2023
Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial
John T, Grohé C, Goldman J, Shepherd F, de Marinis F, Kato T, Wang Q, Su W, Choi J, Sriuranpong V, Melotti B, Fidler M, Chen J, Albayaty M, Stachowiak M, Taggart S, Wu Y, Tsuboi M, Herbst R, Majem M. Three-Year Safety, Tolerability, and Health-Related Quality of Life Outcomes of Adjuvant Osimertinib in Patients With Resected Stage IB to IIIA EGFR-Mutated NSCLC: Updated Analysis From the Phase 3 ADAURA Trial. Journal Of Thoracic Oncology 2023, 18: 1209-1221. PMID: 37236398, DOI: 10.1016/j.jtho.2023.05.015.Peer-Reviewed Original ResearchConceptsThree-year safetyAdverse eventsAdjuvant osimertinibStage IBWeek 12Treatment completionCommon adverse eventsMost adverse eventsResected stage IBSignificant efficacy benefitDisease-free survivalNew safety signalsSF-36 surveyHealth-related qualityInterstitial lung diseaseMental component summaryTotal exposure durationADAURA trialWeek 24Component summaryEfficacy benefitsOsimertinib treatmentSF-36Lung diseaseSafety signals
2021
Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1–Selected NSCLC
Jassem J, de Marinis F, Giaccone G, Vergnenegre A, Barrios CH, Morise M, Felip E, Oprean C, Kim YC, Andric Z, Mocci S, Enquist I, Komatsubara K, McCleland M, Kuriki H, Villalobos M, Phan S, Spigel DR, Herbst RS. Updated Overall Survival Analysis From IMpower110: Atezolizumab Versus Platinum-Based Chemotherapy in Treatment-Naive Programmed Death-Ligand 1–Selected NSCLC. Journal Of Thoracic Oncology 2021, 16: 1872-1882. PMID: 34265434, DOI: 10.1016/j.jtho.2021.06.019.Peer-Reviewed Original ResearchConceptsPD-L1 expressionWT patientsExpression subgroupsWT groupExpression groupHigh PD-L1 expression groupLow PD-L1 expression groupHigh PD-L1 expressionSignificant overall survival benefitNew safety signalsOverall survival benefitPrimary end pointPhase 3 trialPlatinum-based chemotherapyOverall survival analysisAtezolizumab armChemotherapy armOS benefitMetastatic NSCLCSurvival benefitOS improvementSafety signalsAtezolizumabSafety dataPatientsA phase II study of rucaparib in patients with high genomic LOH and/or BRCA 1/2 mutated stage IV non-small cell lung cancer (Lung-MAP Sub-Study, S1900A).
Riess J, Redman M, Wheatley-Price P, Faller B, Villaruz L, Corum L, Gowda A, Srkalovic G, Osarogiagbon R, Baumgart M, Qian L, Minichiello K, Gandara D, Herbst R, Kelly K. A phase II study of rucaparib in patients with high genomic LOH and/or BRCA 1/2 mutated stage IV non-small cell lung cancer (Lung-MAP Sub-Study, S1900A). Journal Of Clinical Oncology 2021, 39: 9024-9024. DOI: 10.1200/jco.2021.39.15_suppl.9024.Peer-Reviewed Original ResearchHomologous recombination deficiencyBRCA1/2 mutationsPARP inhibitorsAdverse eventsSystemic therapyStage IV non-small cell lung cancerNon-small cell lung cancerAdequate organ functionFrequent adverse eventsZubrod performance statusAdvanced NSCLC patientsNew safety signalsPhase II studyStage IV diseaseAdvanced-stage NSCLCCell lung cancerPhenotypic markersBRCA1/BRCA2Day of registrationEligible patientsEligible ptsMedian OSMedian PFSNSCLC ptsHematologic toxicity
2020
IMpower110: Clinical safety in a phase III study of atezolizumab (atezo) monotherapy (mono) vs platinum-based chemotherapy (chemo) in first-line non-small cell lung cancer (NSCLC).
Jassem J, Herbst R, de Marinis F, Cadranel J, Csőszi T, Isla D, Chen G, Syrigos K, Cortinovis D, Hida T, Mocci S, Phan S, Enquist I, Patel H, Villalobos M, Wen X, Deng Y, Kuriki H, Spigel D, Giaccone G. IMpower110: Clinical safety in a phase III study of atezolizumab (atezo) monotherapy (mono) vs platinum-based chemotherapy (chemo) in first-line non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2020, 38: e21623-e21623. DOI: 10.1200/jco.2020.38.15_suppl.e21623.Peer-Reviewed Original ResearchNon-small cell lung cancerPD-L1 expressionSafety profileFirst‐line non‐small cell lung cancerCarboplatin AUC 6ECOG PS 0NCI CTCAE v4.0Chemo-naive patientsNew safety signalsPhase III studyPlatinum-based chemotherapyFavorable safety profileCell lung cancerAtezolizumab monotherapyAUC 5AUC 6Gemcitabine 1250Endocrine therapySystemic glucocorticoidsCTCAE v4.0Data cutoffIII studyPS 0PD-L1GEM 1000
2019
A phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G).
Owonikoko T, Redman M, Byers L, Hirsch F, Mack P, Schwartz L, Bradley J, Stinchcombe T, Leighl N, Al Baghdadi T, Lara P, Miao J, Kelly K, Ramalingam S, Herbst R, Papadimitrakopoulou V, Gandara D. A phase II study of talazoparib (BMN 673) in patients with homologous recombination repair deficiency (HRRD) positive stage IV squamous cell lung cancer (Lung-MAP Sub-Study, S1400G). Journal Of Clinical Oncology 2019, 37: 9022-9022. DOI: 10.1200/jco.2019.37.15_suppl.9022.Peer-Reviewed Original ResearchPrimary analysis populationSquamous cell lung cancerCell lung cancerLung cancerMedian OSMedian PFSAdverse eventsSystemic therapyStage IV squamous cell lung cancerPARP inhibitorsAdequate organ functionZubrod performance statusFrequent adverse eventsNew safety signalsPhase II studyPlatinum-sensitive diseaseSquamous lung cancerDay of registrationMedian DoREligible patientsHematologic toxicityAccrual goalII studyPerformance statusPrior lines
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
2009
Safety of bevacizumab (B) and erlotinib (E) therapy in patients (pts) with treated brain metastases (mets) in the phase III, placebo (P)-controlled, randomized BeTa trial for pts with advanced non-small cell lung cancer (NSCLC) after failure of standard first-line chemotherapy
Otterson G, O’Connor P, Lin M, Herbst R. Safety of bevacizumab (B) and erlotinib (E) therapy in patients (pts) with treated brain metastases (mets) in the phase III, placebo (P)-controlled, randomized BeTa trial for pts with advanced non-small cell lung cancer (NSCLC) after failure of standard first-line chemotherapy. Journal Of Clinical Oncology 2009, 27: e19025-e19025. DOI: 10.1200/jco.2009.27.15_suppl.e19025.Peer-Reviewed Original ResearchNon-small cell lung cancerBrain metsBrain metastasesAdverse eventsTreatment durationAdvanced non-small cell lung cancerAdvanced stage non-small cell lung cancerStage non-small cell lung cancerEpidermal growth factor receptor-targeted therapyLung StudyNervous system adverse eventsStandard first-line chemotherapyWhole-brain radiation therapySafety of bevacizumabSubset of ptsCarboplatin/paclitaxelFirst-line chemotherapyMedian treatment durationAcceptable safety profileAdvanced NSCLC patientsBrain radiation therapyFirst-line treatmentNew safety signalsSubset of patientsReceptor-targeted therapy