2022
Anti-CSF-1R emactuzumab in combination with anti-PD-L1 atezolizumab in advanced solid tumor patients naïve or experienced for immune checkpoint blockade
Gomez-Roca C, Cassier P, Zamarin D, Machiels JP, Gracia J, Hodi F, Taus A, Garcia M, Boni V, Eder JP, Hafez N, Sullivan R, Mcdermott D, Champiat S, Aspeslagh S, Terret C, Jegg AM, Jacob W, Cannarile MA, Ries C, Korski K, Michielin F, Christen R, Babitzki G, Watson C, Meneses-Lorente G, Weisser M, Rüttinger D, Delord JP, Marabelle A. Anti-CSF-1R emactuzumab in combination with anti-PD-L1 atezolizumab in advanced solid tumor patients naïve or experienced for immune checkpoint blockade. Journal For ImmunoTherapy Of Cancer 2022, 10: e004076. PMID: 35577503, PMCID: PMC9114963, DOI: 10.1136/jitc-2021-004076.Peer-Reviewed Original ResearchConceptsNon-small cell lung cancerUrothelial bladder cancerObjective response rateOptimal biological doseImmune checkpoint blockersUBC patientsConfirmed objective response rateTreatment-related adverse eventsCell death 1 ligandPhase 1b studyManageable safety profileImmune checkpoint blockadeCell lung cancerDeath 1 ligandAtezolizumab monotherapyPatients naïveAdverse eventsCheckpoint blockadeCheckpoint blockersNSCLC patientsSkin rashDose escalationClinical benefitSafety profileLung cancer
2021
Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844)
Roussos Torres ET, Rafie C, Wang C, Lim D, Brufsky A, LoRusso P, Eder JP, Chung V, Downs M, Geare M, Piekarz R, Streicher H, Anforth L, Rudek MA, Zhu Q, Besharati S, Cimino-Mathews A, Anders RA, Stearns V, Jaffee EM, Connolly RM. Phase 1 Study of Entinostat and Nivolumab with or without Ipilimumab in Advanced Solid Tumors (ETCTN-9844). Clinical Cancer Research 2021, 27: clincanres.5017.2021. PMID: 34135021, PMCID: PMC8563383, DOI: 10.1158/1078-0432.ccr-20-5017.Peer-Reviewed Original ResearchConceptsCD8/FOXP3 ratioAdvanced solid tumorsAdverse eventsAddition of ICIFOXP3 ratioSolid tumorsGrade 3/4 adverse eventsRegulatory T cell ratioTreatment-related adverse eventsImmune checkpoint inhibitor efficacyTriple-negative breast cancerMulticenter phase I clinical trialPhase I clinical trialObjective response ratePhase II doseT cell ratioCheckpoint inhibitor efficacyPhase 1 studyCombination of entinostatHistone deacetylase inhibitor entinostatRECIST 1.1Primary endpointSecondary endpointsComplete responseDose escalation
2020
A Phase 1 study of RO6870810, a novel bromodomain and extra-terminal protein inhibitor, in patients with NUT carcinoma, other solid tumours, or diffuse large B-cell lymphoma
Shapiro GI, LoRusso P, Dowlati A, T. Do K, Jacobson CA, Vaishampayan U, Weise A, Caimi PF, Eder JP, French CA, Labriola-Tompkins E, Boisserie F, Pierceall WE, Zhi J, Passe S, DeMario M, Kornacker M, Armand P. A Phase 1 study of RO6870810, a novel bromodomain and extra-terminal protein inhibitor, in patients with NUT carcinoma, other solid tumours, or diffuse large B-cell lymphoma. British Journal Of Cancer 2020, 124: 744-753. PMID: 33311588, PMCID: PMC7884382, DOI: 10.1038/s41416-020-01180-1.Peer-Reviewed Original ResearchConceptsLarge B-cell lymphomaPhase 1 studyB-cell lymphomaSolid tumorsCommon treatment-related adverse eventsTreatment-related adverse eventsPeripheral blood mononuclear cellsInjection site erythemaObjective response rateSingle-agent activityBlood mononuclear cellsExtra-terminal (BET) protein inhibitorsSmall-molecule BET inhibitorsConclusionsThis trialAdverse eventsPharmacodynamic assessmentMononuclear cellsNUT carcinomaCD11b levelsExtra-terminal (BET) proteinsClinical trialsTestis carcinomaSustained decreaseFavorable pharmacokineticsPharmacokinetic parameters