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 cytotoxicityFirst Line Chemo-Free Therapy with the BRAF Inhibitor Vemurafenib Combined with Obinutuzumab Is Effective in Patients with Hcl
Park J, Winer E, Huntington S, von Keudell G, Vemuri S, Shukla M, Kinoshita J, Falco V, Gore S, Stone R, Abdel-Wahab O, Tallman M. First Line Chemo-Free Therapy with the BRAF Inhibitor Vemurafenib Combined with Obinutuzumab Is Effective in Patients with Hcl. Blood 2021, 138: 43. DOI: 10.1182/blood-2021-151074.Peer-Reviewed Original ResearchHairy cell leukemiaAdverse eventsEfficacy of vemurafenibCR rateFebrile neutropeniaInfusion reactionsMonth 4Month 2Dose reductionDay 1Grand roundsResponse rateTreatment of HCLDrug-related adverse eventsMedian absolute CD4 countUntreated hairy cell leukemiaRefractory hairy cell leukemiaAdvisory CommitteeComplete response rateDurability of remissionGrade 1 feverMRD-negativity ratesMulti-center clinical trialSubsequent infusion reactionsAbsolute CD4 countFavorable 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