2021
Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study
Jacobs R, Jurczak W, Flinn I, Grosicki S, Giannopoulos K, Wróbel T, Zafar S, Cultrera J, Kambhampati S, Danilov A, Burke J, Goldschmidt J, Beach D, Huntington S, Ibarz J, Sharman J, Siddiqi T, Brander D, Shadman M, Pagel J, Dlugosz-Danecka M, Ghosh N, Kolibaba K, Sportelli P, Miskin H, O'Connor O, Weiss M, Gribben J. Efficacy and Safety of Ublituximab in Combination with Umbralisib (U2) in Patients with Chronic Lymphocytic Leukemia (CLL) By Treatment Status: A Sub-Analysis of the Phase 3 Unity-CLL Study. Blood 2021, 138: 3726. DOI: 10.1182/blood-2021-147460.Peer-Reviewed Original ResearchSarah Cannon Research InstituteProgression-free survivalOverall response rateChronic lymphocytic leukemiaCurrent equity holderMedian progression-free survivalUndetectable minimal residual diseaseNon-infectious colitisBristol-Myers SquibbTreatment-naïveTN patientsTreatment statusAstra ZenecaSpeakers bureauKite PharmaPFS ratesMedian durationStudy drugMedian agePT patientsADC therapeuticsDay 1Primary analysisEnhanced antibody-dependent cellular cytotoxicityAntibody-dependent cellular cytotoxicityFavorable Outcomes for Patients Treated with U2 with Co-Morbidities or Concomitant Medications: A Retrospective Analysis of Unity-CLL Phase 3 Trial
Ibarz J, Jurczak W, Kambhampati S, Maranda E, Wróbel T, Sharman J, Zafar S, Hoffmann M, Huntington S, Jacobs R, Bairey O, Rowland C, Miskin H, Sportelli P, Weiss M, O'Connor O, Flinn I. Favorable Outcomes for Patients Treated with U2 with Co-Morbidities or Concomitant Medications: A Retrospective Analysis of Unity-CLL Phase 3 Trial. Blood 2021, 138: 3748. DOI: 10.1182/blood-2021-151292.Peer-Reviewed Original ResearchSarah Cannon Research InstituteBruton tyrosine kinase inhibitorsProgression-free survivalOverall response rateChronic lymphocytic leukemiaCurrent equity holderUndetectable minimal residual diseaseConcomitant medicationsTreatment-naïveRisk factorsTyrosine kinase inhibitorsMedian ageSpeakers bureauDay 1Median progression-free survivalSuperior progression-free survivalSimilar overall response ratesAdvisory CommitteeAdequate organ functionIncidence of SAEsMultiple concomitant medicationsPre-existing comorbidityBaseline disease characteristicsKey secondary endpointDurable clinical benefit
2020
Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 Unity-CLL Study
Gribben J, Jurczak W, Jacobs R, Grosicki S, Giannopoulos K, Wrobel T, Zafar S, Cultrera J, Kambhampati S, Danilov A, Burke J, Goldschmidt J, Beach D, Huntington S, Ibarz J, Sharman J, Siddiqi T, Brander D, Pagel J, Kolibaba K, Dlugosz-Danecka M, Ghosh N, Sportelli P, Miskin H, O'Connor O, Weiss M, Flinn I. Umbralisib Plus Ublituximab (U2) Is Superior to Obinutuzumab Plus Chlorambucil (O+Chl) in Patients with Treatment Naïve (TN) and Relapsed/Refractory (R/R) Chronic Lymphocytic Leukemia (CLL): Results from the Phase 3 Unity-CLL Study. Blood 2020, 136: 37-39. DOI: 10.1182/blood-2020-134783.Peer-Reviewed Original ResearchProgression-free survivalOverall response rateChronic lymphocytic leukemiaR CLLUndetectable minimal residual diseaseCurrent equity holderRefractory