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
Randomized, double-blind, phase 3 trial of first-line pembrolizumab + platinum doublet chemotherapy (chemo) ± lenvatinib in patients (pts) with metastatic nonsquamous non–small-cell lung cancer (NSCLC): LEAP-006.
Hui R, Nishio M, Reck M, Rodriguez-Abreu D, Fouad T, Flaim D, Yin L, Dang T, Herbst R. Randomized, double-blind, phase 3 trial of first-line pembrolizumab + platinum doublet chemotherapy (chemo) ± lenvatinib in patients (pts) with metastatic nonsquamous non–small-cell lung cancer (NSCLC): LEAP-006. Journal Of Clinical Oncology 2019, 37: tps9118-tps9118. DOI: 10.1200/jco.2019.37.15_suppl.tps9118.Peer-Reviewed Original ResearchPrimary endpointPD-L1 tumor proportion scoreFirst-line lenvatinibMetastatic nonsquamous NSCLCNCI CTCAE v4.0Platinum-doublet chemotherapyFirst-line pembrolizumabPhase 3 trialTumor proportion scoreDose-limiting toxicityKaplan-Meier methodCell lung cancerLog-rank testQuality of lifeDoublet chemotherapyECOG PSMaintenance pembrolizumabAdvanced NSCLCNonsquamous NSCLCSecondary endpointsStudy withdrawalCTCAE v4.0Carboplatin AUCNew cancer therapiesLung cancer
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 AInterim 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
Tumor regression and pharmacodynamic (PD) biomarker validation in non-small cell lung cancer (NSCLC) patients treated with the ErbB/VEGFR inhibitor BMS-690514
Bahleda R, Soria J, Harbison C, Park J, Felip E, Hanna N, Laurie S, Armand J, Shepherd F, Herbst R. Tumor regression and pharmacodynamic (PD) biomarker validation in non-small cell lung cancer (NSCLC) patients treated with the ErbB/VEGFR inhibitor BMS-690514. Journal Of Clinical Oncology 2009, 27: 8098-8098. DOI: 10.1200/jco.2009.27.15_suppl.8098.Peer-Reviewed Original ResearchBMS-690514Skin rashPD biomarkersSkin biopsiesKRAS mutationsPhase I/II studyNon-small cell lung cancer patientsReversible acute renal insufficiencyRandomized phase II trialCell lung cancer patientsEGFR T790M mutationAdequate organ functionOral selective inhibitorDisease control rateAcute renal insufficiencyPhase I portionPhase II trialLung cancer patientsT790M mutationSubsequent surgical removalAnti-tumor activityEGFR copy numberEGFR T790MECOG PSEligible patients
2007
A phase I safety and pharmacokinetic study of apomab, a human DR5 agonist antibody, in patients with advanced cancer
Camidge D, Herbst R, Gordon M, Eckhardt S, Kurzroc R, Durbin B, Ing J, Ling J, Sager J, Mendelson D. A phase I safety and pharmacokinetic study of apomab, a human DR5 agonist antibody, in patients with advanced cancer. Journal Of Clinical Oncology 2007, 25: 3582-3582. DOI: 10.1200/jco.2007.25.18_suppl.3582.Peer-Reviewed Original ResearchTreatment-refractory solid tumorsPhase I safetyColorectal cancer patientsPre-clinical dataEvidence of benefitDR5 agonist antibodyAnti-cancer efficacyIgG1 monoclonal antibodyAsymptomatic transaminitisCohort expansionECOG PSHAHA responseUnacceptable toxicityI safetyObjective responseSymptomatic improvementAdvanced cancerCancer patientsMinor responseReceptor agonistTarget lesionsApomabDisease progressionEfficacy dataPreclinical models