonia S, Holgado E, Spigel D, Arrieta O, Gomez M, Frontera O, Brahmer J, Chow L, Crinò L, Butts C, Coudert B, Horn L, Steins M, Geese W, Li A, Healey D, Vokes E. 1301PD Three-year follow-up from CheckMate 017/057: Nivolumab versus docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC). Annals Of Oncology 2017, 28: v462. DOI: 10.1093/annonc/mdx380.004.Peer-Reviewed Original ResearchOA03.01 First-Line Nivolumab Monotherapy and Nivolumab plus Ipilimumab in Patients with Advanced NSCLC: Long-Term Outcomes from CheckMate 012
Gettinger S, Rizvi N, Chow L, Borghaei H, Brahmer J, Shepherd F, Ready N, Gerber D, Antonia S, Goldman J, Juergens R, Geese W, Young T, Li X, Hellmann M. OA03.01 First-Line Nivolumab Monotherapy and Nivolumab plus Ipilimumab in Patients with Advanced NSCLC: Long-Term Outcomes from CheckMate 012. Journal Of Thoracic Oncology 2017, 12: s250-s251. DOI: 10.1016/j.jtho.2016.11.238.Peer-Reviewed Original Research
2016
ORAL01.03: CheckMate 012: Safety and Efficacy of First-Line Nivolumab and Ipilimumab in Advanced NSCLC Topic: Medical Oncology
Antonia S, Gettinger S, Goldman J, Brahmer J, Borghaei H, Chow L, Ready N, Gerber D, Juergens R, Shepherd F, Laurie S, Young T, Geese W, Agrawal S, Li X, Hellmann M. ORAL01.03: CheckMate 012: Safety and Efficacy of First-Line Nivolumab and Ipilimumab in Advanced NSCLC Topic: Medical Oncology. Journal Of Thoracic Oncology 2016, 11: s250-s251. DOI: 10.1016/j.jtho.2016.09.008.Peer-Reviewed Original ResearchP2.36: Nivolumab (nivo) in Patients (pts) With Advanced (adv) NSCLC and Central Nervous System (CNS) Metastases (mets) Track: Immunotherapy
Goldman J, Crino L, Vokes E, Holgado E, Reckamp K, Pluzanski A, Spigel D, Kohlhaeufl M, Garassino M, Chow L, Gettinger S, Gerber D, Havel L, Ramalingam S, Dy G, Geese W, Li A, Blackwood-Chirchir A, Healey D, Brahmer J, Lopes G. P2.36: Nivolumab (nivo) in Patients (pts) With Advanced (adv) NSCLC and Central Nervous System (CNS) Metastases (mets) Track: Immunotherapy. Journal Of Thoracic Oncology 2016, 11: s238-s239. DOI: 10.1016/j.jtho.2016.08.107.Peer-Reviewed Original ResearchCheckMate 331: An open-label, randomized phase III trial of nivolumab versus chemotherapy in patients (pts) with relapsed small cell lung cancer (SCLC) after first-line platinum-based chemotherapy (PT-DC).
Horn L, Reck M, Gettinger S, Spigel D, Antonia S, Rupnow B, Pieters A, Selvaggi G, Fairchild J, Peters S. CheckMate 331: An open-label, randomized phase III trial of nivolumab versus chemotherapy in patients (pts) with relapsed small cell lung cancer (SCLC) after first-line platinum-based chemotherapy (PT-DC). Journal Of Clinical Oncology 2016, 34: tps8578-tps8578. DOI: 10.1200/jco.2016.34.15_suppl.tps8578.Peer-Reviewed Original ResearchNivolumab (nivo) in patients (pts) with advanced (adv) NSCLC and central nervous system (CNS) metastases (mets).
Goldman J, Crino L, Vokes E, Holgado E, Reckamp K, Pluzanski A, Spigel D, Kohlhaeufl M, Garassino M, Chow L, Gettinger S, Gerber D, Havel L, Ramalingam S, Dy G, Geese W, Li A, Blackwood-Chirchir A, Healey D, Brahmer J. Nivolumab (nivo) in patients (pts) with advanced (adv) NSCLC and central nervous system (CNS) metastases (mets). Journal Of Clinical Oncology 2016, 34: 9038-9038. DOI: 10.1200/jco.2016.34.15_suppl.9038.Peer-Reviewed Original ResearchCheckMate 012: Safety and efficacy of first-line (1L) nivolumab (nivo; N) and ipilimumab (ipi; I) in advanced (adv) NSCLC.
Hellmann M, Gettinger S, Goldman J, Brahmer J, Borghaei H, Chow L, Ready N, Gerber D, Juergens R, Shepherd F, Laurie S, Zhou Y, Geese W, Agrawal S, Li X, Antonia S. CheckMate 012: Safety and efficacy of first-line (1L) nivolumab (nivo; N) and ipilimumab (ipi; I) in advanced (adv) NSCLC. Journal Of Clinical Oncology 2016, 34: 3001-3001. DOI: 10.1200/jco.2016.34.15_suppl.3001.Peer-Reviewed Original Research
2015
417O Phase 3, randomized trial (CheckMate 057) of nivolumab vs docetaxel in advanced non-squamous (non-SQ) non-small cell lung cancer (NSCLC): subgroup analyses and patient reported outcomes (PROs)
Horn L, Brahmer J, Reck M, Borghaei H, Spigel D, Steins M, Ready N, Chow L, Vokes E, Felip E, Holgado E, Barlesi F, Kohlhäufl M, Burgio M, Fayette J, Gettinger S, Harbison C, Li A, Finckenstein F, Paz-Ares L. 417O Phase 3, randomized trial (CheckMate 057) of nivolumab vs docetaxel in advanced non-squamous (non-SQ) non-small cell lung cancer (NSCLC): subgroup analyses and patient reported outcomes (PROs). Annals Of Oncology 2015, 26: ix125. DOI: 10.1093/annonc/mdv532.01.Peer-Reviewed Original Research