chronic lymphocytic leukemiaBristol-Myers SquibbTreatment-naïveDuration of responseBristol-Meyers SquibbDay 1Astra ZenecaSeattle GeneticsSpeakers bureauComplete responseGilead SciencesMaria Sklodowska-Curie National Research InstituteRelapsed/Refractory Chronic Lymphocytic LeukemiaTreatment-naive chronic lymphocytic leukemiaCycle 1Enhanced antibody-dependent cellular cytotoxicityAntibody-dependent cellular cytotoxicityAdvisory CommitteeData Safety Monitoring CommitteeCNS Prophylaxis during Front-Line Therapy in Aggressive Non-Hodgkin Lymphomas: Real-World Outcomes and Practice Patterns from 19 US Academic Institutions
Orellana-Noia V, Reed D, Sen J, Barlow C, Malecek M, Kahl B, Spinner M, Advani R, Voorhees T, Snow A, Grover N, Ayers A, Romancik J, Liu Y, Huntington S, Chavez J, Saeed H, Lazaryan A, Raghunathan V, Spurgeon S, Ollila T, Del Prete C, Olszewski A, Ayers E, Landsburg D, Echalier B, Lee J, Kamdar M, Caimi P, Fu T, Liu J, David K, Alharthy H, Law J, Karmali R, Shah H, Stephens D, Major A, Rojek A, Smith S, Yellala A, Kallam A, Nakhoda S, Khan N, Cohen J, Portell C. CNS Prophylaxis during Front-Line Therapy in Aggressive Non-Hodgkin Lymphomas: Real-World Outcomes and Practice Patterns from 19 US Academic Institutions. Blood 2020, 136: 27-28. DOI: 10.1182/blood-2020-134798.Peer-Reviewed Original ResearchAggressive non-Hodgkin lymphomaNon-Hodgkin lymphomaGenentech/RocheDouble-hit lymphomaCNS-IPIAstra ZenecaSeattle GeneticsBristol-Myers SquibbSpeakers bureauElevated LDHRituximab eraHIV statusUS academic institutionsADC therapeuticsB cellsSignificant differencesMedian age 61 yearsIndolent non-Hodgkin lymphomaAdvisory CommitteeHigh-grade B-cellDiffuse large B-cellAnthracycline-based therapyECOG PS 0Recipients of chemotherapyAge 61 yearsWorldwide Examination of Patients with CLL Hospitalized for COVID-19
Roeker L, Scarfo L, Chatzikonstantinou T, Abrisqueta P, Eyre T, Cordoba R, Prat A, Villacampa G, Leslie L, Koropsak M, Quaresmini G, Allan J, Furman R, Bhavsar E, Pagel J, Hernandez-Rivas J, Patel K, Motta M, Bailey N, Miras F, Lamanna N, Alonso R, Osorio-Prendes S, Vitale C, Kamdar M, Baltasar P, Österborg A, Hanson L, Baile M, Rodríguez-Hernández I, Valenciano S, Popov V, Garcia A, Alfayate A, Oliveira A, Eichhorst B, Quaglia F, Reda G, Jimenez J, Varettoni M, Marchetti M, Romero P, Grau R, Munir T, Zabalza A, Janssens A, Niemann C, Perini G, Delgado J, San Segundo L, Roncero M, Wilson M, Patten P, Marasca R, Iyengar S, Seddon A, Torres A, Ferrari A, Cuéllar-García C, Wojenski D, El-Sharkawi D, Itchaki G, Parry H, Mateos-Mazón J, Martinez-Calle N, Ma S, Naya D, Van Der Spek E, Seymour E, Vázquez E, Rigolin G, Mauro F, Walter H, Labrador J, De Paoli L, Laurenti L, Ruiz E, Levin M, Šimkovič M, Špaček M, Andreu R, Walewska R, Perez-Gonzalez S, Sundaram S, Wiestner A, Cuesta A, Broom A, Kater A, Muiña B, Velasquez C, Ujjani C, Seri C, Antic D, Bron D, Vandenberghe E, Chong E, Lista E, García F, Del Poeta G, Ahn I, Pu J, Brown J, Campos J, Malerba L, Trentin L, Orsucci L, Farina L, Villalon L, Vidal M, Sanchez M, Terol M, De Paolis M, Gentile M, Davids M, Shadman M, Yassin M, Foglietta M, Jaksic O, Sportoletti