2021
Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer
Gettinger SN, Redman MW, Bazhenova L, Hirsch FR, Mack PC, Schwartz LH, Bradley JD, Stinchcombe TE, Leighl NB, Ramalingam SS, Tavernier SS, Yu H, Unger JM, Minichiello K, Highleyman L, Papadimitrakopoulou VA, Kelly K, Gandara DR, Herbst RS. Nivolumab Plus Ipilimumab vs Nivolumab for Previously Treated Patients With Stage IV Squamous Cell Lung Cancer. JAMA Oncology 2021, 7: 1368-1377. PMID: 34264316, PMCID: PMC8283667, DOI: 10.1001/jamaoncol.2021.2209.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerInvestigator-assessed progression-free survivalNivolumab/ipilimumabPlatinum-based chemotherapyCell lung cancerOverall survivalIpilimumab groupLung cancerClinical trialsDisease progressionStage IV squamous cell lung cancerAdvanced non-small cell lung cancerHigher treatment-related adverse eventsTreatment-related adverse eventsSquamous cell lung cancerNational Clinical Trials NetworkStandard platinum-based chemotherapyEnd pointAddition of ipilimumabIntolerable toxic effectsNivolumab Plus IpilimumabMedian response durationPrimary end pointSecondary end pointsProgression-free survivalA Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1
Weiss SA, Djureinovic D, Jessel S, Krykbaeva I, Zhang L, Jilaveanu L, Ralabate A, Johnson B, Levit NS, Anderson G, Zelterman D, Wei W, Mahajan A, Trifan O, Bosenberg M, Kaech SM, Perry CJ, Damsky W, Gettinger S, Sznol M, Hurwitz M, Kluger HM. A Phase I Study of APX005M and Cabiralizumab with or without Nivolumab in Patients with Melanoma, Kidney Cancer, or Non–Small Cell Lung Cancer Resistant to Anti-PD-1/PD-L1. Clinical Cancer Research 2021, 27: 4757-4767. PMID: 34140403, PMCID: PMC9236708, DOI: 10.1158/1078-0432.ccr-21-0903.Peer-Reviewed Original ResearchConceptsAnti-PD-1/PD-L1Non-small cell lung cancerCell lung cancerRenal cell carcinomaPD-L1Lung cancerDisease progressionCommon treatment-related adverse eventsPD-1/PD-L1 inhibitorsTreatment-related adverse eventsPhase 2 doseSubstantial clinical challengeUnconfirmed partial responseDose-limiting toxicityPD-L1 inhibitorsPhase I trialDose-escalation designPro-inflammatory cytokinesMultiple tumor typesAsymptomatic elevationStable diseaseIntolerable toxicityAdverse eventsMedian durationPartial response
2018
Nivolumab 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 biopsiesNivolumab
2017
Brigatinib (BRG) in patients (pts) with crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC) and brain metastases in the pivotal randomized phase 2 ALTA trial.
Ou S, Tiseo M, Camidge D, Ahn M, Huber R, Hochmair M, Kim S, West H, Reckamp K, Molina J, Liu G, Delmonte A, Viteri Ramirez S, Bearz A, Summers Y, Reichmann W, Kerstein D, Gettinger S, Kim D. Brigatinib (BRG) in patients (pts) with crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC) and brain metastases in the pivotal randomized phase 2 ALTA trial. Journal Of Clinical Oncology 2017, 35: e20502-e20502. DOI: 10.1200/jco.2017.35.15_suppl.e20502.Peer-Reviewed Original ResearchNon-small cell lung cancerBaseline brain metastasesBrain metastasesIndependent review committeeIntracranial efficacyCommon treatment-emergent adverse eventsNext-generation ALK inhibitorsTreatment-emergent adverse eventsFirst disease progressionCell lung cancerBlood CPKNSCLC ptsAdverse eventsAcceptable safetyLung cancerDisease progressionIntracranial responseALK inhibitorsBrigatinibMetastasisReview CommitteeGood responseEfficacyTrialsHypertensionBrigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial.
