2021
Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non-small cell lung cancer previously treated with a checkpoint inhibitor: Toxicity update (Lung-MAP non-matched sub-study S1800A).
Reckamp K, Redman M, Dragnev K, Villaruz L, Faller B, Al Baghdadi T, Hines S, Qian L, Minichiello K, Gandara D, Herbst R, Kelly K. Phase II randomized study of ramucirumab plus pembrolizumab versus standard of care for advanced non-small cell lung cancer previously treated with a checkpoint inhibitor: Toxicity update (Lung-MAP non-matched sub-study S1800A). Journal Of Clinical Oncology 2021, 39: 9075-9075. DOI: 10.1200/jco.2021.39.15_suppl.9075.Peer-Reviewed Original ResearchVascular endothelial growth factorThromboembolic eventsAdvanced non-small cell lung cancerNon-small cell lung cancerPlatinum-based doublet therapyPD-L1 inhibitor therapyGrade 5 AEsTreatment-related AEsVEGF receptor inhibitionGrade 3 toxicityAdverse event profilePD-L1 expressionAdverse event assessmentCell lung cancerDuration of responseTumor immune microenvironmentStandard of carePhase IIEndothelial growth factorMultiple tumor typesCare armCommon AEsECOG 0Checkpoint inhibitorsDoublet therapy
2020
O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC
Herbst R, De Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Font E, Andric Z, Geater S, Ozguroglu M, Mocci S, McCleland M, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, Jassem J, Spigel D. O81 IMpower110: interim overall survival (OS) analysis of a phase III study of atezolizumab (ATEZO) monotherapy vs platinum-based chemotherapy (CHEMO) as first-line (1L) treatment in PD-L1–selected NSCLC. Journal For ImmunoTherapy Of Cancer 2020, 8: a1. DOI: 10.1136/lba2019.1.Peer-Reviewed Original ResearchTreatment-related AEsPD-L1 expressionPrimary endpointArm APD-L1Interim overall survival analysisTumor PD-L1 statusPD-L1/PDCarboplatin AUC 6ECOG PS 0Primary efficacy populationUnexpected safety signalsFirst-line treatmentPD-L1 statusPhase III studyPlatinum-based chemotherapyWT populationOverall survival analysisDeclaration of HelsinkiAttractive treatment choiceAtezolizumab monotherapyAUC 5AUC 6CPI monotherapyECOG PS
2019
LBA78 IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC
Spigel D, de Marinis F, Giaccone G, Reinmuth N, Vergnenegre A, Barrios C, Morise M, Felip E, Andric Z, Geater S, Özgüroğlu M, Mocci S, McCleland M, Enquist I, Komatsubara K, Deng Y, Kuriki H, Wen X, Jassem J, Herbst R. LBA78 IMpower110: Interim overall survival (OS) analysis of a phase III study of atezolizumab (atezo) vs platinum-based chemotherapy (chemo) as first-line (1L) treatment (tx) in PD-L1–selected NSCLC. Annals Of Oncology 2019, 30: v915. DOI: 10.1093/annonc/mdz293.Peer-Reviewed Original ResearchTreatment-related AEsPD-L1 expressionPD-L1F. Hoffmann-La RocheBristol-Myers SquibbHoffmann-La RocheBoehringer IngelheimArm ACisplatin 75mg/m2Interim overall survival analysisTumor PD-L1 statusTumor-infiltrating immune cellsPD-L1/PDEli LillyCarboplatin AUC 6ECOG PS 0Primary efficacy populationUnexpected safety signalsPD-L1 statusFirst-line treatmentPhase III studyPlatinum-based chemotherapyOverall survival analysisRoche/GenentechBristol-Meyers Squibb1482O Outcomes with pembrolizumab (pembro) monotherapy in patients (pts) with PD-L1–positive NSCLC with brain metastases: Pooled analysis of KEYNOTE-001, -010, -024, and -042
Mansfield A, Herbst R, Castro G, Hui R, Peled N, Kim D, Novello S, Satouchi M, Wu Y, Garon E, Reck M, Robinson A, Samkari A, Piperdi B, Ebiana V, Lin J, Mok T. 1482O Outcomes with pembrolizumab (pembro) monotherapy in patients (pts) with PD-L1–positive NSCLC with brain metastases: Pooled analysis of KEYNOTE-001, -010, -024, and -042. Annals Of Oncology 2019, 30: v604-v606. DOI: 10.1093/annonc/mdz260.004.Peer-Reviewed Original ResearchStable brain metastasesSubsidiary of MerckGenentech/RocheBrain metastasesDohme Corp.PD-L1Personal feesMerck SeronoPositive NSCLCEMD SeronoBoehringer IngelheimMerck SharpKEYNOTE-001Clovis OncologyData cutoffAdvisory board membersEli LillyRoche/GenentechMesothelioma Applied Research FoundationSeattle GeneticsVertex PharmaceuticalsAdvanced PD-L1Baseline brain metastasesBrain metastasis statusTreatment-related AEsA 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 protocols
2017
Ramucirumab (R) plus pembrolizumab (P) in treatment naive and previously treated advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease phase I study.