P, Barr P, Ramos R, Santiago R, Ruchlemer R, Kersting S, Huntington S, Herold T, Herishanu Y, Thompson M, Lebowitz S, Ryan C, Jacobs R, Portell C, Isaac K, Rambaldi A, Nabhan C, Brander D, Montserrat E, Rossi G, Garcia-Marco J, Coscia M, Malakhov N, Fernandez-Escalada N, Skånland S, Coombs C, Ghione P, Schuster S, Foà R, Cuneo A, Bosch F, Stamatopoulos K, Ghia P, Mato A, Patel M. Worldwide Examination of Patients with CLL Hospitalized for COVID-19. Blood 2020, 136: 45-49. PMCID: PMC8330255, DOI: 10.1182/blood-2020-136408.Peer-Reviewed Original ResearchCase fatality rateInferior overall survivalOverall survivalCOVID-19 diagnosisAstra ZenecaMultivariable analysisSpeaker feesSeattle GeneticsSpeakers bureauAbbVie IncSanofi GenzymeBaseline characteristicsIndependent predictorsF. Hoffmann-La RocheJanssen-CilagCOVID-19ADC therapeuticsStandardized case report formAdvisory CommitteeEducational meetingsHoffmann-La RocheF. Hoffmann-La Roche LtdAdvanced patient ageSevere COVID-19Kaplan-Meier method
2019
Anti-CD47 Antibody, CC-90002, in Combination with Rituximab in Subjects with Relapsed and/or Refractory Non-Hodgkin Lymphoma (R/R NHL)
Abrisqueta P, Sancho J, Cordoba R, Persky D, Andreadis C, Huntington S, Carpio C, Giles D, Wei X, Li Y, Zuraek M, Burgess M, Hege K, Martín A. Anti-CD47 Antibody, CC-90002, in Combination with Rituximab in Subjects with Relapsed and/or Refractory Non-Hodgkin Lymphoma (R/R NHL). Blood 2019, 134: 4089. DOI: 10.1182/blood-2019-125310.Peer-Reviewed Original ResearchIndependent data monitoring committeeCommon adverse eventsDose-limiting toxicityAdverse eventsCD47 antibodyData monitoring committeeSpeakers bureauR NHLFrequent grade 3/4 adverse eventsInternational Working Group response criteriaGrade 3/4 adverse eventsCelgene CorporationRefractory non-Hodgkin lymphomaBCR-ABL kinase domainAdvisory CommitteeMonitoring committeeF. Hoffmann-La Roche LtdDisease control ratePrior systemic therapyTreatment-related deathsDurable complete responseGrade 3 thrombocytopeniaInfusion-related reactionsModest clinical activityDose-limiting thrombocytopeniaUtilization and Early Discontinuation of First-Line Ibrutinib for Patients with Chronic Lymphocytic Leukemia Treated in the Community Oncology Setting in the United States
Huntington S, Soulos P, Barr P, Jacobs R, Lansigan F, Odejide O, Schwartzberg L, Davidoff A, Gross C. Utilization and Early Discontinuation of First-Line Ibrutinib for Patients with Chronic Lymphocytic Leukemia Treated in the Community Oncology Setting in the United States. Blood 2019, 134: 797. DOI: 10.1182/blood-2019-122054.Peer-Reviewed Original ResearchFirst-line settingChronic lymphocytic leukemiaFlatiron Health databaseECOG performance statusFirst-line treatmentEarly discontinuationMultivariable logistic regressionPerformance statusIbrutinib discontinuationSpeakers bureauClinical trialsCLL diagnosisCLL therapyLymphocytic leukemiaHealth databasesLogistic regressionBruton tyrosine kinase inhibitorsFirst-line ibrutinibUse of ibrutinibWorse performance statusPoor performance statusRetrospective cohort studyCommunity oncology settingClinical decision support toolCommunity oncology practices