Ahn M, Camidge D, Tiseo M, Reckamp K, Holmskov Hansen K, Kim S, Huber R, West H, Groen H, Hochmair M, Leighl N, Gettinger S, Langer C, Paz-Ares L, Smit E, Kim E, Reichmann W, Kerstein D, Kim D. Brigatinib (BRG) in crizotinib (CRZ)-refractory ALK+ non-small cell lung cancer (NSCLC): Updates from ALTA, a pivotal randomized phase 2 trial. Journal Of Clinical Oncology 2017, 35: e20503-e20503. DOI: 10.1200/jco.2017.35.15_suppl.e20503.Peer-Reviewed Original ResearchNon-small cell lung cancerObjective response rateRandomized phase 2 trialPhase 2 trialAdverse eventsBrain metastasesMost common treatment-emergent adverse eventsCommon treatment-emergent adverse eventsTreatment-emergent adverse eventsIntracranial objective response rateBaseline brain metastasesPulmonary adverse eventsPhase 1/2 trialCell lung cancerRECIST v1.1Primary endpointNSCLC patientsMedian ageAcceptable safetyLung cancerDisease progressionDose reductionDose levelsResponse rateBrigatinibCirculating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC).
Henick B, Goldberg S, Narayan A, Rossi C, Rodney S, Kole A, Politi K, Gettinger S, Herbst R, Patel A. Circulating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2017, 35: e20652-e20652. DOI: 10.1200/jco.2017.35.15_suppl.e20652.Peer-Reviewed Original ResearchNon-small cell lung cancerTyrosine kinase inhibitorsEGFR-mutant non-small cell lung cancerCtDNA levelsDisease progressionRadiographic progressionTKI therapyEGFR mutationsEGFR mutation-positive non-small cell lung cancerMutation-positive non-small cell lung cancerT790MAnti-PD-1 monotherapyEGFR mutation-positive patientsPD-1 inhibitor monotherapyEGFR-mutant NSCLC patientsSubset of patientsCell lung cancerMutation-positive patientsAssessment of responseLow ctDNA levelsChart reviewClinical characteristicsDurable responsesInhibitor monotherapyNSCLC patients
2013
A phase III comparative study of nivolumab (anti-PD-1; BMS-963558; ONO-4538) versus docetaxel in patients (pts) with previously treated advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC).
Gettinger S, Brahmer J, Rizvi N, Ready N, Chow L, Antonia S, Buyse M, Jassem J, Finckenstein F, Crinò L, Lynch T. A phase III comparative study of nivolumab (anti-PD-1; BMS-963558; ONO-4538) versus docetaxel in patients (pts) with previously treated advanced/metastatic nonsquamous non-small-cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: tps8121-tps8121. DOI: 10.1200/jco.2013.31.15_suppl.tps8121.Peer-Reviewed Original ResearchNon-squamous NSCLCOverall survivalTyrosine kinase inhibitorsPD-L1Maintenance therapyAdvanced diseaseLung cancerDisease progressionPlatinum-based doublet chemotherapyRecurrent non-squamous NSCLCPhase III comparative studyMedian overall survivalObjective response ratePhase III studyProgression-free survivalPhase 1 studyCell lung cancerDurable antitumor activityPD-1 receptorImmune checkpoint receptorsT cell activationDoublet chemotherapyNSCLC ptsOS benefitUnacceptable toxicity
2012
A phase I study of BMS-936558 in combination with gemcitabine/cisplatin, pemetrexed/cisplatin, or carboplatin/paclitaxel in patients with treatment-naive, stage IIIB/IV non-small-cell lung cancer.
Gettinger S, Rizvi N, Shepherd F, Chow L, Laurie S, Spigel D, Sbar E, Shen Y, Brahmer J. A phase I study of BMS-936558 in combination with gemcitabine/cisplatin, pemetrexed/cisplatin, or carboplatin/paclitaxel in patients with treatment-naive, stage IIIB/IV non-small-cell lung cancer. Journal Of Clinical Oncology 2012, 30: tps2615-tps2615. DOI: 10.1200/jco.2012.30.15_suppl.tps2615.Peer-Reviewed Original ResearchBMS-936558Cell lung cancerAdverse eventsTreatment armsLung cancerDisease progressionAnti-PD-1 monoclonal antibodyStage IIIB/IV NSCLCPlatinum-based doublet chemotherapyStage IIIB/IVImpressive tumor responsesCarboplatin/paclitaxelDisease control rateIIIB/IVFirst-line standardPD-1 expressionSerious adverse eventsDose-limiting toxicityGemcitabine/cisplatinPhase 1 studyPlatinum-based chemotherapyPhase 1 trialCancer-related mortalityOverall response rateWithdrawal of consent