Chau I, Bendell J, Calvo E, Santana-Davila R, Arkenau H, Mi G, Jin J, Rege J, Ferry D, Herbst R, Fuchs C. Ramucirumab (R) plus pembrolizumab (P) in treatment naive and previously treated advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma: A multi-disease phase I study. Journal Of Clinical Oncology 2017, 35: 4046-4046. DOI: 10.1200/jco.2017.35.15_suppl.4046.Peer-Reviewed Original ResearchTreatment-related AEsDisease control rateECOG PSMedian durationMedian agePD-L1GEJ adenocarcinomaDay 1Phase 1a/b trialECOG PS 0Experienced grade 3Treatment-related deathsNew safety signalsPD-L1 statusOverall survival rateGastroesophageal junction adenocarcinomaPreliminary efficacy dataMeasurable diseaseMedian PFSAdvanced diseaseTreatment-naïveAdvanced gastricPS 0Junction adenocarcinomaCohort AA multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma.
Petrylak D, Arkenau H, Perez-Gracia J, Krebs M, Santana-Davila R, Yang J, Rege J, Mi G, Ferry D, Herbst R. A multicohort phase I study of ramucirumab (R) plus pembrolizumab (P): Interim safety and clinical activity in patients with urothelial carcinoma. Journal Of Clinical Oncology 2017, 35: 349-349. DOI: 10.1200/jco.2017.35.6_suppl.349.Peer-Reviewed Original ResearchTreatment-related AEsECOG PS 0Median durationPS 0PD-L1Urothelial carcinomaDay 1Phase 1a/b trialPlatinum-based systemic therapyTreatment-related grade 4Advanced urothelial carcinomaElevated alanine aminotransferaseNew safety signalsElevated aspartate aminotransferaseBaseline tumor tissuePreliminary efficacy dataTransitional cell carcinomaEligible ptsMeasurable diseaseMedian PFSStable diseasePartial responseProgressive diseaseSystemic therapyMedian ageInterim safety and clinical activity in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma from a multicohort phase 1 study of ramucirumab (R) plus pembrolizumab (P).
Chau I, Bendell J, Calvo E, Santana-Davila R, Rodon Ahnert J, Penel N, Arkenau H, Yang J, Rege J, Mi G, Ferry D, Herbst R, Fuchs C. Interim safety and clinical activity in patients (pts) with advanced gastric or gastroesophageal junction (G/GEJ) adenocarcinoma from a multicohort phase 1 study of ramucirumab (R) plus pembrolizumab (P). Journal Of Clinical Oncology 2017, 35: 102-102. DOI: 10.1200/jco.2017.35.4_suppl.102.Peer-Reviewed Original ResearchTreatment-related AEsCohort APD-L1GEJ adenocarcinomaPhase 1a/b trialECOG PS 0Treatment-related deathsDisease control rateNew safety signalsPhase 1 studyGastroesophageal junction adenocarcinomaBaseline tumor tissuePreliminary efficacy dataECOG PSMeasurable diseaseMedian PFSAdvanced gastricMaculopapular rashMedian durationPS 0Systemic therapyCohort BJunction adenocarcinomaMedian agePrior progression