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