美国血液学年会Post-ASH CLL.pptxVIP

ChronicLymphocyticLeukemiaandOtherB-CellMalignancies Keyupdates ;CLL Development Plan: Ibrutinib in Relapsed/Refractory CLL;CLL Development Plan: Ibrutinib in Treatment Na?ve CLL;Chronic Lymphocytic Leukemia;Ibrutinib in Combination With Bendamustine and Rituximab Is Active and Tolerable in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Leukemia: Final Results of a Phase 1b Study ;Primary endpoint Safety Secondary endpoints ORR PFS;Patient Disposition and Treatment Summary;Treatment-Emergent AEs (TEAEs) in ≥ 20% of Patients Regardless of Attribution;Treatment Emergent AEs Grade ≥ 3 Occurring in ≥ 2 Patients;Lymphocytosis: Absolute Lymphocyte Count;Lymphocytosis: Lymph Node Size;Sustained Hematologic Improvement for Patients With Baseline Cytopenias;Median treatment duration on this study was 16 months, with an ORR of 93.4% (28 responding patients [5 CR, 3 nPR]) 1 patient achieved a PR with lymphocytosis (not included in ORR);ORR by Risk Feature;Progression-Free Survival;3 patients treated; cohort closed due to a limited number of fludarabine-na?ve patients in the relapsed setting Tolerable safety profile in 3 patients One serious AE (gastritis) All patients received all 6 cycles of FCR 1 patient had a dose reduction Overall response 100% (3/3), with currently 2 confirmed MRD-negative CRs and 1 MRD-positive CR All 3 patients remain progression free on ibrutinib with 22-month follow-up;The combination of BR + ibrutinib had an acceptable safety profile No prolonged myelosuppression during cycle 1 Response to BR + ibrutinib was associated with improved hemoglobin and platelet counts Continuous treatment with ibrutinib after BR therapy was well tolerated BR + ibrutinib resulted in an ORR of 93.4%; the median PFS has not been reached Earlier phase 2 study with BR alone showed an ORR of 59% and median PFS of 15.2 months (Fischer et al, JCO 2011) The BR plus ibrutinib combination is the subject of an ongoing global phase 3 stu