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 Committee
2019
Evaluation of Efficacy and Safety of Front-Line Regimens for the Treatment of Transplant Ineligible Patients with Multiple Myeloma: A Network Meta-Analysis of Phase 2/3 Randomized Controlled Trials
Giri S, Aryal M, Yu H, Grimshaw A, Pathak R, Huntington S, Dhakal B. Evaluation of Efficacy and Safety of Front-Line Regimens for the Treatment of Transplant Ineligible Patients with Multiple Myeloma: A Network Meta-Analysis of Phase 2/3 Randomized Controlled Trials. Blood 2019, 134: 2188. DOI: 10.1182/blood-2019-130389.Peer-Reviewed Original ResearchProgression-free survivalOverall response rateHematopoietic cell transplantFront-line treatmentAdverse eventsOverall survivalMM patientsMultiple myelomaFrontline regimensClinical trialsAdvisory CommitteeCommon grade 3Cumulative ranking (SUCRA) probabilitiesFront-line regimensHigher adverse eventsPrimary efficacy outcomeTransplant-ineligible patientsPhase III RCTsNetwork Meta-AnalysisBias assessment toolRisk of biasEvaluation of efficacyIndividual patient needsEfficacious regimenEfficacious regimens
2018
Outcomes and Toxicities of Programmed Death‐1 (PD‐1) Inhibitors in Hodgkin Lymphoma Patients in the United States: A Real‐World, Multicenter Retrospective Analysis
Bair SM, Strelec LE, Feldman TA, Ahmed G, Armand P, Shah NN, Singavi AN, Reddy N, Khan N, Andreadis C, Vu K, Huntington SF, Giri S, Ujjani C, Howlett C, Faheem M, Youngman MR, Nasta SD, Landsburg DJ, Schuster SJ, Svoboda J. Outcomes and Toxicities of Programmed Death‐1 (PD‐1) Inhibitors in Hodgkin Lymphoma Patients in the United States: A Real‐World, Multicenter Retrospective Analysis. The Oncologist 2018, 24: 955-962. PMID: 30568021, PMCID: PMC6656463, DOI: 10.1634/theoncologist.2018-0538.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdrenal Cortex HormonesAdultAgedAged, 80 and overAntineoplastic Agents, ImmunologicalDrug-Related Side Effects and Adverse ReactionsFemaleFollow-Up StudiesHodgkin DiseaseHumansMaleMiddle AgedNivolumabPrognosisProgrammed Cell Death 1 ReceptorRetrospective StudiesSurvival RateYoung AdultConceptsProgression-free survivalClassical Hodgkin lymphomaPD-1 inhibitorsPD-1iPercent of patientsOverall response rateComplete responseResponse rateSystemic chemotherapyOverall survivalPartial responseSystemic therapyCHL patientsHodgkin's lymphomaClinical trialsRetrospective analysisToxicity profileReal-world settingDeath-1 inhibitor nivolumabMedian progression-free survivalR cHLRefractory classical Hodgkin lymphomaDeath-1 inhibitorsPrior autoimmune diseaseR cHL patients