2022
Maximizing 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 ResearchConceptsPhase 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 outcomes
2017
Circulating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC).
Henick B, Goldberg S, Narayan A, Rossi C, Rodney S, Kole A, Politi K, Gettinger S, Herbst R, Patel A. Circulating tumor DNA (ctDNA) to monitor treatment response and progression in patients treated with tyrosine kinase inhibitors (TKIs) and immunotherapy for EGFR-mutant non-small cell lung cancer (NSCLC). Journal Of Clinical Oncology 2017, 35: e20652-e20652. DOI: 10.1200/jco.2017.35.15_suppl.e20652.Peer-Reviewed Original ResearchNon-small cell lung cancerTyrosine kinase inhibitorsEGFR-mutant non-small cell lung cancerCtDNA levelsDisease progressionRadiographic progressionTKI therapyEGFR mutationsEGFR mutation-positive non-small cell lung cancerMutation-positive non-small cell lung cancerT790MAnti-PD-1 monotherapyEGFR mutation-positive patientsPD-1 inhibitor monotherapyEGFR-mutant NSCLC patientsSubset of patientsCell lung cancerMutation-positive patientsAssessment of responseLow ctDNA levelsChart reviewClinical characteristicsDurable responsesInhibitor monotherapyNSCLC patients