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 ResearchMeSH KeywordsAgedBiomarkers, TumorHumansImmune Checkpoint InhibitorsMedicareMicrosatellite InstabilityNeoplasmsPathologistsUnited StatesConceptsICI 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 applicationMaximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC)
Atkins MB, Abu-Sbeih H, Ascierto PA, Bishop MR, Chen DS, Dhodapkar M, Emens LA, Ernstoff MS, Ferris RL, Greten TF, Gulley JL, Herbst RS, Humphrey RW, Larkin J, Margolin KA, Mazzarella L, Ramalingam SS, Regan MM, Rini BI, Sznol M. Maximizing the value of phase III trials in immuno-oncology: A checklist from the Society for Immunotherapy of Cancer (SITC). Journal For ImmunoTherapy Of Cancer 2022, 10: e005413. PMID: 36175037, PMCID: PMC9528604, DOI: 10.1136/jitc-2022-005413.Peer-Reviewed Original ResearchMeSH KeywordsAnimalsChecklistClinical Trials as TopicImmune Checkpoint InhibitorsImmunologic FactorsImmunotherapyLigandsNeoplasmsProgrammed Cell Death 1 ReceptorConceptsPhase III trialsImmunotherapy of cancerIII trialsCurative responseImmune checkpoint inhibitor monotherapyCell death protein 1Checkpoint inhibitor monotherapyDefinitive predictive biomarkersDurable clinical benefitProgression-free survivalMinority of patientsDeath protein 1Variety of indicationsClinical trial designAnimal tumor modelsLimited Phase IDrug development programsImmunotherapy combinationsInvestigational chemotherapyImmunotherapy fieldInhibitor monotherapyOverall survivalDismal prognosisClinical benefitSurvival outcomesQuantitative assessment of Siglec-15 expression in lung, breast, head, and neck squamous cell carcinoma and bladder cancer
Shafi S, Aung TN, Xirou V, Gavrielatou N, Vathiotis IA, Fernandez A, Moutafi M, Yaghoobi V, Herbst RS, Liu LN, Langermann S, Rimm DL. Quantitative assessment of Siglec-15 expression in lung, breast, head, and neck squamous cell carcinoma and bladder cancer. Laboratory Investigation 2022, 102: 1143-1149. PMID: 35581307, PMCID: PMC10211373, DOI: 10.1038/s41374-022-00796-6.Peer-Reviewed Original ResearchConceptsSiglec-15 expressionNon-small cell lung cancerNeck squamous cell carcinomaProgression-free survivalSquamous cell carcinomaCancer typesOverall survivalCell carcinomaBladder cancerImmune cellsSiglec-15PD-1/PD-L1 blockadePotential future clinical trialsQuantitative immunofluorescencePD-L1 blockadeStromal immune cellsImmune checkpoint blockadeCell lung cancerFuture clinical trialsNew potential targetsCheckpoint blockadePD-L1Lung cancerClinical trialsIntra-tumoral heterogeneityDiscovery of Biomarkers of Resistance to Immune Checkpoint Blockade in NSCLC Using High-Plex Digital Spatial Profiling
Moutafi M, Martinez-Morilla S, Divakar P, Vathiotis I, Gavrielatou N, Aung TN, Yaghoobi V, Fernandez AI, Zugazagoitia J, Herbst R, Schalper KA, Rimm DL. Discovery of Biomarkers of Resistance to Immune Checkpoint Blockade in NSCLC Using High-Plex Digital Spatial Profiling. Journal Of Thoracic Oncology 2022, 17: 991-1001. PMID: 35490853, PMCID: PMC9356986, DOI: 10.1016/j.jtho.2022.04.009.Peer-Reviewed Original ResearchMeSH KeywordsAntineoplastic Agents, ImmunologicalBiomarkers, TumorCarcinoma, Non-Small-Cell LungHumansImmune Checkpoint InhibitorsLung NeoplasmsConceptsImmune checkpoint inhibitorsICI resistanceDigital spatial profilingICI therapyOverall survivalPretreatment samplesQuantitative immunofluorescenceImmune checkpoint blockadeRole of neutrophilsShorter overall survivalCandidate biomarker proteinsCandidate protein biomarkersCohort validationOperable NSCLCUntreated NSCLCCheckpoint inhibitorsCheckpoint blockadeCD66b expressionAdditional patientsClinical efficacyPoor outcomeDiscovery of biomarkersUnivariate analysisNSCLCPatients
2021
Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760)
Leighl NB, Redman MW, Rizvi N, Hirsch FR, Mack PC, Schwartz LH, Wade JL, Irvin WJ, Reddy SC, Crawford J, Bradley JD, Stinchcombe TE, Ramalingam SS, Miao J, Minichiello K, Herbst RS, Papadimitrakopoulou VA, Kelly K, Gandara DR. Phase II study of durvalumab plus tremelimumab as therapy for patients with previously treated anti-PD-1/PD-L1 resistant stage IV squamous cell lung cancer (Lung-MAP substudy S1400F, NCT03373760). Journal For ImmunoTherapy Of Cancer 2021, 9: e002973. PMID: 34429332, PMCID: PMC8386207, DOI: 10.1136/jitc-2021-002973.Peer-Reviewed Original ResearchConceptsDisease progressionAnti-programmed death ligand 1 therapyStage IV squamous cell lung cancerPrior anti-PD-1 therapyResponse rateAnti-PD-1 therapyDeath ligand 1 therapyMedian progression-free survivalSquamous cell lung cancerObjective response ratePhase II studyProgression-free survivalCell lung cancerSquamous lung carcinomaDurvalumab 1500Eligible patientsImmunotherapy combinationsPrimary endpointAdverse eventsII studyOverall survivalPartial responseTRIAL REGISTRATIONLung cancerLung carcinoma
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 microarrayPD-1/PD-L1 Blockers in NSCLC Brain Metastases: Challenging Paradigms and Clinical Practice
Eguren-Santamaria I, Sanmamed MF, Goldberg SB, Kluger HM, Idoate MA, Lu B, Corral J, Schalper KA, Herbst RS, Gil-Bazo I. PD-1/PD-L1 Blockers in NSCLC Brain Metastases: Challenging Paradigms and Clinical Practice. Clinical Cancer Research 2020, 26: 4186-4197. PMID: 32354698, DOI: 10.1158/1078-0432.ccr-20-0798.Peer-Reviewed Original ResearchMeSH KeywordsB7-H1 AntigenBrain NeoplasmsCarcinoma, Non-Small-Cell LungCentral Nervous System NeoplasmsHumansImmune Checkpoint InhibitorsNeoplasm MetastasisProgrammed Cell Death 1 ReceptorConceptsNon-small cell lung cancerImmune checkpoint inhibitorsAnti-PD-1/PD-L1 antibodiesAdvanced non-small cell lung cancerNSCLC brain metastasesBrain metastasesPD-L1 antibodiesAnti-PD-1/PD-L1 agentsPD-1/PD-L1 blockersActive central nervous system (CNS) involvementHigh PD-L1 expressionAnti-PD-1/PD-L1 drugsCentral nervous system involvementPivotal phase III trialsActive brain metastasesCNS response ratesPD-L1 agentsPD-L1 blockersSystemic therapy combinationsNervous system involvementPD-L1 expressionPhase III trialsSubset of patientsCell lung cancerPD-L1 drugsImmune Checkpoint Inhibitors in Thoracic Malignancies: Review of the Existing Evidence by an IASLC Expert Panel and Recommendations
Remon J, Passiglia F, Ahn MJ, Barlesi F, Forde PM, Garon EB, Gettinger S, Goldberg SB, Herbst RS, Horn L, Kubota K, Lu S, Mezquita L, Paz-Ares L, Popat S, Schalper KA, Skoulidis F, Reck M, Adjei AA, Scagliotti GV. Immune Checkpoint Inhibitors in Thoracic Malignancies: Review of the Existing Evidence by an IASLC Expert Panel and Recommendations. Journal Of Thoracic Oncology 2020, 15: 914-947. PMID: 32179179, DOI: 10.1016/j.jtho.2020.03.006.Peer-Reviewed Original ResearchMeSH KeywordsCarcinoma, Non-Small-Cell LungHumansImmune Checkpoint InhibitorsImmunotherapyLung NeoplasmsMesotheliomaThoracic NeoplasmsConceptsImmune checkpoint inhibitorsThoracic malignanciesCheckpoint inhibitorsThymic carcinomaDeath ligand 1 (PD-L1) immune checkpoint inhibitorsAnti-programmed cell death protein 1Cell death protein 1/T-lymphocyte antigen 4 antibodyCombination of ICIsDeath protein 1/Long-term survival benefitHost antitumor immune responseCell death protein 1Immune evasion processStage III NSCLCAntitumor immune responseEarly-stage diseaseDeath protein 1Portion of patientsMalignant pleural mesotheliomaOptimal treatment durationFuture treatment strategiesDefinitive clinical benefitFuture therapeutic developmentAvailable scientific evidence