2022
Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit.
Hayes D, Herbst R, Myles J, Topalian S, Yohe S, Aronson N, Bellizzi A, Basu Roy U, Bradshaw G, Edwards R, El-Gabry E, Elvin J, Gajewski T, McShane L, Oberley M, Philip R, Rimm D, Rosenbaum J, Rubin E, Schlager L, Sherwood S, Stewart M, Taube J, Thurin M, Vasalos P, Laser J. Proceedings From the ASCO/College of American Pathologists Immune Checkpoint Inhibitor Predictive Biomarker Summit. JCO Precision Oncology 2022, 6: e2200454. PMID: 36446042, PMCID: PMC10530621, DOI: 10.1200/po.22.00454.Peer-Reviewed Original ResearchConceptsICI therapyImmune checkpoint inhibition therapyDeath ligand 1 (PD-L1) expressionMultiple predictive biomarkersTumor biomarker testsCheckpoint inhibition therapyLigand 1 expressionDeath ligand 1Field of oncologyICI benefitPredictive factorsPredictive biomarkersInhibition therapyNeoantigen expressionBiomarker testsHealth insurance organizationsUS FoodDrug AdministrationAmerican PathologistsMedicaid ServicesTherapyBiomarker developmentNational InstituteLigand 1Clinical applicationBFAST but be smart: bTMB remains an exploratory biomarker in NSCLC
Kim SY, Herbst RS. BFAST but be smart: bTMB remains an exploratory biomarker in NSCLC. Nature Reviews Clinical Oncology 2022, 20: 3-4. PMID: 36271141, DOI: 10.1038/s41571-022-00698-y.Peer-Reviewed Original ResearchConceptsCell lung cancerTumor mutational burdenLung cancerMutational burdenBlood-based tumor mutational burdenAdvanced-stage solid tumorsFirst phase III trialHigh tumor mutational burdenImmune checkpoint inhibitorsPhase III trialsIII trialsPredictive biomarkersExploratory biomarkersCompanion biomarkersSolid tumorsBiomarkersCancerBurdenPembrolizumabNSCLCPatientsTumorsTrials
2021
Toward personalized treatment approaches for non-small-cell lung cancer
Wang M, Herbst RS, Boshoff C. Toward personalized treatment approaches for non-small-cell lung cancer. Nature Medicine 2021, 27: 1345-1356. PMID: 34385702, DOI: 10.1038/s41591-021-01450-2.Peer-Reviewed Original ResearchConceptsCell lung cancerLung cancerCombination therapyMaintenance combination therapyRobust predictive biomarkersCancer-related deathPersonalized treatment approachesRational combination therapiesAdvanced NSCLCEarly diseasePredictive biomarkersClinical studiesCurrent treatmentCommon causePatient stratificationTreatment approachesTherapyNSCLCBreakthrough therapiesCancerClinical research areasImmunotherapyVast majorityCurrent understandingFuture role
2020
Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling
Zugazagoitia J, Gupta S, Liu Y, Fuhrman K, Gettinger S, Herbst RS, Schalper KA, Rimm DL. Biomarkers Associated with Beneficial PD-1 Checkpoint Blockade in Non–Small Cell Lung Cancer (NSCLC) Identified Using High-Plex Digital Spatial Profiling. Clinical Cancer Research 2020, 26: 4360-4368. PMID: 32253229, PMCID: PMC7442721, DOI: 10.1158/1078-0432.ccr-20-0175.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerPD-1 checkpoint blockadeCell lung cancerCheckpoint blockadeLung cancerAdvanced non-small cell lung cancerUnivariate unadjusted analysisProgression-free survivalImmune cell countsMinority of patientsRobust predictive biomarkersBiomarkers of responseLarge independent cohortsSpatial profiling technologyDigital spatial profilingDigital spatial profiling (DSP) technologyOverall survivalClinical outcomesImmune predictorsHigher CD56NSCLC casesPredictive biomarkersUnadjusted analysesImmune parametersTissue microarray
2017
The Value of Cancer Immunotherapy Summit at the 2016 Society for Immunotherapy of Cancer 31st Anniversary Annual Meeting
Kaufman H, Atkins M, Dicker A, Jim H, Garrison L, Herbst R, McGivney W, Silverstein S, Wigginton J, Yu P. The Value of Cancer Immunotherapy Summit at the 2016 Society for Immunotherapy of Cancer 31st Anniversary Annual Meeting. Journal For ImmunoTherapy Of Cancer 2017, 5: 38. PMCID: PMC5394621, DOI: 10.1186/s40425-017-0241-6.Peer-Reviewed Original ResearchImmunotherapy of cancerCancer immunotherapyThird-party payersBroad clinical activityDurable response rateImmune-based agentsCurrent therapeutic strategiesVariety of malignanciesDistinct side effectsPatient advocacy groupsTraditional cytotoxicsTreatment of cancerConventional therapyPredictive biomarkersClinical activityImmunotherapyClinical OncologyTherapeutic strategiesHealthcare costsSide effectsResponse rateCancerTherapyNational HarborAmerican Society
2015
Clinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): update from a phase Ia study.
Horn L, Spigel D, Gettinger S, Antonia S, Gordon M, Herbst R, Sequist L, Chappey C, Kowanetz M, Sandler A, Soria J. Clinical activity, safety and predictive biomarkers of the engineered antibody MPDL3280A (anti-PDL1) in non-small cell lung cancer (NSCLC): update from a phase Ia study. Journal Of Clinical Oncology 2015, 33: 8029-8029. DOI: 10.1200/jco.2015.33.15_suppl.8029.Peer-Reviewed Original Research
2014
Bayesian Two-Stage Biomarker-Based Adaptive Design for Targeted Therapy Development
Gu X, Chen N, Wei C, Liu S, Papadimitrakopoulou VA, Herbst RS, Lee JJ. Bayesian Two-Stage Biomarker-Based Adaptive Design for Targeted Therapy Development. Statistics In Biosciences 2014, 8: 99-128. PMID: 27617040, PMCID: PMC5014437, DOI: 10.1007/s12561-014-9124-2.Peer-Reviewed Original ResearchBiomarker profilesMD Anderson Cancer CenterPatient's biomarker profileChoice of treatmentAnderson Cancer CenterTreatment effectsMore effective treatmentsOverall treatment effectTargeted therapy developmentMore patientsCancer CenterLung cancerPredictive biomarkersPredictive markerAdaptive randomization designIndividual patientsEffective treatmentBetter outcomesTreatment efficacyPatientsBayesian adaptive designRelevant biomarkersKnown markerTherapy developmentBest treatment
2013
BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC).
Papadimitrakopoulou V, Wistuba I, Lee J, Tsao A, Kalhor N, Fossella F, Heymach J, Alden C, Gettinger S, Coombes K, Saintigny P, Tang X, Duffield E, Boyer J, Davis S, Powis G, Mauro D, Rubin E, Hong W, Herbst R. BATTLE-2 program: A biomarker-integrated targeted therapy study in previously treated patients with advanced non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2013, 31: tps8118-tps8118. DOI: 10.1200/jco.2013.31.15_suppl.tps8118.Peer-Reviewed Original ResearchNon-small cell lung cancerDisease control rateEvaluable ptsKRAS statusPredictive biomarkersRefractory non-small cell lung cancerAdvanced non-small cell lung cancerEML4/ALK translocationsPhase II clinical trialStage 1Lung Cancer EliminationOptimal patient selectionCell lung cancerEffective therapeutic strategyMEK inhibitor selumetinibUnmet medical needBiomarkers of resistanceAKT inhibitor MKPersonalized medicine approachPI3K/AktStage 2NCSLC patientsNSCLC ptsPatient selectionNSCLC treatment
2012
Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819
Redman MW, Crowley JJ, Herbst RS, Hirsch FR, Gandara DR. Design of a Phase III Clinical Trial with Prospective Biomarker Validation: SWOG S0819. Clinical Cancer Research 2012, 18: 4004-4012. PMID: 22592956, PMCID: PMC3409929, DOI: 10.1158/1078-0432.ccr-12-0167.Peer-Reviewed Original ResearchMeSH KeywordsAntibodies, MonoclonalAntibodies, Monoclonal, HumanizedAntineoplastic AgentsBiomarkers, TumorCarcinoma, Non-Small-Cell LungCetuximabClinical Trials, Phase III as TopicDisease-Free SurvivalErbB ReceptorsHumansIn Situ Hybridization, FluorescenceLung NeoplasmsPrognosisProspective StudiesResearch DesignTreatment OutcomeConceptsNon-small cell lung cancerEpidermal growth factor receptorPredictive biomarkersStudy populationAdvanced non-small cell lung cancerEGFR FISH-positive patientsPhase III clinical trialsRole of cetuximabOverall study populationPhase III trialsCell lung cancerEntire study populationFISH-positive patientsInterim monitoring planGrowth factor receptorCoprimary endpointsIII trialsCetuximab efficacyLung cancerClinical trialsPositive groupCetuximabEGFR FISHFactor receptorMolecular targets
2008
Baseline VEGF as a potential predictive biomarker of vandetanib clinical benefit in patients with advanced NSCLC
Heymach J, Hanrahan E, Mann H, Langmuir P, Natale R, Johnson B, Herbst R, Ryan A. Baseline VEGF as a potential predictive biomarker of vandetanib clinical benefit in patients with advanced NSCLC. Journal Of Clinical Oncology 2008, 26: 8009-8009. DOI: 10.1200/jco.2008.26.15_suppl.8009.Peer-Reviewed Original Research